Patent Docs: Written Description

Written Description

January 25, 2012

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)

In a sequel of sorts to the hugely popular Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2011), the Federal Circuit released Streck II (Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)) earlier this month. Not to be upstaged by the original, this ambitious follow-up leaves the priority determination behind, and instead focuses on the infringement proceeding appeal. Notably, Streck II clocks in at over twice the length of its predecessor. However, if you have ever asked yourself whether a counterclaimant could maintain the full scope of a declaratory judgment challenge if a plaintiff narrows the scope of asserted claims early on in litigation, then Streck II could keep you on the edge of your seat. Spoiler alert -- the answer is "no."

The background and cast of characters was basically the same for both opinions. For those unfamiliar with the original Streck, the technology at issue in both cases was integrated controls for hematology analyzers. Prior to 1996, such instruments measured reticulocytes and white blood cells separately, because the various blood components would interfere with each other, causing error in counting or classifying. Such stand-alone controls using either true reticulocytes (also referred to as natural reticulocytes) or reticulocytes analogs were known before the filing dates of the patents-at-issue. As the instrument makers began attempting to develop an integrated analyzer that could measure the different blood components in the same sample, both Streck and Research & Diagnostic Systems (R&D) sought to create an integrated control. As we learned in Streck, one of the difficulties to overcome was the stability of the controls over extended periods of time. Streck obtained a patent to such controls, U.S. Patent No. 6,221,668, and sued R&D in the U.S. District Court for the District of Nebraska for infringement of three patents. Claim 1 of the '668 patent is representative:

1. A hematology control composition comprising:
a) a stabilized reticulocyte component; and
b) a fixed and stabilized white blood cell component capable of exhibiting a five-part differential.

The District Court construed the claims to encompass both true reticulocytes and reticulocyte analogs. Streck's inventor, however, only actually reduced his invention to practice with his previous developed reticulocyte analogs, while R&D's commercial product used true reticulocytes.

At this point, the plot of Streck II gets a bit convoluted. As previously mentioned, Streck filed its lawsuit in Nebraska. However, both parties agreed to be bound by the local patent rules of the United States District Court for the Northern District of California. As a result, Streck served a Disclosure of Asserted Claims and Preliminary Infringement Contentions shortly after the initial case management conference. In this disclosure, Streck narrowed the scope of asserted claims. R&D followed up with preliminary invalidity contentions narrowly drawn to the asserted claims, but later expanded the contentions to include all but one of the claims in the patents-at-issue. Streck further narrowed its asserted claims to ten, and then to nine, prior to the Court's Summary Judgment decision. On September 9, 2009, the Court held that Streck's patents satisfied the Written Description requirement with respect to integrated controls with true reticulocytes, and denied R&D's motion for summary judgment on enablement. The Court also dismissed the counterclaims with respect to Claim 3 of two of the patents, because there was "no reasonable apprehension of suit," and found that, as a matter of law, R&D infringed the asserted claims (and that there was evidence from which a jury could find willfulness). Subsequently, just before trial, the Court sided with Streck and excluded the evidence related to the validity of all unasserted claims, stating that the validity of these claims would not go to the jury. After an eight-day jury trial, the Court granted JMOL for Streck on enablement. The only issues submitted to the jury were priority, damages, and willfulness. The jury did not find R&D's infringement to be willful and awarded damages of 12.5%. As the priority issue was covered in Streck, it will not be addressed here. The procedural background concluded with the District Court entering an injunction against R&D.

Declaratory Judgment Jurisdiction over Counterclaims

The first issue on appeal was whether R&D could maintain invalidity counterclaims against claims that Streck was no longer asserting. Steck originally filed suit in June 2006 alleging infringement of all claims in the patents-in-suit, but within six months, it had narrowed the asserted claims to fifteen specific claims. R&D, in turn, responded with preliminary invalidity contentions against those fifteen claims, but expanded the scope of its invalidity contentions in the next two years to all but one claim of the patents-in-suit. Streck subsequently narrowed the asserted claims to ten, and then to nine. As a result, the District Court dismissed R&D's invalidity counterclaims against two claims because it had "no reasonable apprehension" it would face an infringement suit on any claim other than the claims asserted by Streck. Moreover, prior to trial, the Court excluded R&D's evidence with regard to the unasserted claims, because of these same jurisdictional concerns.

The Federal Circuit agreed with the District Court that there was no jurisdiction, even though it used the outdated "reasonable apprehension" test. As the Federal Circuit pointed out, even though MedImmune rejected strict reliance on the "reasonable apprehension of suit" test, it did not do away with the relevance of this test. The Federal Circuit looked favorably on a New Jersey District Court case as persuasive authority, Hoffman-La Roche Inc. v. Mylan Inc., No. 2:09cv1692, 2009 U.S. Dist. LEXIS 114784, at *17-18 (D.N.J. Dec. 9, 2009). In that case, like here, the patentee narrowed the scope of the asserted claims when it served infringement contentions. That court noted that jurisdiction exists on a claim-by-claim basis at every stage of the litigation, and that even though the plaintiff's decision to change the scope of the suit did not automatically divest the court of jurisdiction, the counterclaimant must show why jurisdiction continues to exist. Applying the same reasoning, the Federal Circuit found that "there was no evidence that R&D met its burden of showing a continuing case or controversy with respect to the unasserted claims." In fact, the Court noted that R&D relied too heavily on the District Court's use of the "reasonable apprehension" test, and pointed out that MedImmune doesn't stand for the proposition that jurisdiction automatically exists whenever a competitor wants to mount a validity challenge.

Interestingly, the Federal Circuit cited favorably to Streck's narrowing of the scope of the claims at the outset of the litigation, prior to any dispositive rulings. In fact, it appears that neither party cited to the preliminary infringement and invalidity contentions, but instead the Court itself identified the early nature of the narrowing of scope of the litigation. This begs the question, therefore, of when is it advisable to narrow the scope of the claims in an infringement suit? Should it be done as soon as possible, thereby possibly foreclosing the ability to assert relevant claims before fact discovery is completed (or perhaps has even begun)? Or can a patentee wait until the eve of filing of Summary Judgment motions? Of course, after MedImmune, courts must look to "all the circumstances," and therefore the answer will be fact specific. Nevertheless, it would be advisable to monitor the claims one is asserting in an infringement suit during all stages of the litigation, especially if it is desirable to move some of those claims out of harm's way, or if the validity of those claims is in such question that taking them to the jury could have prejudicial affect.

Written Description

The second issue on appeal was whether Streck's patents satisfied the written description requirement of 35 U.S.C. § 112, ¶ 1. Specifically, R&D alleged that the patents failed to provide sufficient details to establish that Streck was in possession of a true reticulocyte integrated control. The test, according to Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), is whether the disclosure "conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. at 1351. The Federal Circuit implicitly noted that there are generally two situations where written description can be found lacking: (1) when newly added claim language is not supported by the specification as filed, and (2) when patentees attempt to claim a broad genus without providing adequate support for enough species within that genus. The Court found that neither of these situations applied, because the patents-in-suit specifically referred to several types of true reticulocytes, i.e., several species, as possible embodiments of the claimed invention. And, even though it was more relevant to the enablement requirement, the Court did note that because analogs are designed to mimic true reticulocytes, and because stand-alone true reticulocytes were known in the art, it was not difficult to conclude that one skilled in the art would have recognized that the claimed integrated controls could be made with either true reticulocytes or analogs.

R&D did not appear to take its written description challenge very seriously. Indeed, the District Court noted that the R&D focused primarily on enablement, and the Federal Circuit argument centered almost exclusively on the enablement issue. Instead, R&D appeared to rely mainly on the testimony of a Streck inventor to establish a lack of written description. However, R&D apparently mischaracterized the testimony. The inventor did testified to the commercial practicalities of the use of true reticulocytes, but such evidence does not speak to the feasibility or viability of the use of true reticulocytes in a control. Instead, it merely reflects the inventor's personal preference. Also, R&D pointed to the inventor's difficulty in identifying support in the specification for true reticulocytes. However, he later clarified that the patent covers both kinds of reticulocytes, and cited to the language referenced above. Finally, R&D cited the lack of any reduction to practice by Streck of true reticulocytes. However, actual reduction to practice is not necessary because the filed specification constitutes a constructive reduction to practice. Therefore, such an allegation is without merit.

Enablement

R&D's lack of enablement assertions appeared to have more credibility, but they also ultimately fell short. In fact, the Federal Circuit held that the evidence clearly supported a finding of enablement, and therefore met the exacting standard of taking this fact-laden inquiry away from the jury. The District Court had granted JMOL after the close of evidence but before the case went to the jury, and the Federal Circuit affirmed that decision.

Much like with the written description challenge, R&D alleged that the patents-in-suit do not enable true reticulocyte integrated controls. Of course, to satisfy the enablement requirement, the specification must enable one skilled in the art how to make and use the claimed invention without undue experimentation. And, even though the specification need not disclose what is well known in the art, this rule is not a substitute for a basic enabling disclosure.

The question in this case appeared to center around what the novel aspects of the invention were. R&D relied on Automotive Technologies Int'l, Inc. v. BMW of North America, Inc., 501 F.3d 1274 (Fed. Cir. 2007), which held that a patent that disclosed mechanical side-impact crash sensors for automobile airbags did not, without more, enable the use of electronic side-impact crash sensors. In that case, the Court determined that the electronic sensors were novel, and distinctly different than mechanical sensors. Moreover, the knowledge of one of skill in the art could not supply the missing information, especially when that missing information constituted the novel aspect of the invention. In contrast, in the present case, the novel aspect of the invention was the integrated reticulocyte control, and the use of true reticulocyte in the invention is virtually indistinguishable from analogs. Moreover, even though the burden was on R&D to establish lack of enablement by clear and convincing evidence, R&D failed to submit sufficient evidence to submit the case to a jury. R&D relied heavily on its expert, but the expert provided conclusory assertions which do not give rise to a genuine issue of fact. In fact, R&D's expert admitted on cross-examination that he had never been involved in developing controls. Finally, R&D pointed to the testimony of the Streck inventors that the quantity of experimentation to make and use a true reticulocyte integrated control would be high. However, this testimony was referring to the difficulties of using such a control prior to the patent disclosure.

Overbreadth of Injunction

After a quick flashback to Streck, in which the Court dismissed R&D's appeal of priority and evidentiary ruling as controlled by the outcome of the first case, Streck II concluded rather anticlimactically. R&D argued that the permanent injunction entered by the District Court was over broad because it prohibited R&D "from otherwise infringing the asserted claims of [the Patents-in-Suit] until the expiration of the last to expire of the Patents-in-Suit." Specifically, R&D wanted the injunction limited to the adjudicated products, and products not more than colorably different therefrom. However, the Federal Circuit noted that the injunction as a whole did specifically refer to the products at issue in the case. Therefore, because the injunction already contained the limitation sought, the Federal Circuit affirmed the permanent injunction entered by the District Court.

In conclusion, even though it had its slow points, we would give Streck II two thumbs up, and would recommend it to most patent practitioners, especially those embroiled in litigation, trying to determine whether it is advantageous to narrow the scope of asserted claims.

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Newman, O'Malley, and Reyna
Opinion by Circuit Judge O'Malley

Posted at 11:00 PM in Enablement, Federal Circuit, Injunction, Written Description | Permalink | Comments (0) | TrackBack (0)

July 28, 2011

Johnson & Johnson Petitions Federal Circuit for Rehearing En Banc

By Kevin E. Noonan --

As discussed yesterday, a panel of the Federal Circuit seemingly expanded the scope of the written description requirement in its Boston Scientific Corp. v. Johnson & Johnson decision. At issue was the extent of disclosure required for combination claims, i.e., inventions combining components known in the art to produce a new, useful, and non-obvious article. Rapamycin-coated stents for coronary angioplasty were the subject matter of the lawsuit between the parties, and the basis of the Federal Circuit's decision affirming invalidation on summary judgment by the District Court was that while the claims encompassed various rapamycin analogs, the specifications of the patents-in-suit disclosed only rapamycin itself.

Johnson & Johnson argued that this was a departure from black letter patent law, citing In re Herschler, 591 F.2d 693, 702 (C.C.P.A. 1979), and In re Fuetterer, 319 F.2d 259 (C.C.P.A. 1963), for the principle that "when claiming a combination of known elements, as opposed to a novel compound, the specification 'need not list examples' nor is any 'comprehensive description' required." Johnson & Johnson also argued that the prior art contained "a known correlation between the structure of rapamycin and its analogs and their function," and hence that patentees were entitled to their claims without having a specification that "contains examples of specific macrocyclic lactone analogs of rapamycin." In rejecting these arguments, the opinion expressed agreement with Boston Scientific's position that a patentee is required to show possession of the claimed invention at the time a patent application is filed, and that "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials," citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). The 1997 patents fail this test, according to the Court, due to the complete absence of any examples of a macrocyclic lactone analog in the specification. Citing the en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the opinion states that a "sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." While disclaiming any "bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim," the opinion reiterated the "factors" to be considered from Ariad: "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue."

Now Johnson & Johnson has petitioned the Federal Circuit for rehearing, by the panel or the en banc court. In its petition, the company poses two questions "of exceptional importance" for the Court's consideration:

(1) Where an inventor claims a novel combination of known elements, does the written description requirement of section 112 require a detailed recitation of information already known in the prior art concerning those known elements, if the specification otherwise teaches one of skill in the art how to make and use the invention?

(2) Where an inventor claims a novel combination of known elements, must the inventor provide examples of possible combinations of those known elements, even if otherwise unnecessary to understand how to make and use the claimed invention?

The panel decision is contrary not only to In re Hershcler, but also to Hybritech Inc. v. Monoclonal Antibodies and Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., according to the petition. Moreover, "the written description defense has been rapidly replacing inequitable conduct as the defense of last resort" because "[n]o matter how much an inventor has disclosed, accused infringers are contending that it was not enough," the petition states. This results in courts "exercising their discretion broadly to invalidate meritorious patents based on perceived insufficiencies that are at best ancillary to a patent's teaching of what is new" and this case, the petitions asserts, is an example. Granting the petition will give the Court the "an opportunity . . . to assure patentees that where a novel combination of known elements is claimed, superfluous information about the prior art need not be disclosed in the text or examples of a patent as long as the patent otherwise teaches how to make and use the invention." Failure to do so "will lead to massive over-disclosure of prior art information to the PTO, senseless invalidations of otherwise meritorious patents, and a general loss of confidence in the reliability of U.S. patent protection."

Taking this asserted precedent in turn, the petition cites Herschler (as it did to the panel) for the principle that "claims to combinations of known compounds require a written description 'only so specific as to lead one having ordinary skill in the art to that class of compounds,' Hershcler, 591 F.2d at 702, and distinguished that level of disclosure from the more extensive disclosure required to support claims to a novel compound, Id. at 701." The contrary holding in Hybritech was the oft-repeated maxim that "a patent need not, and indeed should not, repeat what is already known in the art. 802 F.2d at 1384." Finally, the petition asserts that the panel invalidated the patents-in-suit for failing to provide any examples of a rapamycin analog, which is contrary to the principle that "[a] patent specification . . . need not disclose any examples" (italics in original), citing both Ariad, 598 F.3d at 1352, and Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). Making an analogy to the tendency for "excessive and counter-productive disclosures that impeded patent prosecution" caused by an (until recently) expansive inequitable conduct doctrine, citing Therasense, Inc. v. Becton, Dickinson & Co., the petition states that refusing to correct the panel's decision will "likewise increase the burden on applicants, the PTO, and the public by forcing disclosures that go far beyond those needed to describe and enable the patentee's actual contribution to the art."

The question posed by the petition is a fundamental one: "[w]hen an invention is made in an area having an established body of knowledge, how much of that knowledge must the patent recite in order to satisfy the written description requirement?" The petition characterizes as "settled law" that a patentee is not required to repeat (and include within the specification) "what was already known in the art," and that the extent of the adequacy of the written description must be determined in light of what was known to the person of ordinary skill in the art. The panel's error, according to the petition, was in ignoring what was known in the art and focusing too closely on what was expressly disclosed in the specifications of the patents-in-suit. The closest analogy was with Herschler, where the invention was the combination of dimethyl sulfoxide (DMSO) and "physiologically active steroidal agent[s]" and the assertion was whether the disclosure of one example -- dexamethzsone-21-phosphate -- provided an adequate written description. In Herschler, the CCPA held that since the applicant was not "claiming chemical compounds per se," the disclosure of one species of a sub-genus (glucocorticosteroids) of a larger sub-genus (corticosteroids) of an even larger genus ("physiologically active agents") was an adequate written description. One distinction is that the alternate components of the combination claimed in Hershcler's application were "awesome in their diversity. The scope of exemplified 'physiologically active substances' includes iodine (Example 1), pressed pellet feed for rats (Example 4), penicillin (Example 10), procaine (Example 16), various chemotherapeutic agents (Examples 17 & 18), barbiturates (Example 19), oral insulin (Example 21), antihistamines (Example 29), various local anesthetics (Examples 34 & 35), etc." Another distinction is the statement in Herschler that "[w]ere this application drawn to novel 'steroidal agents,' a different question would be posed." Nonetheless, there is no question that the CCPA applied the preclusive effect of the written description requirement more parsimoniously in Herschler than the panel did in this case.

The petition also distinguishes the instant case from the circumstances surrounding the Federal Circuit's decision in Carnegie Mellon University v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008), which the petition fairly characterizes as a basis for the panel decision. In that case, the claimed subject matter was novel DNA molecules encoding novel DNA polymerases, where only three species of "potentially millions" were disclosed. The petition contends that the difference is that the claims in Carnegie Mellon encompassed new molecules, not ones known in the art, and that where the written description may have been properly applied by the Court there it was not consistent with established law to apply in this case, where the art disclosed species of rapamycin analogs. And the petition also challenged another basis for the panel's decision, that the mechanism of rapamycin action was the subject of continued research when the applications were filed, citing Parker v. Frilette, 462 F.2d 544, 547 (CCPA 1972), for the proposition that "[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice." (Indeed, the petition notes that "[t]he precise manner" by which many drugs act in the human body, including aspirin, are not fully understood but does not preclude patentability.)

Finally, the petition cites as erroneous the panel's reasoning that multiple examples of rapamycin analogs must be recited in the specification to satisfy the written description requirement, in light of that information being available in the art.

This case represents the consequences of the Federal Circuit's expansive view of the written description requirement, which necessitates a determination of where to draw the line in every case to answer the question of "how much" disclosure is enough. Since this is a fact-specific question, there can be no easy, bright-line answers generally; here, Johnson & Johnson suggests that the line should be drawn so that "combination" inventions require a lesser degree of disclosure than "composition" inventions. Perhaps it is more fruitful to make the distinction between factual situations like that in Herschler where the art discloses a multiplicity of alternative embodiments, in contrast with this case where the universe of rapamycin analogs was more limited (on the order of about 40 or so). Particularly in view of the complexity of the rapamycin structure and the large number of structural analogs with unpredictable effects on function, it might be more productive to perform the analysis (at least for the 1997 patents) on enablement rather than written description grounds (as suggested by concurring Judge Gajarsa). If the Federal Circuit refuses to rehear this case en banc, Johnson & Johnson could petition the Supreme Court for certiorari, giving the Court the opportunity to opine of an area of patent law that has so far escaped its notice.

Posted at 11:59 PM in Federal Circuit, Written Description | Permalink | Comments (0) | TrackBack (0)

July 27, 2011

Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011)

Federal Circuit's Expanding Application of the Written Description Requirement

By Kevin E. Noonan --

Last month, the Federal Circuit affirmed a District Court finding on summary judgment that claims relating to coronary artery stents coated with rapamycin analogs were invalid for failure to satisfy the written description requirement.

The technology relates to drug-eluting coronary artery stents, used to reduce restenosis after angioplasty. Rapamycin coating inhibits proliferation of arterial smooth muscle cells that caused the restenosis by a process called neointimal proliferation. Plaintiffs Johnson & Johnson, Cordis Corp., and Wyeth ("Johnson & Johnson) sold stents protected by U.S. Patent Nos. 7,217,286, 7,223,286, and 7,229,473 (collectively, "the 1997 patents") and U.S. Patent No. 7,300,662 (the '662 patent); the following claims are representative:

U.S. Patent No. 7,217,286

1. A device comprising a metallic stent, a biocompatible, nonabsorbable polymeric carrier, and a therapeutic agent, wherein: said polymeric carrier comprises an acrylate-based polymer or copolymer, a fluorinated polymer, or a mixture thereof, and said therapeutic agent is rapamycin, or a macrocyclic lactone analog thereof, and is present in an amount effective to inhibit neointimal proliferation.

2. The device according to claim 1 wherein said therapeutic agent is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,223,286

10. [A stent having a coating applied thereto, wherein said coating comprises a biocompatible polymer/drug mixture and said drug is rapamycin or a macrocyclic lactone analog thereof], wherein the coating comprises a lactone-based polyester; a lactone-based copolyester; a polyanhydride; a polyaminoacid; a polysaccharide; a polyphosphazene; a poly(ether-ester) copolymer; a polydimethylsiloxane; a poly(ethylene)vinylacetate; a poly(hydroxy)ethylmethylmethacrylate; an acrylate based polymer; an acrylate based copolymer; a polyvinyl pyrrolidone; a cellulose ester; a fluorinated polymer; or a blend thereof.

27. A stent according to any one of claims 1 to 26 wherein said drug is a macrocyclic lactone analog of rapamycin.

32. A stent according to any one of claims 1 to 26 wherein said rapamycin or macrocyclic lactone analog thereof is present in a therapeutically beneficial amount to inhibit neointimal proliferation.

33. A stent according to claim 32 wherein said drug is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,229,473

1. A metallic stent having a coating applied thereto, wherein: said coating comprises a mixture of a biocompatible polymeric carrier and a therapeutic agent; said polymeric carrier comprises at least one nonabsorbable polymer; said therapeutic agent is rapamycin, or a macrocyclic lactone analog thereof, present in an amount effective to inhibit neointimal proliferation; and said stent provides a controlled release of said therapeutic agent over a period of several weeks.

2. The metallic stent according to claim 1 wherein said therapeutic agent is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,300,662

1. A drug delivery device comprising: an intraluminal stent; a biocompatible, nonerodible polymeric coating affixed to the intraluminal stent; and from about 64 .mu.g to about 197 .mu.g of rapamycin or a macrocyclic triene analog thereof that binds FKBP12 incorporated into the polymeric coating, wherein said device provides an in-stent late loss in diameter at 12 months following implantation in a human of less than about 0.5 mm, as measured by quantitative coronary angiography.

13. A method of inhibiting neointimal proliferation in a coronary artery resulting from percutaneous transluminal coronary angioplasty comprising implanting in the lumen of said coronary artery a drug delivery device comprising: an intraluminal stent; a biocompatible, nonerodible polymeric coating affixed to the intraluminal stent; and from about 64 .mu.g to about 197 .mu.g of rapamycin or a macrocyclic triene analog thereof that binds FKBP12 incorporated into the polymeric coating, wherein said method provides a mean in-stent late loss in diameter in a human population at 12 months following implantation of less than about 0.5 mm, as measured by quantitative coronary angiography.

