Patent Docs: Federal Circuit

Federal Circuit

February 07, 2012

Adair v. Carter (Fed. Cir. 2011)

Today, the Federal Circuit affirmed a decision by the Board of Patent Appeals and Interferences holding that claim 24 of Appellants' application, which was involved in an interference with Appellees' patent, was barred under 35 U.S.C. § 135(b)(1). That section states that:

A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.

Appellants John Robert Adair, Diljeet Singh Athwal, and John Spencer Emtage filed U.S. Application No. 11/284,261 on November 21, 2005, along with a preliminary amendment requesting an interference based on U.S. Patent No. 6,407,213, which was issued to Appellees Paul J. Carter and Leonard G. Presta on June 18, 2002. The Board declared an interference, identifying claims 30, 31, 60, 62, 63, 66, 67, 70, 73, 77-81 of Appellees' '213 patent and claim 24 of Appellants' '261 application to be involved in the count.

Claim 24 of the '261 application recites:

24. A humanised antibody comprising a heavy chain variable domain comprising non-human complementarity determining region amino acid residues which bind an antigen and a human framework region wherein said framework region comprises a non-human amino acid substitution at a residue selected from the group consisting of 23, 24, 49, 71, 73, and 78, and combinations thereof, as numbered according to Kabat.

Claim 66 of the '213 patent, which is representative of the claims in the count, recites:

66. A humanized antibody heavy chain variable domain comprising non-human Complementarity Determining Region (CDR) amino acid residues which bind antigen incorporated into a human antibody variable domain, and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of: 24H, 73H, 76H, 78H, and 93H, utilizing the numbering system set forth in Kabat.

Because claim 24 was not presented to the USPTO prior to June 18, 2003 (i.e., one year from the date on which the '213 patent issued) -- the critical date -- Appellants attempted to rely on claims 1 and 16 of their International application and corresponding national stage application, which were presented prior to the critical date, and which Appellants' contended provided pre-critical date support for claim 24 of the '261 application. Appellants' claims 1 and 16 recite:

1. A CDR-grafted antibody heavy chain having a variable region domain comprising acceptor framework and donor antigen binding regions wherein the framework comprises donor residues at at least one of positions 6, 23 and/or 24, 48 and/or 49, 71 and/or 73, 75 and/or 76 and/or 78 and 88 and/or 91.

16. A CDR-grafted antibody heavy or light chain or molecule according to any one of the preceding claims comprising human acceptor residues and non-human donor residues.

In response to rejections of claims 1 and 16 during national stage under §§ 101, 102(b), 103, and 112, first and second paragraphs, Appellants cancelled those claims.

The Board rejected Appellants' argument that claims 1 and 16 provided pre-critical date support for claim 24, determining in part that Appellants added limitations to overcome the rejection of those claims during national stage, and as a result, material differences presumptively existed between claim 24 (the post-critical date claim) and claims 1 and 16 (the pre-critical date claims).

On appeal, Appellants argued that the Board erred by failing to assess material differences in view of the claim being copied from Appellees' patent. Appellees countered that the question of whether there is a sufficient degree of identity between pre- and post-critical date claims for compliance with § 135(b) is an inquiry that is distinct and independent from any comparison with the patent claims copied. In siding with the Appellees, the Federal Circuit cited Corbett v. Chisholm, 568 F.2d 759 (CCPA 1977), stating that:

In Corbett . . . this court compared the "copied claim" with the pre-critical date claims and affirmed the Board's finding that material differences precluded Corbett from relying on any of the pre-critical date claims to overcome the § 135(b) bar. Id. at 765-66. In identifying certain limitations of Chisholm patent claim 1 as "material," the court was simply noting the material differences that existed between that claim as copied by Corbett after the critical date and those pre-critical date claims Corbett was relying on to overcome the § 135(b) bar. The court did not establish any rule requiring some sort of threshold assessment of which limitations of the copied patent claim are material before determining whether material differences exist between post- and pre-critical date claims.

Pointing to In re Berger, 279 F.3d 975 (Fed. Cir. 2002), the opinion noted that:

[T]he court in Berger referenced the issued Muller patent claim 1 only because the post-critical date claim, claim 7, was a direct copy of the patent claim. Id. at 981-83. This court affirmed the Board's analysis based only on the material differences between the post- and pre-critical date claims. Id. at 983 ("Because Berger's original claims 1-6 [the pre-critical date claims] do not include a material limitation of Berger claim 7 [the post-critical date claim], copied claim 7 is not entitled to the earlier effective date of those original claims for purposes of satisfying § 135(b)." (emphasis added)).

The opinion also notes that in Regents of the University of California v. University of Iowa Research Foundation, 455 F.3d 1371 (Fed. Cir. 2006), "this court expressly approved an analysis of material differences based solely on a comparison of the post- and pre-critical date claims in order to obtain the benefit of the earlier filing date." Citing Corbett, Berger, and Regents, the Court therefore concluded that:

[T]o overcome a § 135(b) bar for a post-critical date claim, an applicant must show that such claim is not materially different from a pre-critical date claim present in the application or any predecessor thereto in order to obtain the benefit of the earlier filing date. Any claims filed within the critical period, whether or not later cancelled, may provide pre-critical date support for the later filed patent claim(s), so long as the pre-critical date claims are not materially different from the later filed claim(s).

Applying its holding to the instant interference, the panel determined that because the Board found material differences between claim 24 (the post-critical date claim) and claims 1 and 16 (the pre-critical date claims), and an assessment of claim 66 of Appellees' patent was not necessary, the Board did not err by failing to assess material differences in view of the claim being copied from Appellees' patent.

Appellants also argued that the Board erred by applying Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), in the context of an interference in order to conclude that a limitation added to a claim in response to a rejection that results in allowance is presumed to be necessary to patentability and therefore material. With respect to this argument, the panel again sided with Appellees, stating that:

When an applicant adds limitations in response to an examiner's rejection, and those limitations result in allowance, there exists a well established presumption that those limitations are necessary to patentability and thus material. See Festo, 535 U.S. at 734; Corbett, 568 F.2d at 765. This presumption applies with equal force in the interference context.

In determining that the Board did not err by applying Festo, the panel noted that:

[B]ecause [Appellants] cancelled claims 1 and 16 of the PCT Application in response to the examiner's rejections, and added limitations into what eventually became claim 24 of the '261 Application to secure allowance, the Board properly presumed material differences between [Appellants'] post- and pre-critical date claims.

The panel, therefore, affirmed the Board's decision that claim 24 of Appellants' application was barred under 35 U.S.C. § 135(b)(1).

Adair v. Carter (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Linn and Moore
Opinion by Circuit Judge Linn

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

January 25, 2012

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

By Andrew Williams --

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)

January 10, 2012

Celsis In Vitro, Inc. v. Cellzdirect, Inc. (Fed. Cir. 2012)

By Kevin E. Noonan --

The effects of the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. continue to ripple unpredictably through the Federal Circuit's jurisprudence, promoting inconsistencies in obviousness determinations by the Court that seem contrary to its mandate to harmonize U.S. patent law. The most recent illustration of this effect is in Celsis In Vitro, Inc. v. Cellzdirect, Inc., where a divided panel affirmed the grant of a preliminary injunction over a dissent based, in part, on a rigid understanding of the implications of the KSR decision.

The suit by Celsis alleged infringement of U.S. Patent No. 7,604,929, specifically a method for providing cryopreserved human hepatocytes:

A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
    (A) subjecting hepatocytes that have been  frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,
    (B) recovering the separated viable hepatocytes, and
    (C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

Thus, the claim recited three steps: subjecting frozen and thawed hepatocytes to a density gradient to separate viable from non-viable cells; recovering the viable cells, and freezing the cells again that have >70% viable cells after a second thaw without requiring density gradient step. Evidence before the District Court established that human hepatocytes are fragile and hard to cryopreserve, being very susceptible to damage when frozen and thawed and that there was an expectation in the art that repetition would make that worse, i.e., there would be even fewer viable cells after several freeze/thaw cycles. Human hepatocytes were in short supply and there was large demand, with available sources in the art being limited to fresh tissue that is rarely available. As a consequence, research was disrupted because it was dependent on sporadic availability of these cells. The opinion in the art was that hepatocytes could not be productively cryopreserved because too many non-viable cells were produced, the Court noting that "experts in this field met initial attempts to freeze hepatocytes with skepticism." The accused infringing article was a pooled multi-cryopreserved hepatocyte product allegedly produced using the claimed method (although the opinion does not give the details of the accused products "[f]or confidentiality reasons") sold in direct competition with the Celsis product (also a pooled multi-cryopreserved hepatocyte product). The District Court (Judge Milton Shadur of the Northern District of Illinois) granted the preliminary injunction.

The Federal Circuit affirmed, in an opinion by Chief Judge Rader joined by Judge Prost, with a dissent by Judge Gajarsa. The majority opinion recited the "four factors" considered with regard to a preliminary injunction: "(1) likelihood of success on the merits, (2) irreparable harm, (3) balance of hardships, and (4) public interest." Defendants challenged the District Court's decision on the first prong based on non-infringement and invalidity (for obviousness). Regarding infringement, there was a "battle of the experts" won by Celsis, perhaps in part because defendants put forward their marketing director as an expert. The Celsis expert provided testimony on the meaning of claim term "density gradient fractionation" and then "applied the term to the accused process." The District Court's decision regarding infringement was also based decision on construction of the term "not requiring" for performing a second density gradient fractionation as being inclusive of methods that actually perform a second density gradient fractionation (provided it is not "required"). The District Court expressly rejected defendants' construction that "not requiring" was equivalent to "prohibited," based on its interpretation that this construction incorporated a limitation from the specification into the claim (which the Court characterized as "hokum"). On this record, the Federal Circuit found no abuse of discretion by the District Court in deciding there was a likelihood that Celsis would succeed in its infringement claim.

The second issue was non-obviousness. Evidence from both parties included a "vast proliferation of authors and articles dealing with hepatocytes and use of cryopreservation." The District Court concluded that the claimed method was non-obvious because "not a single one of that astonishingly large body of literature was devoted to the subject of multi-cryopreservation of hepatocytes" (with the District Court noting stress on "multi"). The District Court rejected testimony from defendants' expert that one of his articles disclosed multi-cryopreservation of hepatocytes, finding that the reference was limited to fetal hepatocytes, which were not the same as adult hepatocytes. Also, since fetal cells were replication-competent, District Court credited testimony from the Celsis expert that it was not possible to determine "whether the same cells were cryopreserved more than once" (which was conceded by defendants' expert). This reference not the issue on appeal, however; there was another reference that taught whether single-cryopreserved hepatocytes could substitute for fresh hepatocytes (in humans, dogs and monkeys).

In reviewing the District Court's non-obviousness determination, the majority recited the Graham v. John Deere Co. analytical framework of factual inquiries regarding: "(1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness," citing Eli Lilly & Co. v. Teva Pharm. USA, Inc., 619 F.3d 1329, 1336 (Fed. Cir. 2010). On this record, the majority found no abuse of discretion, while noting that defendants would be able to "expand upon the arguments it made at the preliminary injunction stage" at trial. The majority "does not opine on the final determination, which lays in the realm of the district court in the first instance." The opinion emphasized the unpredictability in the art, affirming the District Court's finding that "the art was a crowded field for many years and yet there was not one reference to multi-cryopreservation" and "taught away from multiple freezings." In addition, the opinion noted that the expectation in the art was that a second freezing would result in "greater loss of cells after the second cryopreservation than after the first" and relied upon this understanding as grounds for deciding the art did not render obvious the claimed invention.

In a passage noted in the dissent, the majority specifically found that the second reference relied upon in the appeal did not provide "any teaching, suggestion, or motivation . . . that multiple rounds of freezing would somehow increase rather than decrease cell viability" and criticized defendants' argument as "vague reference[] to 'market need.'" Rather, the majority said that "without more" this was evidence of the objective criteria of "long felt need" and thus was "supportive of non-obviousness." And as part of its analysis, the majority found the District Court's decision to be based in art on a (negative) assessment of defendants' witnesses' credibility, something the reviewing court gives "wide discretion" to the district court, citing Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1362-63 (Fed. Cir. 2006), Bristol- Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1236 (Fed. Cir. 2003), Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223, 1231-32 (Fed. Cir. 2007), and Agfa Corp. v. Creo Prods. Inc., 451 F.3d 1366, 1379 (Fed. Cir. 2006). Rather, the opinion states:

Not one of LTC's experts testified to actually performing the claimed process or documenting their alleged understanding before the time of the invention, despite having the financial, scientific, and professional incentive to do so. The district court found that LTC's experts did not predict the results of the claimed methods at the time of the invention, nor could they find any reference in the prior art suggesting that any other scientist had.

The Federal Circuit also found no abuse of discretion by the District Court in determining that the other prongs of the test, irreparable harm, balance of the hardships and the public interest, were satisfied. "Irreparable harm" in this case included "price erosion, damage to ongoing customer relationships, loss of customer goodwill (e.g., when an effort is later made to restore the original price), and loss of business opportunities," all of which the majority found were "valid grounds for finding irreparable harm," citing Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1362 (Fed. Cir. 2008), and Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1382-83 (Fed. Cir. 2006). The Court based its agreement on the balance of the hardships on the fact that "[defendant's] losses were the result of its own calculated risk in selling a product with knowledge of Celsis' patent," citing Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006). The public interest "favors the enforcement of Celsis' patent rights" in this case because "investment in drug research and development must be encouraged and protected by the exclusionary rights conveyed in valid patents," and does not constitute an abuse of discretion because "[t]hat incentive would be adversely affected by taking market benefits away from the patentee and giving them to the accused infringer in this case."

Judge Gajarsa's dissent illustrates how the Supreme Court's KSR decision has a tendency to tip the balance between an objective assessment of the prior art as understood by one having ordinary skill in the art and its relevance to the claimed invention in favor of a court's subjective determination that an invention is obvious (the "I know it when I see it" standard). In addition, Judge Gajarsa evinces a belief that a preliminary injunction is "an 'extraordinary and drastic' remedy" that should be denied if a defendant can raise a (presumably unrebutted) "substantial question" on the patent's validity. Here, he writes that the District Court abused its discretion by committing legal error with regard to obviousness by holding defendants "to a clear and convincing standard of proof" and "reinvigorate[ing] the pre-KSR standard for obviousness, rigidly requiring an explicit teaching, suggestion, or motivation for multi- cryopreserving hepatocytes."

