AbbVie 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 (although one of them, filed on behalf of the High Tech Inventors Alliance and the Computer and Communications Industry Association argues that the Federal Circuit's decision below was correct and consistent with settled law); these amici include AbbVie; Glaxo Smith Kline; 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).

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 [emphasis in Question].

AbbVie's brief is directed at the consequences of the Federal Circuit's recent foray into restricting the scope of so-called "genus" claims to what an applicant has expressly disclosed in her specification.  And those consequences are to "chill investment and innovation" for subject matter like chemicals, pharmaceuticals and biotechnology inventions AbbVie argues.  The Federal Circuit's decisions are contrary to both the text of the statute as well as how enablement interacts with the rest of patent law and is contrary to the Supreme Court's "longstanding patent precedent" in AbbVie's view and should be overturned.

With regard to AbbVie's "innovation and investment" argument the brief extols the genus claim as a way for an inventor to obtain protection not only for the species expressly disclosed but for related compounds that "shar[e] the same innovation."  And this scope of patent protection is what a "pioneering inventor" who discloses "a breakthrough invention with broad applicability" deserves, the brief argues, not just for the inventor's benefit but to "promote the progress of science " (technically, the Useful Arts).  As with many of the briefs this one cites the Federal Circuit's statement that it was "rais[ing] the bar for enablement" in its decisions (emphasis in brief).  This test requires that "patent specifications for genus claims with functional limitations do not comply with the enablement requirement of 35 U.S.C. § 112 unless they enable those skilled in the art 'to reach the full scope of claimed embodiments' experimentation," which in practice means an inventor must "enable a person having ordinary skill in the art . . . to cumulatively identify and make the various embodiments of the invention without 'substantial time and effort.'"  This standard is to be applied to the "full scope" of the claim (which for chemical, biotechnological and pharmaceutical claims could easily encompass millions of compounds), making the requirement into an "insuperable" hurdle to patenting claims having functional language applicable to a broad genus, the brief argues.  The consequence of this standard is to "destroy[] the basic 'bargain' of patent law" by "not giv[ing] pioneering inventors adequate range of patent protection for breakthrough inventions with broad applicability" according to AbbVie.  This affects (negatively) "investment and innovation" because the type of chemical, biotechnological and pharmaceutical inventions having severely reduced scope under this test are also those that "typically require significant risk, substantial investment, and years of research" and thus patent protection for these inventions is particularly vulnerable to the reduced scope the Federal Circuit's test that has "invalidated genus claim after genus claim" in these arts.  As a result, competitors have been able to "design around" claims to such inventions and "captur[e] a patent's economic returns."

On the law, the brief argues that there is nothing in the statutory language suggesting much less mandating that "enablement depends on the cumulative time and effort required to make virtually all variations of the invention," which in the context of the case before the Court amounts to "whether the specification enables virtually every species within the genus without undue experimentation" (emphasis in brief).  In re Wands is the relevant (and correct) standard for enablement, AbbVie argues, and the Supreme Court should affirm its primacy (which of course the Court has never taken the opportunity to do).

The brief casts the question in terms of the "carefully crafted bargain" between the inventor and the public, trading an enabling disclosure of the invention for the exclusivity term of the patent grant, relying on Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480-81 (1974), and Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 63 (1998), for these principles, and emphasizing the public benefit of an increase in scientific progress, economic competition, and prompt delivery of advances in the art from which subsequent inventors can build.  AbbVie argues that the Federal Circuit's test "does not further the fundamental purposes of the enablement requirement" but rather "disrupts the patent bargain, chills investment in new discoveries and innovation, and creates uncertainty and litigation by adding an unnecessary layer of analysis to the settled Wands factors for determining enablement."

This disruption is not limited to the chemical, biotechnological, and pharmaceutical arts AbbVie reminds the Court, because "nearly every field" uses genus claiming to seek broader claim scope than the species expressly disclosed. But genus claims are particularly important to  inventions in the chemical, biotechnological, and pharmaceutical arts because in these disciplines "breakthrough innovations invariably require very significant investments of time and money" that would lose the incentive to be pursued without patent protection of adequate scope (with concomitant loss of scientific progress according to AbbVie).  Taking extensively from the late Dmitriy Karshtedt's paper entitled The Death of Genus Claims (Dmitry Karshtedt, Mark A. Lemley & Sean B. Seymore, The Death of the Genus Claim, 35 HARV. J. L. & TECH. 1, 23-35 (2021), the brief catalogs the Federal Circuit's recent case law applying the "full scope" principle to chemical, biotechnological, and pharmaceutical patent claims, contrary to earlier precedent like In re Angstadt, 537 F.2d 498, 502-03 (C.C.P.A. 1976), as well as Wands.  Illustrating the negative consequences arising from this doctrine, the brief notes that trade secret law is not an available option, for example for claims reciting active pharmaceutical ingredients and in any event the Court recognized it to be a "much weaker choice" in Kewanee Oil.

