GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35 U.S.C. § 112(a).  While these circumstances themselves might motivate amici to file briefs with the Court to weigh in on the Question Presented, the Federal Circuit's trend in recent years to apply more tightly the strictures of Section 112 to chemical, biotechnology, and pharmaceutical cases has provided its own incentive for such briefing.

Nearly three dozen amicus briefs were filed, with twelve supporting petitioners, seventeen supporting respondents, and five filed in support of neither party; these amici include AbbVie; Instil; a combined brief on behalf several pharmaceutical and other companies, and the Association of University Technology Managers; patent law associations, including the NY Patent Law Association, the Intellectual Property Lawyers Association of Chicago, and the National Association of Patent Practitioners; the Intellectual Property Owners association; the American Chemical Society; and more than a dozen intellectual property law professors (with Mark Lemley as Counsel of Record), and the subject of this post, GlaxoSmithKline (GSK).

The Question Presented in the Supreme Court's certiorari grant frames every brief and states:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation ― i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial "time and effort," Pet. App. 14a   in Question].

After establishing its bona fides as a leading biopharmaceutical company, GSK begins its brief by focusing on genus claims per se and their importance for protecting and fostering development of its products and the concomitant benefit to the public that comes from those products.  According to GSK, genus claims often are directed to "major scientific breakthroughs, establish first-in-class medicines, and encourage downstream improvements that can themselves be patented."  The importance of genus claims, GSK explains, is that they encompass "closely related species of modifications" that can be exploited by competitors to expropriate "the heart of the invention" unless the innovator has a genus claim that prevents such expropriation.  And of course if the invention cannot be protected from copying by a competitor the incentive to innovate and bring an innovative compound to market is diminished.  An innovator would be motivated instead "to maintain secrecy over the breadth of her breakthrough for as long as possible" and as a result "[t]he public's ability to build on the collective knowledge of discoveries and inventions would suffer and, most importantly, patients would have access to fewer vital medicines."

GSK also reminds the Court that genus claims encourage further innovation, including for example improved species in the genus that are independently patentable due to "non-obvious benefits or unexpected properties."  This situation can provide access to better medicines even if these downstream products while patentably distinct are not independently patentable, due to the "safe harbor" under 35 U.S.C. § 271(e)(1) during development and regulatory exclusivities thereafter.

GSK argues (as does Amgen as well as other amici) that the proper test is the "undue experimentation" test of inter alia In re Wands and not the "full scope" test purported to have been created below by the Federal Circuit in this case.  This is due to the quid pro quo bargain between patentee (who obtains exclusivity limited in time) and the public (that gains the unfettered right to make, use, sell, offer to sell and import after the term of the patentee's exclusive right has expired).  The enablement requirement has been developed to keep that bargain balanced so the public can understand how to make and use the claimed invention when the patentee's  exclusivity has expired.  But, GSK argues, this does not require the patent to "literally teach every variation of an invention to satisfy the enablement requirement" and the claims' breadth should not be dispositive, according to GSK (and this is true "even if the variations included in the scope are numerous or infinite").  GSK asserts that this is once again another inflexible Federal Circuit test that "den[ies] recourse to common sense" that the conventional undue experimentation standard supplies.  And to make matters worse, the "full scope" test is "atextual," punishes life sciences innovators and usurps Congress's role over patent law, according to the brief which characterizes the "full scope" test as a "domain-specific patentability rule" that has recently resulted in "focused, unfavorable treatment" of biotechnology and pharmaceutical claims by the Federal Circuit.

GSK then makes four related, more detailed arguments in support of its urging the Court to reject the Federal Circuit's analysis and reverse the judgment below.  The first of these is in both practical and doctrinal terms the "critical importance" of genus claims (which the brief apprehends the Court recognized by granting certiorari on this Question Presented and not on the alternative, i.e., whether enablement is a question of fact or law).  This question is important not just in the chemical, biotechnological and pharmaceutical arts, GSK argues (although conceding that these claims have the greatest impact in those disciplines, citing a law review article by the late Dmitry Karshtedt (Karshtedt, Lemley & Seymore, The Death of the Genus Claim, 35 HARV. J.L. & TECH. 1 (2021)) that genus claims are "[t]he central feature of patent law in the chemical, biotechnology, and pharmaceutical industries." (emphasis added in brief).  Genus claims are also important "to protect a class of apparatuses or methods sharing the common advancement of the invention against unscrupulous competitors seeking to evade the literal scope of the claims" in all arts according to the brief, setting forth illustrations of other technology areas where patents are drafted to claims a class, including Edison's lightbulb (Patent No. 223,898) that was claimed broadly enough to ensnare "copycat lightbulbs."  However, the brief stays focused on the importance of genus claims in life sciences patenting for chemical compounds having a use (for treating disease, for example) because related analogues to a particular chemical species are likely to have similar properties.  This produces the risk of copyists that genus claiming solves, evidence for this being that genus claims are "ubiquitous" in life science patents, citing Sean B. Seymore, Patenting the Unexplained, 96 WASH. U.L. REV. 707, 729 (2019).