The basis for this opinion is that, in his view, the absence of "two limitations of the claimed invention" (freezing and thawing hepatocytes a second time and making the density gradient fractionation optional after the second thaw)" in the prior art did not defeat defendants' obviousness argument, because "obviousness does not require that each element of the claimed invention must be present in the prior art," citing Tegal Corp. v. Tokyo Electron Am., Inc., 257 F.3d 1331, 1349 (Fed. Cir. 2001). Indeed, in his view "all of the claimed elements were present in the prior art," including "(1) thawing cryopreserved hepatocytes; (2) using density gradient fractionation to separate viable and non-viable cells; and (3) refreezing and rethawing the hepatocytes." Taking each limitation individually (rather than considering the invention as a whole according to the plain language of the statute), the dissent notes that "[b]oth cryopreservation and density gradient fractionation were well known in the art at the time of the invention." In Judge Gajarsa's opinion, the remaining step recited in the claim was "nothing more than measuring the viability of cells thawed for a second time. If the cells have more than 70% viability, they meet this limitation; if they do not have 70% viability, they do not meet this limitation." Citing Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152-153 (1950), the dissent characterizes the invention as a "patent for a combination which only unites old elements with no change in their respective functions [and] obviously withdraws what already is known into the field of its monopoly." The invention in Judge Gajarsa's view of nothing more than "[r]epeating known steps to obtain a desired result" which is not inventive, citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1330-31 (Fed. Cir. 2009). The dissent also characterizes the majority's recognition that the art was unpredictable, and would have expected the claimed invention to be inoperative, as trying to "have it both ways," citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007), for the principle that "some degree of unpredictability" cannot render an invention non-obvious "so long as there was a reasonable expectation of success," despite the majority's reliance on evidence that there was no such reasonable expectation of success in this case.

The dissent also finds fault with the majority's citation of defendants' failure to provide evidence of any "teaching, suggestion or motivation" in the art as being contrary to the Supreme Court's KSR precedent, eliding the nuance that the Court corrected the Federal Circuit for rigid application of the test and, in fact, preserved the TSM test as being a useful analytical tool for deciding obviousness provided it was not rigidly applied.

The dissent illustrates the difficulties that arise from the Supreme Court's most quoted passage from KSR:

'When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp,' the invention is likely obvious.

The first portion of the sentence conflates the obviousness analysis from Graham v. John Deere with one of the objective indicia of non-obviousness; it is clear that grounds for finding an invention non-obviousness ("long-felt need in the art") cannot also be a basis for finding an invention obvious ("when there is a design need or market pressure to solve a problem"). Rather, it is only when the Supreme Court's statement is taken in its entirety that the two analytical frameworks can be reconciled: that in response to the need (long-felt or otherwise), and when there exists a "finite number of identified, predictable solutions" and (in a portion of the Supreme Court's teachings not recited in the dissent) "[i]f this leads to the anticipated success," then "it is likely the product not of innovation but of ordinary skill and common sense." It would appear that the required expectation of success was missing under the facts of this case.

The other basis for Judge Gajarsa's disagreement with the majority relates to the burden placed on defendant in avoiding the preliminary injunction. According to the dissenting opinion, defendants were required merely to provide evidence that the asserted claims were "vulnerable" and did not need to establish (by clear and convincing evidence) that the claims were invalid. This amounts to merely raising a "substantial question" regarding the claims' validity according to Judge Gajarsa, citing Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001); Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997), and Kimberly-Clark Worldwide, Inc. v. First Quality Baby Products, LLC, 431 Fed. Appx. 884, 886-7 (Fed. Cir. 2011). The District Court (and the majority) improperly shifted the burden to defendants, according to the dissent, and should have "simply decide[d] whether it is more likely than not that the patent will be proven invalid at trial," citing Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1379-80 (Fed. Cir. 2009).

Once again, these diverging standards for deciding questions of obviousness create a certain nostalgia for the wisdom of Judge Learned Hand in considering obviousnses:

The test laid down [in 35 U.S.C. § 103] is indeed misty enough. It directs us to surmise what was the range of ingenuity of a person "having ordinary skill" in an "art" with which we are totally unfamiliar; and we do not see how such a standard can be applied at all except by recourse to the earlier work in the art, and to the general history of the means available at the time. To judge on our own that this or that new assemblage of old factors was, or was not, "obvious" is to substitute our ignorance for the acquaintance with the subject of those who were familiar with it. Reiner v. I. Leon Co., 285 F.2d 501 (2d Cir. 1960)

Courts, made up of laymen as they must be, are likely either to underrate, or to overrate, the difficulties in making new and profitable discoveries in fields with which they cannot be familiar; and so far as it is available, they had best appraise the originality involved by the circumstance which preceded, attended and succeeded the appearance of the invention. Safety Car Heat & Light Co. v. General Electric Co., 155 F.2d 937 (2d Cir. 1946).

Celsis In Vitro, Inc. v. Cellzdirect, Inc. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Gajarsa and Prost
Opinion by Chief Judge Rader; dissenting opinion by Circuit Judge Gajarsa

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January 05, 2012

January 04, 2012

December 28, 2011

In re Biosearch Technologies, Inc. (Fed. Cir. 2011)

By Kevin E. Noonan --

The Federal Circuit's exclusive jurisdiction includes all questions "arising under" the patent laws of the U.S. (among other things). For all other issues the Court applies the law of the circuit in which the action was brought. This practice results in the Court deferring to (and applying the law as developed under) principles "arising under" the application of the law to everything other than U.S. patent law. Often (and perhaps most of the time) this has little effect. Occasionally, however, this practice does raise the question of whether the Court's application of particular circuit law in the context of patent litigation is appropriate, and whether the law can be (or should be) applied so readily to patent issues.

These questions are raised by the latest application of the law of forum selection and the role of forum non conveniens principles in deciding the best situs of patent litigation, in In re Biosearch Technologies, Inc. This question is a little curious, since one of the principal motivations for establishing the Federal Circuit in 1982 was to provide sufficient harmonization of U.S. patent law that so-called "forum shopping" was discouraged to the point of elimination (on the theory that different fora would not matter if the Federal Circuit mandated uniform application of the law in all districts). However, the penchant for patent litigants (primarily plaintiffs) to file suit in the Eastern District of Texas in Marshall, coupled by the perception that that court was "pro-patent," has raised the profile of this issue significantly (including, inter alia, being the basis of successful attempts to prevent "inappropriate" forum selection by legislation; see the Leahy-Smith America Invents Act).

The Federal Circuit has addressed this issue, in In re TS Technologies (Fed. Cir. 2008), where the Court applied the 5th Circuit Court of Appeals decision in In re VW to provide the standard for granting petitions to transfer patent litigation from the Marshall courthouse. The VW case established several factors considered by the 5th Circuit in deciding forum non conveniens questions, including the plaintiff's choice (which the Court cautioned should not be given "inordinate" weight), distance from the defendant's "home," the location of the physical evidence and witnesses and whether the chosen forum was more than 100 miles away from the location of the physical evidence and witnesses (thus impacting the Court's subpoena jurisdiction over both) and the public interest (particularly with regard to the public's interest in having "local" issues decided locally). The Court's application of these factors varies from case to case, of course, but in applying 5th Circuit precedent on the question it is well to consider the circumstances behind the 5th Circuit court's VW decision. The facts provide the relevant information regarding the issues considered by the 5th Circuit:

On the morning of May 21, 2005, a Volkswagen Golf automobile traveling on a freeway in Dallas, Texas, was struck from behind and propelled rear-first into a flat-bed trailer parked on the shoulder of the freeway. Ruth Singleton was driving the Volkswagen Golf. Richard Singleton was a passenger. And Mariana Singleton, Richard and Ruth Singleton's seven-year-old granddaughter, was also a passenger. Richard Singleton was seriously injured in the accident. Mariana Singleton was also seriously injured in the accident, and she later died as a result of her injuries.

[T]he Volkswagen Golf was purchased in Dallas County, Texas; the accident occurred on a freeway in Dallas, Texas; Dallas residents witnessed the accident; Dallas police and paramedics responded and took action; a Dallas doctor performed the autopsy; the third-party defendant lives in Dallas County, Texas; none of the plaintiffs live in the Marshall Division; no known party or non-party witness lives in the Marshall Division; no known source of proof is located in the Marshall Division; and none of the facts giving rise to this suit occurred in the Marshall Division. These facts are undisputed.

With this in mind, the following are the circumstances before the Federal Circuit in the Biosearch Technologies case. Applied Biosystems LLC and Life Technologies Corp. brought suit for patent infringement against Biosearch Technologies, Inc., Eurofins MWG Operon Inc., Midlands Certified Reagent Company, Inc. and Bio-Synthesis, Inc. in the Eastern District of Texas, Marshall Division. Defendants moved to transfer the case to the Northern District of California on the grounds inter alia that "a substantial number of witnesses and documents" are located with the jurisdiction of the California court. In denying the petition, the magistrate judge noted that all of defendant Bio-Synthesis's evidence was located in the Eastern District of Texas, and that while plaintiffs' evidence was located in "Austin, Texas, California, Maryland and New York," and that Eurofin was located in Alabama, the Eastern District of Texas was "convenient" to the parties as being a "proper central location" for the suit. The one factor in favor of transfer noted by the magistrate judge was that certain third party witnesses were located in California and thus the parties would not have access to compulsory process if the suit remained in the Texas court. However, the magistrate judge balanced this inconvenience against the additional costs that would be incurred "due to the number of Bio-Synthesis witnesses in Texas" and increased travel costs for other witnesses if the action was transferred to California. The District Court upheld the magistrate's denial of defendants' transfer motion.

In granting the requested writ of mandamus transferring the case to the Northern District of California, the Federal Circuit (in an order by Judge Linn, joined by Judge Newman and Judge Reyna) acknowledged both the "case-specific" nature of the transfer question as well as the principle that such a motion should not be granted unless the reviewing court determines that there was a "clear abuse of discretion or usurpation of judicial power" by the district court. The panel discerned that the 5th Circuit recognized "public" and "private" considerations or interest factors; the private factors including "(1) the relative ease of access to sources of proof; (2) the availability of compulsory process to secure the attendance of witnesses; (3) the cost of attendance for willing witnesses; and (4) all other practical problems that make a trial easy, expeditious and inexpensive," citing In re TS Technologies, 551 F.3d 1315, 1319 (Fed. Cir. 2008); while the "public interest" factors include "(1) the administrative difficulties flowing from court congestion; (2) the local interest in having localized interests decided at home; (3) the familiarity of the forum with the law that will govern the case; and (4) the avoidance of unnecessary problems with conflicts of laws [or in] the application of foreign law."

The Court noted the following "factors" it considered relevant to its decision to grant the writ: that both plaintiffs are located in California and one in Northern California, as was defendant Biosearch Technologies, Inc., which locale provides a "strong interest" for courts in that venue to try the case as well as suggesting that Northern California would be "convenient with regard to the location of likely sources of evidence." With regard to the latter factor, the panel noted the District Court identified "19 potential witnesses" who were located in Northern California (presumably within the subpoena power of that court), and that having to travel to Texas for trial would "likely incur significant expenses" which would be "significantly minimized or avoided" by transfer. The order also cited that the "large number of witnesses" residing in the "transferee" forum "may be expected to be invaluable in the event process is required to hale the relevant witnesses into court." In contrast, the only defendant having a significant presence within the jurisdiction of the Texas court, Bio-Synthesis Inc., had entered an agreement with plaintiffs that limited its discovery requests (this portion of the agreement contained a reciprocal limitation on discovery from plaintiffs directed at Bio-Synthesis) and waived its right to challenge the validity of the patents-in-suit. This agreement, and "Bio-Synthesis's behavior" (such as "failing even to participate in the claim construction proceedings that are so critical to the outcome of the infringement determinations") convinced the Court that Bio-Synthesis (and their witnesses) would be unlikely to have sufficient impact on the case and should not be awarded "significant weight" in deciding the transfer petition.

The Court was also convinced that this was another case where "an invention [that] has no connection with Texas" was before it and that this case should be decided accordingly (i.e., by granting the transfer motion); earlier cases cited in support of this view included In re Genentech, Inc., 566 F.3d 1338 (Fed. Cir. 2009), In re Nintendo Co., 589 F.3d 1194 (Fed. Cir. 2009), and In re Hoffman-La Roche Inc., 587 F.3d 1333 (Fed. Cir. 2009). Finding that the facts in the pending case were "as compelling" for transfer as the facts supporting its earlier precedent, the Court granted the motion to transfer.

While this outcome is not surprising in view of the Court's precedent, it is notable that many of the witnesses whose availability vel non and who would incur greater cost burdens were plaintiff's witnesses and evidence. The plaintiff's choice of venue thus would seem to preclude the need to use the Court's compulsory subpoena power to produce these witnesses or this evidence. Insofar as the presence of defendants' witnesses or evidence are outside the forum, any difficulties in obtaining such evidence during discovery or by deposition (including under Rule 45) are inconveniences to be borne by plaintiffs, who opposed the motion to transfer. Thus, in applying the factors identified by the 5th Circuit in the VW case the Court appears to be applying these factors without regard to the positions of the parties and where the inconvenience would lie. Such an approach may be relevant under the public interest prong of the VW test, but that is where the circumstances behind the rule become important considerations. It is evident that the public interest is important, and may be paramount, in a case like VW involving public safety and products' liability, with regard to sales of products accused of being defective and hence dangerous. There may be cases where related considerations are important in patent litigation, for example, where a patent-in-suit may protect an industry having a significant economic impact within the court's jurisdiction. But in Biosearch there are no such public interest concerns, and the arguments on convenience are apparently not availing as to the inconvenience to the party proffering the motion in contrast to the inconvenience to the party opposing the motion.

It is difficult to adduce general rules in cases where the decision is based on particular factual circumstances that will be different and have different nuances in each case to be decided. But the Court might consider that its establishment has not eliminated all benefits associated with forum shopping, and that decisions may be better made with a more skeptical view regarding the motivations behind parties requesting transfer of cases for convenience rather than jurisdictional deficiencies. After all, gamesmanship over venue can be used as effectively to gain a litigation advantage now as forum shopping did previously, and recognition of its own mandate should motivate the Court to minimize instances where it permits these practices to occur.

In re Biosearch Technologies, Inc. (Fed. Cir. 2011)
Nonprecedential order
Panel: Circuit Judges Newman, Linn, and Reyna
Order by Circuit Judge Linn

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December 12, 2011

Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2011)

By Kevin E. Noonan --

The Federal Circuit reversed the grant of a preliminary injunction in Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc., an ANDA case brought before Judge Martini in the New Jersey District Court. While not extending or changing the law on the requirements for a preliminary injunction grant, the decision illuminates the considerations the Court finds important in deciding whether a district court has abused its discretion.