The District Court found the claims of each of the patents in suit to be invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112, 1st paragraph. In addition, the Court found the claims of the 1997 patents to be invalid for lacking an enabling disclosure. The patents claimed "rapamycin or a macrocyclic lactone analog of rapamycin" (the 1997 patents) or "a macrocyclic triene analog of rapamycin (the '662 patent). These portions of the molecule that can be derivatized are illustrated below. The District Court construed "macrocyclic lactone analog" and "macrocyclic triene analog" broadly to mean "any molecule with structural similarity to rapamycin."

The District Court relied on testimony and statements in the specification of the patents in suit that indicated there was no "clear path or direction towards a particular drug therapy for restenosis" at the time the invention was made. In addition, the specifications of the 1997 patents contained statements relevant to both the District Court's and the Federal Circuit's opinion regarding the state of (and knowledge in) the art at the time the applications were filed, including:

• "[n]umerous agents [that] are being actively studied as antiproliferative agents for use in restenosis and [that] have shown some activity in experimental animal models."

• rapamycin "is capable of inhibiting both the inflammatory response known to occur after arterial injury and stent implanta-tion, as well as the [smooth muscle cell] hyperproliferative response."

• "the precise mechanism of rapamycin is still under active investigation,"

• "the ideal agent for restenosis has not yet been identified."

The prior art disclosed some limited number (approximately 40) of rapamycin analogs known in the art, including the analog used by Boston Scientific's accused infringing product.

Regarding the '662 patent, rapamycin was defined to include "rapamycin, rapamycin analogs, derivatives and congeners that bind FKBP12 and possess the same pharmacologic properties as rapamycin." However, the '662 patent specification did not identify any specific rapamycin analogs, and did not define a "macrocyclic triene analog" or provide any examples. For both the 1997 patents and the '662 patent there were no teachings, disclosure or data of any species other than rapamycin.

The District Court granted summary judgment to Boston Scientific that the claims of the patents-in-suit were all invalid for failure to satisfy the written description requirement, and the claims of the 1997 patents were also invalid for lack of enablement. With regard to the 1997 patents, the Court found that the term "macrocyclic lactone analogs of rapamycin" "in no way restricts the universe of potential analogs fitting the limitations as construed by the court." The District Court also found that the specifications of the 1997 patents did not disclose any "definitions, examples, or experimental models . . . for determining whether a compound is a structurally similar analog as contemplated by the patentees." With regard to the ~40 rapamycin analogs known in the prior art, the Court noted that there were "numerous potential analogs of rapamycin," a number much greater than the ~40 known analogs. The District Court also found that merely specifying the required function of the rapamycin analog was insufficient to fulfill the written description requirement, because "describing certain functions of the genus of claimed analogs does not equate to a description of the claimed analogs themselves." The Court also relied on deposition testimony from the inventors that the had not experimented with any rapamycin analogs, saying that "[l]ogically, the inventors could not have described a knowledge that they did not possess."

The District Court distinguished the content of the '662 specification, recognizing that the scope of the rapamycin analogs was lower (limited to macrocyclic triene analogs) and the '662 patent specification provides more detail on the analogs and their properties, including mechanism of action. However, the Court found that this disclosure was also insufficient, because "[n]o macrocyclic triene analogs are named, structurally depicted, exemplified, or otherwise described in the '662 patent specification. No assays or other experimental models are provided with respect to testing an analog candidate's ability to function as rapamycin." Even though the claimed genus is limited by function, there is no description of any species falling within the scope of the genus. As a consequence, the District Court found that the disclosure did not specify the "sufficient species" required by Federal Circuit precedent to fulfill the written description requirement. The Court thus "concluded that '[t]he inventors were required to describe at least one representative macrocyclic triene analog; having failed to do so, the '662 patent is [therefore] invalid for lack of written description.'"

The Federal Circuit affirmed in an opinion by Judge Moore, joined by Judge Bryson and by Judge Gajarsa with regard to the '662 patent. The opinion specifically rejected Johnson & Johnson's argument that the disclosure was sufficient based on the facts:

1) that the structure and the mechanism of action of rapamycin were known;

2) that the correlation between the structural elements of rapamycin and its mechanism of action and biological activity was known;

3) that dozens of rapamycin analogs having the same macrocyclic ring structure as rapamycin and comparable biological activity were known; and

4) that persons of ordinary skill knew of assays to determine if analogs had the same mechanism of action as rapamycin and thus would also inhibit cell proliferation.

Johnson & Johnson's argument was that the amount of the disclosure the patent specification was required to provide was reduced based on what was known in the art, citing In re Herschler, 591 F.2d 693, 702 (C.C.P.A. 1979), and In re Fuetterer, 319 F.2d 259 (C.C.P.A. 1963), for the principle that "when claiming a combination of known elements, as opposed to a novel compound, the specification 'need not list examples' nor is any 'comprehensive description' required." Johnson & Johnson also argued that the prior art contained "a known correlation between the structure of rapamycin and its analogs and their function," and hence Johnson & Johnson was entitled to its claims without having a specification that "contains examples of specific macrocyclic lactone analogs of rapamycin." In rejecting these arguments, the opinion expressed agreement with Boston Scientific's position that a patentee is required to show possession of the claimed invention at the time a patent application is filed, and that "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials," citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). The 1997 patents fail this test, according to the Court, due to the complete absence of any examples of a macrocyclic lactone analog in the specification. Citing the en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the opinion states that a "sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." While disclaiming any "bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim," the opinion reiterated the "factors" to be considered from Ariad: "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue."

The specifications of the 1997 patents fail this test, containing "virtually no information regarding macrocyclic lactone analogs of rapamycin." Significantly, citing the absence of the term "macrocyclic lactone analog" until the claims were amended "nine years after the effective filing date," the opinion cites in detail the lack of disclosure relating to analogs. While not relying exclusively on the absence of any examples of macrocyclic lactone analogs in the specification, the opinion notes that such a lack of disclosure is a factor that "may be considered" when making a determination of whether the written description requirement is satisfied. In language reminiscent of how courts perform an enablement analysis, the opinion states that the 1997 patent specifications contain "no examples of macrocyclic lactone analogs of rapamycin, and give no guidance on how to properly determine whether a compound is a macrocyclic lactone analog of rapamycin besides vaguely indicating they must be 'structural[ly] similar' to rapamycin." The Court also recites the "structural complexity" of rapamycin (even going so far as enumerating the "fifty-one carbon atoms, seventy-nine hydrogen atoms, thirteen oxygen atoms and a nitrogen atom" comprising rapamycin). The opinion states that "the universe of potential compounds that are structurally similar to rapamycin and classifiable as macrocyclic lactones is potentially limitless" (and mentions the District Court's determination that "tens of thousands of potential macrocyclic lactone analogs [of rapamycin] exist"). Finally, the opinion states that "even the minor structural changes to the molecular structure of rapamycin that are necessary to create analogs may have significant and unpredictable effects on functionality," none of which were disclosed in the patent specifications.

The opinion discounts the existence of rapamycin analogs in the prior art, saying that "[a]ny suggestion that these references represented existing knowledge in the art so well known as to excuse including a more detailed disclosure of the macrocyclic lactone analogs genus in the specification is belied by the state of the art at the time of the invention." The patentees' own arguments (relating to non-obviousness) were turned against them in this regard, as the Court used the unpredictability associated with assertions of non-obviousness to establish that what was known in the art was insufficient to provide the knowledge of macrocyclic lactone analogs absent in the specifications. These arguments were also supported by statements in the 1997 patent specifications, including:

• "The exact hormonal and cellular processes promoting restenosis are still being determined."

• "The exact mechanism for restenosis is still under active investigation."

• "The mechanisms for most agents employed [to prevent smooth muscle cell proliferation] are still unclear."

• "The ideal agent for restenosis has not yet been identified."

• "The precise mechanism of rapa-mycin is still under active investigation."

The Federal Circuit expressly addressed the argument that there is (or should be) a distinction between claims directed to chemical compounds per se and claims (like the ones in suit) directed to a combination comprising chemical compounds. Citing Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d. 1115, 1126 (Fed. Cir. 2008), the Court said that "our case law regarding generic claims is applicable to both inventions claiming novel genera of chemical and biological compounds as well as inventions claiming combinations of prior art compounds with other elements." "The test for written description is the same whether the claim is to a novel compound or a novel combination of known elements. The test is the same whether the claim element is essential or auxiliary to the invention," citing in support the statement in Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 345 (1961), that "there is no legally recognizable or protected 'essential' element, 'gist' or 'heart' of the invention in a combination patent."

Ultimately, the Court based its opinion on the knowledge in the prior art of a small subset of macrocyclic lactone analogs of rapamycin out of the "tens of thousands" of possible species, coupled with the failure to establish a correlation between the structure of such analogs and their function as restenosis inhibitors; in this regard the Court rebutted Johnson & Johnson's proffered expert evidence and a prior art article on rapamycin function with express statements in the 1997 patent specifications (such as "the precise mechanism of rapamycin is still under active investigation"; italics in opinion). Again echoing a traditional enablement analysis, the Court affirmed the District Court based on "the absence of information regarding structural characteristics of macrocyclic lactone analogs or examples of macrocyclic lactone analogs in the specification, the unpredictability of the art and the nascent state of using drug-eluting stents to inhibit restenosis."

With regard to the '662 patent, while coming to the same ultimate conclusion, the Court acknowledged that this specification contained more information regarding the mechanism of rapamycin action than the specifications of the 1997 patents. Regardless, the Court notes that Johnson & Johnson's own experts admitted that "researchers continued to struggle to find compounds that would work in a drug-eluting stent to prevent restenosis," and thus "the technology was still in its infancy" at the effective filing date of the '662 patent. And the '662 patent "fails to disclose even a single member of either the genus of 'analogs' of rapamycin or the more specific genus of "macrocyclic triene analogs" of rapamycin" recited in the '662 patent claims. Citing Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996), the opinion holds that the '662 specification lacked sufficient "blaze marks . . . 'as to what compounds other than those disclosed as preferred, might be of special interest . . . simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses.'" In view of the "nascent state of using drug-eluting stents to treat restenosis" at the effective filing date of the '662 patent, the opinion states that the "lack of such blaze marks . . . prevents any conclusion that the patent contains sufficient written description of the claimed triene analogs of rapamycin." This conclusion was supported, according to the opinion, by the fact that the mechanism of action of rapamycin was not well known, and thus the knowledge in the art "did not excuse[] the patentee's failure to explicitly disclose the claimed sub-genus or any species within the sub-genus." As with the 1997 patents, the express disclosure of the '662 patent specification rebutted Johnson & Johnson's arguments regarding the sufficiency of its disclosure based on the knowledge of one of ordinary skill in the art, insofar as that disclosure indicated that "the mechanism of action corresponding to the function of rapamycin and its analogs [was] still under investigation." The '662 patent claims also suffered, according to the opinion, by the specific activity required by the expressly recited range of macrocyclic triene analogs, in view of the absence of any information (in the specification or the art) about how such analogs having such activity could be selected (other than "trial and error," again utilizing an enablement ("undue experimentation") analysis). Returning to written description, the opinion states that "[t]here is . . . no indication of which structural features of analogs of rapamycin are necessary to achieve these results."

Judge Gajarsa, perhaps reacting to the portions of the Court's analysis sounding in enablement, concurred in part because he would expressly affirm (regarding the 1997 patents) on enablement rather than written description grounds, saying that this portion of 112, 1st paragraph is "the appropriate tool for invalidating claims that are broader than their disclosure."

One explanation for the result in this case is that the 1997 patents, and even the '662 patent, were drafted at a time before the Federal Circuit's current emphasis on the written description requirement became fully evident. However, the opinion illustrates once again that the Federal Circuit is not cabining its written description jurisprudence to chemical, pharmaceutical, or biotechnological patents. In this case, the "invention" was the combination of the stent, which was known in the art, with compounds (rapamycin and analogs) that inhibited restenosis. Traditionally, the extent of the disclosure in the 1997 patents and the '662 patent regarding the restenosis-inhibiting compound might have been enough to satisfy the written description requirement; certainly disclosure of chemical genera has not been conventionally limited by the ratio of the species disclosed and the species in the genus, or no chemical specification could ever satisfy the requirement. After Ariad (and Carnegie Mellon), it is clear that the Court will apply its written description rubrics developed (sensibly) for biotechnology inventions (where the doctrine prevents applicants from claiming complex molecules that they have not yet isolated or identified) to more traditional chemical genera. The consequence, as here, is that claim scope will be limited, particularly for those claims drafted and granted prior to the sea change started by Regents v. Eli Lilly. Whether this stimulates or inhibits innovation in these technologies appears to be the legal and technological experiment that the Court will now have performed.

Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011)
Panel: Circuit Judges Bryson, Gajarsa, and Moore
Opinion by Circuit Judge Moore; opinion concurring-in-part by Circuit Judge Gajarsa

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May 05, 2011

Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (Fed. Cir. 2011)

By Donald Zuhn --

Last week, in Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc., the Federal Circuit determined that the District Court for the Central District of California had properly granted summary judgment of invalidity with respect to U.S. Patent Nos. 5,674,681 and 6,355,425. In particular, the panel affirmed the District Court's decision that the asserted claims of the '681 patent were invalid for lack of written description, and its decision that the asserted claims of the '425 patent were invalid as anticipated by U.S. Patent No. 6,025,130.

In 2009, Plaintiff-Appellant Billups-Rothenberg, Inc. sued Defendants-Appellees Associated Regional and University Pathologists, Inc. (doing business as ARUP Laboratories) and Bio-Rad Laboratories, Inc. ("ARUP"), asserting that ARUP infringed certain claims of the '681 and '425 patents by providing or using diagnostic assays or kits for detecting Type I hereditary hemochromatosis. Type I hereditary hemochromatosis, which is an iron disorder characterized by excessive iron absorption by the body, is caused by specific mutations in the High Fe ("HFE") gene, which is located on the short arm of chromosome six in humans.

The '681 patent, which issued from an application filed by Billups in 1994, discloses that the gene responsible for hemochromatosis is located on human chromosome six. The '681 application also discloses that "[a] mutation in a nucleic acid sequence can be detected by various methods to analyze nucleic acids [which] are well known to those in the art." Claim 2 of the '681 patent recites:

2. A method to identify an individual having or predisposed to having hemochromatosis, comprising the steps of:
a) providing from the individual a sample containing a gene encoding a nonclassical MHC class I heavy chain and
b) detecting a mutation in said gene, which mutation results in the reduced ability of said heavy chain to associate with said β2 microglobulin, wherein the presence of said mutation identifies said individual as having or predisposed to having hemochromatosis.

The '681 patent does not, however, disclose the HFE gene or identify any mutations associated with hemochromatosis.

In 1996, a different group of researchers isolated and sequenced the hemochromatosis (or HFE) gene and identified three mutations in the gene that are associated with hemochromatosis: C282Y, H63D, and S65C. This research led to the issuance of the '130 patent, which discloses the HFE gene sequence and the C282Y, H63D, and S65C mutations (identified in the '130 patent as 24d1, 24d2, and 24d7, respectively):

The '130 patent, which is owned by Bio-Rad and licensed to ARUP, also discloses genetic tests for hemochromatosis that utilize the mutations and sequence variants identified in the patent.

Using the sequences disclosed in the '130 patent, Billups developed a method for diagnosing an iron disorder by testing for the S65C mutation. In 1999, Billups filed an application directed to this method, which issued as the '425 patent. Claim 1 of the '425 patent recites:

1. A method of diagnosing an iron disorder or a genetic susceptibility to developing said disorder in a mammal, comprising determining the presence of a mutation in exon 2 of an HFE nucleic acid in a biological sample from said mammal, wherein said mutation is not a CàG substitution at nucleotide 187 of SEQ ID NO: 1 and wherein the presence of said mutation is indicative of said disorder or a genetic susceptibility to developing said disorder.

At trial, Billups and ARUP filed cross-motions for summary judgment, Billups seeking summary judgment of infringement and ARUP seeking summary judgment of invalidity. The District Court denied Billups' motion and granted ARUP's motion of invalidity for lack of written description (as to the '681 patent) and anticipation (as to the '425 patent). With respect to the '681 patent, the District Court noted that neither the sequence of the HFE gene nor any mutations in the HFE gene were disclosed in the patent, and the "patentee has merely directed the person of ordinary skill in the art to a general location of a mutation on a chromosome and suggested that the mutation may be found in that vicinity." With respect to the '425 patent, the District Court determined that the '130 patent was prior art to the '425 patent, and further, that the '425 patent claims the same genetic test for the S65C mutation that is disclosed in the '130 patent.

Writing for the Federal Circuit, and addressing the issue of written description first, Judge Gajarsa noted that "Billups claims that its disclosure of the mutation's general location somewhere 'within less than a 300 base pair region of a defined exon of a well studied multi-gene family,' combined with the knowledge that existed at the time of filing the '681 patent, established that [the inventors] possessed the claimed invention." While "[t]he '681 patent claims a test for mutations," he also noted that "it is undisputed that the specification and originally filed claims of the '681 patent disclose neither the hemochromatosis gene sequence nor any specific mutations within that gene." In summarizing Billups' argument on appeal, Judge Gajarsa stated that:

Billups contends that the '681 patent taught structure, i.e., that hemochromatosis has a genetic basis, and function, namely, its adverse effect upon the binding of β2 microglobulin with a non-classical MHC class I heavy chain. Specifically, Billups argues that the '681 patent's correlation of function with the general location of the C282Y mutation, combined with the knowledge of a person of ordinary skill in the art in the field at the time of filing, satisfied the written description requirement by localizing the mutation to a 300 base pair region.

Agreeing with the District Court's findings that "[p]atentee's general location disclosure is too imprecise to constitute structural features necessary to meet the written description requirement," and that the "specification for the '681 patent contains only functional, not structural, characteristics of the predicted mutations," Judge Gajarsa determined that the District Court properly granted summary judgment of invalidity for lack of written description.

Turning to the issue of anticipation, Judge Gajarsa quickly concluded that:

The asserted claims of the '425 patent are invalid because they are anticipated by the '130 patent. The '130 patent was filed nearly three years before the '425 patent and is prior art under § 102(e). The district court correctly ruled that the '130 patent discloses use of the S65C mutation as a "HH [(hereditary hemochromatosis)] diagnostic," and, thus, Billups was not the first to disclose diagnosis of hemochromatosis using the S65C mutation.

While Billups argued on appeal that the '130 patent concludes that "the S65C mutation was only a clinically insignificant polymorphism unrelated to disease state," and therefore that "the '130 patent did not teach using the S65C mutation to diagnose hemochromatosis," Judge Gajarsa countered that "[d]espite the inventors' uncertainty regarding the utility of the S65C mutation because of their small sample size, the '130 patent describes two genetic tests for hemochromatosis that involve detection of the S65C mutation as an input for the diagnosis of hemochromatosis." Citing Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998), Judge Gajarsa noted that "[a]lthough the '130 patent discounts the utility of the S65C mutation in diagnosing hemochromatosis, we have held that a 'reference is no less anticipatory if, after disclosing the invention, the reference then disparages it.'" Thus, "[e]ven though the inventors of the '425 patent performed experiments revealing greater diagnostic utility of the S65C mutation than initially suspected," Judge Gajarsa concluded that "the use of the S65C mutation as a diagnostic tool was already contemplated by the '130 patent," and therefore affirmed the District Court's finding of invalidity with respect to the '425 patent.

Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (Fed. Cir. 2011)
Panel: Circuit Judges Gajarsa, Linn, and Moore
Opinion by Circuit Judge Gajarsa

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February 23, 2011

Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011)

By Donald Zuhn --

Today, in Centocor Ortho Biotech, Inc. v. Abbott Laboratories, the Federal Circuit reversed the District Court's denial of judgment as a matter of law ("JMOL") of invalidity, holding the asserted claims of U.S. Patent No. 7,070,775 invalid for lack of written description.

Plaintiffs-Appellees Centocor Ortho Biotech, Inc. and New York University ("Centocor") sued Defendants-Appellants Abbott Laboratories, Abbott Bioresearch Center, Inc., and Abbott Biotechnology, Ltd. ("Abbott"), asserting that Abbott's Humira® antibody infringes claims 2, 3, 14, and 15 of the '775 patent, which Centocor owns. At trial, a jury found the asserted claims valid and Abbott liable for willful infringement, awarding Centocor $1.67 billion in damages. The District Court for the Eastern District of Texas granted Abbott's motion for JMOL of no willful infringement, but denied its other JMOL motions, including Abbott's motion for JMOL of invalidity.

The case involves antibodies to human tumor necrosis factor α ("TNF-α"). While Centocor and Abbott both sought to develop anti-TNF-α antibodies that would have high affinity, the desired neutralizing activity, and reduced immunogenicity, they pursued different strategies to develop their anti-TNF-α antibodies. Centocor, for example, identified a mouse antibody to human TNF-α ("A2 mouse antibody") that had high affinity and neutralizing activity and reduced the antibody's immunogenicity by exchanging the antibody's mouse constant region with a human constant region, creating a chimeric antibody having a mouse variable region and a human constant region. Abbott, meanwhile, screened a phage library of human variable regions for variable regions that bind human TNF-α, and then used various techniques to improve the binding affinity of selected variable regions. The resulting variable regions were then combined with human constant regions to create fully-human antibodies, from which the therapeutic antibody Humira® was identified.

Centocor filed a patent application in 1991 claiming its A2 mouse antibody and chimeric antibody. In 1993 and 1994, Centocor filed a series of continuation-in-part applications, and in 2002, Centocor added claims reciting human variable regions in the thirteenth member of the application family, which issued as the '775 patent in 2006. Claims 1 and 2 of the '775 patent recite:

1. An isolated recombinant anti-TNF-α anti-body or antigen-binding fragment thereof, said antibody or antigen-binding fragment comprising a human constant region, wherein said antibody or antigen binding fragment (i) competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNF-α, and (ii) binds to a neutralizing epitope of human TNF-α in vivo with an affinity of at least 1x10⁸ liter/mole, measured as an association constant (Ka), as determined by Scatchard analysis.

2. The antibody or antigen-binding fragment of claim 1, wherein the antibody or antigen binding fragment comprises a human constant region and a human variable region.

Abbott filed a patent application directed to high affinity, neutralizing, fully-human antibodies to human TNF-α (such as the Humira® antibody) in 1996, and was granted a patent in 2000.

Writing for the Court, Judge Prost notes that:

The pivotal issue in this case concerns whether the '775 patent provides adequate written description for the claimed human variable regions. As noted above, Centocor first sought claims to human variable regions and fully-human antibodies in 2002. At that time, Abbott had already discovered and patented a fully-human antibody to TNF-α that had high affinity and neutralizing activity. To ensnare Abbott with later-filed claims, Centocor must use a priority date from an earlier application. Because Abbott's application was filed in 1996, Centocor relies on a priority claim to the 1994 CIP applications. Thus, in order for Centocor to prevail, the asserted claims must be supported by adequate written description in the 1994 CIP applications.

Summarizing Abbott's argument on appeal, she writes:

To underscore the inadequacy of Centocor's written description, Abbott points out that the specification does not disclose any fully-human, high affinity, neutralizing, A2 specific antibody. Moreover, the specification does not disclose a single human variable region. Abbott argues that the only described antibody is the chimeric antibody, which has a mouse variable region. Abbott also argues that Centocor has merely disclosed tools that might be used in an attempt to make the claimed invention -- essentially, that Centocor's disclosure is no more than a mere wish or plan for how one might search for a fully-human antibody that satisfies the claims.

