Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement

    By Kevin E. Noonan --

Beginning with Regents of the University of California v. Eli Lilly and Company, the Federal Circuit has applied the written description requirement stringently in many art areas as a requirement of 35 U.S.C. § 112, first paragraph, that is separate from the enablement requirement.  Judge Linn, at least, believes that is a doctrinal mistake, as he expressly stated in a concurring opinion in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. that read more like a dissent.  But how Ariad attempted to avoid the strictures of the written description requirement illustrates the wisdom of the theoretical framework for written description developed in large part by Judge Lourie over the past two decades.

The claims at issue in the Ariad case include these (as the Court said in its opinion, including the limitations incorporated by independent claims):

80.  [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

95.  [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.

144.  [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

145.  [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells], carried out on human cells.

A careful perusal of these claims reveals that nowhere in the claims is there recited what can reduce NF-κB activity in a cell.  This is in contrast to the claims in University of Rochester v. G.D. Searle & Co., which the district court and the Federal Circuit found did not satisfy either the written description or enablement requirements for failing to identify a compound useful for practicing the claimed method:

1.  A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

Ariad's claim format represented the strategy behind their legal arguments:

Ariad claims methods comprising the single step of reducing NF-κB activity.  Lilly argues that the asserted claims are not supported by written description because the specification of the '516 patent fails to adequately disclose how the claimed reduction of NF-κB activity is achieved.  The parties agree that the specification of the '516 patent hypothesizes three classes of molecules potentially capable of reducing NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules.  Lilly contends that this disclosure amounts to little more than a research plan, and does not satisfy the patentee's quid pro quo as described in Rochester.  Ariad responds that Lilly's arguments fail as a matter of law because Ariad did not actually claim the molecules.  According to Ariad, because there is no term in the asserted claims that corresponds to the molecules, it is entitled to claim the methods without describing the molecules.

That failed:

Ariad's legal assertion, however, is flawed.

In Rochester, we held very similar method claims invalid for lack of written description.  Id. (holding patent invalid because "Rochester did not present any evidence that the ordinarily skilled artisan would be able to identify any compound based on [the specification's] vague functional description"); see also Fiers v. Revel, 984 F.2d 1164, 1170–71 (Fed. Cir. 1993) (holding a claim to a genus of DNA molecules not supported by written description of a method for obtaining the molecules); cf. Eli Lilly, 119 F.3d at 1567–68 (holding claims to a broad genus of genetic material invalid because the specification disclosed only one particular species).  Ariad attempts to categorically distinguish Rochester, Fiers, and Eli Lilly, because in those cases, the claims explicitly included the non-described compositions.  For example, in Rochester, the method claims recited a broad type of compound that we held was inadequately described in the specification of the patent:

1. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

Id. at 918 (emphasis added).  Ariad's attempt to distinguish these cases is unavailing.  Regardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods, and Ariad admits that the specification suggests only the use of the three classes of molecules to achieve NF-κB reduction.  Thus, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity so as to "satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed."  Capon, 418 F.3d at 1357.

This strategy, of drafting broader claims to avoid a determination of invalidity, is reminiscent of the strategy Genetics Institute attempted to employ regarding its erythropoietin composition claims in Amgen Inc. v. Chugai Pharmaceutical Co.  Genetics Institute asserted the following claim against Amgen in the first litigation (Amgen I):

1.  Homogeneous erythropoietin characterized by a molecular weight of about 34,000 daltons on SDS PAGE, movement as a single peak on reverse phase high performance liquid chromatography and a specific activity of at least 160,000 IU per absorbance unit at 280 nanometers.
(U.S. Patent No. 4,677,195)

This claim was upheld at trial but invalidated by the Federal Circuit (in Amgen II) for non-enablement:

Defendants have produced no evidence that it ever prepared EPO with a specific activity of at least 160,000 IU/AU in vivo using the disclosed methods.  In its report to the FDA, GI stated that it had purified uEPO material "to homogeneity" by subjecting partially purified uEPO material to reverse phase high performance liquid chromatography (RP-HPLC), the technique taught by Hewick in the '195 patent.  The district court found that GI reported to the FDA that the specific activity of uEPO, based on in vivo bioassays, was only 109,000 IU/AU . . . GI originally arrived at the figure of 160,000 IU/AU by calculation, before it had the capacity to derive quantitative information from bioassays.  Hewick subjected the EPO to RP-HPLC, the EPO having an actual value of 83,000 IU/AU.  After weighing the chromatograph, he found that "at least fifty percent" of the area under the chromatograph curve was attributable to something other than EPO.  He then doubled the 83,000, and arrived at a theoretical specific activity of "at least about 160,000 IU/AU."  That procedure, while possibly valid as a means for estimating the specific activity of a pure sample, does not establish that GI had a workable method for actually obtaining the pure material that it claimed.