The case involved the antibiotic doxycycline hyclate, sold in 75-, 100-, and 150 mg tablets by Warner Chilcott as Doryx® under a license from the NDA holder, Mayne Pharma International Pty. Mayne also owns Orange Book listed U.S. Patent No. 6,958,161, which is related to a modified release coated form of doxycycline. Suit was initiated subject to the Hatch-Waxman statutory scheme when defendant Mylan filed an ANDA for the 150 mg tableted version of the drug containing a Paragraph IV certification that the listed patent was invalid, unenforceable, and not infringed. Filing the lawsuit triggered the automatic 30-month stay of FDA approval of the generic drug, and Warner Chilcott moved the District Court for a preliminary injunction shortly before the period of the stay would have expired (when Mylan anticipated the FDA would grant its approval).

As part of the litigation below, the District Court construed the asserted claims in a Markman hearing. While claim construction was not directly at issue in the appeal, it was relevant to the first prong of the preliminary injunction test: whether Warner Chilcott had shown a reasonable likelihood of success on the merits. The District Court considered expert witness reports from both Warner Chilcott and Mylan regarding whether Mylan's product satisfied the recited limitations of the claims. (The Federal Circuit characterized this as "a battle of the experts.") The outcome of the "battle" was hardly definitive, the District Court saying that there were "some serious factual disputes" between the parties' experts that would need to be resolved after "further testimony and examination and credibility" at trial. The District Court denied Mylan's request for an evidentiary hearing and, despite its reservations about the differences between the experts, granted a preliminary injunction to Warner Chilcott, finding that it had fulfilled the requirements of (1) a likelihood of success on the merits; (2) irreparable harm; and (3) a balancing of the hardships in favor of the plaintiff. Neither the parties nor the Court appear to have considered the fourth prong, the public interest. "Notably," the opinion states, "the district court did not address Mylan's arguments that the '161 Patent is invalid because of anticipation or obviousness."

There is one additional factor at play in the case. The District Court informed the parties that it would not be able to conduct a trial on the merits until January 2012 due to a lengthy murder trial scheduled for autumn 2011.

The Federal Circuit reversed, in an opinion by Judge O'Malley joined by Chief Judge Rader and Judge Dyk. The Court applied the law of the regional (Third) Circuit for whether the preliminary injunction was granted as the result of "an abuse of discretion, an error of law or a clear mistake in the consideration of proof." Factual findings were reviewed for clear error. Here, the panel found clear abuse of discretion, based on the District Court's failure to hold an evidentiary hearing, which the Federal Circuit found was an absolute requirement in the Third Circuit for grant of a preliminary injunction. The opinion states that the District Court granted the injunction on "an unsettled record" in full appreciation that there was a factual dispute between the parties' experts that it did not resolve prior to the injunction grant. While the Federal Circuit "recognize[d] and [was] not unsympathetic to the district court's scheduling demands and the difficulty in balancing a busy criminal docket with pressing civil matters," the opinion reversed because the District Court's decision to grant the injunction was "contrary to Third Circuit law."

Finally, the opinion asserted as another ground for reversing the preliminary injunction that the District Court "failed to make any findings as to Mylan's invalidity challenge" and as a consequence the Federal Circuit was prevented "from engaging in any meaningful review of that issue." Under Federal Rule of Civil Procedure 52(a)(1), a district court must "find the facts specially and state its conclusions of law separately" and here the District Court failed to comply with the Rule. Supreme Court (Mayo v. Lakeland Highlands Canning Co., 309 U.S. 310, 316 (1940)) and Third Circuit (Kos Pharms., Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004)) precedent (as well as Federal Circuit law, for example, Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1378-79 (Fed. Cir. 2009)) mandated compliance with Rule 52. The District Court's "utter failure" to comply with Rule 52 with regard to Mylan's invalidity allegations provided yet another basis for overturning the District Court's injunction. Nevertheless, the opinion vacated and remanded with instructions that the District Court could consider entering a temporary restraining order and consolidating the evidentiary hearing for the injunction with a (bench) trial on the merits. The opinion also "[took] no issue with the adequacy of the trial court's findings on irreparable harm and the balance of the hardships" and mandated no reconsideration of these prongs of the test "unless [the District Court] chooses to do so."

While not breaking new ground on preliminary injunction jurisprudence, the case does present an interesting issue, particularly in view of the Supreme Court's penchant over the last decade to chastise the Federal Circuit for adopting patent-specific rules for matters like injunctions. The High Court has made it very clear (in cases such as eBay Inc. v. MercExchange, L.L.C.) that the Federal Circuit is bound by and must apply the same rubrics for making decisions about injunctions and other procedural matters as are applied in the other several circuit courts. And as the Federal Circuit has done here, the Court must apply the law of the regional circuit in which the district court sits.

This raises the question of whether it might be better for appeals such as this one, which depends more on the application of procedural rules and precedent developed in said regional circuits (rather than Federal Circuit-specific case law) to be decided by the regional circuit courts of appeal. The question presented for review in this case is illustrative: the Federal Circuit did not apply any patent-specific rules or precedent to the matter; indeed, the cases cited were (by and large) Third Circuit cases. For both procedural consistency and as a way to reduce the workload on the Federal Circuit it might make sense for these cases not to go to that Court. The particular regional circuit court could always (on party motion or sua sponte) transfer the appeal to the Federal Circuit if the issues appeared to be controlled by questions of patent law. But for many cases, judicial efficiency might be better served to render unto the Federal Circuit those things limited to patent law, and to leave for the regional circuits those issues that are not so limited.

Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Dyk and O'Malley
Opinion by Circuit Judge O'Malley

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December 07, 2011

Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP (Fed. Cir. 2011)

By Andrew Williams --

Last week, in Teva Pharma. Indus. Ltd. v. AstraZeneca Pharma. LP, the Federal Circuit reiterated that, in the context of 35 U.S.C. § 102(g), "[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made." The complication is, however, how do you define what the invention is? This is because the invention is not necessarily what is claimed -- "'[t]he invention is not the language of the [claim] but the subject matter thereby defined'"(citing Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001)). Therefore, in this case, because AstraZeneca "appreciated" that it had a formulation with a stable compound (the defined invention), and it knew what the components of the formulation were, it conceived and reduced to practice a stabilized pharmaceutical composition of rosuvastatin (a statin) before Teva's date of invention, even though AstraZeneca did not appreciate the stabilizing property of one of the components, which was a limitation found in Teva's claims.

The technology at issue in this case involved statin formulations, which are inherently unstable and as a result need to be stabilized to be medically viable. Teva discovered that, among other things, amido-group containing polymeric compounds ("AGCP compound") can be used to stabilize statins, and obtained a patent (RE39,502) with the following representative claim:

1. A stabilized pharmaceutical composition for the treatment of dyslipidemia, comprising
an active component consisting essentially of one or more compounds selected from the group consisting of (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptafloic acid or a pharmaceutically acceptable acid salt thereof, and (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and
a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.

(emphasis as found in the opinion). Teva's earliest effective filing date was April 10, 2000, and the earliest date that it alleges it could establish conception and reduction to practice was December 1, 1999. Teva sued AstraZeneca for infringement in October 2008 for the stabilized statin (rosuvastatin calcium) formation that it was marketing for the treatment of dyslipidemia. The relevant facts were uncontested, and AstraZeneca conceded infringement for the limited purpose of advancing its summary judgment motion (AstraZeneca appears to have been able to challenge infringement because its formulation contained a second stabilizer, tribasic calcium). The facts related to AstraZeneca's prior invention allegation included: (1) AstraZeneca had manufactured a 10,000-unit batch of the formulation with the same ingredients as its commercial drug in mid-1999, (2) it had made additional batches in the summer and fall of 1999, (3) it had disclosed the ingredients and quantities for the formulation that match all commercial drug dosage strengths, and (4) it included crospovidone, an AGCP-compound, as a disintegrant, but did not understand that it had a stabilizing effect on the statin. As a result, the sole legal question for the Court was whether AstraZeneca conceived and reduced to practice the claimed invention before Teva.

It is clear that prior invention in the context of 102(g) requires a showing that the challenging party (1) reduced its invention to practice first, or (2) was the first to conceive and then exercised due diligence in reducing the invention to practice. In order to conceive, the inventor needs a specific and settled idea, a particular solution to a problem at hand. Reduction to practice, on the other hand, requires that the inventor constructed an embodiment that met all of the claim limitations, and determined that it would work for its intended purpose. However, the inventor need not understand precisely how the invention worked. There is another requirement that is relevant in the chemical and biotech arts -- conception of something reduced to practice requires more than an unrecognized accidental creation, but instead, the inventor must appreciate what he has invented. In other words, "'a party who first reduced to practice, but who 'fail[ed] to recognize that he had produced a new form [of matter] . . . is indicative that he never conceived the invention''" (quoting Dow at 1341 (quoting Heard v. Burton, 333 F.2d 239, 243 (C.C.P.A. 1964)).

Teva argued that because AstraZeneca did not appreciate that crospovidone was a stabilizing agent, it could not have appreciated the invention of a formulation with "a stabilizing effective amount" of an AGCP. The lower court, however, held that all AstraZeneca had to appreciate was the stabilization of its overall pharmaceutical composition that contained crospovidone. On appeal, Teva complained that the District Court implicitly construed the claims to encompass stabilized statin formations that contained AGCP, without taking into account that AGCP had to act as a stabilizer. However, the Federal Circuit pointed out, while quoting William Shakespeare, that AstraZeneca was not required to appreciate the invention in the same terms as those recited by the claims ("[T]hat which we call a rose [b]y any other name would smell as sweet."). Therefore, because AstraZeneca appreciated that the statin in its formulation was stable, and because it appreciated what the components of the formation were, it appreciated the invention.

On its face, this outcome appears to be inequitable. After all, reducing Teva's claim to "a stabilized [statin-containing] pharmaceutical composition" appears to ignore the rest of the claim, including Teva's alleged inventive contribution. In fact, the panel questioned both sides during the hearing as to whether Teva should be entitled to this patent because it provided the public with something that it didn't have before the filing of the application -- the knowledge that AGCPs can act as stabilizing agent for statins. Nevertheless, this line of reasoning has its limits, in part because Teva did not claim the use of AGCPs as stabilizing agents in this patent. Instead, Teva claimed a composition that used such stabilizing agents. The important thing to consider is that AstraZeneca was using its composition (the same one that Teva alleged infringed) before Teva's elucidation of the mechanism of action of AGCPs. And, it is still true that, that which infringes after, anticipates before, even if the use before was without the benefit of the knowledge as to why it worked. Teva should not be allowed to now take this composition out of the public domain just because it discovered why the composition was so successful -- specifically, because it determined the inherent stabilizing effect that crospovidone has on statins. This case does have the flavor of inherent anticipation. The panel was very clear in its opinion and during the hearing that the concept of inherency was not implicated in this case or its decision. However, one cannot help think that this outcome smells a lot like inherency jurisprudence. Perhaps this rose just has a different name.

Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Linn and Dyk
Opinion by Circuit Judge Linn

Posted at 11:59 PM in Federal Circuit, Novelty | Permalink | Comments (12) | TrackBack (0)

November 29, 2011

In re Stepan Co. (Fed. Cir. 2011)

By Kevin E. Noonan --

It is widely appreciated that the Supreme Court has spent the better part of the last ten years exercising its supervisory role over the Federal Circuit, something the Court generally refrained from doing for the first 15-20 years of the appellate court's existence (see "Is It Time for the Supreme Court to Stop Flogging the Federal Circuit?"). One of the first cases serving as a bell-weather for the High Court's new thinking about the Federal Circuit was Dickinson v. Zurko, 527 U.S. 150 (1999), where the Supreme Court found that the Federal Circuit, like all appellate courts, was constrained by the provisions of the Administrative Procedures Act of 1948 in the exercise of its supervisory authority over the U.S. Patent and Trademark Office. This standard required the Federal Circuit to defer to factual determinations made by the Patent Office, imposing a "substantial evidence" standard for reversing decisions by the Office. This was a much more deferential standard than the one the Federal Circuit was used to, albeit not rising to the "arbitrary and capricious" standard espoused by the PTO Commissioner (Q. Todd Dickinson). But in rejecting the argument that the Federal Circuit was special and entitled to satisfy its own standards (due inter alia to its unique position among the regional Circuit Courts of Appeal), the Supreme Court clearly mandated that the Federal Circuit comply with legal standards the Court had established rather than ones the Federal Circuit felt appropriate for the fulfillment of its peculiar purpose of interpreting U.S. patent law.

It is both ironic and perhaps fitting, then, that the Federal Circuit had the opportunity to turn the provisions of the APA on the Patent Office in reversing the Board's decision in In re Stepan Co. Stepan Co. ("Stepan") appealed the Board's decision affirming an Examiner's obviousness rejection in reexamination proceedings. The Examiner based his rejection on a prior art reference to Singh (WO 97/21764) applied under 35 U.S.C. § 102(b). The Board affirmed the rejection that the claims were obvious, but considered the reference to be prior art under 35 U.S.C. § 102(a). In making its determination, the Board determined that a Declaration submitted by Stepan during the reexamination pursuant to 37 C.F.R. § 1.131 was "ineffective to remove Singh as a reference qualifying under 35 U.S.C. § 102(a)"; this determination was relevant because, unlike the absolute statutory bar of § 102(b), the requirement of § 102(a) that the invention was known or used in this country "before the invention thereof" by the patent applicant permits an inventor to "swear behind" the asserted reference.

Stepan contended that the difference in the grounds of the rejection constituted a "new ground of rejection" that should have triggered the provisions of the APA (and the Office's own procedural rules) to provide (of right) an opportunity for further examination by the examiner, i.e., that the Board should have remanded the case back to the Group for further consideration.

In a opinion by Judge Prost, joined by Judge Dyk, the Federal Circuit[1] agreed. Citing "a series of [prior] opinions," the panel found that:

[B]oth this court and our predecessor court, the United States Court of Customs & Patent Appeals ("Patent Court"), have recognized that if the appellant has not had a full and fair opportunity to litigate the Board's actual basis of rejection, the administrative validity proceedings before the United States Patent and Trademark Office ("PTO") should be allowed to continue.

In re Kumar, 418 F.3d 1361, 1367–68 (Fed. Cir. 2005) (collecting cases). This right to a "full and fair hearing" is embodied in Patent Office regulations, inter alia, 37 C.F.R. § 41.50(b), which the Court says is required to satisfy the statutory notice requirement embodied in 35 U.S.C. § 6. In addition, as a procedural matter, Stepan argued that it had been denied the opportunity to address whatever deficiencies the Board found existed in its Rule 131 Declaration. At root, this constituted a claim that Stepan's administrative due process rights had been violated.