As a consequence, according to GSK's brief, if genus claims are not allowed (i.e., are not considered to be enabled absent a recitation of an impossible number of species) the incentive to innovate will be harmed, citing Karshtedt that the "full scope" test is a trap because it is impossible to satisfy the test so the choice is to disclose the invention claimed narrowly and thus invite copycat competitors or perform "impractical, wasteful experiments" to support a genus claim.  GSK argues that the futility of the latter approach was recognized by the CCPA in In re Angstadt, 537 F.2d 498, 502 (C.C.P.A. 1976), because even then (should an applicant attempt to disclose a multitude of species) a court could decide that "in the far corners of the genus" there could be species that were too difficult to make to support the genus and thus invalidate the claim.  The brief also asserts that the Federal Circuit's decision if allowed to stand will have a disastrous, retroactive effect on already-disclosed innovation in life sciences claims.

GSK's second argument is that, perhaps counterintuitively to the casual observer genus claiming encourages follow-on innovation.  The very risk the Federal Circuit recognized as a policy basis for its decision paradoxically (according to GSK) is more likely to be caused by the decision.  The reason for this outcome is that genus claims to an invention do what all claims do: provide an incentive for additional innovation, here to species within the genus that are separately patentable, being "non-obvious improvements to past discoveries, including for species with unexpected properties that fall within the genus claims of a preexisting patent," citing Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014); accord, Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1098 (Fed. Cir. 2015); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1321–22 (Fed. Cir. 2004); Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270 (Fed. Cir. 2003); In re Petering, 301 F.2d 676, 683 (C.C.P.A. 1962).  This provides the patent incentive to patentably distinct species which will  (of course) be subject to the dominating effect of the genus patent.  As a result "[m]arket forces then encourage cooperation" in the form of cross-licensing.  These incentives are even more compelling in pharmaceutical and biotechnology inventions because seeking (and obtaining) injunctions can be "untenable" for important medicines, GSK argues.  And the patent does not provide a disincentive to "downstream" innovators because their efforts are protected from infringement liability (at least for regulated products like drugs) by the safe harbor of 35 U.S.C. § 271(e)(1).

GSK's third argument focuses on the undue experimentation test and its rationale.  This portion of the brief recapitulates arguments by others that the enablement requirement is part of the patent quid pro quo under Supreme Court precedent, citing Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 418 (1822); Kellogg Co. v. Nat'l Biscuit Co., 305 U.S. 111, 120 (1938); Universal Oil Co. v. Globe Co., 322 U.S. 471, 484 (1944); Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480–81 (1974).  But, GSK argues, "artisans are not automatons" (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)) and "[u]ntil recently, courts have recognized the folly of counting the number of species included within the scope of a claim for determining its validity (In re Cavallito, 282 F.2d 357, 361 (C.C.P.A. 1960)), culminating in the "undue experimentation" analysis set forth in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), that GSK asserts provides the proper standard for enablement. In the face of this precedent the brief characterizes the Federal Circuit's decision under review as a "rigid and inelastic" one that "leave[s] no room for nuance and den[ies] factfinders recourse to common sense," citing KSR.  And this test is "untethered" to the reason enablement is part of patent law, again citing Professor Karshtedt's The Death of Genus Claims law review article.  Moreover, GSK argues, the law already contains limits on the scope of genus claiming, such as O'Reilly v. Morse, 56 U.S. (15 How.) 62, 135 (1853), making the Federal Circuit's "more stringent" test unnecessary in GSK's view.

Finally, GSK argues that the test punishes pharmaceutical and biotechnology companies.  According to the brief, the Federal Circuit's test is an example of a "domain-specific" rule because its effects will largely fall on life-science inventions, citing Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1382 (Fed. Cir. 2013), and Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1153–54 (Fed. Cir. 2019).  The reason for this situation is "no accident," because biotech and pharma inventions depend, perhaps disproportionately on genus claims.  This is because the nature of chemical and biological science is that there are large but finite ("countable") numbers of species within the genus of many inventions in these disciplines (noting that in the patents before the Court there are 97,000 antibody species that can be envisioned using the amino acid substitutions in Table 1 in these patents).  If it is truly necessary to "fine-tune intellectual property law and incentives for particular industries," GSK asserts, then that should be up to Congress, not the courts, using the Hatch-Waxman Act, the Plant Variety Protection Act, the and the Biologics Price Competition and Innovation Act (BPCIA) as examples of Congress doing such fine-tuning.

For all these reasons, GSK urges the Court to reverse the Federal Circuit's decision below.

Comments

[James Scott Elmer]

I sense that the harm to innovation referenced here is already being felt in the diagnostic field where patent eligibility is the culprit. Companies seek diagnostic improvements they can keep as trade secrets. This means that collaborations with academics, who must publish, are off the table. This also means that academics may be unduly repeating research already conducted by companies in secret. I am not sure how one would go about gathering evidence of this.

[Kevin E Noonan]

Dear JSE: David Kappos has done some studies on this question that are found (I think) on IP Watchdog and elsewhere.

I hope this case does not have a similar chilling effect on innovation in therapeutics.

Thanks for the comment

[skeptical]

Without (hopefully) sounding too conspiratorial, one must allow that “chilling” is an aimed-for effect.