After reviewing Centocor's 1994 CIP applications to assess whether their disclosure provides adequate written description for the asserted claims, Judge Prost concludes that:

Contrary to Centocor's assertions, very little in the '775 patent supports that Centocor possessed a high affinity, neutralizing, A2 specific antibody that also contained a human variable region. The overwhelming majority of the '775 patent describes the A2 mouse antibody and the single chimeric antibody that Centocor made based on A2's mouse variable region. . . . As for describing suitable variable regions, the application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common.

Because the undisputed testimony at trial established that the sequence of the A2 variable region and a human variable region are "very different," the Court declares that "the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims." In finding that Centocor's fully-human antibody claims go beyond the scope of its disclosure, Judge Prost notes that:

[W]hile the patent broadly claims a class of antibodies that contain human variable regions, the specification does not describe a single antibody that satisfies the claim limitations. It does not disclose any relevant identifying characteristics for such fully-human antibodies or even a single human variable region. Nor does it disclose any relationship between the human TNF-α protein, the known mouse variable region that satisfies the critical claim limitations, and potential human variable regions that will satisfy the claim limitations. There is nothing in the specification that conveys to one of skill in the art that Centocor possessed fully-human antibodies or human variable regions that fall within the boundaries of the asserted claims [citations omitted].

Citing Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and the USPTO Written Description Guidelines, Centocor argues that because it fully disclosed the human TNF-α protein, it has provided adequate written description for any antibody that binds to human TNF-α. Judge Prost, however, counters that Centocor's "suggestion is based on an unduly broad characterization of the guidelines and our precedent," noting that Noelle and the Guidelines stand for the proposition that "an applicant can claim an antibody to novel protein X without describing the antibody when (1) the applicant fully discloses the novel protein and (2) generating the claimed antibody is so routine that possessing the protein places the applicant in possession of an antibody" (emphasis added). She points out that in this case, "both the human TNF-α protein and antibodies to that protein were known in the literature."

Thus, the panel concludes that, as in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), the jury lacked substantial evidence to find that the asserted claims were supported by adequate written description, and the District Court erred when it declined to grant Abbott's motion for JMOL that the asserted claims were invalid for lack of written description.

Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011)
Panel: Circuit Judges Bryson, Clevenger, and Prost
Opinion by Circuit Judge Prost

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January 03, 2011

September 07, 2010

Goeddel v. Sugano (Fed. Cir. 2010)

By Kevin E. Noonan --

Today the Federal Circuit reversed a priority determination in an interference over claims to human beta-interferon, in an opinion teeming with irony, déjà vu, anachronism, and the peculiar effects on outcome caused by the form of interference counts.

Two interferences, Nos. 105,334 and 105,337 between Junior Party David Goeddel and Robert Crea and Senior Party Haruo Sugano, Masami Muramatsu, and Tadatsigi Tanaguchi, were directed towards claims to isolated human DNA encoding beta-interferon (also termed "human fibroblast interferon" or hFIF in the opinion) as well as the isolated interferon protein itself. The "DNA Interference" was declared between Goeddel patent application No. 07/374,311 and Sugano patent Nos. 5,326,859 and 5,514,567 and contained one count:

A DNA encoding a mature human fibroblast interferon having a total of 166 amino acids of the sequence

Met Ser Tyr Asn Leu Leu Gly Phe Leu Gln Arg Ser Ser Asn Phe Gln Cys Gln Lys Leu Leu Trp Gln Leu Asn Gly Arg Leu Glu Tyr Cys Leu Lys Asp Arg Met Asn Phe Asp Ile Pro Glu Glu Ile Lys Gln Leu Gln Gln Phe Gln Lys Glu Asp Ala Ala Leu Thr Ile Tyr Glu Met Leu Gln Asn Ile Phe Ala Ile Phe Arg Gln Asp Ser Ser Ser Thr Gly Trp Asn Glu Thr Ile Val Glu Asn Leu Leu Ala Asn Val Tyr His Gln Ile Asn His Leu Lys Thr Val Leu Glu Glu Lys Leu Glu Lys Glu Asp Phe Thr Arg Gly Lys Leu Met Ser Ser Leu His Leu Lys Arg Tyr Tyr Gly Arg Ile Leu His Tyr Leu Lys Ala Lys Glu Tyr Ser His Cys Ala Trp Thr Ile Val Arg Val Glu Ile Leu Arg Asn Phe Tyr Phe Ile Asn Arg Leu Thr Gly Tyr Leu Arg Asn

and unaccompanied by a human fibroblast interferon presequence.

The "Protein Interference" was declared between Sugano's application No. 08/463,757 and Goeddel's patent No. 5,460,811. The sole count of the "Protein Interference" is:

A composition comprising water and a nonglycosylated mature human fibroblast interferon polypeptide having a total of 166 amino acids and the following amino acid sequence

said composition being free of any glycosylated human fibroblast interferon.

In each interference, Junior Party Goeddel was given the benefit of priority to U.S. patent application Serial No. 06/190,799, filed September 25, 1980. Senior Party Sugano was given priority to a Japanese application, No. 33931/80, filed March 19, 1980. The Board of Patent Appeals and Interferences decided the priority question in favor of Sugano in each interference, based on its determination that the Japanese application constituted a constructive reduction to practice of an invention within the scope of each interference count.

On appeal, Goeddel argued that Sugano's Japanese priority application did not satisfy the enablement or written description requirements of 35 U.S.C. § 112, first paragraph; interference practice permits a party to rely on a prior, foreign filed application only if that application satisfies the requirement of § 112, first paragraph (Hyatt v. Boone, 146 F.3d 1348, 1351 (Fed. Cir. 1998)). The basis of Goeddel's argument is that both counts were directed to nucleic acids encoding or an isolated protein having the amino acid sequence of the "mature" (active) form of human beta-interferon. The mature form has the 166 amino acid sequence set forth in each of the interference counts, but beta-interferon DNA encodes a 187 amino acid (inactive) form that is produced in human cells and then specifically cleaved to produce the mature, active, 166 amino acid form (i.e., the first 21 amino acids of the immature form are removed from the protein to produce the mature form). The Sugano priority Japanese application disclosed this immature, 187 amino acid form (both the nucleic acid and protein) but did not disclose the mature, 166 amino acid form. Instead, the application referenced a scientific publication by Knight, entitled "Human Fibroblast Interferon: Amino Acid Sequence Analysis and Amino Terminal Amino Acid Sequence," which disclosed amino terminal protein sequencing that identified the first 13 amino acids of the mature form. The Sugano Japanese priority application disclosed production of human beta-interferon in bacteria, which do not specifically cleave the immature, 187 amino acid form into the mature, 166 amino acid form, and also does not disclose either the mature form nor the specific cleavage site that could be used to produce the mature form of human beta-interferon. (As quoted in the Federal Circuit's opinion, the Board found that "[t]he sequences of mature hFIF DNA or polypeptide are not explicitly disclosed.") Because of these deficiencies, Goeddel argued that Sugano's Japanese priority application did not satisfy the requirements of 35 U.S.C. § 112, first paragraph, was not a competent priority document, did not provide Sugano with an earlier priority date for either of the interference counts and thus that Goeddel should be awarded priority in both interferences.

The Board found (correctly, Sugano argued on appeal) that its disclosure in the Japanese priority application satisfied the enablement and written description requirements. For enablement, Sugano argued that the determination of whether a priority document satisfied the statutory requirements must take into consideration the knowledge of the person of ordinary skill in the art. ("[P]atent applications are 'written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before,' [argued Sugano], and thus 'it is unnecessary to spell out every detail of the invention in the specification,'" citing Lizard Tech, Inc. v. Earth). Supplementing the express disclosure of the Japanese priority application with the knowledge from the art, including the disclosure of the Knight reference, would have been sufficient to enable the skilled worker to produce the mature form of beta-interferon, according to Sugano. The Board relied on testimony from a Goeddel expert, to the effect that "no new technology" would have been required for the skilled worker to produce the mature form in view of the disclosure of the Japanese priority application disclosing the immature, 187 amino acid form and the identification in the Knight reference of the "line of demarcation" between the 21 amino-terminal presequence and the amino terminus of the mature, 166 amino acid form. Regarding the written description requirement, the Board found, and Sugano argued, that the combination of the complete 187 amino acid immature sequence expressly disclosed in the Japanese priority application, and the disclosure by Knight of the amino terminal amino acids of the mature, 166 amino acid form of beta-interferon would permit the skilled worker to "envision" the mature form and thus satisfy the written description requirement. The Board stated that "although not explicitly described in the Japanese Application, 'the amino acid of, and DNA sequence encoding, mature hFIF would be readily apparent,'" and that "a person of skill in the field of the invention, reading the Japanese Application, would conclude that Sugano was in possession of the invention of the interference counts" (despite an admission by Sugano's expert that the Japanese priority application "does not state where the presequence ends and where the mature hFIF sequence begins").

The Federal Circuit disagreed with the Board and Sugano, in an opinion written by Judge Newman and joined by Judge Lourie and Judge Bryson. The Court rejected the standard that an application merely enable the skilled worker to "envision" the claimed invention to satisfy the requirement for constructive reduction to practice in an interference proceeding. "[C]onstructive reduction to practice 'is "not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure. . . . Rather, it is a question whether the application necessarily discloses that particular device," according to the Federal Circuit opinion, citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326-27 (Fed. Cir. 2000) (quoting Jepson v. Coleman, 314 F.2d 533, 536 (CCPA 1963). "[I]n the context of interference priority, [Section 112] requires that the subject matter of the counts be described sufficiently to show that the applicant was in possession of the invention," said the Court, which in this case meant possession of the 166 amino acid, mature and active form of beta-interferon.

That a modified gene encoding the 166 amino acid protein could have been "envisioned" does not establish constructive reduction to practice of the modified gene. The question is not whether one skilled in this field of science might have been able to produce mature hFIF by building upon the teachings of the Japanese Application, but rather whether that application "convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) . . . The Japanese application does not describe a bacterial expression vector that directly produces the mature hFIF, nor does it suggest producing a modified gene to directly encode the 166 amino acid mature hFIF.

And thus, the Board erred in granting priority to Party Sugano, the Federal Circuit concluded. Sugano's attempts to support its claims with reference to the Court's decisions in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002), and University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 923 (Fed. Cir. 2004), were similarly unavailing, the Court stating that "these cases do not hold that envisioning an invention not yet made is a constructive reduction to practice of that invention." The panel aded that "[p]recedent in evolving science is attuned to the state of the science, but remains bound by the requirement of showing 'that the inventor actually invented the invention claimed,'" citing Bradford Co. v. Conteyor North Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010), and Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993).

Hence the irony, since "Fiers v. Revel" is the caption of an interference decision that is more properly styled "Fiers v. Revel v. Sugano," also involving an interference between Sugano and different parties almost twenty years ago. The Fiers v. Revel case is arguably the first case in the line of written description jurisprudence that goes through University of California v. Eli Lilly, Enzo Biochem., Rochester, and Ariad. Sugano prevailed in that interference, precisely because its priority document contained the nucleotide sequence of human beta-interferon where the other two parties' applications did not. Perhaps fittingly. Sugano lost this interference because its priority application could not satisfy the standards that its earlier interference helped to establish.

Goeddel v. Sugano (Fed. Cir. 2010)
Panel: Circuit Judges Newman, Lourie, and Bryson
Opinion by Circuit Judge Newman

Image of beta-interferon (above) by AJC1, from flickr under the Creative Commons license.

Posted at 11:59 PM in Enablement, Federal Circuit, Written Description | Permalink | Comments (0) | TrackBack (0)

September 06, 2010

Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2010)

By Kevin E. Noonan --

The old proverb "success has many fathers, while failure is an orphan" comes to mind when considering the Federal Circuit's decision in Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. In the Court's decision, repeated failures, even by Lilly scientists in developing its osteoporosis drug Evista® (raloxifene hydrochloride), were sufficient to defeat Teva's counterclaim that patent claims related to methods of use were obvious.

The action arose following Teva's ANDA filing containing a Paragraph IV certification that the patents-in-suit were invalid (there was no discussion in the opinion of any inequitable conduct allegations below). The patents fell within three broad categories, and included the Bone Loss patents (U.S. Patent No. 6,906,086 and Reissue Patents Nos. RE39,049; and RE38,968), the Low Dose patent (Reissue Patent No. RE39,050) and the Particle Size patents (U.S. Patents Nos. 6,458,811 and 6,894,064). Specific claims representative of the patents-in-suit include the following:

Claim 1 of the '086 patent (Bone Loss patent):

A method of inhibiting post-menopausal bone loss in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis comprising administering a single daily oral dose to said woman of an effective amount of [raloxifene] hydrochloride.

Claim 14 of the '050 reissue patent (Low Dose patent):

A method of preventing post-menopausal osteoporosis in a post-menopausal woman in need of treatment to prevent post-menopausal osteoporosis comprising administering to said woman a hydrochloride salt of . . . [raloxifene] in an amount of 60 mg/day.

Claim 1 of the '811 patent (Particle Size patent; emphasis added):

A compound of formula I . . . [raloxifene] and pharmaceutically acceptable salts and solvates thereof, characterized in that the compound is in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns.

The District Court (Judge Sarah Evans Parker) found the Bone Loss and Low Dose patents not invalid under §§ 103 and 112, 1st paragraph (enablement), but that the Particle patents were invalid for failing to satisfy the written description requirement under 112, 1st paragraph, and granted a permanent injunction keeping generic raloxifene hydrochloride off the market until Lilly's patents expire.

Relevant to the Federal Circuit's analysis was the developmental history of raloxifene. Originally pursued as an "antiestrogen" breast cancer treatment (similar in mode of action to tamoxifen), clinical experience with the drug showed low bioavailability in humans (despite significant bioavailability in experimental animals). This result appeared to be related to the presence of free hydroxyl groups in raloxifene that were modified by conjugation with glucaronide as part of the detoxification and elimination pathways in humans. The Court cited several prior art references disclosing low bioavailability and that raloxifene underwent "rapid metabolic conversion." These included the Buzdar reference (1988) that disclosed results showing that raloxifene elicited no complete or partial responses for breast cancer patients resistant to tamoxifen (although the reference did not directly attribute these results to low bioavailability). These bioavailability concerns regarding raloxifene were an express ground for the District Court to find that Lilly's claims for its Bone Loss and Low Dose patents were non-obvious, since the known low bioavailability for raloxifene would have precluded the skilled worker from having a reasonable expectation that the drug would be clinically useful for treating osteoporosis.

In its opinion, written by Chief Judge Rader joined by Judge Linn and Judge Prost, the Court affirmed the District Court's determination that Teva had not provided clear and convincing evidence that the claims of the Bone Loss or Low Dose patents were obvious. On appeal, Teva argued three prior art references in support of its obviousness arguments. U.S. Patent No. 5,075,321 (Schreiber patent) disclosed the use of raloxifene for treating autoimmune disorders (and according to the opinion was the basis for Lilly reissuing three of the patents-in-suit). The Court found that this reference did not provide clear and convincing evidence of obviousness, because osteoporosis is not an autoimmune disease, and the evidence suggested different mechanisms of action. "Without a closer relationship, Teva cannot show that an ordinarily skilled artisan would have expected Dr. Schrieber's article to have relevance for the treatment of postmenopausal osteoporosis," the Court said. The opinion also rejected Teva's argument that the reference is relevant for showing clinically-significant bioavailability for raloxifene, based on the different uses (osteoporosis versus autoimmune disorders) as well as the fact that what was prior art in the Schrieber reference was based on animal studies that did not address the bioavailability issue in humans.

The second reference, a scientific journal article by Jordan, disclosed rat studies on the effects of tamoxifen and raloxifene on bone density. According to the Court's opinion, "Dr. Jordan concluded that these results 'may have important implications for the clinical [human] applications of antiestrogens'" and that "'[i]t is possible . . . that in the future, tamoxifen could be considered to be used as a substitute for estrogen [for the prevention of osteoporosis in postmenopausal women]'" (emphasis added). The reference also contained an assertion calling for clinical investigation of the use of tamoxifen for treating osteoporosis. Unfortunately for Teva's argument, the Federal Circuit did not consider these teachings relevant for the use of raloxifene, because the reference suggested that tamoxifen, not raloxifene, be explored for use as an osteoporosis treatment. In addition, not only was the reference silent as to the bioavailability issue, but the opinion cited the District Court's reasoning that the Jordan reference "exemplified" the bioavailability concerns with raloxifene and that the skilled worker "'would not have had a reasonable expectation of success in using raloxifene to treat human postmenopausal osteoporosis.'" The Federal Circuit particularly faulted the portion of Teva's arguments relying on how Lilly scientists interpreted the Jordan results in support of its case for obviousness, since these inventors have greater than ordinary skill. In addition, the Lilly scientists possessed internal information relating to the capacity for conjugation of raloxifene to be reversed in vivo (resulting in improved bioavailability), but this knowledge was also unavailing in support of Teva's arguments the court held, relying on KSR Int'l. Co. v. Teleflex Inc. ("The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person of ordinary skill in the art.") Not expressly stated in the Court's opinion was the extent to which its determination was affected by Lilly scientists possessing information not within the knowledge of the worker of ordinary skill.

Finally, with regard to the Jones patent (which disclosed raloxifene), the opinion relied on this patent having been filed before any of the bioavailability results were obtained or concerns were raised, and that "[t]he record does not contain any reason that a person of ordinary skill would have ignored those later publications." The Court also said that further evidence, specifically the results of the "failed" Buzdar study, would have precluded the skilled worker from having a reasonable expectation of success using raloxifene. The Court rejected Teva's arguments that the Buzdar reference did not attribute its results to bioavailability issues, saying the skilled worker could draw that inference.

The Court came to the same conclusions and affirmed the lower court's non-obviousness determination for the claims of the Low Dose patent. On appeal, Teva also argued that these claims were invalid under the doctrine of obviousness-type double patenting, based in part on the District Court's finding that the nature of the experiments to determine a clinically-effective low dose were routine (in its analysis addressing Teva's enablement challenge to these claims). The Federal Circuit noted that this challenge was not raised below, and that the "record is insufficiently clear for it to conclude that the proper resolution is beyond any doubt." Possibly significant (in view of the several recent instances of claims being invalidated for obviousness-type double patenting), the Court expressly stated that the policy rationales raised by Teva (that these patents extended Lilly's exclusivity term for Evista®) were not great enough to overcome the procedural deficiencies.

Teva also challenged the Bone Loss and Low Dose patents in the District Court on enablement grounds, and the Federal Circuit also affirmed the District Court's determination that the claims of these patents were enabled. Teva's enablement challenge sounded in operability under 35 U.S.C. § 112, 1st paragraph (which the Court has held has its own utility requirement distinct from the utility requirement under § 101; In re Brana). Here, the opinion cites the Manual of Patent Examining Procedure for its provisions relating to the effect of human clinical trials on the question of operability raised under 35 U.S.C. § 112, 1st paragraph (i.e., that having an on-going clinical trial is evidence that the invention is sufficiently operable for patenting purposes):

Before a drug can enter human clinical trials, the sponsor, often the applicant, must provide a convincing rationale to those especially skilled in the art (e.g., the Food and Drug Administration) that the investigation may be successful. Such a rational would provide a basis for the sponsor's expectation that the investigation may be successful. In order to determine a protocol for phase I testing, the first phase of the clinical investigation, some credible rationale of how the drug might be effective or could be effective would be necessary. Thus, as a general rule, if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility. MPEP (2008) § 2107.03 at IV (emphasis added).

The Court's opinion recognized that Teva's arguments relate to an inherent "Catch 22" regarding the relationship between the enablement requirement and the lack of a reasonable expectation of success in an obviousness determination:

To the extent that Teva revisits this [obviousness] argument in the enablement context, it appears to contend that Lilly's actions provide circumstantial evidence that an ordinarily skilled artisan would not have found helpful the facts on which the district court relied to hold that the patents are enabled. This court rejects that argument as well, and for essentially the same reason: it conflates the expertise of Lilly scientists with the knowledge of one of ordinary skill in the art. . . . Indeed, Lilly appears to have had many advantages that a person of ordinary skill would not have had, not the least of which was the FDA's prior approval of Lilly's IND application. Lilly's reliance on those advantages rather than its knowledge of Black's conjugate studies [relating to greater than expected bioavailability] to proceed with human trials does not create clear and convincing evidence that a person of ordinary skill would fail to find comfort in the latter.

The Federal Circuit also affirmed the District Court's finding that the asserted claims of the Particle Size patents were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112, 1st paragraph. These patents disclosed a range of particle sizes that increased bioavailability, wherein "within the claimed particle size range, the raloxifene particles provide 'surprisingly consistent in vivo absorption/bioavailability characteristics.'" The District Court construed the relevant claim language, "in particulate form," to include the size of the particles either in the pure active pharmaceutical ingredient (API) or in the tablet after formulation (which construction benefited Lilly's contention that the API had been prepared with easily-dissociated particles so that the API, but not the formulated tablet, would fall outside the scope of the Particle Size patent claims). Unfortunately for Lilly, however, the District Court found that the patent specifications did not disclose or describe determining particle size in the formulated tablet, and the Federal Circuit agreed:

[A]fter reading the patent, a person of ordinary skill in the art would not understand how to extract raloxifene particles from a formulation in order to determine whether they fall within the claimed particle size range and, in fact, would have no indication that size measurements on anything other than unformulated raloxifene would bear any relevance to the invention.

The Court affirmed, because since satisfaction of the written description requirement is a question of fact, it could not find that the District Court's decision was clearly erroneous, in particular due to admissions by Lilly's own expert regarding whether these embodiments were disclosed.

Since the Federal Circuit affirmed the District Court's decision that neither the Bone Loss nor the Low Dose patents are invalid, the injunction preventing Teva from providing generic raloxifene hydrochloride stands until expiration of the last expiring of these patents (March 2, 2014).

Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2010)
Panel: Chief Judge Rader and Circuit Judges Linn and Prost
Opinion by Chief Judge Rader

Posted at 11:48 PM in Double Patenting, Enablement, Federal Circuit, Obviousness, Written Description | Permalink | Comments (0) | TrackBack (0)

March 22, 2010

Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (Fed. Cir. 2010) (en banc)

By Kevin E. Noonan --

It's settled, then -- unless the Supreme Court decides to weigh in, there is a separate written description requirement in 35 U.S.C. § 112, first paragraph. The precedent developed since Regents of the University of California v. Eli Lilly & Co. is good law. This is the judgment of the Federal Circuit in an opinion by the en banc Court, written (appropriately) by Judge Lourie, and joined by every member of the Court except (predictably) Judge Linn and soon-to-be Chief Judge Rader.

The en banc opinion addressed all of Ariad's arguments, and found in favor of Lilly. Ariad helped the Court in arriving at this decision, in how it framed its responses to the questions presented by acknowledging that the statute contained a requirement for a written description. Ariad's position, according to the opinion, was that the measure of whether the written description was satisfied was enablement, and here the Court parted ways with Ariad's argument. The Court characterized this situation as the parties agreeing that the specification must contain a written description of the invention, but disagreeing on the standard for fulfilling it (as well as whether the requirement applies to originally-filed claims). The Court discussed Ariad's grammatical construction of 35 U.S.C. § 112, first paragraph, and particularly the argument regarding the significance of the comma after the phrase "and the manner and process of making and using it," and decided that Lilly's interpretation is the correct one. Specifically, the Court held that § 112, first paragraph, contains two separate description requirements: a written description of the invention and a written description of how to make and use it. The Court dismissed the grammatical argument thusly:

[W]e see nothing in the statute's language or grammar that unambiguously dictates that the adequacy of the "written description of the invention" must be determined solely by whether that description identifies the invention so as to enable one of skill in the art to make and use it.