The Court agreed with Stepan that changing the statutory basis for deciding that the Singh reference was prior art (specifically, what kind of prior art) was a new ground of rejection. The Federal Circuit rejected the Office's contention that since the basis for the rejection was the same -- obviousness -- there was no "new ground of rejection" asserted by the Board and thus due process was not implicated in its decision. The panel also found insufficient the government's argument that, since Stepan had had the opportunity to present evidence and argument (and in fact had done so) during proceedings before the Board on the issue, it had been afforded with the required opportunity to be heard. Finally, and equally unavailingly, the government argued that Stepan was under an obligation to petition for rehearing and by having failed to do so had squandered the right to "allege that it was deprived of its administrative due process rights." Not so, according to the panel:

It is crucial that the examiner issue a rejection (even if that rejection is subsequently withdrawn) so the applicant is on notice that it is obligated to respond. Mere reliance by the Board on the same type of rejection or the same prior art references relied upon by the examiner, alone, is insufficient to avoid a new ground of rejection where it propounds new facts and rationales to advance a rejection -- none of which were previously raised by the examiner.

It was "mere fortuity" that Stepan had argued the validity of its Rule 131 Declaration during reexamination (its validity vel non not having been raised by the Examiner). Further, the Court found that the phraseology of § 41.50(b), that "[s]hould the Board have knowledge of any grounds not involved in the appeal for rejecting any pending claim, it may . . . [issue] a new ground of rejection" (emphasis added) did not make discretionary notice of a new ground of rejection and remand to the examiner.

It is this part of the argument that raises the sweet irony of the Zurko case. In rejecting the government's arguments, the Court reminded the Office that "the PTO's regulatory interpretation is due no deference in view of the agency's statutory obligation under the Administrative Procedure Act ("APA") to provide prior notice to the applicant of all 'matters of fact and law asserted' prior to an appeal hearing before the Board. 5 U.S.C. § 554(b)(3)." Granting the Office such discretion (i.e, to designate whether there was a new ground of rejection) would "frustrate the notice requirements of the APA," said the Court, citing the Zurko decision. And the Court noted that the Office's own regulation predicated an applicant's obligation to request rehearing on the Board having designated its decision as a "new ground of rejection," recognizing that the Board's failure to do so here not only absolved Stepan of the obligation to request hearing but actually had prevented it from doing so. Accordingly, the Court vacated the Board's decision and remanded to the Office "with instructions to designate its rejection as a new ground of rejection," leaving Stepan "free to pursue its patent application according to the requirements of 37 C.F.R. § 41.50(b)."

In re Stepan Co. (Fed. Cir. 2011)
Panel: Circuit Judges Dyk, Friedman[1], and Prost
Opinion by Circuit Judge Prost

[1] Judge Friedman was on the panel that heard oral argument and was involved in the panel’s deliberations, but his death this past July prevented him from contributing to the opinion.

Posted at 11:42 PM in Federal Circuit | Permalink | Comments (2) | TrackBack (0)

November 14, 2011

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2011)

By Andrew Williams --

In Streck, Inc. v. Research & Diagnostic Systems, Inc., the Federal Circuit clarified that when a party to an interference appeals the decision of the Board of Patent Appeals and Interferences to a district court in a civil action pursuant to 35 U.S.C. § 146, and new evidence is submitted, the district court must conduct a de novo determination of the issue of priority. The Federal Circuit also clarified that in a § 146 action in the district court, the junior party still has the burden of persuasion if new evidence is introduced, regardless of whether the Board awarded them priority. Finally, the Court pointed out that the standard of proof for priority in a § 146 action is preponderance of evidence when the applications were initially copending at the Patent Office, in contrast to the clear and convincing standard that is required when priority to an issued patent is challenged in district court.

The technology at issue in Streck was blood composition controls for hematology instruments. 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. As the instruments 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. The difficulty that the inventors had to overcome was interference between the various blood components, and that the controls needed to be stable over extended periods of time. Streck obtained a patent to such controls and sued R&D in the U.S. District Court for the District of Nebraska. The jury found that R&D did not provide clear and convincing evidence that its inventor was the first to invent any of the claims without abandonment, suppression, or concealment, and the District Court entered judgment against R&D.

At about the same time, an interference was declared in the Patent Office between the two parties, with the Streck inventors being named the senior party. In contrast to the outcome in the District Court, however, the Board awarded priority to the R&D scientist. Streck then filed a § 146 action in the same Nebraska court, and the case was assigned to the same judge. Based on a provision in 35 U.S.C. § 146, the PTO record was admitted. However, the District Court also considered live testimony and evidence not before the PTO, and decided that priority should be awarded to Streck. In appealing to the Federal Circuit, R&D objected to the procedure used by the District Court, the burden of proof it applied, and its ultimate findings and conclusions.

First, the District Court reviewed the facts of priority de novo on the entirety of the PTO record and the evidence at trial. R&D argued that the Court was required to accept the findings of the Board if those findings were supported by substantial evidence. This position was contrary to the controlling case Winner International Royalty Corp. v. Wang, 202 F.3d 1340 (Fed. Cir. 2000), which clearly held that "the admission of live testimony on all matters before the Board in a section 146 action, as in this case, makes a factfinder of the district court and requires a de novo trial." Id. at 1347. R&D's proposed standard is the same standard that the Federal Circuit is required to apply when an appeal is made directly to it from the Board (a § 141 action), as required by the Supreme Court in Dickinson v. Zurko, 527 U.S. 150 (1999). The problem with R&D's position is that Winner considered Zurko, and still established the de novo trial requirement, because that is the purpose of a § 146 action -- to provide the ability to introduce new evidence, including live testimony. R&D alleged that the standard had shifted since Winner, as evidenced by Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009). However, the Agilent Court allowed the consideration of new evidence at the district court level without deference to the Board, even while stating that it was to "shor[e] up evidentiary gaps that may have been evident by the end of the inter partes interference procedure." Id. at 1380. R&D apparently took the position that if there were no "evidentiary gaps," then no new evidence could be introduced. Nevertheless, Agilent is consistent with Winner, and is silent as to whether it was modifying the de novo standard, and as such, the Federal Circuit affirmed the District Court's de novo determination of the issue of priority under § 146.

One concern about using this de novo approach, however, is that it makes the hearing before the Board almost meaningless, and could result in potentially duplicative proceedings. In almost every case, the losing party at the Board could contend that it needs the opportunity to elicit live testimony, and both parties will therefore be required to litigate the case anew. This is true even though testimony subject to cross-examination can be presented before the Board, albeit as deposition testimony. Nevertheless, the law on this issue is currently clear. It will be interesting to see if the Supreme Court will comment on this issue with regard to § 146 actions in the Hyatt case, which is set to consider the standard for the related § 145 actions (appeals to district court from ex parte actions before the Board).

R&D also alleged that the District Court should have placed the burden of proof on Streck instead of R&D, because Streck appealed the case from the Board's decision. However, the Federal Circuit distinguished between the burden of persuasion and the burden of production. Because the civil proceeding was subject to de novo review, the burden of persuasion was still on R&D, regardless of the outcome before the Board. It is apparent, however, that Streck had the burden of production, or in other words, they were the party that had to come forward with evidence at that stage of the litigation. Of course, in a § 146 action, it is fairly trivial to clear such a hurdle, because the party with the burden of production can simply request live testimony.

The Federal Circuit also addressed the standard of proof. However, Streck was awarded priority by a jury in the originally filed case where the standard was clear and convincing. It is not surprising, therefore, that the District Court would come to the same conclusion in the § 146 action where the standard is the more lenient preponderance of the evidence, and it is not clear whether this standard was even challenged.

Finally, R&D challenged the District Court's findings and conclusions regarding whether its inventor had reduced the invention to practice before Streck's inventors. To show possession of the subject matter sufficient to establish reduction to practice, an inventor must show or know that the invention will work for its intended purpose. R&D questioned whether a count to "a hematology control" could have an intended purpose of being "free of inaccuracy due to interference from reticulocytes," as the Court found, requiring that the inventor have shown that there was no such interference. The count itself did not include such a requirement. Nevertheless, the District Court determined that if there was such interference, the invention could not properly be used as a control, and the Federal Circuit concluded that these findings were not clearly erroneous. Therefore, the lower court's decision was affirmed.

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2011)
Panel: Circuit Judges Newman, O'Malley, and Reyna
Opinion by Circuit Judge Newman

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November 10, 2011

Mikkilineni v. Stoll (Fed. Cir. 2011)

By Donald Zuhn --

Today, the Federal Circuit affirmed the denial by the District Court for the Eastern District of Virginia of Plaintiff-Appellant M.R. Mikkilineni's motion under Fed. R. Civ. P. 60(b)(3) requesting relief from a final judgment due to alleged fraud by the U.S. Patent and Trademark Office. In denying the motion, the Federal Circuit determined that Mr. Mikkilineni failed to show any evidence of fraud, misrepresentation, or misconduct by the USPTO.

In an earlier appeal arising from this case, the Federal Circuit dismissed Mr. Mikkilineni's challenge of the USPTO's Interim Patent Subject Matter Eligibility Examination Instructions ("Interim Guidelines") (see "Mikkilineni v. Stoll (Fed. Cir. 2010)"). Mr. Mikkilineni had filed an application claiming "a method to fall-asleep by learning to use the process-algorithm in the brain [to] transform brain-neurons into a different[]physical state and produce melatonin and serotonin . . . without the use of drugs," and his claims were subsequently rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter. After responding to the Examiner's non-final rejection, Mr. Mikkilineni filed suit against the Commissioner of Patents, alleging that the USPTO violated 5 U.S.C. § 553(b)-(c) of the Administrative Procedure Act ("APA") by failing to provide notice and an opportunity to comment with respect to the Interim Guidelines, on which the § 101 rejection was based. The Federal Circuit affirmed the District Court's dismissal of the case, finding that the Interim Guidelines are interpretive, rather than substantive, and were thus exempt from the notice and comment requirements of § 553 of the APA.

With respect to the instant appeal, Mr. Mikkilineni filed a motion under Fed. R. Civ. P. 60(b)(3) with the District Court, arguing that the USPTO had obtained the previous judgment based on fraud. The District Court denied the motion, holding that Mr. Mikkilineni failed to meet the clear and convincing evidence standard, and instead was "merely repeat[ing] the legal arguments that he already presented." The Federal Circuit affirmed, stating that:

Mr. Mikkilineni fails to show any evidence of fraud. Instead, he reargues the merits of the First Appeal and accuses the PTO of fraud and misrepresentation for disagreeing with his positions.

Mikkilineni v. Stoll (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Chief Judge Rader and Circuit Judges Lourie and Moore
Per curiam opinion

Posted at 11:08 PM in Federal Circuit | Permalink | Comments (1) | TrackBack (0)

November 09, 2011

Sanofi-Aventis v. Apotex Inc. (Fed. Cir. 2011)

By Donald Zuhn --

In an appeal decided last month, the Federal Circuit reversed a decision by the District Court for the Southern District of New York awarding prejudgment interest to Plaintiffs-Appellees Sanofi-Aventis, Sanofi-Synthelabo, Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership ("Sanofi"); affirmed the District Court's denial of a motion for leave to file a supplemental answer, affirmative defenses, and counterclaims by Defendants-Appellants Apotex Inc. and Apotex Corp. ("Apotex"); and affirmed the District Court's holding that Apotex Inc. is jointly and severally liable for all damages. The appeal was the third heard by the Court regarding clopidogrel bisulfate tablets, which are sold by Sanofi under the brand name Plavix®. In the first appeal, the Federal Circuit affirmed the District Court's grant of a preliminary injunction (see "Sanofi-Synthelabo v. Apotex, Inc. (Fed. Cir. 2006)"). In the second appeal, the Federal Circuit affirmed the District Court's judgment that Sanofi's U.S. Patent No. 4,847,265 was not invalid, infringed, and not unenforceable (see "Sanofi-Synthelabo v. Apotex, Inc. (Fed. Cir. 2008)").

Seeking approval to market a generic clopidogrel bisulfate tablets, Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA. In response to Apotex's ANDA filing, Sanofi brought suit against Apotex for infringement of the '265 patent, which triggered a thirty-month stay of FDA approval for Apotex's ANDA, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii). Eight months after the stay expired, the FDA approved Apotex's ANDA.

Prior to FDA approval, the parties began settlement negotiations that culminated in a tentative agreement. Under that agreement, Sanofi granted a license to Apotex, allowing it to begin selling generic clopidogrel bisulfate tablets before the '265 patent expired, and agreed not to launch an authorized generic during the pendency of the license. The Federal Trade Commission objected to the agreement, in part because of the provision not to launch an authorized generic (FTC approval was required as a result of a previous litigation involving Bristol-Myers Squibb Company, which is an owner of Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership). As a result of the FTC's objections, Sanofi withdrew the agreement and the parties reinstituted settlement negotiations.

Two months later, the parties entered into a second settlement agreement that did not include a provision prohibiting Sanofi from launching an authorized generic. Instead, the BMS executive negotiating the agreement orally promised Apotex that Sanofi would not launch an authorized generic during the pendency of the license. However, when BMS presented the second settlement agreement to the FTC for approval, it did not disclose the oral agreement. After Apotex subsequently disclosed the oral agreement to the FTC, the FTC requested written certification from BMS that there was no oral promise not to launch an authorized generic. Although BMS provided such certification, the second settlement agreement was not approved pending an investigation into the existence of the oral agreement.

Subject to a regulatory denial provision in the second agreement, Apotex launched its clopidogrel bisulfate product. In response, Sanofi moved for a preliminary injunction, which the District Court granted. The District Court then held a bench trial regarding liability, finding the '265 patent to be valid and enforceable, and bifurcating on the issue of damages.

During the damages stage, Apotex sought leave to file a supplemental answer, in which Apotex alleged that the '265 patent was unenforceable for patent misuse due to BMS's failure to disclose the oral agreement to the FTC and its subsequent false certification to the FTC. The District Court denied Apotex's motion, determining in part that BMS's actions likely did not constitute patent misuse. Sanofi, meanwhile, moved for summary judgment on the issue of damages, noting that the second settlement agreement set Sanofi's "actual damages" as 50% of Apotex's net sales. The District Court granted Sanofi's motion, and ordered Apotex to pay $442,209,362 in damages (50% of Apotex's net sales) and an additional $107,930,857 in prejudgment interest, rejecting Apotex's argument that the second settlement agreement precluded an award or prejudgment interest. The District Court also held that Apotex Inc. and Apotex Corp. were jointly and severally liable for the damages.

On appeal, Apotex argued, in part, that the District Court erred by awarding Sanofi prejudgment interest, holding Apotex Inc. and Apotex Corp. jointly and severally liable, and denying Apotex's motion for leave to file a supplemental answer. With respect to the award of prejudgment interest, Apotex contended that as a result of paragraph 14(ii) of the second settlement agreement, Sanofi contractually limited its full recovery to 50% of Apotex's net sales. Paragraph 14(ii) states:

If the litigation results in a judgment that the '265 patent is not invalid or unenforceable, Sanofi agrees that its actual damages for any past infringement by Apotex, up to the date on which Apotex is enjoined, will be 50% of Apotex's net sales of clopidogrel products . . . . Sanofi further agrees that it will not seek increased damages under 35 U.S.C. § 284.