Moreover, the work of others shows that Hewick did not enable the preparation of uEPO having an in vivo specific activity of at least 160,000, as the claims required.  Dr. Kawakita, a scientist at Kummamoto University in Japan, reported an in vivo specific activity of 101,000 IU/AU when using RP-HPLC according to Hewick's method.  This is similar to the 109,000 value reported to the FDA by GI.  Kawakita did report a value of 188,000, but did not follow the teachings in the '195 patent.

Faced with this decision, Genetics Institute returned to the Patent Office and obtained the following claim (which, lacking the activity limitation was broader than the claim invalidated by the Federal Circuit):

1.  A pharmaceutical composition for stimulating production of red blood cells comprising a therapeutically effective amount of homogeneous human EPO protein characterized by a molecular weight of about 34,000 daltons in a single band on SDS PAGE and movement as a single peak in reverse phase high performance liquid chromatography and a pharmaceutically acceptable vehicle.
(U.S. Patent No. 5,322,837)

Genetics Institute then sued Amgen on this patent.  On summary judgment, Judge Young concluded:

After thoroughly examining the content and structure of Amgen II, the arguments made to the Federal Circuit by the parties, the context in which that decision was rendered, and the history of the preceding litigation, it is this Court's opinion that the Federal Circuit necessarily considered the '195 patent as claiming homogeneous EPO, an essential element of which was a specific activity level of 160,000 IU/AU.  Thus, the '195 patent simply "fails to enable purification of either rEPO or uEPO," Amgen II, 927 F.2d at 1217, which, in the view of this Court, means that the specification of the '195 patent does not enable one skilled in the art to obtain homogeneous EPO, which by Genetics's own definition is EPO with a specific activity level of 160,000 IU/AU.

From this conclusion, the ineluctable logic of the doctrine of claim preclusion compels a declaration that Genetics may not invoke the spectre of the '837 patent against Amgen and its privies.  Whether under the name claim preclusion or res judicata, the principle and its elements are familiar: a claim is precluded where there is (1) a final judgment on the merits in an earlier action; (2) an identity of the cause of action in both the earlier and present suits; and (3) an identity of parties or privies in the two suits.  Kale v. Combined Ins. Co. of America, 924 F.2d 1161, 1165 (1st Cir.), cert. denied, 502 U.S. 816, 116 L. Ed. 2d 44, 112 S. Ct. 69 (1991); Hartley v. Mentor Corp., 869 F.2d 1469, 1471 n.1 (Fed. Cir. 1989) (applying regional circuit law of res judicata to patent dispute).

The Court then supplied the doctrinal rationale for the importance of a full and complete disclosure of a claimed invention:

From the early days of the republic, our patent law has required that in exchange for a government-sanctioned monopoly on the rights to an invention or discovery, the inventor must teach the world the secret behind the method or device.  Compare 35 U.S.C.A. § 112 (1984), supra, with Act of April 10, 1790, ch. 7, § 2, 1 Stat. 109 ("specification shall be so particular . . . as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art of manufacture . . . to make, construct or use the same, to the end that the public may have the full benefit thereof, after the expiration of the patent term"); see also Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146-51, 103 L. Ed. 2d 118, 109 S. Ct. 971 (1989); In re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (specification must teach how to make and use the invention as broadly as it is claimed).  The rationale for the enablement requirement is that

an inventor deprives the public of nothing which it enjoyed before his discovery, but gives something of value to the community by adding to the sum of human knowledge.  He may keep his invention secret and reap its fruits indefinitely.  In consideration of its disclosure and the consequent benefit to the community, the patent is granted.  An exclusive enjoyment is guaranteed [the inventor] for seventeen years, but upon the expiration of that period, the knowledge of the invention inures to the people, who are thus enabled without restriction to practice it and profit by its use.

United States v. Dubilier Condenser Corp., 289 U.S. 178, 186-87, 77 L. Ed. 1114, 53 S. Ct. 554 (1933) (citations omitted); see also O'Reilly v. Morse, 56 U.S. 62, 119-20, 14 L. Ed. 601, (15 How. 62, 127-28) (1853) (Taney, C.J.) (one skilled in the art must be able to produce precisely the described result by using the means specified by the inventor); Grant v. Raymond, 31 U.S. 217, 247 (31 Peters 141, 160) (1832) (Marshall, C.J.) (correct specification is a prerequisite to obtaining a patent in order to give the public "the advantage for which the privilege is allowed, and is the foundation of the power to issue the patent.").  When a putative inventor fails or refuses to fulfill the obligation to teach precisely what is claimed, the inventor is not entitled to the protections of the patent law.  See, e.g., Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1469-70 (Fed. Cir. 1993) (affirming determination of lack of enablement where fifty examples in specification "obviously teach something," but not what was defined in the claims).

The Federal Circuit agreed, and granted Amgen its costs of responding to Genetic Institute’s appeal.

These decisions illustrate why Judge Linn's position fails to account for the strong policy considerations behind a separate written description requirement.  Judge Linn (at right) argues that the claims have primacy in defining an invention, and that concentrating on a separate written description requirement obscures the question (in Ariad) of whether the claims are enabled.  In addition, citing In re Hyatt, he suggests that Ariad's claims are "single means claims" that encompass unknown methods that cannot be enabled.