The argument rests on the parallelism of the language (an analysis that forms one of the bases for Judge Rader's dissent, joined by Judge Linn). The Court also dismissed Judge Linn's position, that enablement is sufficient to satisfy the requirement of § 112, first paragraph, but on the backs of several of the amici's arguments (Judge Linn makes his "enablement is enough" argument in a separate dissent, joined by Judge Rader). According to the en banc opinion, this reading of the statute renders either "and the manner and process of making and using it" or "[a written description] of the invention" as surplusage, "violating the rule of statutory construction that Congress does not use unnecessary words," citing U.S. v. Menasche, 348 U.S. 528, 538-39 (1955). The Court completed this portion of its analysis by citing previous versions of the Patent Act, as well as first principles: "[e]very patent must describe an invention. It is part of the quid pro quo of a patent; one describes an invention, and, if the law's other requirements are met, one obtains a patent."

The en banc Court then reviewed the several instances of Supreme Court precedent raised by the parties, including Evans v. Eaton, O'Reilly v. Morse, Schriber-Schroth Co. v. Cleveland Trust Co., and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., agreeing with Lilly that this precedent recognizes a written description requirement that is separate from the enablement requirement of § 112, first paragraph. And the Court rejected the argument that interpreting § 112, first paragraph, as containing a separate written description requirement conflicts with § 112, second paragraph, saying that the claims "define the subject matter that, after examination, has been found to meet the statutory requirements for patent"; their purpose is not to describe the invention, but "to provide notice of the boundaries of the right to exclude and to define [the] limits" of the invention.

The Court also held that stare decisis principles required its decision. Having expounded on the existence of a separate written description requirement for over forty years, the Court held that they must "tread lightly" in upsetting the "settled expectations" of the patenting community. "If the law of written description is to be changed, contrary to sound policy and the uniform holdings of this court, the settled expectations of the inventing and investing communities, and PTO practice, such a decision would require good reason and would rest with Congress." The Court also opined that, while its use of the term "possession" regarding the written description requirement has "never been very enlightening," at the same time the Court had consistently applied the law in this area. And any inconsistencies in the application of the law in this area arose, according to the Court, because satisfaction of the written description requirement is a question of fact, and the different facts in each case (and arguments based on those facts) produced (not unexpectedly) varied conclusions. Thus, the Court did not intend to attempt to set forth any "bright line rules," for example, with regard to the number of species required to adequately describe a genus (thus dashing any hopes that this particular area of uncertainty would be settled by this opinion). However, there were "a few broad principles" that the Court said "hold across all cases":

We have made clear that the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366-67 (Fed. Cir. 2006). Conversely, we have repeatedly stated that actual "possession" or reduction to practice outside of the specification is not enough. Rather, as stated above, it is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008), or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565, 1571-72 (Fed. Cir. 1997).

The majority opined that while there may be many instances where there is "little difference" between describing an invention and enabling it, that will not always be the case, particularly in the chemical and biotechnological arts. A separate written description requirement "plays a vital role in curtailing claims that that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described." And "particularly for the biological arts," having a separate written description requirement "ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function."

Turning to the distinction, if any, between amended claims and original claims, the Court held that the analytical differences espoused by the parties with regard to the case law concerning amended claims -- Ariad contending that the distinction was based on enablement and Lilly on written description -- were semantic differences that did not change the outcome. Regarding original claims, the Court agreed with Lilly that, although rare, even original claims could encompass subject matter not sufficiently described to satisfy the disclosure requirements of § 112, first paragraph. There is "no principled basis" for distinguishing the requirements of original claims versus amended claims, or for restricting the written description requirement to policing priority (including nothing in the statutory language to support such a limitation). The "truism" that the claims are part of the original specification, as advocated by Ariad, does not mean that the invention has been sufficiently described merely by reciting it in an original claim:

For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.

"[G]eneric claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed." The Court also rejected Ariad's argument that the written description requirement was disproportionately applied to biotechnology inventions: generic language in an application as filed does not automatically satisfy the written description requirement in instances such as Fiers v. Revel, Eli Lilly and Enzo v. Genprobe.

The majority also rejected Ariad's argument that the Court applied the written description requirement disproportionately to basic research and inventions by academics and universities. This result is not inconsistent with sound policy that "basic" research may not lead to patentable inventions, characterizing the difference between "academic theories, no matter how groundbreaking," which are not patentable with inventions having a practical use, citing Brenner v. Manson that "[a] patent is not a hunting license. It is not a reward for the search, but compensation for a successful conclusion." While this situation may decrease incentives for university research, the Court is mindful of disincentives on "downstream research"; the goal, according to the Court, is to strike the right balance, which the majority believes it does: "giving the incentive to actual invention and not 'attempt[s] to preempt the future before it has arrived,'" citing Fiers.

Turning to the subject matter of the appeal, the Federal Circuit reversed the District Court's denial of JMOL, on the basis that no reasonable jury could have found for Ariad based on the facts adduced at trial. Specifically, the CAFC held that Ariad's evidence was either directed to the wrong priority date (the jury having found that the patent-in-suit was entitled to a priority date in 1989 while the majority of the evidence did not extend earlier than 1991) or was insufficient to support the "vast scope of these generic claims," especially in view of the "gaping holes in its disclosure" and the "primitive and uncertain" state of the art (considerations that, admittedly, resonate with the Wands factors used to assess compliance with the enablement requirement). The Court specifically disapproved Ariad's strategy of avoiding reciting any NF-kB inhibitor molecules in the claims in an effort to avoid the court's holding in University of Rochester v. G.D. Searle (that claims were invalid for failure to satisfy the written description requirement based on the failure to support a claim term for an inhibitor of COX-2).

Judges Newman and Gajarsa filed separate concurring opinions, Judge Newman addressing the need to protect early-stage technologies such as those developed by universities, and Judge Gajarsa opining that the majority's statutory construction was "reasonable" but not the only (or even a preferable or necessary) way to construe the statutory disclosure requirements (calling the text of 35 U.S.C. § 112, first paragraph, "a model of legislative ambiguity"). Judge Linn dissented based on his opinion that enablement is a sufficient measure of the proper extent of disclosure, and Judge Rader dissented (vigorously) based on his entirely contrary interpretation of the statute.

Regardless of these disparate voices, the Court majority affirmed the existence of a separate written description requirement. This opinion puts to bed one of the many recurring examples of uncertainty that have crept into its jurisprudence in recent years (at least until sufficient members of the Court have accepted senior status and new judges bring their views to bear on the question).

Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (Fed. Cir. 2010) (en banc)
Before: Chief Judge Michel and Circuit Judges Newman, Mayer, Lourie, Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore
Opinion by Circuit Judge Lourie, joined by Chief Judge Michel and Circuit Judges Newman, Mayer, Bryson, Gajarsa, Dyk, Prost, and Moore; additional views by Circuit Judge Newman; concurring opinion by Circuit Judge Gajarsa; dissenting-in-part and concurring-in-part opinion by Circuit Judge Rader, joined by Circuit Judge Linn; dissenting-in-part and concurring-in-part opinion by Circuit Judge Linn, joined by Circuit Judge Rader

Posted at 10:52 PM in Federal Circuit, Written Description | Permalink | Comments (11) | TrackBack (0)

December 14, 2009

Ariad v. Lilly: Oral Argument - Addendum

By Kevin E. Noonan --

At the outset of the en banc oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. last week, Chief Judge Michel asked Lilly's counsel whether Lilly had preserved the written description issue by timely objecting to District Court Judge Zobel's jury instruction (see "Ariad v. Lilly: Oral Argument"). This question was curious: perhaps Judge Michel (at right) wanted to be certain that the question was properly before the Court; perhaps he wanted to ascertain whether there was a simple answer to the complex question the Court had posed to the parties and amici; perhaps he wanted to avoid having the en banc Court make a definitive statement on the existence and scope of the written description requirement and invite Supreme Court review (a petition for certiorari is almost certain no matter how the Federal Circuit rules).

Charles E. Lipsey, Lilly's counsel, responded to the Court by pointing to a particular part of the record (specifically, A172-173), and promised the Court that Lilly would provide "additional information" on the question. That information has taken the form of a letter from Lilly's counsel to the Court, outlining how the jury instructions were proposed by the parties and adopted by the District Court during the patent infringement lawsuit, and the steps Lilly took to preserve the issue for appeal.

The letter (which contains copious citation to the record) is signed by co-counsel Howard W. Levine, and relates that both parties submitted written jury instructions to the District Court, and that there was a charge conference on April 26, 2007. However, at the charge conference, Judge Zobel informed the parties that "she had not determined how to phrase the parties' written description instructions in her 'own language' and needed additional time." She also informed the parties that they would not have the opportunity to review the instruction before she charged the jury, but would be able to make their objections after she had charged the jury. Mr. Levine states in his letter to the Court that Lilly timely objected to the instruction "at a sidebar conference" after the jury was charged (citing A172-173, the portion of the record cited at oral argument by Mr. Lipsey).

This objection "preserved the issue for appeal" according to Mr. Levine, citing Fed. R. Civ. P. 51(c)(2)(B) and Suprenant v. Rivas, 424 F.3d 5, 15 (1st Cir. 2005). In addition, Mr. Levine confirmed for the Court that Lilly raised the written description jury instruction in its motion for a new trial (A2774) and in pre- and post-verdict motions for judgment on the written description issue.

Finally, the letter reminds the Court that Ariad did not argue that Lilly had not preserved the issue for appeal.

After all the effort expended by the parties, amici, and the Court in bringing this issue to the brink of an en banc decision, it is comforting to know that the entire enterprise won't be derailed on procedural grounds.

For additional information regarding this topic, please see:
• "Ariad v. Lilly: Ariad's Reply Brief," December 10, 2009
• "Ariad v. Lilly: Oral Argument," December 9, 2009
• "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al.," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 11:59 PM in Federal Circuit, Written Description | Permalink | Comments (2) | TrackBack (0)

December 10, 2009

Ariad v. Lilly: Ariad's Reply Brief

By Donald Zuhn --

On Monday, an en banc panel of the Federal Circuit heard oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (see "Ariad v. Lilly: Oral Argument"). During the hearing, several members of the Court as well as counsel for the Government focused on perceived differences between the positions taken by Plaintiffs-Appellees ("Ariad") in their principal and reply briefs. (For a discussion of Ariad's principal brief, please see "Next Up: Ariad v. Lilly Rehearing En Banc"). Today, we examine Ariad's reply brief.

Ariad begins the brief by listing the points on which the parties and amici find common ground, stating that:

Lest it be obscured by rhetoric, it is important to note that there is much common ground amongst the parties and amici. Specifically, they agree that:
    1. The specification must provide a written description of the invention and of the manner and process of making and using it.
    2. The description requirement of § 112 applies to all claims, whether they were originally present in the application or not.
    3. The description requirement of § 112 polices an applicant's ability to add or amend claims during prosecution.
    4. A patent may not claim an invention that is not described in the specification.
    5. The description requirement of § 112 prevents claims that extend beyond the inventor's contribution as set forth in the specification;
claims of broad applicability must correspond to an invention that is identified in the specification by a broadly applicable common principle.

Ariad then summarizes the "actual disagreement" between the parties as concerning the issue of:

[W]hether § 112, first paragraph requires a written description of the invention that is separate from enablement. Specifically, is the entire written description required by § 112 (i.e., the description of the invention, and of the manner and process of making and using it) measured by the statutory duty to describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same," as Plaintiffs-appellants contend? Or, as urged by Lilly, does § 112 impose a written description requirement independent of the rest of the statute and measured by the judicially-created "possession" test of Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) and its progeny?

Ariad's brief next addresses the language of § 112, first paragraph, providing a table comparing the statutory constructions proposed by the parties:

Noting that "Lilly has effectively rewritten the statute by adding the italicized words," Ariad contends that Lilly's construction:

[S]evers the "written description of the invention" not only from the requirement to enable, but also from the requirement that it be in "full, clear, concise, and exact" terms. There is no reason for Congress to demand a written description of "the manner and process of making and using" the invention that is "full, clear, concise, and exact" while tolerating a "written description of the invention" that is incomplete, unclear, long-winded, and inexact.

As in its principal brief, Ariad examines and compares the statutory language from the Patent Acts of 1793, 1836, and 1952, and concludes that:

The history of the Patent Act also shows that, since 1793, the requirement for a description of the invention has always been linked with the requirement to describe the manner of making and using the invention, and has been measured by the text that follows, i.e., clear, concise and exact, etc.

Ariad's brief next provides a discussion of relevant Supreme Court precedent. Contending that Lilly "mischaracterizes the Supreme Court decisions on which it relies," Ariad states that "Supreme Court precedent both before 1836 and after 1836 provides no support for the view that the written description requirement is to be separated from its statutory standard for enablement, let alone that it be judged by this Court's current 'possession' test." Ariad notes that Lilly has failed to produce "even one post-1836 Supreme Court opinion in which the description of an invention claimed or otherwise identified at the time of filing was found to be deficient under any standard other than the enablement standard." According to Ariad, the reason for this failure is that:

The Supreme Court cases have never decoupled the "written description of the invention" from rest of the statutory language and have never held that a written description of an invention sufficient to enable others to practice a claimed invention could nonetheless fail because the description somehow did not "establish that the applicant was in possession of the claimed invention."

Ariad explains that when § 112, first paragraph, is interpreted as proposed in its briefs, the "description requirement" serves two purposes by: (1) "prevent[ing] patent applicants from introducing new or amended claims directed to a different invention than is described in an earlier-filed specification," and (2) "ensur[ing] that the claims -- whether original or amended -- match the inventor's contribution to the art." With respect to the second objective, Ariad notes that claims encompassing more than the particular embodiments disclosed in the specification must be supported by an identification of "the common principle that defines the invention and distinguishes it from the prior art."

In the last portion of its reply brief, Ariad outlines how the claims at issue in the appeal satisfy the "description requirement" of § 112, when § 112, first paragraph, is construed as proposed in Ariad's briefs. Ariad then summarizes its opponent's argument by stating that:

Under Lilly's view, even though the claims-in-suit might be directed to novel, useful, non-obvious, and statutory methods, and even though the '516 patent applicants might have complied with their statutory duty to provide a written description of their invention "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same," the asserted claims are nevertheless worthless and void because the '516 patent applicants purportedly did not comply with a "separate", non-statutory, judicially-devised duty to describe their invention in terms that a court or jury might deem sufficient to prove that the '516 patent applicants had "possession" of the claimed methods to a legally sufficient degree.

Ariad, however, counters by arguing that:

The discoverer of a new and non-obvious process, whose use is not tied to particular materials or machines, has never been restricted in his or her patent protection to the details of particular instrumentalities that were then the best-known ways of carrying out the process. Lilly's "written description" arguments are aimed at denying patent protection to upstream researchers who discover and disclose generally applicable methods that Lilly would then subsequently exploit.

For additional information regarding this topic, please see:
• "Ariad v. Lilly: Oral Argument," December 9, 2009
• "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al.," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 11:50 PM in Federal Circuit, Written Description | Permalink | Comments (2) | TrackBack (0)

December 09, 2009

Ariad v. Lilly: Oral Argument - Updated

By Kevin E. Noonan --

Oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. was heard on Monday before an en banc panel of the Federal Circuit. Counsel for Ariad (John M. Whealan), Lilly (Charles E. Lipsey) and the U.S. Patent and Trademark Office (Mark R. Freeman) argued before an active Court, with most questioning coming from Judges Rader, Dyk, Lourie, Linn, Moore, and Newman. While active, the Court and counsel avoided the principal question lurking under the question of whether there is a separate written description requirement (one of the questions posed to the parties and amici by the Court). That question is what is the standard for assessing patentability under circumstances when the mere recitation of an invention -- i.e., simply naming it -- is insufficient to inform the skilled worker of what the invention is, even if the disclosure as a whole enables the skilled worker to make and use the invention.

Mr. Lipsey, Lilly's counsel, began the argument, and was almost immediately sidetracked by two questions from the Court. First, Judge Lourie asked whether written description should be considered a question of law or fact. Mr. Lipsey answered that it always was described as a question of fact, but had "come to be resolved like claim construction," being determined from "the four corners of the document." He said written description was akin to the question of conception, citing Professor Liivak's amicus brief to the effect that the specification is the "corroboration of conception." This colloquy continued, with Judge Gajarsa suggesting that the written description issue could be treated like obviousness, being a question of law with underlying facts, to which Mr. Lipsey noted that this is how conception is assessed, so it would provide a logical way to do it.

At this point Chief Judge Michel (at right) asked whether there is any evidence that there is a harm in considering the written description requirement as a question of fact? And more importantly, whether there was any evidence that any cases would have a decision changed if written description was considered a question of law versus a question of fact? And finally, he pointedly asked Mr. Lipsey whether, if it's a question of fact, "do you lose?" When Mr Lipsey answered "no," Judge Rader quickly asked, "Then why do you care?" Lilly's counsel quickly responded, "I don't, I was asked the question," prompting the first of several outbursts of laughter from the gallery.

Chief Judge Michel also delayed counsel arriving at the substantive portion of his argument by asking whether the District Court had ruled on alternative jury instructions regarding the written description issue. This portion of the argument devolved quickly into specific questions of whether a timely objection was made and alternative jury instruction proffered, and whether there was a charge conference where the District Court considered the "proper" instruction. Mr. Lipsey replied that the jury instruction permitted Ariad's claim to satisfy the written description requirement if the claims recited NF-kB inhibitors functionally, while Lilly insisted that the Federal Circuit's jurisprudence required there be some disclosed structural correlation with function.

Judge Linn (at left) then asked, "if the original claims are published, how can they fail the public notice test?" Mr. Lipsey responded that claims satisfy the notice function as to what the boundary of the invention is but do not describe the invention. The Court countered, asking "don't the claims describe what the inventor considers to be his invention?" "They sometimes do, but they often do not," according to Mr. Lipsey, reciting Judge Rich in a footnote in the In re Vanco case. There, Judge Rich said, patent claims describe the boundaries of the invention, like lot lines do with real property. But those boundaries do not describe the land itself, or in this context, the invention according to Mr. Lipsey's argument. Judge Lourie then applied the question to genus/species claims, asking: "Isn't the question of support that you possess a sufficient portion of the genus to be entitled to the boundary?" Mr. Lipsey's answer was that this is always the inquiry if you claim a genus, whether you have sufficient support for a generic invention in the description, which can be satisfied "in any one of a number of ways," reciting a sufficient number of species or a generic description of a chemical compound as examples. Judge Linn then asked: "Doesn't the statute specify the way to do it, sufficiency is measured by enablement?" Mr. Lipsey responded that this is one thing the statute requires. The second thing the statute requires, he argued, is that the thing claimed be something that the applicant invented -- as shown by an objective analysis of the four corners of the patent document. He maintained that this description of what the inventor had invented had "always been required," citing O'Reilly, Schriber-Schroth, In re Moore, and In re Ruschig.

Judge Dyk (at right) asked: "In light of what Mr. Whealan has conceded in his brief, what is the practical difference in Lilly's position and Ariad's position?" (It should be noted here that Ariad's reply brief seems to have hurt its position somewhat, because some of the judges seem to believe that Ariad had "retreated" from the position it espoused in its opening brief.) Mr. Lipsey took this occasion to make the strongest statement of Lilly's position, saying that "the question of whether the specification describes what an inventor has invented is fundamentally different than the question of what a hypothetical person of ordinary skill (in possession of all that is known in the art) might without undue experimentation be able to do." Judge Dyk pressed its question, asking: "But don't you take Mr. Whealan to have conceded that the specification must provide a written description as part of the enablement requriement?" Mr. Lipsey answered by both taking advantage of this characterization by the Court yet distinguishing Lilly's position from Ariad's. He said that while Mr. Whealen "does concede that, but then he circularly says the sufficiency of it is to be determined by enablement." This was the error in Ariad's position, according to Mr. Lipsey, since "the case law is clear that if an inventor has not originated the subject matter, has not invented it, as reflected in the corroborated conception, the patent document, he is not entitled to a patent on it, that is how our system is set up."

Mr. Lipsey continued in this vein, that the patent must go to the "originator" and not to a third party who could build upon what is contained in the patent specification. He cited Schriber-Schroth as making this "abundantly clear," because the Supreme Court "accepted that people of ordinary skill in the art would recognize that a flexible web could be used" with the claimed invention, but that wasn't described in the patent. Judge Rader asked whether the case said that the flexible-web embodiment of the invention in Schriber-Schroth had not been "described or identified" (foreshadowing a distinction made later by Mr. Whealan). The reason for this distinction, according to Judge Rader, was that applying the written description requirement as advocated by Lilly would "turn claim construction into a validity doctrine." (Mr. Lipsey later expressly answered this question, saying that that was claimed in the Schriber–Schroth case "was not the invention described, so it was a matter of description there.") The Judge went on to say that "[c]laim construction is the most difficult area, given the philosophical imprecision of language, we find that varies even from panel to panel, yet now you are making that a validity doctrine, does that trouble you at all?" Mr. Lipsey responded that he "wasn't making anything anything," and that the statute and a long history of court decisions supported his position. Judge Rader disagreed, asking (repeatedly) for one example of a case where the written description requirement was used outside the priority context. Mr. Lipsey responded that if there was a written description requirement in the statute (and both the Court and Mr. Lipsey agreed that Ariad had conceded that there was), "it has to apply to all claims in all applications in all arts." In response to repeated demands from Judge Rader for a case law example supporting Lilly's position, Mr. Lipsey proferred In re Sus and In re Moore without further argument.

Mr. Lipsey was permitted to make the following cogent statement of his argument:

The cases are clear, from O'Reilly to the present day, that there is a requirement separate and apart from what anyone else looking might have been able to do it, that will limit what a patent applicant can claim in his application, and that is that he must have demonstrated within the four corners of the application as it is read by one of skill in the art that this is something he invented, i.e., something he conceived, and because not all ideas are legally sufficient conceptions, and indeed many of them are not, research plans, the germ of an idea as in Genentech v, Novo Nordisk, not all ideas are conceptions, and it's up to the court to look at what this inventor actually invented what he is now claiming, and normally, I agree, in 99 out of a 100 cases, written description and enablement stand and fall together, but they need not as Schriber–Schroth indicates and it is now and has always been a validity defense and a validity requirement.

He then turned to a further response to Judge Rader's question of whether the written description requirement applies outside the priority context, making reference to the language of § 120 of the statute.

Section 120 of the statute tells you when you are entitled to an earlier application filing date and it doesn't say that the claim has to be presented in the earlier case. There is only one requirement, it says it has to comply with Section 112, and if it does, you are entitled to that date. And indeed, I believe it has been conceded by Ariad that in that environment, the written description analysis is performed all the time, and if that's the case it can only go on under that statutory framework if it is a statutory requirement of Section 112, and if you accept that, there is no principled reason why the written description requirement does not apply to all claims in all applications at all times in all arts, which is what we contend.

(Judge Lourie helpfully asked, "isn't it true that there is no limitation of 112 to the priority question?" to which Mr. Lipsey answered: "Indeed, it does not.")

Judge Rader then asked: "Why did Judge Rich create the written description requirement in Ruschig? Why did he say in Rasmussen that he was applying it as it had been applied in priority questions? It was created for that purpose and he moved it out of the 130 Section because he was uncomfortable with the narrow interpretation of new matter? So if it was created to be so narrow, how did it suddently get to be so broad?"