Apotex also noted that paragraph 10 of the agreement, which defined the amount Sanofi would reimburse Apotex for Apotex's investment in inventory, expressly provided for a separate interest payment, in contrast with paragraph 14(ii). The District Court, however, determined that because the second settlement agreement only explicitly limited damages, the agreement did not preclude an additional award of interest on those damages pursuant to 35 U.S.C. § 284.

In reversing the District Court's award of prejudgment interest, the Federal Circuit concluded that the parties intended that the phrase "actual damages" in the second settlement agreement include all damages necessary to compensate Sanofi for Apotex's infringement, and because prejudgment interest is a form of compensatory damages, the majority concluded that the District Court had erred in awarding additional prejudgment interest pursuant to 35 U.S.C. § 284. The Federal Circuit explained that:

By agreeing to a simple formula to quantify Sanofi's "actual damages" in paragraph 14(ii), the parties avoided litigating a potentially complex issue. Such certainty is beneficial to both parties. Apotex benefited by knowing the exact amount of its potential liability. Sanofi benefited because it could fix damages without having to resort to further litigation, including complex and potentially lengthy discovery. These benefits disappear, however, if prejudgment interest is not included in "actual damages" since -- as demonstrated here -- the parties must engage in further litigation over an additional large liability.

On the issue of liability, Apotex argued that Apotex Inc. was not liable for damages because Apotex Inc. never engaged in the "commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug," as required by 35 U.S.C. § 271(e)(4)(C). Apotex noted instead that while Apotex Inc. manufactured the drug in Canada, Apotex Corp. imported the drug and made all commercial sales in the United States. Apotex contended that Apotex Inc. could not be held liable for infringement under § 271(e)(4)(C) because Sanofi failed to present evidence that Apotex Inc.'s actions took place in the United States. In affirming the District Court's determination that Apotex Inc. was jointly and severally liable for Sanofi's damages, the Federal Circuit pointed to the second settlement agreement, which defined Sanofi's compensatory damages from Apotex's infringement, and broadly defined "Apotex" to include "Apotex Inc. and Apotex Corp., collectively and individually, and including any entity now or hereafter owned or controlled by any of them."

Finally, with respect to Apotex's supplemental answer, the Federal Circuit determined that "BMS's failure to disclose the oral side deal with Apotex, and its false certification to the FTC regarding the same, in no way broadened the scope of the ’265 patent grant." As a result, the Federal Circuit determined that "[t]he district court properly rejected Apotex's patent misuse defense as futile," citing Princo Corp. v. International Trade Commission, 616 F.3d 1318 (Fed. Cir. 2010) (en banc), for the proposition that "the key inquiry under the patent misuse doctrine is whether . . . the patentee has impermissibly broadened the physical or temporal scope of the patent grant and has done so in a manner that has anticompetitive effects," and adding that "[p]aragraph 14 of the Settlement Agreement states the way damages shall be measured, and does not mention that such damages shall be free of the routine award of interest."

Judge Newman, dissenting with respect to the reversal of the District Court's award of prejudgment interest, argued that the second settlement agreement "did not alter the general rule that prejudgment interest is awarded on damages for patent infringement." As to the interest provision in paragraph 10 of the second settlement agreement, she stated:

That the parties, in a different section of the Agreement dealing with purchase of inventory, expressly provided for payment of interest on those purchases, does not support the panel majority's theory, for prejudgment interest on sale of inventory is not the established rule, as is prejudgment interest on infringement damages.

Sanofi-Aventis v. Apotex Inc. (Fed. Cir. 2011)
Panel: Circuit Judges Newman, Schall, and Moore
Opinion by Circuit Judge Moore; opinion dissenting-in-part by Circuit Judge Newman

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November 03, 2011

Federal Circuit Continues to Avoid En Banc Review of Claim Construction

By Kevin E. Noonan --

Sometimes it is what a court doesn't do that points to what needs to be done. That appears to be the case for claim construction and the Federal Circuit's standard, since Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998), that the appellate court should review claim construction de novo with no deference to the factual determinations underlying claim construction by a district court. Even Cybor (decided en banc in the days just after the Supreme Court's decision in Markman v.Westview Instruments, Inc.), holding that claim construction was a question for a judge rather than a Seventh Amendment right to trial by jury, had its detractors (including Chief Judge Rader) and its skeptics (including Judge Plager, who suggested that the consequences of the court's "no deference" standard would need time to be appreciated). Now, in a decision by the court not to review this policy en banc in Retractable Techs., Inc. v. Becton, Dickinson & Co., the dissents by three judges illustrate most clearly the deficiencies of the policy decision by the court not to permit any deference in its claim construction jurisprudence.

The panel decision, by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader, reversed the District Court's claim construction as to one claim term and affirmed as to another, remanding for consideration of infringement under the Doctrine of Equivalents. The claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury. The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments. The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure. The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece construction. The specification described the claimed invention as comprising a one-piece body, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies. Moreover, there was no disclosure of a multiple piece syringe body in specification. In reversing the District Court's construction, the majority said:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims. See Phillips, 415 F.3d at 1323. In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention. Id. at 1323–24.

Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more." Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

There were two dissents filed in the court's decision not to hear the claim construction decision en banc: one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley. Judge Moore's dissent characterizes claim construction as "the single most important event in the course of a patent litigation." However, the Federal Circuit's rules for making claim construction determinations are "still ill-defined and inconsistently applied," even by the Court. While citing commentators to support this conclusion, the dissent focuses on the question at issue in Retractable Technologies and, according to Judge Moore, comprising generally a deficiency in the Court's application of the law: where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims." The dissent contends that this is the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

Judge Moore relies principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude." She discounts the concerns voiced by the majority in Retractable Technologies, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification." In that case, the question is one of validity rather than claim construction, and it is not the role of the court to "tailor the claim language to the invention disclosed." Citing Phillips, the dissent relies once again on the mantra that the "plain meaning" of the clams controls (and the dissent voices surprise that this question was not resolved in Phillips). Judge Moore states her (stringent) standard for the relationship between the claims and the specification: "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002). Any deviation from this procedure should be applied narrowly, and specifically, the dissent opines that the choice of an overbroad term may affect validity but should not be considered for claim construction. Tellingly, she recites that "[w]e [the court] are not lexicographers." Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent here contrasts the majority decision in Phillips with the panel decision here: in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied. And the evidence, according to the dissent, fails to support a claim limited to single-body embodiments.

Judge Moore identifies the problem with the panel decision with particularlty:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim. Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

While the dissent then explicates why Judge Moore believes that this construction isn't supported by the specification, more particularly she illustrates the subjectivity and difficulty an appellate court can be expected to encounter in reviewing claim construction without deference to a district court's fact finding. And "[c]hanging the plain meaning of a claim term to tailor its scope to what the panel believes was the 'actual invention' is not consistent with the standard enunciated by Phillips." While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, the dissent states simply that the Court "does not rewrite claims"; this is not a case, Judge Moore contends, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification." Rather, this case is illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation." That is enough to convince Judge Moore and Chief Judge Rader that claim construction requires reconsideration by the court en banc. Judge Moore also writes that this case has a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction permits or requires deference to a district court's factual determinations under Markman v. Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

Judge O'Malley dissents separately, a posture reflecting her singular experience as a district court judge tasked with performing factual determinations in support of claim construction decisions. She is forthright: "[i]t is time to revisit and reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)," if only because "the court's decision necessarily would change if even minimal deference were afforded to the trial judge's claim construction." Her dissent notes that the Court's decision to give no deference to district court factual determinations is not required by the Supreme Court in Markman, and indeed the High Court "did not affirm this court's earlier conclusion that resort to a jury was unnecessary because claim construction is a pure question of law." She sees the appellate court's decision to be "ill considered" when it was enunciated thirteen years ago and that it has not proven "beneficial" to patent jurisprudence "in the long run."

Reflecting her own experience, Judge O'Malley opines that:

[D]istrict judges have been trained to -- and do -- engage in detailed and thoughtful analysis of the claim construction issues presented to them. They conduct live hearings with argument and testimony, sometimes covering several days, and certainly always extending beyond the mere minutes that courts of appeals have to devote to live exchanges with counsel. Simply, "the trial court has tools to acquire and evaluate evidence that this court lacks." Cybor, 138 F.3d at 1477 (Rader, J., dissenting).

She goes on to say that "[w]hile no one would urge deference to cryptic, unthinking rulings born of little or no real inquiry, where, as here, the trial court has thoroughly vetted all relevant aspects of the claim constructions at issue, 'careful consideration of the institutional advantages of the district court would counsel deference.'" Reciting the history of the case, she notes that these claims had been construed by two separate district court judges and that the asserted "wrongdoing" reversed by the panel decision "did not promote the consistency and uniformity in patent law that Cybor was intended to foster; the decision here accomplished the opposite."

In Judge O'Malley's view, the panel did not misapply the claim construction canons in Phillips; more pedestrianly, she states that she merely disagrees with their application. But this fact, and the experience of the panel members that they "could not agree on the proper claim construction in this case, despite careful consideration of their respective obligations under Phillips," strongly suggests to Judge O'Malley that the "complicated and fact-intensive nature of claim construction" mandates "the need to rethink our approach to it." For her, the "review of extensive documentary evidence" and possibly expert testimony suggest factual, not legal questions are being posed to the Court. And:

Where, as here, there is fair debate about the scope of the invention after application of Phillips's principles, we should defer to reasoned district court choices. Reasonable minds can -- and do -- differ over the correct interpretation of the term "body" as used in the patent in suit. These are not the circumstances under which we should be reversing carefully reasoned claim constructions and putting aside years of litigation in the process.

Taking into account the five "active" judges who voted to grant rehearing in Amgen Inc. v. Hoechst Marion Rousell, Inc., 469 F.3d 1039 (Fed. Cir. 2006), Judge O'Malley's dissent suggests that the active members of the Court are almost evenly split on the question of whether to grand en banc review. Although her call to arms ("[i]t is time we stop talking about whether we should reconsider the standard of review we employ when reviewing claim construction decisions from district courts; it is time we do so") is stirring, the question won't be put to the en banc Court until either its composition changes or an even more compelling case is presented to it.

Posted at 11:43 PM in Claim Construction, Federal Circuit | Permalink | Comments (1) | TrackBack (0)

September 22, 2011

Monsanto Co. v. Bowman (Fed. Cir. 2011)

Patent Exhaustion Does Not Apply to Genetically Engineered Seed

By Kevin E. Noonan --

Yesterday, the Federal Circuit once again upheld a judgment of infringement brought by Monsanto against a farmer who replanted its patented Roundup Ready® seed. As it had in Monsanto Co. v. McFarling, Monsanto Co. v. David, and Monsanto Co. v. Scruggs, the Court in Monsanto Co. v. Bowman rejected defendant's argument, here that Monsanto's infringement action should be dismissed under the doctrine of patent exhaustion. The difference is that this decision comes after the Supreme Court's opinion in Quanta Computer, Inc. v. LG Electronics, Inc., which might be expected to influence the outcome.

Here, the patents-in-suit are (as they have been in other cases) U.S. Patent No. 5,352,605 and RE39,247 (a reissue of 5,633,435). Claims 1 and 4 of the '605 patent are representative:

1. A chimeric gene which is expressed in plant cells comprising a promoter from a cauliflower mosaic virus, said promoter selected from the group consisting of a CaMV (35S) promoter isolated from CaMV protein-encoding DNA sequences and a CaMV (19S) promoter isolated from CaMV protein-encoding DNA sequences, and a structural sequence which is heterologous with respect to the promoter.

4. A plant cell which comprises a chimeric gene that contains a promoter from cauliflower mosaic virus . . . .

and claims 103, 116, 122, 128, 129, and 130 of the '247 patent are representative:

103. A recombinant, double-stranded DNA molecule comprising in sequence:
    (a) a promoter which functions in plant cells to cause the production of an RNA sequence;
    (b) a structural DNA sequence that causes the production of an RNA sequence which encodes an EPSPS enzyme having the sequence of SEQ ID NO:70; and
    (c) a 3' non-translated region that functions in plant cells to cause the addition of a stretch of polyadenyl nucleotides to the 3' end of the RNA sequence;
    where the promoter is heterologous with respect to the structural DNA sequence and adapted to cause sufficient expression of the encoded EPSPS enzyme to enhance the glyphosate tolerance of a plant cell transformed with the DNA molecule.

116. A glyphosate-tolerant plant cell comprising a DNA sequence encoding and EPSPS enzyme having the sequence of SEQ ID NO: 70.

122. A seed of the plant of claim 116, wherein the seed comprises the DNA sequence encoding an EPSPS enzyme having the sequence of SEQ ID NO: 70.

128. A glyphosate[-]tolerant plant cell comprising the recombinant DNA molecule of claim 103.

129. A plant comprising the glyphosate[-]tolerant plant cell of claim 128.

130. A method for selectively controlling weeds in a field containing a crop having planted crop seeds or plants comprising the steps of:
(a) planting the crop seeds or plants which are glyphosate-tolerant as a result of a recombinant double-stranded DNA molecule being inserted into the crop seed or plant . . .
(b) applying to the crop and weeds in the field a sufficient amount of glyphosate herbicide to control the weeds without significantly affecting the crop.

(where the Federal Circuit's opinion italicized portions relating to the scope of the claims).

Pioneer Hi-Bred (Pioneer), one of Monsanto's licensed seed producers, sold seed to Bowman; these sales were subject to a Technology Agreement similar to the Agreements Monsanto typically requires for farmers who purchase its seed. Under the Technology Agreement, the licensed grower agrees: (1) "to use the seed containing Monsanto gene technologies for planting a commercial crop only in a single season"; (2) "to not supply any of this seed to any other person or entity for planting"; (3) "to not save any crop produced from this seed for replanting, or supply saved seed to anyone for replanting"; and (4) "to not use this seed or provide it to anyone for crop breeding, research, generation of herbicide registration data, or seed production." It was undisputed that Bowman complied with these provisions as to its "first planting" each year. Monsanto's complaint arose from farmer Bowman's "second planting," which was made using so-called "commodity seed" obtained from local grain elevators. Farmers under the Technology Agreement could freely sell seed to grain elevators for commodity use, which did not include replanting. However, since Farmer Bowman's "second planting" was riskier (in terms of potential yield) he decided to use commodity seed because it was significantly cheaper than Roundup Ready® seed. After planting this seed, Farmer Bowman tested this second crop for Roundup® resistance, and finding that substantial amounts of the seed were resistant, used Roundup® on these plantings and replanted this seed. Because the Technology Agreement did not cover this use, Monsanto did not allege breach of contract (as it was able to in other cases brought against farmers for improper replanting of Roundup Ready® seed).