While it is certainly true that the Court's application of the written description requirement has occasionally "created mischief" (for example, in Enzo v. Genprobe I), it has also served a legitimate purpose.  It is certainly the case that it provides a bright line rule for determining what an applicant has invented at the time the application was filed.  It avoids the effects of improving technology, wherein an applicant can enable production of additional species (for example, of cDNA species encoding orthologs) that an applicant has not obtained.  It has also beneficially prevented applicants, including the Rochester and Ariad inventors, from foreclosing the future with broad claims to all compounds or all methods for achieving a particular result.  While Judge Linn may be correct that in certain circumstances an applicant will fail to satisfy both the written description and enablement requirements (as in Rochester), in others this may not always be the case (for example, isolation of a cDNA encoding one ortholog of a mammalian protein might enable the skilled worker to isolate orthologs from all other mammalian species); under these circumstances a separate written description requirement precludes overclaiming and rewarding an applicant with claims supported by a specification that does not satisfy the patent quid pro quo.  If for no other reason, these situations implicate the Constitutional requirement that patents be granted only that "promote the progress" of the useful arts.  That, alone, provides ample justification for the Federal Circuit's separate consideration of the written description and enablement requirements when determining whether claims are supported by a specification that adequately satisfies 35 U.S.C. § 112, first paragraph.

Comments

[EG]

Kevin,

Yeah, Judge Linn is now in Judge Rader's camp on written description as applied to biotech. There's obviously not a uniformity of view on separating written description from enablement in the biotech area.

As I said before, my only quibble with Judge Moore's opinion is that the appellate standard for reviewing the jury verdict of satisfaction of the written description requirement ("substantial evidence") comes very late (and in my opinion, very tardy) in her opinion. By not describing the appellate standard of review earlier in her opinion (as most other Federal Circuit opinions usually do), it's never clear whether Judge Moore is applying a question of law ("de novo") standard (question of law) or "substantial evidence" standard (is the jury verdict legally supported by the evidence presented to them). This also isn't a mere matter of form as it can cause confusion as to what circumstances the holding is (and may not be) applicable.

[SK]

What claims are the inventors of Ariad and Rochester entitled to? Screening for compounds claims? Those are commercially useless after Merck v. Integra. These inventors deserve some protection for their "progress of useful arts". I am just not sure what that is in light of the strict written description requirements.

[Kevin E. Noonan]

Dear SK:

Under current case law, the answer is "Not much, unless" there is some disclosure of a "representative number" of compounds that have the biological effect.

The problem is one of skill sets: the people who make the molecular biological/biotech inventions are typicaly not the people who develop compounds that affect the biological processes identified by the molecular biologists. There are ways for the groups to partner, either between academic departments or with industry. Other discliplines have made those "town and gown" partnerships; in biotech, the start-up model that has existed since the beginning of the industry has taken a different path.

There is a point to be made that these decisions (Rochester and Ariad) are encouraging academics and industry to adopt more traditional roles. It remains to be seen whether that is a good idea.

Thanks for the comment.

[SK]

Thanks Kevin. Very true. I just hope the academia realize this and do those partnerships early on instead of waiting until the research is about to be published for patent protection.

[IPW]

What claims are the Ariad inventors entitled to?
I think the proper question is "did Ariad actually invent anything at all?"
Looking at the claims what could a (potential) Ariad inventor point to and say "I made that."
Discovering how (or why) a pathway/receptor/gene impacts a disease state is a great scientific achievement but that doesn't make it patentable subject matter. (just my opinion)

[Kevin E. Noonan]

Dear IPW:

Under current case law, the answer is that these inventors are not entitled to very much, and certainly not claims that encompass (read: foreclose) molecules not envisioned by the inventors.

The Ariad inventors identified an important biological molecule, NF-kB, that is involved in many responses to the environment etc. for mammalian cells. They certainly enabled the skilled worker to screen compounds for activity in inhibiting NF-kB expression, and they came up with 3 different types of molecules that would have worked to inhibit certain NF-kB-dependent activities in eukaryotic cells. But to do so they needed to identify something that would work, and as of their filing date they had not.

Thanks for the comment.

[Jeff Kuester]

Kevin,

"It is certainly the case that it [a separate written description requirement] provides a bright line rule for determining what an applicant has invented at the time the application was filed."

Do you really think there is a bright line rule? Written description has been widely criticized as "incoherent" and even as "an unmitigated disaster."

Using your example, if isolation of a cDNA encoding one ortholog of a mammalian protein does enable a reasonably skilled worker to isolate orthologs from all other mammalian species, shouldn't ownership of such greater breadth be warranted? Why should evidence that an inventor envisioned EVERY possible variant of claim language be necessary? More importantly, taking this reasoning to its logical conclusion, couldn't arguments always be made that claims encompass all variants not specifically claimed otherwise?