Mr. Lipsey replied that he begged to differ: "It [the written description requirement] was not created in In re Ruschig, it had been in existence a long time by the time of Ruschig and was not an unusual rule." Responding to Judge Rader's challenge for "evidence that it had been in existence a long time," Mr. Lipsey replied that "O'Reilly v. Morse said, you are trying to claim something you didn't describe and haven't invented, you're out of here, Schriber–Schroth said you are trying to claim something you didn't describe." When Judge Rader characterized these cases as "enablement cases," Mr. Lipsey replied that "the word they used was described." Judge Rader then made his most direct statement of his previously-asserted position on the question, saying that the Court in these earlier cases used the word "described" "consistent with the statutory requirement, because the description was so as to enable, so you can use either term and be discussing the same thing." Mr. Lipsey asserted in response that "the Schriber–Schroth case described the thing changed that everyone would have known, and the only reason not to allow the patentee to claim it is that it was not what he had described." Judge Rader countered that "Schriber–Schroth said that the patentee must describe his invention so that others may construct and us it. They used description in its proper enablement context, identification and enablement, the claim scope identifying and the description enabling."

In his response, and final argument before his time was up, Mr. Lipsey made Lilly's argument for the difference between Ariad (and Judge Rader's) view, along with a suggestion that "overturning settled expectations" was not the Court's proper role:

What gets left out is the fundamental requirement of a U.S. patent that the person who applied for it invented what is being claimed, and that is judged by reference to his own description of his invention, the corroborated evidence of what he conceived, and if he didn't invent it, he isn't entitled to a patent, whether anyone else could have done it or not. And that's the structure of our system, and if this is to be changed, this interpretation of the statute has been in effect from 30, 40, 50, 100 years, and the Act has been amended many times, and not once has it been suggested that it be changed, and we suggest that the prudent thing, rather than upset settled expectations, it is for Congress.

The Court then heard from the Patent Office representative, Mr. Freeman, who directly addressed Judge Rader's argument that the early Supreme Court cases cited in support of a written description requirement were enablement cases, saying: "We don't think there is any way to read Schriber–Schroth, Permutit, or Moore as merely reflecting an enablement question," and then proceeded to recite the Question Presented in Schriber–Schroth, asking whether the defendant could be held liable wherein elements of the claimed combination were not described.

Judge Moore (at right) asked whether any of Ariad's claims at issue were originally-filed claims, and whether originally-filed claims could fail the written description requirement. She also asked specifically whether there were cases outside the genus/species situation in chemical cases where an originally-filed claim could fail the WD requirement? Mr. Freeman answered that, yes, claiming in purely functional terms, even as an original claim, could fail the requirement, citing the Office's Written Description Guidelines "where the specification describes how to make a compound but it is claimed by function, having a scope to any compound having that function." He went on to say that fulfillment of the written description requirement by originally-filed claims is presumed, and cases where these claims failed to satisfy the written description requirement should be "rare." He said that the "fight over original claims is a fight over whether it is always true that original claims describe themselves or if in the rare instance they may not."

Judge Dyk asked whether there was "really a difference" between what the Patent Office was saying and Ariad was saying (again, seeming to adhere to the position espoused in Ariad's reply brief rather than its principal brief) -- "what are we arguing about," he asked. Mr. Freeman responded that this would be "a great question for Mr. Whealan," provoking another round of laughter. Responding to the question, Mr. Freemand characterized Ariad's reply brief as being "baffling," and said that if all agree this means that when we judge "whether a patent does A and B, we look only at B -- we don't think it consistent with the text [of the statute]. The statute does not say the description is required only insofar as it enables."

Returning to the fray, Chief Judge Michel asked: "Why does the PTO care? How many applications are there that can't be rejected on other grounds?" and "I'm not asking about history, I'm asking about impact?" Mr. Freeman responded that he didn't know the precise numbers, "but number must be high -- there are 400,000 applications examined each year, and it has become increasing popular to claim inventions by their functions or effect or to describe species and claim the genus." The written description requirement was "one of the basic tools" the Office uses "to constrain these claims and to make the patentee make clear to the public what the scope of the invention is."

Judge Rader countered that he didn't see any evidence of the written description requirement being used in Office rejections in the 300-400 cases that come to the Court each year -- not a "a single case." Although Mr. Freeman began a substantive response -- "You cannot assume away 400,000 cases, the vast majority of the PTO's decisions are not litigated," Judge Newman (at left) chimed in, quietly saying: "Let me help you" (and provoking another round of laughter). Judge Newman said:

When I started, chemistry was the hot area, and the question of how many species you needed was assessed by the written description requirement, and while many things have happened [since] . . . we have come full circle, where there are generic concepts, this case is a good example, and how one describes the genus depends on how much detail is required. In some areas, description and enablement are not co-extensive. And generally when it comes up in the Office it is resolved, so I agree completely that it is quite rare to see those cases on appeal; they are not insoluble, it is much easier to run some experiments than to appeal and come back a decade later. The principle is importantly illustrated in this case, where the outcome may depend on how we answer the questions.

Judge Lourie then threw Mr. Freeman a softball, asking: "Doesn't it occur that someone files a broad claim and exemplifies it with very little, because it is all they have, and the PTO rejects on written description?"

In answering "Yes" to this question, Mr. Freeman used the Tronzo case as an example. Judge Rader remained unconvinced, asking: "Why isn't that covered in the vast majority of cases by the doctrine of enabling throughout the scope of the claim?" While agreeing that this could be the case, Mr. Freeman maintained that while it could be true in some cases, it is "not always true that what isn't described isn't enabled," using In re DiLeone as an example.

To this, Judge Lourie said: "It's because they are related, you have enabled other species but have not described it," and Mr. Freeman agreed as Judge Rader informed him that his time had expired.

Mr. Whealan (after exchanging pleasantries with Chief Judge Michel) was immediately directed to Judge Lourie's perception that there were significant differences in the positions taken in Ariad's opening brief and its reply brief. He was pointedly asked if Ariad had "retreated," and parried this question with a clear statement of Ariad's position:

What this Court has done is delinked the written description of the invention from the rest of the words of the statute, and what we are suggesting is that the description of the invention, and of how to make and use it is measured by the following terms. Therefore it has to be clear, precise and exact, and it has to enable. If this were not the case, then Congress would have said that the written description of the invention does not have to be clear, precise and exact terms, but the written description of the manner of making and using it does. That makes no sense.

He then also announced that he was not going to use "labels" (presumably, "written description" and "enablement"), but was stopped from developing this theme by a question from Judge Prost (at left), citing to that inconvenient reply brief -- with reference to the statements in the reply brief about the written description matching the inventor's contribution: "Are you saying that there is no way that you can enforce the written description requirement except by the enablement portion?" "Absolutely not," Mr. Whealan replied. Ariad's position was that the Court had delinked the written description and enablement requirements, leaving the Court with no standard for assessing compliance with the written description requirement. This led to the development of the "possession" standard, which led to the requirement to supply sequences and structure. "Possession does not exist in the statute," he said, "and it doesn't exist in the case law."

The main portion of his argument was linked to the Telephone cases and (to a lesser extent) to other early cases, where he maintained that the evidence was that the inventor had not made the invention and had not actually made all embodiments within the scope of the patent claims, was permitted to claim broadly because he had enabled the skilled worker to practice the invention. He said that the standard under the Court's jurisprudence had shifted from whether the inventor put the public in possession of the invention to whether the inventor was in possession of the invention, and ultimately to what the inventor had actually done. He said that Bell would have failed under the possession test used by the Court, because Bell didn't get the invention to work, others did. Judge Dyk noted that Lilly was not espousing that there has to be an actual reduction to practice, and Judge Linn asked what was the difference between possession and identification? Mr. Whealan used a perpetual motion machine as an example, where you could identify it but not enable it.

Judge Lourie (at right) then mentioned that almost all the amici, across all technologies and sizes, and most of the major patent bar associations, all disagreed with Ariad's position (at least the one taken in its principal brief). "What do they know that you don't?" he asked. When his initial response ("people like invalidating patents for any reason") was shot down by the bench, noting that the opinion was held "on both sides" (presumably, companies like Microsoft that frequently criticize patents and companies like Amgen that depend on patents), Mr. Whealan charged that Lilly and amici had set up "a strawman," that Ariad was not suggesting that the written description requirement be "read out" of the statute (something that might come as a surprise to anyone who read Ariad's principal brief and the grammatical parsing of the statutory language), but that the Court needed to enunciate the right standard. He also said that, in view of the vast sentiment against Ariad's position (characterizing the amici as "noise"), Ariad could only prevail if he were to convince the Court that ruling in Ariad's favor would not "harm the system."

When he began his argument with regard to the Supreme Court never having held, as the Federal Circuit has done, that there are separate written description and enablement requirements, he was interrupted by Judge Newman, who noted that while there are not cases that have come before the Court, that is because of the nature of the inventions in which the problem arises that they can be enabled -- "getting a gene out of a chromosome," which is "well known" how to do -- without being described. Mr. Whealan asserted in response that an applicant would not get a patent under these circumstances, without supporting that statement with any citation or other authority (perhaps erroneously believing that In re Kubin has foreclosed patentability to gene claims).

He also maintained that "an original claim defines itself," and that Lilly had changed this requirement because "under Lilly you would have to show possession." In response to Judge Lourie's question concerning whether the factfinder needs to believe a genus has been described, Mr. Whealan said the Federal Circuit should "follow the Supreme Court" with regard to "whether the description matched the inventor's contribution." He then contrasted the Telephone cases -- where Bell was granted broad claims to his manner of transmitting voice over a distance -- to the Incandescent Light cases, where the broad claims were not valid since most of the claimed "fibrous material" did not work (prompting one of the judges to ask whether Mr. Whealan was arguing a utility aspect to the question). Judge Dyk asked Mr. Whealan to describe the difference between "identifying" and "describing" in view of his position that he would use the former but not the latter term. Without directly responding, Mr. Whealan argued that "putting the statute back together" would lead the Court to applying the Telephone cases and that precedent, which he characterized as Supreme Court teaching that a patentee would not be limited to "how you did it" (i.e., practiced the invention). If you had "changed the way to do something, then [you are] entitled [to a patent,]" he said.

Judge Lourie then asked whether there were "a lot of broad claims with little support that [have] to be rejected?" Mr. Whealan turned again to the Incandescent Light cases, to which Judge Lourie said: "That was 150 years ago, we're dealing with today," and asked about the Gentry Gallery case. The question wasn't that the claim wasn't enabled, Mr. Whealan said, but that if you failed to identify, you failed enablement. Judge Moore asked in this regard whether requiring that a claim be enabled throughout its full scope would "satisfy this problem." Again pointedly reminding the Court that he was "avoiding labels," Mr. Whealan agreed. Judge Moore then turned to the facts of this case, and asked whether the other examples disclosed in Ariad's specification would "work like decoy molecules." Mr. Whealan said the answer is no, but that the patentee had identified the concept of preventing NF-kB from "hitting" (actually, entering) the cell nucleus, and identified three ways to achieve that goal. He then asserted that "others" did just what the patentees had told them to do and "got it to work." He cited the "Michigan paper" that the patentee had "told them what to do" and that they "just did it with the exact sequences disclosed by the patentee." He characterized the inventors -- "research university people" -- as "figuring out the key thing to do," and that "the Michigan people wouldn't have known to look at NF-kB."

Judge Moore then asked whether the Court should use the principle of stare decisis to "leave it alone?" Mr. Whealan responded that since the Supreme Court had not "done the analysis," there was no stare decisis (nicely disparaging the Federal Circuit's own precedent). He also noted the disagreements between the judges of the Federal Circuit, and said that this case was a "progression of the Court's jurisprudence" on the issue.

Judge Newman acknowledged that this case presented questions that concerned "very fundamental aspects of policy based on areas of technology -- how far an applicant must go with a scientific concept before the fundamental requirements of patentability will be met." She said it was "easy to understand why this issue has not been before the Supreme Court," and that in the earlier cases "the issues were much easier," mentioning that in O'Reilly, "the Supreme Court said of course you couldn't patent electromagnetism." Mr. Whealan countered that to the people in the late 19th Century, the telephone was "revolutionary" technology.

In his final remarks, Mr. Whealan restated Ariad's position that "if you teach enough that someone could do it, that satisfies it [the disclosure requirements of Section 112]." He said that "Ariad taught people what to do and they did it."

In rebuttal, Mr. Lipsey dismissed Ariad's reliance on the Telephone cases, saying that these cases "have nothing whatsoever to do with written description," involving a "unique" claim set reciting the apparatus "as herein described." He said that there was "no holding that identification of a common principle entitles you to claim every way of attaining it. The cases are legion that what you are trying to do is claim the desired result, as in Morse and the ice cutting case, those claims are improper."

He also dismissed the argument about the word "possession," saying that "Carnegie Mellon and LizardTech makes clear that it is a synonym for 'did he invent it?'"

Judge Dyk asked whether the issue was "the difference between a research plan and an invention, and that the parties would draw the line in different places?" Mr. Lipsey agreed, but said that "the only way to get there is to do away with the statutory requirement." The statute defines what is required -- did the inventor conceive the invention and reflect that conception? He also agreed with the final question posed by Judge Lourie, to the effect that "possession" is a synonym for what an inventor invented and disclosed.

While there is little to be gained by speculating on how the Court will rule based on the questioning from the bench, a remarkable aspect of the argument is that neither party addressed four-squarely the issue underlying the argument: how much disclosure is required for inventions and in arts where merely naming something is insufficient to describe it? There are consequences (positive and negative) for patentees and the public under the Court's current written description jurisprudence, as evidenced by the arguments from the amici involved, as targets or enforcers of patents under the current interpretation of § 112. What the Court should consider is whether or not these consequences are in sufficient balance, and what the consequences would be if the Court significantly modified its application of the written description requirement, thereby unsettling the expectations that have arisen in the patenting community during the development of the modern form of the written description requirement.

Patent Docs thanks Professor Oskar Liivak of Cornell Law School, who attended the oral argument and kindly provided identifications of a number of judges who asked questions during the hearing.

Posted at 11:24 PM in Federal Circuit, Written Description | Permalink | Comments (13) | TrackBack (0)

December 06, 2009

Amicus Briefs in Ariad v. Lilly: Regents of University of California et al.

By Donald Zuhn --

In anticipation of tomorrow's oral argument in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (scheduled to begin at 2:00 pm (EST) in Courtroom 201), Patent Docs has spent the past three weeks reviewing a number of the briefs submitted by various amici. By the November 20th filing deadline, twenty-five amicus briefs had been submitted (by our count), with nineteen briefs filed in support of Defendant-Appellant-Respondent Eli Lilly & Co. and/or judgment of affirmance, six briefs filed in support of neither party, and no amicus briefs filed in support of Plaintiffs-Appellees-Petitioners Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the Presidents and Fellows of Harvard College ("Ariad"). Amici supporting Lilly and/or affirmance include:

• Abbott Laboratories (see Patent Docs report);
• The American Intellectual Property Law Association (AIPLA) (see Patent Docs report);
• Amgen Inc. (see Patent Docs report);
• Professor Christopher A. Cotropia (brief);
• The Federal Circuit Bar Association (see Patent Docs report);
• GlaxoSmithKline (see Patent Docs report);
• Google Inc., Verizon Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
• Hynix Semiconductor Inc. and Samsung Electronics Co., Ltd. (see Patent Docs report);
• The Intellectual Property Owners Association (IPO) (see Patent Docs report);
• Oskar Liivak (brief);
• Medtronic, Inc. (see Patent Docs report);
• Microsoft Corp. (see Patent Docs report);
• Monsanto Co. (see Patent Docs report);
• Public Patent Foundation (PUBPAT) (brief);
• RealNetworks, Inc. (see Patent Docs report);
• The Regents of the University of California, Wisconsin Alumni Research Foundation, The University of Texas System, University of Rochester, Rensselaer Polytechnic Institute, STC.UNM, The Research Foundation of State University of New York, NDSU Research Foundation, and Research Corporation Technologies, Inc. (discussed below);
• United States (see Patent Docs report);
• Washington Legal Foundation (brief); and
• William Mitchell College of Law (brief).

Amici supporting neither party include:

• Professor Christopher M. Holman (see Patent Docs report);
• Mark D. Janis and Timothy R. Holbrook (brief);
• Dr. Roberta J. Morris (brief);
• The New York Intellectual Property Law Association (brief);
• Novozymes A/S (see Patent Docs report); and
• University of Kentucky Intellectual Property Law Society, Universal Support Systems LLC, Polymer Construction Products Ltd., and Safeteccs LLC (brief).

On the eve of oral argument, we examine the amicus brief filed by The Regents of the University of California, Wisconsin Alumni Research Foundation, The University of Texas System, University of Rochester, Rensselaer Polytechnic Institute, STC.UNM, The Research Foundation of State University of New York, NDSU Research Foundation, and Research Corporation Technologies, Inc. in support of affirmance of judgment. The university amici begin their brief by describing written description as a doctrine once used only to police claims to priority of invention, but having "evolved judicially into a separate and oftentimes insurmountable requirement, particularly when applied to biological inventions." The amici argue that "[t]he Federal Circuit's creation of this separate barrier to patentability . . . effectively imposes an actual reduction to practice requirement on biotechnology inventions," and that "[s]uch a requirement prejudices universities and research institutions that do not have the resources to reduce each pioneering biotechnological innovation to a 'precise definition.'"

Stating that "[t]here is no statutory support and certainly no policy rationale for the technology-specific impact the current written description law has on the university and scientific research community," the university amici contend that:

[T]he current incarnation of written description is not only at odds with the Federal Circuit's own jurisprudence bestowing broader patent protection to pioneering inventions, it muddies clear federal policy with respect to the role of the patent system. Patent exclusivity granted for pioneering biological inventions fuels the creation and recruitment of commercial entities willing to undertake the huge investments necessary to refine and develop foundational university research into medical and biopharmaceutical products widely accessible to the general public.

The amici suggest that the Federal Circuit "take the opportunity now to realign the written description law with the constitutional, statutory, and policy rationales that underlie the patent system, and return the doctrine to its proper role of assessing new matter rejections and claims to priority."

In arguing that § 112, first paragraph, does not contain a written description requirement separate from the enablement requirement, the university amici spend some time discussing In re Ruschig, 379 F.2d 990 (CCPA 1967), a decision the amici contend was not based on § 112, but rather concerned the issue of whether a new claim added during prosecution was properly rejected as new matter. The university amici believe it is "noteworthy that the cases after Ruschig purporting to apply a separate written description requirement were limited to those involving (1) the presentation of claims not presented in the application when originally filed, (2) entitlement to the benefit of an earlier filing date for claims in a later-filed application, and (3) interference proceedings," adding that "[e]ach of those 'written description' cases involved evaluating the sufficiency of the claims in accordance with statutes governing a patent claim's entitlement to priority and the prohibition against adding new matter." Noting the written description case for which one of the amici is closely associated, especially in the minds of biotech practitioners (i.e., The Regents of the University of California is v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)), the brief states that:

It was not until Lilly that a truly separate written description requirement -- untethered to any other patent statute -- was first created. Beyond evaluating the sufficiency of claims added during prosecution, written description became a device for evaluating the sufficiency of disclosures in already-issued patents. There was, however, no statutory change or legislative pronouncement to justify departing from the previous thirty years of precedent that limited written description to its corollary function of policing priority.

The university amici also argue that there was no need to expand written description, because through In re Wands, "[t]he enablement inquiry already considers factors intended to assess the sufficiency of the disclosure."

Returning to the impact of a separate written description requirement on universities, the amici argue that the separate requirement "operates to prejudice inventors at universities and other research institutions who often make the most important basic scientific discoveries," as "[u]niversities do not have the resources to support the time and labor-intensive process of reducing every species of a genus to practice or describing, for example, every possible amino acid or DNA sequence in exhausting detail as needed to 'precisely define' and adequately describe a biological invention." According to the university amici, the impact of a separate written description requirement on universities also frustrates federal patent policy:

A statutory interpretation of the written description requirement that unfairly prejudices biotechnology and university inventions impedes . . . growth and frustrates the goals of the patent system. It limits universities' ability to obtain biotechnology patents, depriving the public of the full economic benefits and potentially life-saving products that flow from licensing relationships between universities and private corporations.

The amici also argue that a separate written description requirement conflicts with the broad patent scope the Federal Circuit has bestowed on pioneer patents, stating that "what this Court grants to pioneering inventions with one hand, it takes away with the other." In particular, the university amici contend that the Federal Circuit has used the separate written description requirement to invalidate some patents, "claiming the patent disclosures do not support the breadth of their claims," and that "[s]uch a requirement values minor incremental improvements well-suited to precise description over the monumental advances in technology often incapable of precise written description." The amici state that "[i]t is inconsistent for Federal Circuit jurisprudence to acknowledge pioneer patents' entitlement to broad claims, while applying a written description standard that invalidates them on those same grounds."

The university amici conclude by asking the Federal Circuit to return the written description requirement "to its historic role in the priority context, ensuring that later-filed claims are supported by the disclosures in an earlier-filed patent application."

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 11:59 PM in Federal Circuit, Written Description | Permalink | Comments (2) | TrackBack (0)

Amicus Briefs in Ariad v. Lilly: Briefs by Companies

By Kevin E. Noonan --

Several companies have filed amicus curiae briefs with the Federal Circuit on the questions presented by the en banc Court in the Ariad case. Although we have explored the positions taken by some of these companies in detail, on the eve of oral argument, we set forth here briefer synopses of the positions taken by the remaining technology companies that have filed amicus briefs. While most of these companies have taken positions supportive of Lilly on the question of the existence of a separate written description requirement, one company (Novozymes) supports Ariad's position and another (Monsanto) argues for the existence of a separate written description requirement but at the same time maintains that the Federal Circuit has misapplied the standard in Regents of the University of California v. Eli Lilly & Co. and subsequent cases.

Amgen: Amgen has an interest in the outcome of this case insofar as Amgen filed a declaratory judgment action against Ariad on the same patents at issue in Ariad v. Lilly. Amgen prevailed in its action on summary judgment of non-infringement, based inter alia on the extracellular situs of the action of its Enbrel® product on NF-kB activity. Amgen filed its brief in support of affirmance of the judgment, and answers the first question presented by the en banc Court in the affirmative, that 35 U.S.C. § 112, first paragraph, contains a written description requirement separate from the enablement requirement. The brief argues that the written description requirement promotes innovation by ensuring that inventors "carry their work to fruition" before filing a patent application. The brief also asserts the notice function of patents, so that the public can appreciate the metes and bounds of the invention to determine its preclusive effects on their inventions. The brief distinguishes both enablement (requiring a disclosure that permits public to practice invention once patent expires) and definiteness (which requires a precise delineation of the boundaries of exclusive power granted to a patentee) from the written description requirement, which ensures that an applicant had possession of the invention at the filing date. The brief argues that:

Without a written description requirement, there would be no reliable basis to assess the future patent risk of continued research and development, and far less enthusiasm or incentive to proceed. In short, by requiring each applicant to describe in writing and thereby delimit their professed invention, the written description requirement promotes rather than quells innovation,

characterizing this as an "objective standard" and citing Evans v. Eaton, O'Reilly v. Morse, Schriber-Schroth, Festo, and Permutit v. Graver.