The District Court granted summary judgment of patent infringement and entered judgment against Farmer Bowman in the amount of $84,456.20. In a decision by Judge Linn, joined by Judges Bryson and Dyk, the Court rejected farmer Bowman's arguments that were predicated directly on the Supreme Court's Quanta decision. In Quanta, the Supreme Court reiterated its "substantial embodiment" test to apply the patent exhaustion principle, which applied to both composition and method claims (reversing the Federal Circuit as to method claim exhaustion), citing Ethyl Gasoline Corp. v. United States, 309 U.S. 436 (1940), and United States v. Univis Lens Co., 316 U. S. 241 (1942). Specifically, the Court stated the standard that sales that "substantially embody" the patents in suit will be sales that exhaust the patent right to obtain royalties, citing Univis. The immediately evident application of this decision to biotechnology patent claims include cases, as in Monsanto, where a patented article has the biological property of replication, where the license precludes use of replicates of the article after purchase. Although critically important economically (since it is clear that Monsanto would not be in the seed business for very long in the absence of these restrictions), the rubrics for applying patent exhaustion set forth in the Court's Quanta decision could be applied to Monsanto's claim. For example, it is without question that the seeds "embody" (figuratively and literally) the "essential features" of the patented invention, and thus the types of limitations Monsanto (and other seed producers) have placed on replanting of their patented seeds implicate the application of these standards to Monsanto's claims.

The Federal Circuit did not see it this way. Farmer Bowman argued that exhaustion applied to all Roundup Ready® soybean seeds, including those present in grain elevators as undifferentiated commodity. "Sales of second-generation seeds by growers to grain elevators, and then from grain elevators to purchasers (like Bowman) are authorized according to the terms of Monsanto's [T]echnology [A]greement[], and are thus exhausting sales . . . under the Supreme Court's analysis in Quanta [Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008)]," according to farmer Bowman.

In response, Monsanto argued that sale of soybeans are not "authorized" when those soybeans are replanted (i.e., used as seed rather than as commodity grain). Monsanto further argued that, even if sale to grain elevators resulted in exhaustion, infringement occurred when the seed was replanted because "patent protection 'is independently applicable to each generation of soybeans (or other crops) that contains the patented trait,'" arguments Monsanto had previously (successfully) made in other infringement actions. Monsanto also urged that J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), was controlling for patent exhaustion in seeds, specifically that exhaustion "must be limited to the seeds sold." In this regard, Monsanto urged the portion of the J.E.M. opinion that stated that "there are no exemptions for research or saving seed under a utility patent." Id. at 143 (emphases added).

The Federal Circuit agreed that patent exhaustion did not apply. It distinguished McFarling as not implicating the doctrine, rather being directed towards enforcement of the Monsanto Technology Agreement. Citing the McFarling opinion, the panel stated that "[t]he 'first sale' doctrine of patent exhaustion . . . [wa]s not implicated, as the new seeds grown from the original batch had never been sold. The price paid by the purchaser 'reflects only the value of the 'use' rights conferred by the patentee.'" Id. at 1299 (citing B. Braun Med., Inc. v. Abbott Labs., 124 F.3d 1419, 1426 (Fed. Cir. 1997)).

Turning to the specific facts in this case, the Court stated that the important consideration is that "the grower has created a newly infringing article" when commodity seed was planted by farmer Bowman and the "next generation" of seeds comprising Monsanto's Roundup Ready® technology were produced. "The fact that a patented technology can replicate itself does not give a purchaser the right to use replicated copies of the technology," according to the opinion, and "[a]pplying the first sale doctrine to subsequent generations of self-replicating technology would eviscerate the rights of the patent holder," citing Scruggs, 459 F.3d at 1336. According to the opinion, the right to use patented technology upon purchase "do[es] not include the right to construct an essentially new article on the template of the original, for the right to make the article remains with the patentee," citing Jazz Photo Corp. v. Int'l Trade Comm'n, 264 F.3d 1094, 1102 (Fed. Cir. 2001). The opinion applied the "substantial embodiment" test with regard to separate generations of seed, stating that present seed does not "substantially embody" "all later generation seeds," because with regard to the commodity seeds "nothing in the record indicates that the 'only reasonable and intended use' of commodity seeds is for replanting them to create new seeds, citing Quanta, 553 U.S. at 631 and noting that other uses for commodity seed existed (such as use as feed). "While farmers, like Bowman, may have the right to use commodity seeds as feed, or for any other conceivable use, they cannot 'replicate' Monsanto's patented technology by planting it in the ground to create newly infringing genetic material, seeds, and plants."

The Federal Circuit thus has once again affirmed that patent exhaustion applies to seeds that are sold and not to progeny seeds that were not sold by the patent owner or not made by authority of the patent owner (for self-replicating seeds). The patency of these distinctions await possible Supreme Court review.

Monsanto Co. v. Bowman (Fed. Cir. 2011)
Panel: Circuit Judges Bryson, Linn, and Dyk
Opinion by Circuit Judge Linn

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September 20, 2011

Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen

By Kevin E. Noonan --

A little more than one year after the Supreme Court issued its opinion on the patent-eligibility of (business) method claims in Bilski v. Kappos, the Court has granted certiorari in one case (Prometheus Laboratories, Inc. v. Mayo Collaborative Services) and may consider two others (Classen Immunotherapies, Inc. v. Biogen Idec. and Association for Molecular Pathology v. U.S. Patent and Trademark Office) relating to diagnostic methods. The Court handed down its decision in Bilski on the last day of the 2010 term (June 28, 2010), and shortly thereafter granted certiorari, vacated the Federal Circuit opinion, and remanded both the Prometheus and Classen cases. The Federal Circuit decided the Prometheus case on remand on December 17, 2010, and on June 20, 2011, the Court again granted certiorari. Since the question of patent eligibility is completely dependent on the scope and meaning of properly construed claims (see "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?"), a comparison of the claims in Prometheus, Myriad, and Classen might shed some light on the reasoning used by the Federal Circuit in arriving at the answers to the patent-eligibility question posed in each of these cases.

Perhaps the most clear-cut decision by the Federal Circuit involves the method claims in the patents at issue in the Myriad case. These claims all require the steps of "analyzing" or "comparing" a mutated BRCA gene sequence with the wildtype, "normal" sequence without any express claim language requiring that either sequence be determined as part of the claim:

U.S. Patent No. 5,709,999:

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

U.S. Patent No. 5,710,001:

1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

U.S. Patent No. 5,753,441:

1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

U.S. Patent No. 6,033,857:

1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

Significantly, other diagnostic method claims, including ones using antibodies to detect altered BRCA proteins, were not recited in the complaint and thus not at issue. Also not recited in these claims were "additional, transformative steps," including "the steps of (1) extracting DNA from a human sample, and (2) sequencing the BRCA DNA molecule, . . . steps [that] necessarily precede the step of comparing nucleotide sequences."

The Federal Circuit panel unanimously agreed that these claims do not satisfy the "machine or transformation" (MOT) test under Bilski. These claims "recite[] nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position," according to Judge Lourie's majority opinion. Also significant for the Court is that the specification required the term "sequence" to refer "more broadly to the linear sequence of nucleotide bases of a DNA molecule" per se. The panel found that Myriad's method claims can be satisfied (i.e., infringed) by "mere inspection" alone, and thus encompass merely an abstract idea.

In contrast, on remand, the Federal Circuit found the claims in Prometheus to satisfy the MOT test and thus recite patent-eligible subject matter, whether the claim recites an affirmative administration step or not:

U.S. Patent No. 6,355,623:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and 
    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, 
    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and 
    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder, 
    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and 
    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The distinction between the claims in Myriad and claim 1 of the '623 patent can be appreciated in light of the difference in what is being detected in each claim: a naturally occurring nucleic acid in the Myriad claims and an administered drug or its metabolite in Prometheus. Insofar as patent eligibility for method claims must either satisfy the Bilski machine or transformation test or otherwise not be so abstract as to entirely preempt an abstract idea, law of nature, or natural phenomenon, the absence of the drug or its metabolite without administration of the drug would appear to provide the Federal Circuit with its rationale regarding the patent eligibility of claim 1 of the '623 patent. Claim 46 of the '623 patent does not have an affirmatively recited administration step. However, the "detecting" step recites that 6-thiopurine or one of its metabolites is performed on "a subject administered [one of the recited] drug[s]," again encompassing only those patients who have been transformed by drug administration. It would seem that the Court refused to exalt form over substance in making a distinction between claims that recite administration of the drug to a subject and claims that are restricted to detecting a drug or its metabolites only in that subset of subjects to whom the drug has been administered; in either case, the Federal Circuit discerned a transformation. Neither of these considerations are likely to be before the Supreme Court, however, since defendant's certiorari petition focused on the purported interference with the practice of medicine and the non-inventiveness of the portions of the claim that recited the transformation step. In this regard it should be remembered that the case that raised this aspect of medical diagnostic method claims, Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), was like Myriad, directed at detecting a naturally occurring metabolite, homocysteine, and not an administered drug as in the Prometheus claims.

The most surprising Federal Circuit decision relating to diagnostic method claims is the most recent, in the Classen case. There, a divided panel (Judge Newman joined by Chief Judge Rader, with Judge Moore dissenting) found a distinction between the claims of U.S. Patent No. 5,723,283:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Which the majority found not to be patent-eligible, with the claims of U.S. Patent Nos. 6,420,139 and 6,638,739 (claim 1 of the '739 patent being representative):

1. A method of immunizing a mammalian subject which comprises:
    (i) screening a plurality of immunization schedules, by
        (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and 
        (b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s), 
    (ii) immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Which the panel found were patent-eligible. Judge Moore, on the other hand, found no difference. The difference appears to be in whether the determination of an appropriate immunization schedule directs an affirmative (and transformative) step or steps. In the '283 claim, the majority construed the scope of the claim to encompass mere comparison of the results of immunization schedules that produce a conclusion (i.e., information) without any further steps in the claimed method. The claims in the '739 patent, in contrast, require that an appropriate immunization schedule be determined, and then that a mammal or mammals be immunized according to that schedule to achieve the beneficial result of immunization with the least "incidence, prevalence, frequency or severity" of deleterious side effects.

Seen in this light, the question can be framed (according to Supreme Court precedent) as whether immunizing according to different immunization schedules in the '283 patent is considered "mere data gathering" activity and could be performed by evaluating previously performed immunizations, and whether the immunization step recited in the '739 patent can be considered to be "insignificant post-solution activity." It is evident that the first proposition is better supported that the second; as in the Myriad claims, the structure of the '283 patent claim encompasses activity (immunization according to a plurality of immunization schedules) not performed in the practice of the claimed method (as opposed to the comparison, in this view the only active step in the claim). The immunization step in the '739 patent claim is harder to construe as "insignificant post-solution activity" since the claim is directed towards "a method for immunizing a mammalian subject."

This analysis may seem like an exercise in counting dancing angels on the head of a pin, but it is the path set out by the Supreme Court in Benson v. Gottschalk, Parker v. Flook, Diamond v. Diehr, and Bilski v. Kappos (and for some members of the Court and commentators, LabCorp). While Judge Moore recites a common-sense conclusion that the scope of the '283 and '739 claims should not logically be different, they must be when considered under the relevant Supreme Court rubrics, which give significance (no matter how undeserved) to these distinctions. That is not to say that reciting the immunization step should be enough to render the '739 patent claims patent eligible, but like drug administration in Prometheus, immunization is transformative (as Judge Moore recognized by expressly equating immunization with drug administration).

Perhaps another way of performing the analysis is to recognize that another salient difference between the Myriad claims and the '283 claim in Classen on the one hand, and the Prometheus claims and the '739 patent claims in Classen, on the other, is that the former claims involve producing intangible information, while the latter use the information to direct the claim practitioner to perform a tangible, transformative step. Claims that produce information may not be patent-ineligible per se (see "Patenting Information"); however, as in Bilski (and Benson and Flook) they are more likely to raise patent eligibility concerns. Indeed these considerations arose in the concurring Justices' opinion in Bilski:

For even when patents encourage innovation and disclosure, "too much patent protection can impede rather than 'promote the Progress of . . . useful Arts.'" Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U. S. 124, 126–127 (2006) (BREYER, J., dissenting from dismissal of certiorari). . . . Patents "can discourage research by impeding the free exchange of information," for example, by forcing people to "avoid the use of potentially patented ideas, by leading them to conduct costly and time-consuming searches of existing or pending patents, by requiring complex licensing arrangements, and by raising the costs of using the patented" methods. Id., at 127.

While the Supreme Court gave the Federal Circuit precious little time or opportunity to flesh out its patent eligibility jurisprudence after the Bilski v. Kappos decision by granting certiorari in Prometheus, the Supreme Court's Bilski decision provided no clear instruction for resolving the different results in the Prometheus and Classen cases. Thus, its guidance may be necessary (provided that such guidance is more "pellucid" than the Court's opinion in Bilski).

For biotechnology, it remains the case that including active, technology-dependent steps in method claims is prudent, and to draft claims that minimize the likelihood that the invention will be characterized as merely an "abstract idea."

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September 18, 2011

Federal Circuit Denies Petition for Rehearing in AMP v. USPTO

On Friday, the Federal Circuit (presumably) denied Defendants' petition for panel rehearing in Association for Molecular Pathology v. U.S. Patent and Trademark Office. Unlike the Court's earlier notice regarding denial of Plaintiffs'/Appellees' petition, this notice did not identify the party (but Defendants' petition was the only one pending). In their petition, counsel for Defendants asserted a single grounds for rehearing, of points of law and fact overlooked or misapprehended by the Court (see "Defendants File Petition for Panel Rehearing"). In particular, Defendants' petition asked the Court to review the standing issue based on their allegation that Dr. Harry Ostrer, the only plaintiff found to have standing, no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing" upon invalidation of the Myriad patents. It also asked the Court not to vacate the panel decision even if it found that Plaintiff Dr. Ostrer no longer had standing.

Either party could now ask the Court to rehear the case en banc, or could file petitions for certiorari with the Supreme Court. It is likely that the Court will decide the Prometheus Laboratories, Inc. v. Mayo Collaborative Services case before reaching the invalidated method claims in Myriad, but the Court could review the Federal Circuit panel's decision on the composition of matter claims this term.