The brief also recites the high cost of investment and high rates of failure in developing biotech drugs, because "it is also important to ensure that such innovation is not preempted by those who provide no solution but only describe a problem and attempt to claim in a patent any or all solutions to the problem."

Expanding beyond the parochial scope of its own concerns, Amgen's brief cites the concern of the "high technology" companies regarding "recasting the claimed scope of his invention to dominate the innovations of others in the field":

While failure is an orphan, success knows many fathers. Few patent-holders assert their claims against products that fail in the clinic. But when innovators are successful after years of painstaking, costly research and development, others with patent applications still pending often try to dominate that proven success by claiming the innovator's success as their own invention. The written description requirement prevents patent applicants from treating their disclosures as "a nose of wax."

The brief admits that courts and the Patent Office may apply the written description requirement too stringently and that this could negatively impact universities and small entities without the resources to rigorously establish every detail of how their inventions work. But the brief agrees with the position taken in the Intellectual Property Owners amicus brief that the Court does not write on a clean slate and has a body of well-developed case law to rely upon:

Amgen agrees that requiring excessive detail or analysis in a patent disclosure or narrowing the scope of claims to the precise details of the disclosure would be injurious to the patent system and stifle innovation. But, in our view, the written description pendulum has not swung that far.
The description requirement, as currently applied, walks the fine line between rewarding a patentee for his/her actual invention and encouraging innovation by a competitor by requiring that a specification reasonably convey to an ordinarily skilled artisan "possession" of the claimed invention. It is only if this balance is tipped, as Ariad and some of the amici suggest, to do away with the description requirement all together, or alternatively, to require an actual reduction to practice in all instances, that innovation will be quelled.

Medtronic: Medtronic filed its brief in support of Eli Lilly. This brief emphasizes the notice function of the disclosure, particularly with regard to medical devices. Pointedly maintaining that its brief is not an "academic or intellectual exercise," the brief asserts its "unique position as a large company straddling all areas of technology, who deals with real world issues of intellectual property valuation on a daily basis." The brief argues that "[t]he U.S. patent system is out of balance" due to "uncertainty" that makes it "difficult to operate effectively in the marketplace." Eliminating the written description requirement would just make this situation worse, they argue.

Reminiscent of Judge Rader's opinion in Sage Products v. Devon, the brief argues that patent applicants are responsible for what they claim in their patents, and that the notice function requires that the onus be placed on patentees to describe commensurate with the scope of what they claim. The brief argues that the written description requirement is not only not being applied too stringently but is not applied stringently enough, because applicants can (presently) "combine disparate parts of the specification" to claim inventions not disclosed at the time of filing. The brief also asserts that at present the written description requirement "allows applicants to broadly rename elements during prosecution so as to give them a breadth not contemplated at filing," resulting in the "peril of late claiming."

The brief lists three reasons why a separate written description requirement is required in addition to enablement: 1) without it, an "enabled" invention would enjoy "an indefinite, subjective boundary due to an additional layer defined by the standard that a claim is enabled if it can be practiced by the skilled worker 'without undue experimentation;'" 2) publication becomes "meaningless" without a requirement that the specification sets forth an adequate written description separate from the requirement for an enabling disclosure; and 3) the "predicate basis" for assessing compliance with § 112, ¶ 2 "disappears."

The essence of the argument in this brief is "notice, notice, notice." Its absence "harms competition and innovation, seriously inhibits the ability of companies to evaluate the value and breadth of its own and its competitor's intellectual property, and reduced the predictability of success in litigation." The brief proposes setting a limit of the originally-filed claims for public notice -- the "clearest written description," with amended claims being limited to subject matter that finds "direct and unambiguous support in the specification." As stated succinctly in the brief, claims should be limited to what was actually "described in writing" rather than what can be "derived from the writing" (emphasis added) and cites Kennecott Corp. v. Kyocera for permitting what is inherent in the specification to be claimed. The brief recites the benefits of requiring clarity in this requirement as it would "improve the investment decisions of businesses and promote better competition, improve the library of prior art, and force a clearer and more predictable claim construction, thereby reducing litigations and its related costs as well as its unpredictability."

The brief cites three examples -- from the computer (LizardTech), mechanical (Gentry Gallery) and chemical (In re Ahlbrecht) arts -- where the Federal Circuit has used the written description requirement to invalidate "overbroad" claims. This amicus argues that an important distinction between enablement and the written description requirement is that written description precludes any experimentation with regard to what is claimed as the invention, while enablement permits all but "undue" experimentation. The importance of this distinction for the medical device industry depends on "convergence of a wide range of technologies" required for these inventions, which are frequently combinations of predictable and unpredictable arts. As a consequence, there can arise the need to apply "inconsistent standards" of enablement should the court eliminate a separate written description requirement.

The brief also proposes that the problem of initial overclaiming can be handled by requirements of the oath/declaration, regarding that the inventor swears is her invention. Perhaps a little naively, the brief ties decisions about claim breadth -- something typically less understood by inventors than by their attorneys -- to penalties for false swearing including fines, imprisonment, and patent unenforceability. While this might not be a very practical approach, its in terrorem consequence might be one that would appeal to a big company with specifically-directed patents.

Abbott: Abbott's brief also argues in favor of a separate written description requirement. The brief asserts that enablement and written description are different and distinct requirements, wherein written description imposes an independent duty "to describe the invention such that persons skilled in the art will know that the applicant actually invented the subject matter claimed" -- "a critical check against overreaching by inventors." The danger, according to this amicus, is applicants "prematurely claim[ing] subject matter they did not invent" or that they "lie in wait for others to discover it." The brief characterizes Ariad's logic as being equivalent to "throwing the baby out with the bathwater" because eliminating the written description requirement would also destroy it as a check against late claiming. The brief calls contentions that the Federal Circuit has fashioned a "heightened" standard for biotechnology inventions a "caricature of [the Court's] decisions" on the subject, which decisions the brief characterizes as an "appropriate standard" and a "nuanced and flexible approach."

The company's brief is not overburdened with legal argument, with most of it advancing policy rather than legal arguments for interpreting § 112, 1st paragraph, as having a separate written description requirement. The brief argues that enablement can be used to encompass "concurrent accomplishments of [an applicant's] competitors" with regard to the level of skill in the art, and thus extend what is claimed past what the applicant actually invented, citing several academic law review articles to this point.

The written description requirement has independent value for "polic[ing] priority," according to this amicus, who asserts this as a reason for the en banc Court to reject Ariad's contention that there is no written description requirement in § 112. The brief also addresses several specific contentions raised by Ariad, including the argument that the enablement requirement and § 132 are sufficient for priority policing. These provisions would not be enough, they say, citing purported deficiencies and loopholes. For example, the brief refutes Ariad's contention that there is no case where something that is enabled is not described, citing In re Alonso and In re Curtis (and, indeed, could have cited the Lilly case as well) and Chiron v. Genentech, since enablement did not invalidate these claims but the written description requirement did (albeit in the context of a priority determination). The brief cites In re Rasmussen to support its contention that § 132 cannot supply the required priority policing function, making a distinction between new matter added to an application (prohibited by § 132) and broadening a claim to encompass undisclosed subject matter (§ 112, ¶ 1). The brief also notes that the language of §§ 119 and 120 of the patent statute don't support this use of § 132, since they refer to compliance with § 112, not § 132.

The brief contends that the appropriate standard for whether a specification provides an adequate written description of an invention was the one enunciated by the Federal Circuit in Vas-Cath: that the disclosure must "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she [i.e., the applicant] was in possession of the invention." The fact that this standard must be applied to each technology based on its complexity and the "maturity" of the field and knowledge in the art does not mean that requirement is improperly applied, amicus argues.

Abbott's particular concern is the decision in Noelle v. Lederman, which permits the inventor of a novel antigen to claim all antibodies that bind to it. The focus of this concern is the $1.67 billion judgment against Abbott in Centocor v. Abbott over the company's Humira® product; the trial court in October denied Abbott's motion for judgment as a matter of law and the company is awaiting entry of final judgment so it can file its appeal with the Federal Circuit. Thus, in its brief, this amicus argues that the Federal Circuit should clarify that Noelle does not stand for a per se rule that antibodies are always described by a description of the antigen.

Hynix and Samsung: In addition to the brief filed by Google, Verizon, and Cisco, four other companies in the "high technology" or "information technology (IT) industry filed amicus briefs in this action: Microsoft, RealNetworks, and a combined brief by Hynix and Samsung. In their brief, these amici argue that there is a separate written description requirement contained in 35 U.S.C. § 112, first paragraph. In addition, like several other amici, this brief argues that the written description requirement should be considered as a matter of law. The brief argues that U.S. patent law "appropriately rewards innovation and provides protection from opportunistic claims by patentees," terming the latter practice a "pernicious abuse of the patent system." The brief does not cover new ground here on the cases cited in support of a separate written description requirement -- including Evans, Morse, Schriber-Schroth, and Permutit. The brief skirts the semantic argument over the grammatical structure of the statute by saying either interpretation is plausible, and thus that the Court can and should adopt the interpretation most consistent with promoting innovation. The brief cites references to "settled expectations" (Festo) and "Congressional acquiescence" as reasons not to change statutory interpretation requiring a separate written description requirement. Finally, the brief bases its contention that compliance with the written description should be a question of law for the Court on analogies with the Federal Circuit and Supreme Court decisions in Markman v. Westview Instruments on construing claims and in KSR International Co. v. Teleflex Inc. on deciding whether an invention is obvious.

Microsoft: In its brief in support of Lilly, Microsoft contends that there is a separate written description requirement in the statute and agrees with Hynix and Samsung (and others) that compliance with the requirement should be decided as a matter of law. The brief emphasizes the role of the written description in the "quid pro quo" aspect of the patent "bargain," saying that the written description requirement prevents the patentee from claiming more broadly that she discloses. The brief addresses and rejects Ariad's grammatical reconstruction of the statute, saying that courts do not construe statutes by "pars[ing] each word or clause in the statute or focus[ing] on 'statutory phrases in isolation,' but rather must 'read [the] statute[] as a whole,'" citing U.S. v. Morton:

In this analytical framework, statutory interpretation is not a search for hidden meanings or embedded requirements, which can, when unearthed, then be numbered and categorized and reduced to formulae and checklists. Rather, statutory interpretation discerns the intent of the legislature, as revealed, of course, in the words of particular provisions, but understood in the context of the purpose motivating the statute as a whole.

The brief relies on O'Reilly v. Morse for the proposition that the enablement requirement is not enough, also citing Johns Hopkins v. CellPro, Invitrogen v. Clontech, and Spectra Physics v. Coherent Technologies for the proposition that broad claims can be enabled by disclosure of a single embodiment, but that this is a different and distinct requirement from requiring disclosure of the invention as broadly as it is claimed. The brief analogizes software claiming concerns with genus/species issues in the chemical arts, insofar as it may be possible to enable production of a genus by disclosure of a single species, but that disclosure of a single species may not disclose invention of the genus. The brief also looks to the provisions of § 112, 6th paragraph, for evidence of Congressional intent requiring consistency between what is claimed and what is disclosed (although this is not a particularly effective argument in view of the purpose of § 112, 6th paragraph, for permitting functional claiming and overturning a Supreme Court decision (the Halliburton case) to the contrary).

As in the Hynix and Samsung brief (and others), this amicus argues that the written description requirement should be decided as a question of law, similarly analogizing written description with the jurisprudential considerations raised over claim construction in Markman and regarding definiteness and compliance with § 112, ¶ 2, and citing academic commentary (including two articles written by Judge Moore prior to her taking the bench).

RealNetworks: This brief supports Lilly and argues for a separate written description requirement without taking a position on the validity of Ariad's claims. The brief asserts that there is "longstanding" Supreme Court, CCPA, and Federal Circuit precedent on the question, parsimoniously citing O'Reilly v. Morse, In re Ruschig, and Vas-Cath in support of this contention. The brief also notes several cases where claims can be enabled yet not adequately disclosed throughout their scope, including University of Rochester v. G.D. Searle, In re Alonso, In re Curtis, In re Wertheim, In re Ahlbrecht, and In re Ruschig.

The brief makes the policy argument that a separate written description requirement furthers the objectives of the patent system: "the protection of legitimate inventions by preventing overreaching by patentees, and encouraging further inventive activity by the patentee and others in the industry." "A separate written description requirement balances the need to reward legitimate invention while preventing overreaching, and encouraging innovation," this amicus asserts. RealNetworks argues that while broad disclosure supports broad claims, citing In re Sus, patentees are not entitled to claims broader than the disclosure, citing Morse. The brief also contends that requiring evidence of possession protects technology companies from being accused of infringing patents having no evidence of the claimed "invention" asserted against these companies.

Novozymes: This brief argues against the existence of a separate written description requirement and contends not only that the existence of original claims is enough, but that functional description of the claimed invention is sufficient to satisfy the disclosure requirements of § 112. The issue for this amicus is the ease of "designing around" biotechnology claims limited in scope by the application of the written description requirement by the Patent Office in view of the Federal Circuit's jurisprudence in this area. The problem identified by this amicus is the ability of a competitor to make "insubstantial changes" in a claimed biomolecule and successfully design around claims as they are currently issued (i.e., too narrowly).

While the brief argues that there is a requirement that an applicant describe her invention, this amicus contends that the Federal Circuit has transformed this requirement into a heightened requirement differentially applied to biotechnology claims, particularly of nucleic acids and polypeptides. This heightened requirement is identified by the "representative number" of species required to be disclosed to entitle an applicant to claims to a genus of molecules, here particularly those comprising the genus of sequence variants of a disclosed (and usually deduced) amino acid sequence as encoded by a claimed nucleic acid. The solution urged by this amicus to the en banc Court is to "restore" the written description requirement to its "traditional" limits of preventing amended claims to extend past the disclosure as filed, citing In re Ruschig and In re Robins in support of this interpretation.

The brief maintains that traditionally, and properly, the question of whether an applicant has complied with the written description requirement arises in only three instances: "1) when an applicant presents a claim which is not present in the application as filed; 2) when an applicant claims the benefit of the filing date of an earlier-filed foreign of U.S. application for claims in a later-filed application; and 3) when an applicant presents a claim corresponding to an interference count." The brief cites In re Gardner, In re Koller, In re Wertheim, and In re DiLeone in support of the proposition that an originally filed claim is itself sufficient to satisfy the requirement. The brief in particular attacks the three pillars of the Federal Circuit's application of the written description requirement to biotech cases directly, saying that the written description requirement does not require "a precise structural definition" as recited in Fiers v. Revel because that was an interference case directed to priority to a specific nucleic acid sequence and in the context of an interference, where the requirement is reduction to practice of a single species. Thus, amicus argues, the case cannot stand for a requirement of a "precise definition" of a genus. The brief also contends that the holding in Lockwood v. American Airlines was limited to a priority situation, one of the "traditional" uses for the doctrine, and distinguishes the other cases relied upon by the Lilly panel (In re Smythe, In re Grimme) as being limited to priority situations. Finally, as for the "representative number of species" requirement, enunciated in Lilly, the brief says it constitutes a "super-enablement" requirement differentially applied to biotechnology inventions (interestingly, Professor Lemley is the source of that characterization) (and while this argument is not well supported by citations, the brief does cite Judge Rich in the Robins case).

As for functional claiming and the purported prohibition thereof contained in Lilly, this amicus contends that functional claiming properly falls within the scope of adequate written description, citing the "convention" in biotechnology that what something is can be conceptualized by what it does, citing In re Wallach and Capon v. Eshar in support. The brief is least convincing when contending that in Lilly, production of a human insulin cDNA may not have been enabled but was disclosed, based (it appears) on the knowledge (or disclosure) of the amino acid sequence. The brief also cites Invitrogen v. Clontech for the proposition that disclosure of one sequence is enough to claim any polypeptide having a specific function, and Enzo v. Genprobe, regarding satisfaction of the written description requirement by a deposit.

The brief contends that in biotechnology, "cDNAs, enzymes, and other biomolecules may properly be described solely by reference to their specific biological functions," a stance directly at odds with the Court's written description jurisprudence and one unlikely to be particularly persuasive if the en banc Court is interested in answering the written description requirement question broadly over all technologies.

Monsanto: Monsanto's brief takes the (on first blush) paradoxical position that there is a separate written description as part of the statute and that this requirement was properly interpreted by the courts prior to the Federal Circuit's Lilly opinion. Thus the brief argues in favor of a "traditional" written description requirement that is different from the requirement that the Court and the Patent Office have applied since the Lilly case.

The brief emphasizes the notice function of the written description requirement, consistent with arguments made by other amici, so that it and other biotech companies will be able to "accurately determine whether a future patent will impede either research and development or commercial use of its innovations." Where Monsanto takes an original approach is in arguing that the "traditional" written description requirement is sufficient to satisfy this need, "if applied correctly and coupled with vigorous enforcement of the separate enablement requirement." The basis for this contention is that this amicus needs to "obtain suitably broad patent claims to prevent competitors from simply designing around its inventions." Like Ariad and amici supporting Ariad, Monsanto argues that the Federal Circuit's written description jurisprudence since the Lilly case is an improper "enhanced" requirement that "imposes a severe burden on biotechnology innovators" because it offers insufficient scope of claims to prevent designing around.

The brief argues that the written description requirement, properly applied, would be satisfied per se by any claim disclosed in haec verba in the patent specification. Original claims and original disclosure should be enough (citing In re DiLeone, In re Gardner, In re Wertheim, and In re Koller), and there is room even for satisfaction of the written description requirement when in haec verba support is lacking if one of skill in the art would "immediately discern the limitation at issue," citing Purdue Pharma v. Faulding and In re Robins. The written description requirement should be limited to new matter and claiming aggregates of words and phrases in the specification to encompass inventions not contemplated by the patentee at the time of filing, according to this amicus. The brief analogizes the use of the written description requirement to prevent such "cobbling" of words and phrases to encompass inventions not identified in the original specification to anticipation cases where the elements must be recited as they are recited in the claims.

The brief also asserts, in agreement with Ariad and other amici, that the enablement requirement is sufficient to police overclaiming. In the instant case, the brief argues that Ariad has failed to provide an adequate written description of the invention because it claimed all ways of reducing NF-kB activity using functional language that lack enablement. The brief also cites In re Hyatt for prohibition of "single means claims" (which the brief contends properly characterizes Ariad's claims in suit) and asserts that prohibitions against such claims, based on failure to satisfy the enablement requirement, is sufficient to address the important policy considerations of the scope of patent disclosure without invoking the need for a separate written description requirement.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 11:55 PM in Federal Circuit, Written Description | Permalink | Comments (0) | TrackBack (0)

December 01, 2009

Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association

By Kevin E. Noonan --

The American Intellectual Property Law Association (AIPLA) has joined the chorus of patent bar groups opining on whether there is a separate written description requirement contained in 35 U.S.C. § 112, first paragraph, in an amicus curiae brief filed in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. The AIPLA agrees with other amici that there is such a requirement, but emphasize that properly construed, such a requirement must be assessed in the "context" of the entirety of 35 U.S.C. § 112 (but, in reality, that "entirety" extends no further than the second paragraph). Similar sentiments were expressed by the Federal Circuit Bar Association in its amicus brief, but the basis of the argument is uniquely the AIPLA's. The AIPLA also notes that it does not take a position on the validity of Ariad's patent-in-suit.

The brief argues that the written description requirement should be construed to ensure that the patent specification "advances the well-recognized patent policies of disclosure," defining these as:

(1) particularly and distinctly identifying the invention,
(2) putting the invention in the hands of the public at the end of the patent term as part of the quid pro quo bargain for exclusive rights,
(3) ensuring that the applicant was in possession of his/her invention at the time of filing to limit any exclusive rights to the subject matter he/she actually invented, and
(4) informing the public of the patent scope so that potential competitors know how to avoid infringement and can reasonably design around the claimed invention.

The brief argues that the written description requirement, as construed as being part of § 112, first paragraph, by the Court's jurisprudence, satisfies these different but related roles. Enablement, the amicus argues, "serves a different and distinct purpose" -- providing a disclosure that would permit the worker of ordinary skill to practice the invention. The brief also notes, as have others, that the requirements differ in that the enablement inquiry includes the knowledge and skill of the worker of ordinary skill in the art, and that these can be "very different from any invention identified by the inventor as his/her own."

In discussing the statute at length, the brief counsels the Court to "resist the temptation to dwell on parsing the statutory language to the point of drawing legal conclusions based on the placement of commas." "Instead," they counsel, the Court should employ an "as a whole" rationale that would be "faithful to the statute's literal language and policy objectives." The amicus also asks the Court not to make a "radical departure" from precedent and reminds the Federal Circuit to be sure to "conform to Supreme Court precedent." The brief asserts that the CAFC should adopt a "sufficiently flexible" approach that will avoid an "unfair standard of compliance that fails to take account of inherent differences in technologies and claim formats."

The brief does admit that "statutory language, legislative history and judicial precedent" -- all the tools the Court would normally employ in deciding this question -- "fail to solve the puzzle." Policy may be what ultimately drives (or should drive) the Court's conclusions, and the policy requires that the specification must:

1) Sufficiently identify the invention;
2) Put the invention in the hands of the public at the end of the patent term as part of the quid pro quo bargain for exclusive rights;
3) Ensure that the applicant was in possession of his/her invention at the time of filing to limit any exclusive rights to subject matter he/she actually invented; and
4) Inform the public of the patent scope so that potential competitors know how to avoid infringement and can reasonably design around the claimed invention,

citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002); Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 150-51 (1989); McClain v. Ortmayer, 141 U.S. 419, 424 (1891); Praxair, Inc. v. ATMl, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); and Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998).

Amicus argues that the question before the Court can be resolved by not considering the "number of distinct disclosure requirement[s] that must be met," but by using the totality of the specification to determine what was disclosed. This "as a whole" approach they analogize with various "claims as a whole" provisions such as § 103. Thus:

[F]or purposes of determining whether a patent is invalid for failing to comply with the disclosure requirements, a specification should be judged by the sufficiency of the disclosures in the application as filed, taken as a whole, not by the sufficiency of the portion of a specification deemed the "written description" or the separate portion deemed the "enabling disclosure."

The brief then explicates further its understanding of the totality approach, using the equally-compelling rubric of faithfulness to the statutory scheme taken as a whole, in the context of criticizing the panel for failing to utilize the approach. Here, amicus argues, the panel considered whether Ariad's specification contained an adequate written description, concluded it did not, and ended the inquiry. The error was the belief that the written description requirement could be "viewed in isolation from the other requirements of Section 112." Had the Federal Circuit applied the AIPLA's "as a whole" approach, the brief argues, it could have performed "a practical evaluation of the sufficiency of the disclosure" as understood by one of ordinary skill in the art, "taking into account the interaction and codependence of [all of] the Section 112 requirements." By analogy, the brief compares (favorably!) this approach with the "common sense" approach to obviousness imposed by the Supreme Court in KSR International Co. v. Teleflex Inc. However, the amicus argues that this "as a whole" approach "does not relieve [the patent owner] of identifying in the patent a 'written description' of the invention commensurate with the scope of the claims at issue," citing Tronzo v. Biomet. Ultimately, what is required is that the specification properly puts the public on notice "of what the inventor contemplates as the invention encompassed by the claims at issue."

The brief emphasizes that the approach must be employed with sufficient flexibility to be able to adapt to different technologies. This, the brief asserts, is the flaw in the argument that the enablement requirement is sufficient -- there will be some instances where enablement simultaneously satisfies the written description requirement, and other instances (and technologies) when this will not be the case. A particular example cited in the brief is genus/species claims, where it can certainly be the case that the specification enables making and using species within a claimed genus, but does not provide a written description "for a claim covering . . . a particular species." On this point the brief concludes:

In the end, it is the dynamic interaction of the Section 112 requirements that produce the kind of disclosures necessary to advance the policies recited above. Whatever the answer on the sufficiency of the written description or enabling disclosure in the case, the proposal here would not allow the court to simply stop the analysis after examining only one of the requirements in isolation, and to ignore the others. It would rather permit a party to point the court to the disclosure as a whole, which would be evaluated in light of the patent policies.

The "as a whole" approach to assessing the sufficiency of disclosure in a specification proposed by AIPLA's brief is consistent with the statute, because the requirement for a written description, an enabling disclosure and a claim that "particularly points out and distinctly claims the subject matter the applicant regards as his invention" must be considered together, amicus argues. Amicus ignores the best mode requirement (understandably, perhaps) but builds its "as a whole" argument by combining two of the requirements from the first paragraph of Section 112 with the "claims" requirement from the second paragraph of Section 112. While this has been done by other amici, its consequence is to expand the scope of § 112, 2d ¶, from its traditional role of providing a statutory basis for the peripheral claiming requirement to being part of the sufficiency of disclosure requirement of § 112, 1st ¶. The brief supports this interpretation of the statute by arguing, first, "there is no requirement that the written description of the invention be in a separately designated section of the specification, nor that the enablement be in a separately designated section," further saying that both requirements are "intertwined" in some specifications. Second, the requirements of §112, 1st ¶, must be evaluated in the context of what is claimed according to §112, 2d ¶, saying that this has "always" been the requirement for enablement, citing Christianson v. Colt Indus. Operating Corp., 870 F.2d 1292, 1299 (1989). "Taking ¶ 1 and ¶ 2 together, it is not the written description requirement but the claim, interpreted in light of the specification and the patent file-history, that identifies the invention," amicus asserts. Third, a claim can and will very often identify the invention without 'describing' it," says this amicus, citing Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1154 (Fed. Cir. 2004). This argument relates to the "legal" wording of a claim, in contrast to the language used in a specification (which the brief contends is directed not at a lawyer but a person of ordinary skill in the art). This argument appears to envision a "translation" function of the written description requirement, between the legal wording of the claim and the technical wording of the specification. Finally, the brief appeals to the "inherent circularity" of the analysis, which they argue "points to the necessity for an 'as a whole' analysis," wherein the specification must be assessed in light of the "invention" and the claimed invention must be assessed in view of the description in the specification.

Adopting this approach would not change the "content" of each individual requirement, the brief argues, but rather would affect "only the ultimate determination of the sufficiency of the disclosure." Using the approach advocated by this amicus would require establishing the "context" of the "invention" in terms of the circularly-dependent claims and specification, and ultimately resulting in an approach that may make up in "common sense" what it seems to lack in analytical vigor. Its greatest advantage may be that it is more consistent with the Supreme Court's "totality of the circumstances" approach to patent jurisprudence than the traditional efforts by the Federal Circuit to bring clarity to the application of U.S. patent law.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 05:40 PM in Federal Circuit, Written Description | Permalink | Comments (25) | TrackBack (0)

November 29, 2009

Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association

By Kevin E. Noonan --

In Anna Karenina, Leo Tolstoy wrote, "All happy families resemble one another, each unhappy family is unhappy in its own way." This sentiment could also be applied to the briefs submitted to the Federal Circuit for its en banc consideration of the written description requirement. A large proportion of those briefs support the current construction of 35 U.S.C. § 112, first paragraph, to include a separate written description requirement, but like unhappy families each amicus takes its position in a slightly different way. The Federal Circuit Bar Association's brief is one example: their position is that there is a separate written description requirement, but that there is much less of a difference between those who agree and those who believe the only requirement is enablement, including even Ariad who (understandably) has made the strongest argument that the statute should not be construed to contain a separate written description.

The brief begins with the argument that there is "substantial common ground" among all the parties involved, including Ariad, Lilly, and the various amici. The basis for this assertion is that all parties agree (according to this amicus) that the "invention" must be disclosed in the specification. "Ultimately," they write, "the real issue on written description is not whether the law requires a description of the invention in a patent application, but whether that condition is its own statutory requirement or merely an 'aspect' of enablement without independent force."

"Law and logic" converge in the conclusion that written description is a separate requirement, they argue. In reaching this conclusion, they don't rely merely on the language of 35 U.S.C. § 112, first paragraph, but cite the provisions of the second paragraph, that the claims be directed to subject matter that an inventor "regards as his invention." That statutory requirement requires that patents be granted only on what an inventor has invented, but there are instances where enablement is "insufficient to protect against overclaiming," according to this brief.

The "central truth" providing "fundamental common ground" for the parties is the "simple common sense" that "a patent must identify what the inventor believes to be his or her invention," say the amicus (emphasis in original). This requirement is based on the quid pro quo of the patent system. The brief cites Ariad's principal brief for "the undisputed proposition that the claims must be directed to an invention that is identified in the specification" (emphasis in original). Indeed, amicus make a strong argument based on this section of the brief that the dispute is one more semantical than real. Amicus' brief further cites Ariad's principal brief that "[t]he specification must state what the invention is, for otherwise it fails to inform a person of ordinary skill in the art what to make and use" (emphasis in original). (This "admission" is so significant that amicus feels compelled to state that it is "not a slip of the pen or poor proofreading.") Further (and from the first page of Ariad's brief), "[p]roperly interpreted, the statute requires the specification to describe (i) what the invention is, and (ii) how to make and use it" (emphasis in original).

Not content to rely on the "common sense" of its position, the brief cites precedent from the CCPA (In re Moore, In re Sus, Jepson v. Coleman) for the requirement that the specification disclose what the inventor regarded as her invention. Specifically discussing In re Ruschig, the amicus states that "all parties agree that the specification must disclose what the inventor actually invented."

Turning to the specific questions asked by the Court, the amicus asserts that the "common ground" discussed above provides the "starting point" for resolving the debate. However, they argue that there is a "much narrower" question before the Court, specifically whether it is "possible to satisfy the enablement requirement without also satisfying" the written description requirement. In most cases, the brief argues, these requirements are "so closely related" that satisfaction of one provides satisfaction of the other, citing LizardTech Inc. v. Earth Resource Mapping, Inc. and University of Rochester v. G.D. Searle & Co. Inc. (tellingly, cases involving electromechanical and biotech/pharma claims, respectively). The problem with Ariad's argument, according to this amicus, is that "it fails to provide any statutory safeguard to keep an inventor to what he or she has actually invented in the limited class of cases where enablement is insufficient to prevent abuse." This is because the two requirements -- written description and enablement -- serve independent purposes. These purposes are related to the fact that "the heart of innovation" is not always its implementation, i.e., there are instances where the inventor's "true contribution" is in implementing an invention, and other cases where an inventor recognizes that an "already-enabled system or method can be applied to solve a problem or otherwise advance a field of art." In the latter instances, it is the identification of the solution that is the invention, and in these instances, this amicus argues, the enablement requirement "can be inadequate to ensure that the inventor's patent monopoly is limited to his or her contribution." (This brief, as have other briefs, uses cases like Rochester and Amgen v. Hoescht Marion Roussel to support this point, some of the very cases Ariad and those challenging the separate written description requirement contend is a misapplication of the law.)

The brief sets forth a hypothetical to illustrate the point: an invention involving an "easy-to-make compound" to be used in a specific medical or biological application. The inventor did not contribute by identifying how to make the compound; rather, the inventor's contribution is "to identify for the first time that the compound will be effective for the desired application." Often, perhaps frequently, the inventor will disclose this new application in the patent specification. But, the brief questions, "what happens when the inventor's patent application . . . evolves over the course of amendments to his or her claims?" It is possible, amicus argues, that the claims "may shift to identify for the first time . . . compounds that are useful in solving a problem underlying the invention, but that the inventor had not identified in his or her original application." The brief also raises the specter of such a change in the "invention" -- i.e., what is claimed -- as not even involving the inventor but being accomplished by a patent attorney (which while true, incongruously directs the source of the problem of misapplication of the written description requirement towards a substantial portion of the FCBA's membership). Under these circumstances, the brief argues, enablement "can be wholly inadequate as a vehicle to prevent abuse . . . the newly-claimed compounds are undeniably enabled, even if they were never identified as part of the invention in the specification." The brief also cites for this principle situations of belated claiming of a species falling within the scope of a disclosed genus but not expressly described in the specification as filed. Other instances cited in the brief include those where "the specification describes a feature of the invention that is indispensible to the inventor's contribution but where the inventor -- or his or her patent attorney -- failed to include it in the claims as properly construed." (This was the situation in the LizardTech case.) In LizardTech, according to the amicus, without the written description requirement "neither principles of enablement nor claim construction would always keep the scope of the patent monopoly faithful to the inventor's invention -- the claims could be completely untethered to his or her technical contribution." (As an aside, the brief casts the written description requirement as being needed to constrain the "patent monopoly" much more frequently than might have been expected from a group that should understand the inaccuracy inherent in the phrase and the extent to which the Supreme Court has used the concept of "monopoly" to unduly restrict patent rights in the past.) This portion of the brief closes by describing the written description in a patent specification to be "a snapshot in time" of the invention that is "indispensible" to identify the invention, and that serves to limit the scope of granted claims to what the inventor invented and to which she is "fairly entitled."

Secondly, the brief argues that Ariad's position that the "requirement" that the inventor disclose what she thinks is her invention devolves to the enablement requirement is "not faithful to the text of Section 112." Calling the first paragraph of § 112, "far from a model of clarity," the brief argues that interpretation of the statute to require a separate written description requirement "flows not only from the statutory text and history" but also "from the overall context of the patent statute . . . itself." This is the error in focusing (as Ariad and some amici have) on how § 112, first paragraph, should be parsed as a matter of English language sentence construction. Rather, they argue that the statute should be construed with regard to context, specifically the interplay of the first paragraph of § 112 with the second paragraph. The amicus construes the second paragraph as having two requirements: that the claims "set forth what the applicant regards as his invention" and "that is to do so with sufficient particularity and distinctiveness." While the second requirement is the usual focus of analysis regarding fulfillment of the second paragraph of § 112, the amicus argues that the first requirement "provides powerful proof that an inventor's claim scope is tied directly to his or her invention as defined in his or her patent specification," a reading the brief argues is supported by Allen Engineering Inc. v. Bartell Industries Inc. (Fed. Cir. 2002). By this interpretive legerdemain, this amicus moves the statutory situs of the written description requirement from the first paragraph (where it is inconveniently linked to the enablement requirement) to the second paragraph where it is free of the encumbrances of enablement. The brief also argues that the Allen Engineering precedent, and the statutory context, confirm the "common sense principle" that a patentee is entitled to claims that extend as far and no farther than what the inventor sets forth as her invention in the specification.

The brief then delves briefly into the waters of English language sentence analysis, on what it terms Ariad's "grammatical argument." The amicus notes that this argument "largely revolves around the presence of a comma between the phrases 'of the manner and process of making and using it' and 'in such . . . terms'." The objection to finding a separate written description requirement based on the position of this comma advanced by Ariad and amici in agreement with Ariad was also voiced by Chief Judge Markey in dissent to the Court's opinion in In re Barker (CCPA 1977) and by Judge Linn dissenting from the Rochester opinion. But this amicus refutes the argument with a simple "not so." For amicus, "[a]n at least equally-plausible reading of the [and manner and process of making and using it] phrase is that the comma between the phrases . . . represents a natural pause between the two clauses." The amicus tests this analysis by assessing the meaning of the first paragraph of § 112 if its drafters had removed the phrase "written description of the invention" from the statute. The comma still has a function, as a pause according to the amicus, and thus "the comma between the phrases . . . -- relied upon so heavily by opponents of a separate written description requirement -- does not undermine a separate written description requirement because proper English would include it in the statute even if the statute did not include language requiring a written description of the invention." In short, according to this amicus, Ariad's principal grammatical argument is a nullity. Moreover, the brief argues, if Congress wished to limit the scope of § 112, first paragraph, to require enablement alone, Congress could have achieved this end by "a couple of minor revisions." Of course, Congress has not availed itself of this opportunity. And the brief further notes that the phrase "of the invention" is set off from the phrase "the manner and process of using is" by its own comma, and thus Congress could have more clearly indicated an intention to equate a description of the invention with enablement by deleting this comma.

The brief ends its survey of what it calls the "comma conundrum" by performing its own "grammatical deconstruction" of § 112, first paragraph, saying "it can hardly be a coincidence that the enablement requirement directly parallels the requirement contain the manner and process of making and using the invention but not the written description of the invention," saying that "[t]his parallelism of language reflects a parallelism of thought," that "an enabling disclosure must allow those of ordinary skill in the art to make and use the manner and process of making and using the invention."

Finally, the brief surveys and rejects Ariad's contention that the written description requirement is but a relic of a time before the statute mandated peripheral claiming, saying "[t]his theory reads far too much into the statutory history of Section 112."

The brief also addresses the second question posed by the Federal Circuit for en banc consideration. According to amicus, the written description should be applied on a case-by-case basis, the brief arguing that there is "no one-size-fits-all approach" that can be properly used. However, they do recommend to the Court two principles important for guiding development of written description jurisprudence. First, claims should only be found valid to the extent that they are directed to "what the inventor 'regards has his invention'." This is "[t]he key to a fair and balanced written description requirement," amicus argue.

Second, fulfillment of the written description requirement should be assessed as a matter of law based on underlying facts, rather than as a factual matter. Their basis for this contention is that "ultimately" patent validity is a question of law (citing Graham v. John Deere) and the written description requirement is something "fundamentally focused on the text of the patent's disclosure itself," in analogy to claim construction under Markman v. Westview Instruments (seemingly disregarding the difficulties and criticisms the Court's application of Markman decision to claim construction has engendered, by members of the FCBA as well as several current Federal Circuit judges). Because satisfaction of the written description requirement goes "hand-in-hand" with satisfaction of the enablement requirement (except, as amicus argues in another portion of the brief, when they don't), both should be assessed as a matter of law, based on the "inventor's disclosure within the four-corners of the patent specification." The argument focuses on the "black-and-white" nature of these analyses, meaning (it seems) that both are objective rather than subjective tests (as opposed, for example, to the best mode requirement). However, the argument ignores the other distinction, made by other amici, that enablement permits consideration of what was known by one having ordinary skill in the art, while written description involves only what the inventor has described as being her invention. The brief characterizes en banc consideration as being a "golden opportunity" for the Federal Circuit to address this "inconsistency."

The FCBA's brief thus invites the Federal Circuit to once again take an issue of patent validity away from the jury, and potentially to add yet another aspect of patent infringement litigation to its de novo review. As the history of Markman claim construction has amply showed, de novo review results in the opposite of what Congress intended when instituting the Federal Circuit -- less consistency and less predictability in outcomes. Unless the Court intends to revise its treatment of such de novo review situations -- such as reviewing the factual underpinnings of legal conclusions for substantial evidence or clear error and basing its de novo review of the legal conclusions on trial court-determined facts -- following the FCBA's recommendations seem curious coming from an amicus that would be expected to best understand the burden de novo review has been to the Federal Circuit, and the negative effects it has had on U.S. patent law and litigation.

For additional information regarding this topic, please see:
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Posted at 11:30 PM in Federal Circuit, Written Description | Permalink | Comments (0) | TrackBack (0)

November 25, 2009

Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association

By Kevin E. Noonan --

The Intellectual Property Owners Association (IPO) has filed an amicus brief in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., supporting neither party but arguing in favor of a separate written description requirement as part of 35 U.S.C. § 112, first paragraph. The IPO's brief is significant, if only because the organization represents inventors across the spectrum of American industry (from sole inventors to Fortune 100 companies) and thus may represent a consensus of the views of its disparate membership.

IPO's précis of its argument is simple. A separate written description requirement exists according to traditional and settled judicial interpretations of the statute. The requirement serves two related purposes: it requires a patentee to show that she had possession of the claimed invention on its filing date and it serves a public notice function of what the inventor believes is her invention. In these respects the written description requirement comprises part of the quid pro quo of the patent right, so that a patentee's disclosure is sufficiently certain to entitle the patent grant. Merely providing an enabling disclosure is not enough, IPO's brief argues, since there could be situations where the specification enables a broader scope than the inventor described, and thus the ensuing scope of protection would be "unfairly broad."

But IPO does not advocate that claims should be limited to the disclosed embodiments or "that unclaimed details of such embodiments should necessarily be used to limit claim scope." IPO further argues that it would be inappropriate to craft a "bright line rule" of what constitutes an adequate written description. This determination should be performed on a case-by-case basis, will depend on the technology and the state of development of that technology. The brief recognizes that this increased the potential for uncertainty, but an inflexible rule "would either be too stringent for incremental improvements in well-developed technologies or too lenient for ground-breaking discoveries in undeveloped technologies."

IPO's argument for the existence of a separate written description requirement relies heavily on Supreme Court precedent as well as case law from the CCPA and Federal Circuit, and of course comparisons of the statutory language in its various incarnations (the 1790, 1836, 1870, and 1952 Acts). The brief cites pre-1952 Act cases including Evans v. Eaton, O'Reilly v. Morse, and In re Moore. Turning to the 1952 Act, the brief cites In re Ruschig for the proposition that the statute requires "blaze marks" setting forth the metes and bounds of what the patentee believes to be her invention. This case also exemplifies the distinction between written description and enablement, wherein enablement was said to be "beside the point for the question is not whether he would be so enabled but whether the specification discloses the compound to him, specifically, as something appellants actually invented." The brief is also quick to mention (in a footnote) that it would be a misinterpretation of the judicial record to think that Ruschig was somehow the genesis of the concept of the distinctly different enablement and written description requirements, citing In re Lund and In re Cavallito as additional, earlier judicial expressions of the same principle. Citing more recent cases from both the Supreme Court and the Federal Circuit, the brief then advocates for stare decisis:

This Court should not disrupt over 200 years ofprecedent beginning with the Patent Act of 1790 and continuing until today. Accordingly, this Court should hold that Section 112 does set forth a written description requirement separate from the enablement requirement.

Turning to the concept of the quid pro quo, the brief once again cites Supreme Court precedent, specifically Bonito Boats, Inc. v. Thunder Craft Boats, Inc. (the first instance of Supreme Court review of the Federal Circuit) for the proposition that "[t]he federal patent system . . . embodies a carefully crafted bargain for encouraging the creation and disclosure of new, useful, and nonobvious advances in technology and design in return for the exclusive right to practice the invention for a period of years." The brief then ties this proscription in favor of disclosure as the basis for the exclusive patent grant to the written description requirement, citing University of Rochester v. G.D. Searle that "'[t]he written description requirement serves as a teaching function, as a 'quid pro quo' in which the public is given meaningful disclosure in this carefully crafted bargain."

This requirement can be further broken down into two features: that the inventor had possession of the claimed subject matter on the filing date, and that the public is fairly put on notice by the disclosure in the patent specification as to what the inventor thinks her invention encompasses. For the first point, the brief argues that an inventor is entitled to the exclusionary right "on only that subject matter that he has actually invented" (emphasis in original), supported by citation to abundant recent Federal Circuit precedent (of dubious applicability in view of the en banc Court's interest in deciding whether these cases have been properly decided in the first place). As to the public notice function, the brief turns to more fruitful Supreme Court precedent, specifically Evans v. Eaton and, of course, Judge Rich's decision in Ruschig. The brief brings the discussion somewhat into the modern era by arguing that the public notice function of the specification "begins" upon publication of the application, and "provides a reasonable guide to the likely scope of claimed that will ultimately issue." The brief argues that since the claims in the published application are frequently broader than the claims that ultimately issue, focusing on the scope of the written description helps prevent innovation from being "stifled" out of fear of overbroad published claims.

The enablement requirement is insufficient to police the boundary between the scope of the claims and the extent of the disclosure, according to amicus, because situations can arise where enablement may be satisfied even though the specification provides "no evidence that the inventor was in possession of the invention" throughout the scope of the granted claims. The brief cites In re DiLeone for this proposition, specifically a "hypothetical example" recited in the case to illustrate the different purviews of the written description and enablement requirements:

For greater clarity on this point, consider the case where the specification discusses only compound A and contains no broadening language of any kind. This might very well enable one skilled in the art to make and use compounds B and C; yet the class consisting of A, B, and C has not been described.

The brief also cites In re Ahlbrecht, where the issue involved entitlement to a priority claim (the traditional ambit of applications of the written description requirement). (In Ahlbrecht, the range of methylene groups claimed (2 to 12) was broader than the range of methylene groups disclosed (3 to 12), and thus the written description requirement was not satisfied.)

The brief then argues that it would be a mistake for the en banc Court to attempt to construct a "bright line rule" for the extent of disclosure that satisfies the written description requirement, perhaps being leery of the Court's ancient and recent propensity along those lines (and particularly its perverse perserverence in the practice, as illustrated by the en banc decision in In re Bilski in the face of a decade of Supreme Court opinions to the effect that the Court does not condone bright line rules in this (or perhaps any) area). The brief reminds the Federal Circuit of the Supreme Court's displeasure with this practice, citing KSR International Co. v. Teleflex Inc., albeit only after arguing that the better reason for avoiding a bright line rule for the written description requirement is the impracticability of such a rule. Instead, amicus argues, "[t]he sufficiency of written description should therefore be evaluated under a flexible standard on a case-by-case basis, with an understanding that what is sufficient to satisfy the written description requirement will vary according to the art to which the invention pertains and as the knowledge of those skilled in the art develops." The brief is also careful that the en banc Court does not read this argument as advocating that claims be limited to those embodiments actually carried out (perhaps being mindful of the restrictive decision on enablement rendered by a panel of the Court in the In re '318 Patent Litigation case). The brief even goes so far as to set forth what it characterizes as "[s]everal well-established tenets" for "delineating the boundaries of the written description requirement." These include:

1. Examples: "[E]xamples [explicitly covering the full scope of the claim language] are not necessary to support the adequacy of a written description." Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006); see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005).
2. Actual Reduction to Practice: "[A]n actual reduction to practice is not required for written description." Falkner, 448 F.3d at 1366; see also University of Rochester, 358 F.3d at 922, n.5 (although "[c]onstructive reduction to practice" is sufficient so long as the application "describe[s] the claimed subject matter in terms that establish that [the applicant] was in possession of the . . . claimed invention, including all of the elements and limitations.") (alteration in original) (citation omitted).
3. Literal Support for the Claimed Invention: The disclosure need not match the claim word for word to satisfy the written description requirement. See Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) ("the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue."); see also Martin v. Johnson, 454 F.2d 746, (C.C.P.A. 1972) (noting that "the description need not be in ipsis verbis to be sufficient").
4. Identical Type or Depth of Disclosure for Each Invention: The written description requirement does not require "that every invention must be described in the same way. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution." Capon, 418 F.3d at 1357-58.
5. Express Disclosure of Each and Every Species in a Genus: "Mention of representative compounds encompassed by generic claims language clearly is not required by §112 or any other provision of the statute. But, where no explicit description of a generic invention is to be found in the specification, "mention of representative compounds may provide implicit description upon which to base generic claim language." In re Robins, 429 F.2d 452, 456-57 (C.C.P.A. 1970).