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September 15, 2011

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011)

By Kevin E. Noonan --

The Federal Circuit reaffirmed the primacy of the factual disclosures used to establish obviousness, and how deficiencies thereof can defeat an obviousness claim, in reversing an invalidity determination in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. It also showed how persistently defendants pursue the tarnish of inequitable conduct even under circumstances where the Federal Circuit has held that no inequitable conduct occurred.

The patents-in-suit, U.S. Patent Nos. 6,202,649 and 6,425,401 (filed as a continuation of the '649 patent), were directed to methods for curing tobacco in a way that reduced the amount of a carcinogen, tobacco-specific nitrosamines (TSNAs), in the cured product used in cigarettes and other tobacco-containing products. The patents were specifically directed to "indirect" flue curing with gas or propane heaters. Former methods used "direct" flue curing that mixed the exhaust gasses with the tobacco, but this resulted in an oxygen-free environment that fostered the growth of bacteria on the leaves, leading to production by the bacteria of the carcinogenic TSNAs. The patented methods can be used with either direct or indirect curing methods by using "controlled conditions" involving humidity, temperature, rate of temperature exchange, carbon monoxide levels, carbon dioxide levels, oxygen levels, and how the tobacco plants are arranged in the curing shed. The claims specify "controlling conditions" by "determining and selecting" the "appropriate" values for these variables that results in the reduction of TSNA production "at least one"). However, the patents admit that the choice of these conditions are "more art than science," so need to choose the appropriate combination of these variables; however, the important consideration is maintaining an aerobic environment that prevents bacterial growth.

Claims 4 and 12 of the '649 patents are set forth for the Court as being representative (emphasis in the opinion):

4. A process of substantially preventing the formation of at least one nitrosamine in a harvested tobacco plant, the process comprising:
    drying at least a portion of the plant, while said portion is uncured, yellow, and in a state susceptible to having the formation of nitrosamines arrested, in a controlled environment and for a time sufficient to substantially prevent the formation of said at least one nitrosamine;
    wherein said controlled environment comprises air free of combustion exhaust gases and an airflow sufficient to substantially prevent an anaerobic condition around the vicinity of said plant portion; and
    wherein said controlled environment is provided by controlling at least one of humidity, temperature, and airflow.

12. The process according to claim 4, wherein the treatment time is from about 48 hours up to about 2 weeks.

The lawsuit arose after R.J. Reynolds (RJR) acquired previous licensee Brown and Williamson and terminated the license. In addition, RJR has its own patents (referenced in the opinion as the Peele reference), issued as U.S. Patent No. 6,805,134 that specified a "not direct" heat source and curing in the absence of nitrocv oxide gas, which was performed by retrofitting direct cure barns into indirect-cure barns.

As an initial matter, the District Court granted summary judgment that the '649 and '401 patents were not entitled to priority to a provisional application, based on disclosure in the provisional that the claimed methods utilized an air flow of "at least 28,000 cubic feet per meter (CFM)" whereas the common specification of the '649 and '401 patents specified an air flow of "approximately 25,000 CFM." As a consequence, the District Court was able to consider intervening art to be prior art, and to decide that the patentee did not disclose the best mode (based on development of the commercial embodiment (and acknowledged best mode) in the period between the provisional and non-provisional filing dates.

In an earlier decision, the Federal Circuit reversed a finding that the claims were indefinite for reciting the term "anaerobic condition" and reversed a finding of inequitable conduct for failure to disclose a purported prior art reference (termed the "Burton letter"). Despite this decision, the District Court permitted defendants to display a slide (below) during closing argument showing a shadowy person disclosing information to the PTO examiner but holding the disputed Burton letter reference behind his back, during part of closing argument relating to invalidity rather than inequitable conduct.

The jury delivered a verdict of non-infringement and invalidity based on obviousness, anticipation, indefiniteness, and failure to disclose the best mode. The obviousness determination was based on a prior art scientific journal review relating to methods for air curing and a published Japanese patent. In view of the District Court's decision on the priority question, the jury applied the method disclosed in the Peele '134 patent as well as the practice of methods at two farms (Spindletop and the Brown farm) as a public use (the Brown tobacco farm being under contract to RJR). The indefiniteness determination was directed at the term "controlled environment," which the Court found as a matter of law was incapable of being construed because the disclosed "controlled environment" conditions overlapped with "conventional" curing conditions so that the skilled worker could not understand the difference. The best mode determination was based squarely on the District Court's priority determination, since it was uncontested that the best mode commercial embodiment was not disclosed and had been developed prior to the non-provisional filing dates. Finally, the jury found that there was no infringement, based on oxygen levels in RJR's barns alleged to be infringing. The District Court denied Star's motions for JMOL of these adverse decisions.

The Federal Circuit, in an opinion by Chief Judge Rader, joined by Judge Linn and by Judge Dyk in part, who dissented as to the Court's decision to reverse invalidation for indefiniteness, reversed the District Court's grounds for invalidating the '649 and '401 patents, and affirmed the District Court's denial of JMOL on the jury's non-infringement decision. The Federal Circuit also reversed the finding that the '649 and '401 patents were not entitled to the provisional filing date, on the basis that the specification satisfied the priority standard: that the specification disclosed an adequate written description and enabled the patents' claims.

This part of the opinion was supported by an intervening decision by the USPTO in a reexamination of the '649 and '401 patents that these patents were entitled to the priority date (although the PTO found certain of the claims were invalid for obviousness). The Court based its decision on language in the provisional specification that the recited air flow speed (in CFM) could "vary according to conditions and may be determined on a routine basis," and thus held that the District Court had improperly narrowed the claim scope based on later examples in the non-provisional application.

As a consequence of the Court granting the priority date of the provisional application to the '649 and '401 patents the best mode violation evaporated, since it was equally undisputed that the commercial method was not known at the time the provisional application was filed. Another consequence, germane to anticipation and obviousness is that the Peele '134 patent was not prior art that could be asserted against the patents in suit.

In reversing the District Court's indefiniteness determination, the majority opinion cites Datamize LLC v. Plumtree Software Inc. for the standard that a claim must be "insolubly ambiguous" or "not amenable to construction" to be found indefinite. However, the majority cautioned that "[a]bsolute clarity [is] not required" and that the term at issue -- "controlled environment" -- does not require disclosure of exact values for the various parameters because the skilled worker would understand the variable and empirical nature of determining these conditions. In this the opinion cites language from the Peele '134 patent -- owned by RJR -- consistent with its interpretation of the understanding of the worker skilled in the art.

Regaring obviousness, the Court disagreed with jury verdict that the references render the claims obvious. The opinion characterized the Japanese patent as being directed at improving fast curing to avoid "nasty odor" (an advantage not related to TSNA production) and found the Wiernik reference to be inconclusive on whether bacteria were involved in TSNA production. In addition, the opinion notes that neither reference discusses exhaust gases or anaerobic conditions. Thus, the Court found that there would be no motivation (or in the mantra approved by the KSR Court, "reasoned basis") for the skilled worker to combine these references to arrive at a solution to the problem of TNSA production during tobacco curing. The Court also found significant evidence of secondary considerations, including: a recognized, unmet need in the art for reducing TSNA in cured tobacco; unsuccessful attempts (i.e., failure) by others to solve this recognized problem; purported unexpected results (never expressly set forth in the opinion); and commercial success (ironically for RJR, using the lucrative B&W licenses as evidence thereof).

The Court reversed the jury's anticipation finding as to the Peele method because it was no longer prior art in view of the earlier priority date. The two "public uses" were not prior art, because the Court found that the "Spindletop" use involved tobacco cured before treatment in the drying shed (so that it was not "uncured" tobacco, as required by the claims). The "Brown farm" use did not anticipate, according to the Court's opinion, because the reported test results were below the detection threshold for TNSAs and thus provided no evidence that this method satisfied the specifically recited range of TSNA reduction required by the claims.

Finally, the Court upheld the non-infringement decision based on the jury's prerogative to believe one (RJR's) expert over another (Star's), and that the evidence did not establish that no reasonable jury could come to such a decision (i.e., the District Court properly denied Star's JMOL motion).

The Court also refused to deny Star's appeal on evidentiary rulings permitting (inter alia) display of the "shadowy figure" slide (although the Court found its use "troubling"), because Star did not show harm resulting from the objectionable evidence.

Judge Dyk dissents in part, arguing that the patents are invalid for indefiniteness -- in his view, the specification did not sufficiently distinguish the "controlled" conditions from "conventional" conditions and thus did not "particularly point out and distinctly claim" the invention so that the skilled worker could not ascertain the metes and bounds of infringing behavior.

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Federal Circuit 2011)
Panel: Chief Judge Rader and Circuit Judges Linn and Dyk
Opinion by Chief Judge Rader; opinion concurring-in-part and dissenting-in-part by Circuit Judge Dyk

Posted at 11:59 PM in Definiteness, Federal Circuit, Inequitable Conduct, Novelty, Obviousness | Permalink | Comments (4) | TrackBack (0)

September 14, 2011

Federal Circuit Denies Plaintiff(s)' Petition for Rehearing in AMP v. USPTO

By Kevin E. Noonan --

Yesterday, the Federal Circuit denied Plaintiffs' petition for panel rehearing in Association for Molecular Pathology v. U.S. Patent and Trademark Office. In their petition, counsel for Plaintiffs/Appellees asserted two grounds for rehearing, of points of law and fact overlooked or apprehended by the Court (see "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO"). First, the petition contended that the Court "failed to consider whether the DNA fragments claimed in these patents are products of nature." Second, the Court was alleged to have erred by not finding that two other named Plaintiffs, the American College of Medical Genetics and specifically named plaintiff Ellen Matloff, satisfied the standards for standing enunciated by the Court.

The Court did not address Defendants' petition for panel rehearing. That petition asked the Court to review the standing issue based on their allegation that Dr. Harry Ostrer, the only plaintiff found to have standing, no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing" upon invalidation of the Myriad patents.

The one certain consequence of the filing of Plaintiffs' petition is that any petition for certiorari will be delayed, making it likely that the Supreme Court will decide the Prometheus Laboratories, Inc. v. Mayo Collaborative Services case before reaching the invalidated method claims in Myriad.

For additional information regarding this and other related topics, please see:

• "Defendants File Petition for Rehearing in AMP v. USPTO," August 30, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO -- Update," August 29, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 28, 2011
• "CyberSource and the Tragedy of Bad Analogies," August 24, 2011
• "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?" August 23, 2011
* "WFU Law Professor Says Federal Circuit Failed as "Keeper of the Constitution" in AMP v. USPTO," August 22, 2011
• "AMP v. USPTO: Standing," August 4, 2011
• "AMP v. USPTO: Judge Bryson's Opinion," August 3, 2011
• "AMP v. USPTO: Judge Moore's Concurring Opinion," August 2, 2011
• "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2011)," August 1, 2011
• "Standing in AMP v. USPTO: The Plot Thickens," July 29, 2011
• "Federal Circuit Issues Decision in AMP v. USPTO," July 29, 2011
• "Myriad Writes to Federal Circuit on Standing Issue," July 28, 2011
• "AMP v. USPTO: Oral Argument at the Federal Circuit," April 4, 2011
• "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO -- Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO -- Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO -- Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO -- Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO -- Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying - Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th -- Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010

Posted at 10:49 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (12) | TrackBack (0)

September 08, 2011

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) -- Additional Views from Chief Judge Rader

By Kevin E. Noonan --

Accompanying the Federal Circuit's majority decision in Classen Immunotherapies, Inc. v. Biogen IDEC is a separate explication of "additional views" by Chief Judge Rader (at right) joined by Judge Newman. These views tend towards the policy and philosophical implications of patent eligibility challenges before the Court in several cases (In re Bilski, Prometheus Laboratories, Inc. v. Mayo Collaborative Services, Association for Molecular Pathology v. U.S. Patent & Trademark Office, and the instant case), and it is clear that the Chief Judge does not believe § 101 is the proper vehicle for challenging the validity of these patents.

The opinion begins by recalling that the language of Section 101 is very broad, and that challengers of patent-eligibility typically urge the Court to impose limits on scope not supported by statutory language. The opinion likens this to "substantive due process" in other contexts, something the opinion suggests has more "historical and contextual" support because patent law has other provisions that protect against "vague" claims. "[I]t is difficult to 'invent' any category of subject matter that does not fit within the four classes [recited in] the statute: process, machine, [article of] manufacture or composition of matter," in Chief Judge Rader's view, and the Court should "decline to accept invitations to restrict subject matter eligibility," for "public policy" reasons.

The opinion likens patent eligibility to a "'coarse filter' that excludes entire areas of human inventiveness" on "judge-created standards." The result, according to Chief Judge Rader, is what he terms a "healthy dose of claim-drafting ingenuity" whereby claim drafters "devise new claim forms and language that evade the subject matter exclusions" created by judges. The consequence is an increase in the "cost and complexity" of the patent system, which is bad enough, but "may cause technology research to shift to countries where protection is not so difficult or expensive."

The opinion then illustrates these general principles with two specific examples. The first are so-called "Beauregard" claims, which the opinion characterizes as being developed to circumvent limitations on claiming software caused by the Supreme Court's opinion in Gottschalk v. Benson, 409 U.S. 63 (1972). This claim type substitutes language directed to "intangible [patent-ineligible] computer code" from Benson with language that recites "a[ patent-eligible] encoded tangible medium." The implication is that the "invention" has not changed, just the claim language used to describe it. The second example is the "Swiss-type" claim, devised to overcome restrictions in medical treatment claims created by the European Patent Convention. These claims take the form of "use of a compound X for the manufacture of a medicament for the treatment of disease Y" instead of "a method of treating disease Y using compound X." Such a reaction to judge-imposed limitations on patent eligibility is to be expected, according to the opinion, because patents by their nature "translate technology into text, i.e. patent claims," giving rise to the opportunity for "careful claim drafting or new claim forms" to be created to avoid restrictions on patent-eligible subject matter. The opinion characterizes this situation as "a game where lawyers learn ingenuous ways to recast technology in terms that satisfy eligibility concerns." The product of this exercise, termed "hollow" in the opinion, does not result in any "substantive improvement in the patent landscape" while causing "high costs on patent prosecution and litigation" and raising the possibility that patent protection will depend on (and reward) "gamesmanship."

In addition, the opinion asserts that there is a "real-world [negative] impact" of such judge-made restrictions on innovation that could "drive research to more hospitable locations." The opinion calls such a possibility "not theory but history," recounting as an example the difference in response to biotechnology patenting between the U.S. and Europe. Europe "imposed [patent-]eligibility restrictions" on biotechnology inventions while the U.S. (principally as a result of the Supreme Court's Diamond v. Chakrabarty decision) "embraced strong patent protection" for biotechnology inventions. (It cannot have escaped the Chief Judge's notice that one specific example of this difference involved patenting isolated DNA molecules.) Such restrictions on patent eligibility had the following impact on innovation:

Europe became known for subjecting such inventions to delays in the patent office, challenges in litigation, increases in cost, and uncertainties in the legal landscape. With those difficulties as a primary contributing factor, investors, corporations, and clinics shifted their research from Europe to the United States. See Opinion of European Union Economic and Social Committee, COM (1995) 661 final (July 11, 1996), (recognizing that "Europe is lagging further and further behind the USA," as evidenced by the stark contrast in number of biotech patents, firms, and products; proposing strong patent protection as in the United States to solve "Europe's backwardness"); Council Directive 98/44, 1998 O.J. (L 213) (EC) (finally providing some protection for biotech inventions to counter the trend of companies preferring to patent in the United States). Thus, with some considerable blame on its eligibility doctrines, Europe lost innovation investment to the United States. Our country became the world leader in biotechnology innovation.

But "the tide can turn against us, too" the opinion cautions. Thus, "judges should tread carefully when imposing new limits on the protection for categories of human innovation." The correct approach, the Chief Judge counsels in his conclusion, is to use the "substantive conditions" of the patent statute, including "particularities of claim language" and "questions of prior art and adequate disclosure" to prevent overly-expansive claims rather than "litigation-spawned applications of section 101."

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore

Posted at 11:59 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (4) | TrackBack (0)

September 06, 2011

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) -- Judge Moore's Dissent

By Kevin E. Noonan --

The Federal Circuit majority decision in Classen Immunotherapies, Inc. v. Biogen IDEC engendered a strong dissent from Judge Moore on almost every aspect of that decision. Judge Moore disagreed with the majority's opinion that the claims were patent-eligible, that the issue of inherent anticipation was not properly before the Court, and that certain activities by defendant GlaxoSmithKline fell within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1). While all of her arguments warrant consideration, the importance of the question of patent-eligibility (particularly in view of Judge Moore's role in Association for Molecular Pathology v. U.S. Patent & Trademark Office, aka the Myriad case) compels this part of her dissenting opinion be discussed first.

Judge Moore contends in her dissent that the claims in all of the patents-in-suit are ineligible because they are directed to a "fundamental scientific principle" and are "so basic and abstract" as to provide "a monopoly over the scientific method itself." The dissenting opinion begins by comparing the claims at issue here with the claims in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, agreeing with the majority that the Prometheus claims were "inapt"; the opinion disagrees with the majority's conclusion because, in Prometheus the Court provided a detailed analysis that distinguished the Prometheus claims from the principles enunciated in the earlier In re Grams case, and requires the conclusion that the transforming step (administering 6-thiopurine) was not a mere data gathering or insignificant post-solution activity, concluding that the administration step in the Prometheus claims "not preempt broadly the use of [the] natural correlation, but rather recited specific treatment steps with specific drugs."

In contrast, Judge Moore (at left) contends in her dissent that the majority gave "no consideration of the extent of preemption by these staggeringly broad and abstract claims" in the instant case. This included no specificity for treatment steps, "drugs" (including immunogens) or ("even") specific chronic immune disorders. In addition, the dissent fails to discern the distinctions between the claims of the '283 patent that the majority found patent-ineligible and the claims of the '139 and '739 patents that the majority find patent-eligible. In Judge Moore's analysis, claim 1 of the '283 patent has two steps: immunizing mammals according to a schedule and comparing the incidence of chronic immune mediated disorder (CIMD) to a control group:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

(In a footnote, she says that she is "perplexed" that the majority sees this as reciting one step, when she clearly sees two, i.e., the immunizing step and the comparison step). She contrasts this with claim 1 of the '739 patent, which she says requires the steps of "comparing the incidence of [CIMD] between two groups of mammals . . . immunized according to different schedules and immuniz[ing] a mammal according to the lower risk schedule":

1. A method of immunizing a mammalian subject which comprises:
    (I) screening a plurality of immunization schedules, by 
        (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
        (b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s), 
    (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

She sees "virtually no difference" between the claims with regard to the § 101 analysis: immunizing and then comparing (the '238 patent) versus comparing and immunizing (the '139 and '739 patents).

For Judge Moore, "this case is not even close" regarding patent-eligibility. In her view, the '283 patent "claims the scientific method as applied to the field of immunization," since there are no limits on "the type of drug used to immunize[], the schedules that should be used for immunization, the type of [CIMD] to look for, or any limitation on the control group":

It is hard to imagine broader claims. It is harder to imagine a more conceptually abstract claim in the immunization area. Classen's claims are directed to a thought apart from any concrete realities, specific objects or actual instances. This is very much like patenting E=mc². Compare any two schedules to determine which one has fewer instances of immune disorders. Compare two substances to determine which one tastes sweeter. Compare two cups of coffee to determine which one is stronger. Actually these examples are more concrete than the Classen claims in that I tell you what to look for -- sweetness or strength. The Classen claims do not even specify which immune disorder should be studied. Likewise the representative claim from the '139 and '739 patents specifies no specific immune disease, drug, or schedule. These claims cover any kind of comparison between any two schedules, using any drugs and comparing the incidence of any chronic immune disease. After the user performs this completely abstract mental comparison, then the user should immunize the subject with the drug they choose on the schedule they deem lower risk.

Citing Diamond v. Diehr for the principle that claims must be considered as a whole, Judge Moore also opines that these claims are "exactly the type of 'abstract intellectual concepts' that 'are the basic tools of scientific and technological work,'" citing Gottschalk v. Benson, 408 U.S. 63, 67 (1972). And she rejects the idea that the claims are patent-eligible because they are limited to a single field of use, citing Parker v. Flook as cited with approval in Bilski v. Kappos, 130 S. Ct. 3218, 3230 (2010).

In Judge Moore's view, the very simplicity of the claims (requiring only two steps, immunizing and comparing regardless of the order), mandates the conclusion that they impermissibly preempt a fundamental principle, which the dissent illustrates with scenarios of infringement.n The opinion contends that "any researcher seeking to investigate new immunogens or immunization schedules relevant to chronic immune-mediated disorders would infringe," as would a doctor who "immuniz[es] a patient and compar[es] the patient's outcome to another patient's" (regarding the '283 patent) or "compar[es] well known schedules and then immuniz[es] according to the one he thinks best" (regarding the '739 patent). Even a patient could be jointly liable for infringement, the opinion suggests, if the patient receives an immunization and then "wonder[s]" why a friend got sick even though he got the same immunization (this is a reach). Even Judge Moore realizes there are "[m]any other examples, more absurd than the last" that could be envisioned -- for her this is additional evidence that the claims should not be eligible for patenting. In words reminiscent of Justice Frankfurter in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the claim's principal defect is that:

Having discovered a principle -- that changing the timing of immunization may change the incidence of chronic immune mediated disorders -- Classen now seeks to keep it for himself.

Compare:

Insofar as the court below concluded that the packaging of a particular mixture of compatible strains is an invention and as such patentable, I agree, provided not only that a new and useful property results from their combination, but also that the particular strains are identifiable and adequately identified. I do not find that Bond's combination of strains satisfies these requirements. The strains by which Bond secured compatibility are not identified and are identifiable only by their compatibility . . . [The patentee] appears to claim that since he was the originator of the idea that there might be mutually compatible strains and had practically demonstrated that some such strains exist, everyone else is forbidden to use a combination of strains whether they are or are not identical with the combinations that Bond selected and packaged together. It was this claim that, as I understand it, the District Court found not to be patentable, but which, if valid, had been infringed . . . The consequences of such a conclusion call for its rejection. Its acceptance would require, for instance in the field of alloys, that if one discovered a particular mixture of metals, which when alloyed had some particular desirable properties, he could patent not merely this particular mixture but the idea of alloying metals for this purpose, and thus exclude everyone else from contriving some other combination of metals which, when alloyed, had the same desirable properties. In patenting an alloy, I assume that both the qualities of the product and its specific composition would need to be specified. The strains that Bond put together in the product which he patented can be specified only by the properties of the mixture.

Id. at 133-34.

In Judge Moore's view, because the '283 patent claims "the use of the scientific method to study the incidence of [CIMD]," the entire field of study is preempted, which "prevents any investigation into any immunogen, known or unknown, and to any disease, known or unknown, over any period of time." Again citing Gottschalk, the dissent concludes that this is the same as patenting "the idea itself."

The dissent also cites (somewhat unfortunately) Justice Breyer for the idea that patent law "seeks to avoid the dangers of overprotection just as surely as it seeks to avoid the diminished incentive to invent that underprotection can threaten," Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp"), because if Classen's claims are patent-eligible "nobody else can search for new immunogens, for use of new immunizations, to treat either existing or currently unknown chronic immune-mediated disorders without infringing." Returning to the language of Parker v. Flook, the dissent characterizes the immunizing step recited in the '283 claim as "mere data-gathering" and compares the immunization step in claim 1 of the '739 patent with "updating the alarm limit" in Flook as insignificant post-solution activity." In doing so, the dissent apparently ignores the distinction that Flook involved an algorithm for resetting the alarm limit, and that the Court was concerned with permitting patent protection for a purely mathematical formula. Ironically, the dissent then cites the very portion of the Supreme Court opinion that illustrates this distinction:

The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved could be usefully applied to existing survey techniques.

For Judge Moore, it appears that Classen's claims are similar to the claims in LabCorp, and that her reasoning parallels Justice Breyer's that "one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between [immunization and the chronic immune-mediated disorder] . . . that the researchers uncovered," citing LabCorp, 548 U.S. at 137-38.

The dissent characterizes this case as "illustrat[ing] the challenge our patent system faces 'in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles," citing Bilski. And that is an analytical error, because Judge Moore (and some Supreme Court Justices) seems to consider invention to be continuous, in that "someone would otherwise have discovered any invention 'by independent, creative application of general principles.'" However, the only honest assessment of this statement can be "maybe," because invention tends to be sporadic and "lumpy" rather than continuous. In addition, the sentiment removes the temporal element: yes, someone may discover the same invention using these "general principles," but then the question is, when? There are many inventions that seem self-evident once they are arrived at that are not arrived at as quickly or as timely as would be expected -- hence the phrase "why didn't I think of that?" Finally, even if this other mythical inventor would arrive at the same invention "by independent, creative application of general principle" in a timely fashion (i.e., at about the same time as the patentee), prohibiting patent protection disincentives disclosure of the invention (particularly in view of the soon to be enacted "prior user rights "provisions of the Leahy-Smith America Invents Act). Judge Moore believes that the inventor here (and ones like him) "are not without incentives to innovate in this area," setting forth a variety of potential alternative inventions that could be claimed ("a method of treating a chronic immune-mediated disorder by using a new and specific immunization schedule" or "new therapeutic immunogens which were identified as potential compounds of interest" or (even) "specific testing methods to assay and explore his new discovery"). While Judge Moore is concerned with the inventor choosing instead to claim "the study of" immunization schedules and their relationship to CIMD, and that this is thus too broad to be patent-eligible, her dissent ignores the alternative that the correlation is valuable in itself and potentially protectable as a trade secret, with equally (or greater) deleterious effects on "the Progress of Science and the Useful Arts." This is not to say that the Classen claims are not overbroad, just that the "blunt tool" of patent-eligibility may not be the best implement to restrict their scope.

Nevertheless, Judge Moore ultimately believes that the claims embody a law of nature and thus are not patent-eligible: "[w]hen, as here, the claims so clearly offend the constitutional imperative to promote the useful arts, where they preempt all application of a principle or idea, it is entirely appropriate to hold them unpatentable subject matter before reaching anticipation, obviousness, or any other statutory section that might also prove invalidity." And the step of immunizing post rather than ante that the majority uses to distinguish the claims of the '283 patent from the '139 and '739 patents is unpersuasive, since in her view the claims nonetheless preempt the "scientific method" for discovering the correlation between immunization schedule and CIMD.

Turning to the § 102 issue, Judge Moore believes that Merck had provided "alternative grounds for affirming" the District Court, and she believes the Court should have considered them.

Regarding infringement and whether the activities of some of the defendants fell within the ambit of the "safe harbor" provisions of 35 U.S.C. § 271(e)(1), Judge Moore believes that the scope of the safe harbor is broader than simply "pre-approval" activities, citing Merck KGAA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), for an expansive reading of the statute. In doing so, Judge Moore focuses on the several times the Merck opinion emphasized that the statute provided a safe harbor against infringement liability for "all" activities related to submitting information under "any" federal law regulating "the manufacture, use, or distribution of drugs." For Judge Moore, this interpretation includes activities related to post-approval activities, such as monitoring drugs to detect adverse event. This is a textual argument, sounding very much like the arguments used by the Supreme Court in deciding not only Merck v. Integra but many other statutory construction cases (including, for example, Stanford v. Roche earlier this summer). However, the dissent draws a distinction between post-approval activities that do not fall within the safe harbor, specifically where "[defendants] are not required by law or regulation to perform such post-approval vaccinations in order to generate data," which are thus not "reasonably related to the development and submission of data to the FDA and therefore do not fall within § 271(e)(1)'s safe harbor exception." Thus, the dissent would have vacated dismissal of Counts I, II, and IV against GlaxoSmtithKline and Biogen and remanded to the District Court.

Judge Moore's dissent illustrates the difficulties the Federal Circuit, and the Supreme Court, can have with drawing the distinctions between patent-eligible and patent–ineligible claims. Part of this difficulty has to do with the vagaries of claim drafting, and (frankly) the expansive scope for these claims advanced by the inventor. Perhaps the Court would have had less difficulty if the claims were drawn to specific activities informed by the correlation rather than focusing on methods for developing the correlation in the first place; for example:

For the '283 patent claim:

A method for immunizing a mammal with a vaccine effective in provoking a desired immune response in the mammal, according to an immunization schedule that minimizes chronic immune-mediated disorder or the incidence, severity, prevalence or frequency thereof, wherein said immunization schedule is produced by a) immunizing a treatment group of mammals with one or more doses of one or more immunogens according to a first immunization schedule, and b) determining whether the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, is higher or lower than the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder that occurs when a control group of mammals is immunized with said one or more doses of one or more antigens according to a second, control immunization schedule, and
immunizing said mammal according to said first immunization schedule when the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder is lower in said first immunization schedule than in said control immunization schedule.

For the '739 patent claim:

1. A method of immunizing a mammalian subject with a vaccine specific for an infectious disease-causing organism, the method comprising:
(I) immunizing each of a plurality of treatment groups of mammals with an vaccine effective in provoking a desired immune response according to a plurality of immunization schedules; and
(II) immunizing said mammalian subject according to the immunization schedule in step (i) that produces the lowest incidence, prevalence, frequency or severity of a chronic immune-mediated disorder in said treatment groups.

Posted at 11:55 PM in Federal Circuit, Patentable Subject Matter | Permalink | Comments (18) | TrackBack (0)

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