Finally, IPO argues that, however the en banc Court rules, claims should not be limited to their specifically-disclosed embodiments. "The separate written description requirement also should not undermine the courts' reluctance to narrow claim scope by importing limitations appearing in the specifications," amicus argues in its brief, under that well-established principle of claim construction.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

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November 24, 2009

Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline

By Donald Zuhn --

In anticipation of the upcoming oral argument in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., scheduled for December 7th, we have been reviewing a number of the briefs submitted by various amici. (We learned of an additional amicus brief that was filed last week, this one by William Mitchell College of Law in support of Defendant-Appellant-Respondent Eli Lilly & Co., which brings the total number of amicus briefs filed in the rehearing en banc to twenty-five, and the number filed in support of Lilly and/or affirmance to nineteen.) Today, we examine the amicus brief filed by GlaxoSmithKline ("GSK") in support of Lilly.

GSK's brief focuses primarily on the importance of the patent system to the biotech/pharma industry, and the need by that industry for certainty that comes from having well-settled requirements for patentability. GSK opens the brief by noting that it invests sizeable amounts of money in R&D -- more than $6.5 billion in 2008 -- and that it protects this investment by seeking patent protection on its innovations -- filing more than 300 U.S. patent applications per year. The pharmaceutical company explains that "[p]rotecting and encouraging scientific investment like GSK's large research and development effort is not possible without a long-term predictable, stable, legal system that provides sufficient confidence to invest and sufficient time to recoup investment and secure a reasonable return," and contends that "[r]etroactively changing standards for patent protection, standards that for the most part have been in place since at least the enactment of the 1952 Patent Act, introduces uncertainty and instability, risks the invalidation of once valid patents, and potentially nullifies investment-backed business decisions based on then-correct interpretations of the law."

GSK argues that changes in well-settled requirements for patentability will inject uncertaInty and instability into long-term business decisions. The company points to the Federal Circuit's recent decision in In re Kubin as illustrative of the impact resulting from a change in judicial law, stating that "[l]ost with [the] patent application on that invention was any chance to recover the research money and lost employee time invested in the invention's discovery and development based on a good faith compliance with the law in effect at the time the application was flIed."

After providing a summary of several CCPA and Federal Circuit decisions that have helped establish the current legal regime, including In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967); In re DiLeone, 436 F.2d 1404 (C.C.P.A. 1971); In re Wilder, 736 F.2d 1516 (Fed. Cir. 1984); and Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991), GSK notes that:

Since the Vas-Cath decision in June of 1991, more than 2.5 million patents have been prosecuted and issued based on the fundamental premise that 35 U.S.C. § 112, first paragraph contains a written description section separate and distinct from an enablement requirement. Should the Court change that well settled understanding of the law by either removing the written description requirement from the current § 112 analysis or by changing the interpretation of the enablement requirement, some patents that businesses thought were valid might now be considered invalid if litigated, and patents that have been thought invalid might now be held valid. This particularly affects pharmaceutical and biotech patents that seem to be more often the focus of a § 112 review. Both outcomes can change prior long-term investment-backed decisions with the potential result of wasted capital and research or new-found patent infringement exposure.

Stating that "the Supreme Court stresses that the doctrine of stare decisis is of particular importance in patent law," GSK argues that "[w]here corporations collectively have invested billions based on settled interpretations of law, stare decisis counsels against departure from prior interpretations of the law."

GSK concludes its brief by stating that "[p]harmaceutical companies must be able to trust that they can make long term decisions based on current law that will remain correct over the 10-15 years needed to get a product approved and then during its patented years," and asserting that "[f]or this reason, the Court should protect the investment-backed expectations of patent holders by ensuring the law remains stable and predictable, and is not subject to dramatic changes in statutory interpretation."

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

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November 23, 2009

Amicus Briefs in Ariad v. Lilly: United States

By Donald Zuhn --

With oral argument in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. scheduled for Monday, December 7, 2009, last Friday marked the deadline for the filing of amicus curiae briefs. Twenty-four amicus briefs were submitted (by our count), with eighteen briefs filed in support of Defendant-Appellant-Respondent Eli Lilly & Co. and/or affirmance, six briefs filed in support of neither party, and no amicus briefs filed in support of Plaintiffs-Appellees-Petitioners Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the Presidents and Fellows of Harvard College ("Ariad"). Amici supporting Lilly and/or affirmance include:

• Abbott Laboratories (brief);
• The American Intellectual Property Law Association (AIPLA) (brief);
• Amgen Inc. (brief);
• Professor Christopher A. Cotropia (brief);
• The Federal Circuit Bar Association (brief);
• GlaxoSmithKline (brief);
• Google Inc., Verizon Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
• Hynix Semiconductor Inc. and Samsung Electronics Co., Ltd. (brief);
• The Intellectual Property Owners Association (IPO) (brief);
• Oskar Liivak (brief);
• Medtronic, Inc. (brief);
• Microsoft Corp. (brief);
• Monsanto Co. (brief);
• Public Patent Foundation (PUBPAT) (brief);
• RealNetworks, Inc. (brief);
• The Regents of the University of California, Wisconsin Alumni Research Foundation, The University of Texas System, University of Rochester, Rensselaer Polytechnic Institute, STC.UNM, The Research Foundation of State University of New York, NDSU Research Foundation, and Research Corporation Technologies, Inc. (brief);
• United States (brief); and
• Washington Legal Foundation (brief).

Amici supporting neither party include:

• Professor Christopher M. Holman (see Patent Docs report);
• Mark D. Janis and Timothy R. Holbrook (brief);
• Dr. Roberta J. Morris (brief);
• The New York Intellectual Property Law Association (brief);
• Novozymes A/S (brief); and
• University of Kentucky Intellectual Property Law Society, Universal Support Systems LLC, Polymer Construction Products Ltd., and Safeteccs LLC (brief).

The amicus brief filed by the United States in support of Lilly begins by noting that "[a] complete and exact description of the claimed invention is the sine qua non of the patent system: it allows USPTO to examine applications, the courts to construe claims, and the public to recognize and avoid the boundaries of the patentee's exclusive rights." Stating that the Supreme Court has "repeatedly recognized that the function of the written description is not merely to enable, but also to describe the claimed invention itself and thereby provide notice to the public of the boundaries of the patentee's rights," the United States asserts that "[t]o construe Section 112, ¶ 1 as a bare enablement requirement would defy the text and history of the statute and disregard nearly two hundred years of judicial and administrative interpretation." Contending that the written description requirement "is as venerable as the patent system and remains instrumental to its operation," the United States asserts that "Petitioners identify no basis for discarding it now."

The United States devotes the first portion of its brief to an analysis of several Supreme Court decisions interpreting the written description provision of the 1870 Act, including Gill v. Wells, 89 U.S. 1 (1874); Permutit Co. v. Graver Corp., 284 U.S. 52 (1931); and Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938). The United States then concludes that "[n]othing in the new statute [i.e., the 1952 Act] or its legislative history indicated that Congress intended to abrogate cases such as Schriber-Schroth, Permutit, and Gill, or to break from more than a century of accumulated decisions interpreting the disclosure requirements of the patent laws."

With respect to Ariad's argument that the grammatical structure of § 112 creates a single description requirement whose sole measure is enablement, the United States asserts that "it is petitioners who overread the statutory text," adding that:

[N]othing in the statute requires petitioners' additional inference that any description that enables the invention will suffice. That inference disregards two centuries of judicial and administrative interpretation and collapses Congress's careful distinction in the statutory text between a "written description of the invention" and a description of the "manner and process of making and using the same" -- a dichotomy that, as noted, Congress has preserved in every iteration of the patent laws since 1790.

The United States points out that in Ariad's view:

[A]ny description that enables others to make and use the invention is sufficient, whether or not it describes "the invention" itself. Thus, for example, if an applicant's description of how to make and use a new chemical compound enabled others skilled in the art to make and use five, fifty, or even five hundred thousand additional compounds, it would be irrelevant that the applicant had neither described those compounds nor provided any reason to believe they would function as claimed. The applicant could claim them all -- or, more likely, amend his claims later when it became clear that a particular compound was commercially valuable. . . .
Likewise, under petitioners' construction of the statute, any scientist with a promising plan of research need only file a patent application describing her research plan and its expected outcome. If the plan produces the desired outcome, the application may have enabled others skilled in the art to make and use the "invention." And if the research plan fails, all that is lost is the filing fee and the cost of preparing the patent application. Such abusive tactics -- which allow opportunistic claimants to withdraw from the public domain entire fields of nascent scientific endeavor while setting down a priority stake for all future work in the field -- cannot properly be attributed to the statutory design.

Noting that "[p]etitioners argue that Section 112 requires not only a description of how to make and use the invention, but also a description of 'what the invention is, for otherwise it fails to inform a person of skill in the art what to make and use,'" the United States observes that "the similarity between the enablement test advocated by petitioners and this Court's written-description jurisprudence is striking." According to the United States, "[t]hat petitioners prefer to characterize this inquiry as a component of enablement, rather than as a distinct written-description requirement, is irrelevant -- nothing turns on the doctrinal labels."

The United States also contends that the U.S. Patent and Trademark Office requires a written description of the invention in order to carry out its examination function:

Though [a biological or chemical molecule claimed solely by reference to its function or effect] may be enabled, USPTO is not an experimental laboratory: it lacks both the facilities and the statutory mandate to determine, through empirical testing, whether any of millions of prior art inventions may have exhibited the recited function. By insisting that each applicant provide a full and exact "written description of the invention" as part of the specification, Congress protected the ability of USPTO to perform its essential function of distinguishing patentable inventions from the prior art. Indeed, this is one of the original and enduring purposes of the written description requirement: to "distinguish the invention or discovery from other things before known and used."

Noting that written description principles are firmly embedded in the U.S. Patent system, the United States asserts that:

[E]ven if Section 112 could have been construed to require enablement only, the plain fact is that it has not been. The patent laws have been understood to require more than bare enablement since the inception of the patent system. This Court alone, by the government's count, has issued at least twenty precedential decisions distinguishing between written-description and enablement. When CCPA cases drawing the same distinction are included, the total rises to at least thirty-five published decisions issued over fifty years -- an average of more than one precedential decision every two years under the 1952 Patent Act. That total, moreover, does not include the Supreme Court and CCPA cases predating the 1952 Act.

The United States concludes that "[i]t is rare that a federal court contemplates upsetting statutory interpretations as settled as this, and only the most extraordinary justification could warrant doing so." With respect to Ariad's embrace of Judge Markey's dissenting opinion in In re Barker, 559 F.2d 588 (CCPA 1977), the United States argues that:

[P]etitioners' arguments were fully aired and resolved more than thirty years ago. In the subsequent decades, this Court has repeatedly reaffirmed the holding in Barker, the USPTO has examined millions of patent applications under the principles established by this Court's precedents, and Congress has not intervened to change the law. Even if petitioners were correct that Judge Markey's view should have carried the day in 1977, that would not warrant reopening the question now.

Patent Docs thanks David Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for kindly providing us with many of the amicus briefs.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

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November 22, 2009

Amicus Briefs in Ariad v. Lilly: Google, Verizon Communications Inc. and Cisco Systems, Inc.

By Kevin E. Noonan --

The three members of the "high technology" community named above have weighed in on the Federal Circuit's en banc review of the written requirement and provide their own unique perspective on a debate that has raged primarily in the biotechnology sector over the past several years (see amicus brief). These companies are clear that they not only believe there is a separate written description requirement, but that it serves an important and unique purpose in preventing "overreaching" by patentees. And they are equally clear that limiting or abandoning the written description requirement would exacerbate the litigation difficulties they face that have motivated them to promote sweeping "reform" of U.S. patent law.

These concerns arise in the amici's Statement of Interest:

Having obtained a number of patents based on their own extensive research and development efforts, and having also been improperly charged with infringing others' patented technology, amici have a strong interest in a fair and rational patent system. Amici have seen up close the important role that the written description requirement plays in reducing uncertainty and distinguishing legitimate from abusive patent applications.

Moreover:

Because the written description requirement serves the vital purpose of reducing uncertainty posed by ambiguous claims, its evisceration would stifle the very innovation the patent laws are designed to encourage. Such uncertainty creates opportunities for speculative patent litigation that plagues high-technology companies and diverts resources from research and development to legal budgets. This problem would get markedly worse if the written description requirement were eliminated.

And reducing the requirement to enablement would not suffice:

The purposes of the written description requirement are not adequately served by the separate enablement requirement, in part because enablement takes account of not only the patent's specification, but also additional knowledge of a person skilled in the art. For that reason, an "invention" might be enabled by a specification even if the patent applicant had not thought of it or intended to claim it at the time the patent application was filed.

Perhaps wisely, the first section of the brief essays Supreme Court precedent relating to the importance of the written description as a requirement under U.S. patent law from the first years of the Republic, citing Grant v. Raymond (1832), Evans v. Eaton (1822) (the written description must "put the public in possession of what the party claims as his own invention") and O'Reilly v. Morse (1853). These cases all stand for the same principle, they assert, that the written description is "the cornerstone of the quid pro quo underlying all patent rights: a patent holder is entitled to exclusivity for a period of years, but only for things the applicant actually invented and disclosed to the public." This focus on the correspondence between the scope of the claims and the extent of the disclosure (and how the written description requirement acts to ensure the correspondence thereof) is the principal theme of the brief. The brief does not limit its citation of precedent to 19th Century cases, citing Schriber Schroth Co. v. Cleveland Trust Co. (1938) for the principle that "the patent monopoly does not extend beyond the invention described . . . it cannot be enlarged by claims in the patent not supported by the description." This citation supports their argument that the Court has recognized a separate written description requirement, since in the Schriber Schroth case the patent was invalidated because the accused infringing article "'was not the invention which [the patentee] described' in the specification." Morse is cited for the same proposition, whereby amici argue that Morse's claims that were invalidated sought to include "'a manner and process which he ha[d] not described and indeed had not invented, and therefore could not describe when he obtained his patent'." Also cited is Festo Corp. v. Shoketsu Kinzoku Kogyo Kabuchiki Co., where the Court opined that "the patent application must describe, enable, and set forth the best mode of carrying out the invention." (Indeed, in view of the Federal Circuit's almost obsequious adherence to Supreme Court precedent recently -- in cases such as In re Bilski and in response to the Court's decisions in KSR International Co. v. Teleflex Inc. and Medimmune, Inc. v. Genentech, Inc.), this argument may provide the majority with a rationale to let the Supreme Court decide the question by merely upholding the status quo.) According to amici, this statement "reinforces" the conclusion that the statute contains separate enablement and written description requirements. They also cite Festo as requiring that "[w]hat is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue" (which they argue the Court found to be a requirement separate and distinct from "the other requirements – enablement and best mode – of §112").

Amici take the opportunity in this portion of the brief to address -- and rebut -- Ariad's contention that the Supreme Court's earlier precedent stemmed from the form of patents prior to the 1836 Act, whereby patents did not include "peripheral" claims -- i.e., that the Court's emphasis on the description was due to inventions being described solely by the description in the patent. This argument does not refute the clear indication in Schriber-Schroth, Morse, and Festo, they argue. Nor has anything been changed in the current form of the statute, according to amici, here refuting the "misplaced comma" argument advanced by Ariad (that proper sentence construction makes significant the comma following the word "invention" in the portion of the statute that reads: "The specification shall contain a written description of the invention, and of the manner and process of making and using it, . . ."). According to this portion of amici's argument, Ariad's construction would render superfluous the phrase "and of the manner and process of making and using it," because if the intent was merely to require enablement, the remainder of the statutory language would accomplish that without this phrase. Since statutory construction eschews interpretations that make language mere surplusage, amici argue that Ariad's interpretation must be erroneous.

The next portion of the argument regards the role of the written description requirement in preventing patentees from claiming what they have not invented. This behavior takes two forms: first, advocating claim construction that extends beyond what is supported by the specification, and second pursuing claims that likewise are beyond the scope of what the inventors have invented. The risk of abolishing the written description requirement would be to encourage patentees to "disclose narrowly and claim broadly," say amici. The consequence according to amici would be "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims [that] would discourage invention only a little less than unequivocal foreclosure of the field," citing United Carbon Co. v. Binney & Smith Co. (1942). This ambiguity is a real threat, the amici assert, because claims and their interpretation do not "provide reasonable certainty." Citing the Federal Circuit's Phillips v. AWH Corp. and Exxon Research & Eng'g Co. v. United States, they argue that even claims that are not "insolubly ambiguous" can give rise to "difficult issue[s] of claim construction," and that the specification is the source of public notice of what a patent "does and does nor claim."

These amici then argue that they have had "first hand experience with the problems stemming from overbroad and ambiguous patent grants." They cite academic commentary to the effect that software patent claims are particularly difficult to properly construe and that "[n]umerous ambiguous patent claims are asserted against amici and other high tech companies each year." Indeed, they state that the very possibility that claims may be broadly construed "inflates the valuation" of such patents (citing Lemley and Shapiro, 2005) and they cite the FTC Report (2003) and Michael Heller's book (2008) that the need to confront "the jaw dropping number of patents" impedes innovation (under the current interpretation of the written description requirement). This situation makes difficult if not impossible the task of determining whether there is freedom to operate, and that "technology companies are regularly forced to defend against litigation involving patents with ambiguous claim scopes." Litigation, of course, is costly, and these costs "divert resources from innovation" and represent "wasteful transaction costs." The role of the written description requirement in mitigating such adverse consequences in "critical," amici argue. Indeed, that it may be difficult to accurately put into words the metes and bounds of patent claims "is a reason to require more description, not less," they say. And citing Schriber-Schroth, this is why the Supreme Court has required a written description "to ensure that the patent grant does not exceed the inventor's disclosed contribution."

In addition to the role of the written description requirement to proscribe construction of claims that exceeds the extent of the disclosure in the specification, amici argue that the requirement also prevents an applicant from "abusing" amendment and continuation practice in the Patent and Trademark Office. Such abuse was famously the thesis of Professor Lemley and (now) Federal Circuit Judge Moore and was the theoretical underpinning of the Office's ill-fated and now-withdrawn claim and continuation rules that were the subject of judicial challenge in Tafas v. Kappos. Amici argue that the written description requirement is the guardian against such "overreaching" by patent applicants. They cite the practice of "seemingly endless continuations" made (according to them) "in order to hold them open for future amendments." (Like Lemley and Moore, amici fail to recognize that such continuations are frequently necessary, especially in complex arts like biotechnology, to obtain claims having a scope appropriate to the applicant's written description and to which their specification entitles them.) They also argue that applicants assert the right (purportedly improperly) to submit claims in such continuation applications that encompass subject matter not disclosed in the specification and in fact developed by their competitors. "[T]he amendment and continuation practice, without the discipline of the written description requirement, engenders significant potential for abuse" they argue, citing another Lemley and Moore paper on the subject. This role for the written description requirement is supported by amici with a quotation from Schriber-Schroth, that "the patent . . . cannot be enlarged by claims in the patent not supported by the description."

In another savvy argument, amici contend that Congress has endorsed this aspect of the written description requirement when establishing the priority right for provisional, divisional, and continuation applications: in each instance the statute requires that a priority date will be granted only if the invention is disclosed in the manner provided by the first paragraph of section § 112 (35 U.S.C. § 119(e)(1) and 35 U.S.C. § 120). They further argue that these statutory provisions refute Ariad's assertion that Congress intended the written description requirement to be limited to "subsequent and not original claims," since the priority requirements in the statute do not differentiate between claims present in the application as filed and those submitted by amendment thereafter.

Amici then rebut Ariad's argument that other sections of the statute -- notably, the enablement provisions of § 112 -- can be sufficient to satisfy the proper limitation on claim scope. In addition to arguing that such an interpretation is contrary to proper statutory construction principles and prior Supreme Court precedent, amici distinguish the roles of the enablement and written description requirements based on the scope of the considerations applied to determine compliance with each of them. Written description analysis is confined to what is contained within the four corners of the patent document, they argue, while enablement also takes into consideration what is known to one having ordinary skill in the art. Once again citing Schriber-Schroth, amici argue that a specification may "enable" an invention "even if the patent applicant never thought of it and never meant to claim it," something that is particularly likely in the "more predictable arts such as engineering and computer programming." They cite both Gentry Gallery and Tronzo (the most (in)famous non-biotech written description cases) as examples of instances where what was enabled is greater in scope than what was disclosed. In addition to requiring the enablement statute to "take more weight than it can bear," amici argue that Section 101's "overbreadth doctrine" would also be implicated in addressing sufficiency of disclosure questions raised by elimination of the written description requirement, citing as an example the test enunciated in Gottschalk v. Benson. However, this test "has not always proven easy to apply," they say, and "there would be costs to overburdening that test." In short, amici argue that there is "no reason to turn to other doctrines to take the place of the foundational written description requirement."

In the final portion of the brief, amici argue that if there have been problems associated with application of the written description requirement to biotechnology claims, the solution is to address these problems by improving application of the requirement to such claims rather than "jettisoning the longstanding requirement altogether." They cite a dozen cases concerning "claims of all stripes" that the Federal Circuit has held invalid since 2006 in support of their argument that the written description requirement has not been confined merely to biotechnology claims: In re Reiffin, 199 F. App'x. 965, 2006 WL 2860589 (Fed. Cir. 2006) (multithreading computer application); Adang v. Umbeck, No. 2007-1120, 2007 WL 3120323 (Fed. Cir. Oct. 25, 2007) (transformed cotton plantlet); Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370 (Fed. Cir. 2007) (ball bearings); Ziarno v. Am. Nat'l. Red Cross, 55 F. App'x. 553, 2003 WL 57060 (Fed. Cir. 2003) (internet-based fundraising system); McMullin v. Carroll, 153 F. App'x. 738, 2005 WL 2840281 (Fed. Cir. 2005) (golf shoe cleat); LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005) (method for eliminating edge artifacts); Energizer Holdings, Inc. v. ITC, 275 F. App'x. 969, 2008 WL 1791980 (Fed. Cir. 2008) (mercury free alkaline batteries); In re Curtis, 354 F.3d 1347 (Fed. Cir. 2004) (dental floss); McKechnie Vehicle Components USA, Inc. v. Lacks Indus., Inc., 122 F. App'x. 482, 2005 WL 121840 (Fed. Cir. 2005) (automobile wheel covering); PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248 (Fed. Cir. 2002) (tuber sprout growth inhibitor); Williams v. Gen. Surgical Innovations, Inc., 60 F. App'x. 284, 2003 WL 932449 (Fed. Cir. 2003) (removal of tissue expander during surgery).

Interestingly, amici note that Ariad does not cite a single biotechnology case that had been decided incorrectly based on an application of the written description requirement except its own. Ariad argues that the claims in earlier biotechnology cases may have been invalid on enablement grounds, something Judge Linn (in concurring on the panel majority's opinion) opined may also be the case for Ariad's claims. In this regard they make an important point: the written description requirement is a question of fact, and fact-based inquiries "will necessarily vary depending on the nature of the invention claimed," citing Enzo Biochem Inc. v. Gen Probe Inc. "Even if Ariad were correct that this Court's written description jurisprudence had been too rigid for some biotechnology inventions, the solution would be to apply the requirement more contextually, on a case-by-case basis, to such inventions -- not to eviscerate completely this longstanding and foundational requirement for all inventions."

In a brief colored heavily by their own industry's particular concerns, these amici raise for the Federal Circuit's analysis several important considerations that apply (perhaps to varying degrees) to all technologies.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

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