The full scope test is also unnecessary insofar as it does not "further the purpose of the enablement requirement because it departs from the practical inquiry of what a PHOSITA needs to know in order to make and use an invention," something the Supreme Court recognized to be the purpose of the enablement requirement in The Telephone Cases, 126 U.S. 1, 536 (1888), and Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916).  The Wands test has "provided a predictable framework for analyzing enablement and undue experimentation" since 1987, is "derived from [the] Court's precedent" (citing cases in a long footnote) and has "demonstrated a time-tested ability to operate effectively for all kinds of claims" based on case-specific facts.  For these reasons, AbbVie urges the Court not to "engraft" the full scope test onto the Wands analysis, which is a "context-specific, case-by-case method [that] provides a balanced and workable enablement test" and should be preserved, AbbVie's brief urges.

Finally, the brief argues that the test is contrary to the statutory language and Supreme Court precedent (finding not surprisingly no mention of the "full scope" test in the statute) and comparing the required disclosure for enablement with what is required for priority (i.e., a single embodiment) (but to be fair these requirements are directed at two different aspects of patent law).  The brief argues that other sections of the Patent Act police overbroad claiming, such as Sec. 101 and 103 and Sec. 112(a) itself, in the written description requirement (something the Court has also not opined upon and affirmatively avoided doing so in denying certiorari in Juno v. Kite).  Regarding the Court's putatively contrary precedent, the brief recites (in addition to The Telephone Cases and Minerals Separation; Mowry v. Whitney, 81 U.S. 620 (1871); Tilghman v. Proctor, 102 U.S. 707 (1880); Expanded Metal Co. v. Bradford, 214 U.S. 366, 380 (1909); and Eibel Process Co. v. Minn. & Ontario Paper Co., 261 U.S. 45, 65-66 (1923).

Only rarely (Graver Tank and Bowman v. Monsanto) has the Supreme Court been persuaded by the types of arguments AbbVie makes in its brief, particularly with regard to the negative economic consequence of permitting an "unscrupulous copyist" to reap the benefits of a claimed invention.  The Court can be inscrutable regarding the reasons the Justices decide to take a case and have been known to appear to be sensitive to arguments of questionable provenance but ample public passion (see Assoc. Molec. Pathol. v. Myriad Genetics as an example).  Similar passions are at play here, regarding for example increasing drug costs, and how the Court ultimately decides the issues before it in this case, in the face of these extralegal considerations, may not depend as much AbbVie might hope on the arguments and precedents set forth in its brief.

Comments

[Kyle]

The biggest hole I see in this argument is that the “innovation” lies in the validation of a disease theory (e.g. an antibody that competitively binds to PCSK9 receptors can treat high LDL cholesterol). That is increasingly true with biologics. But genus patents do not enable that utility, and if they were endorsed, they could be used by unsuccessful pharmas to discourage competitors who sought to validate the same or related disease theories.

Ideally, bad circuit law on utility and how-to-use enablement (eg Krimmel, Nelson, Fujisawa, Brana, etc.) would be overruled, so that pharma patents would maximally encourage advancing first-in-class candidates to Phase 2 and 3 trials. Then a genus-wide patent would likely be appropriate.

[Kevin E Noonan]

Kyle: while validating disease theories is always a part of pharma development, I think the issue is focused on the molecule and how to protect it. As an example, the basis of antacids is to modify the function of the proton pump in the stomach. This can be achieved by omeprazole or lansoprozole, both distinct molecules having the desired clinical effect. A genus claim to either does not affect patenting or commercializing the other due to the different chemical species within each genus (i.e., they do not overlap).

Very different situation for antibodies, where (in the strictest sense) an antibody having a valine at a particular position in its amino acid sequence is a different antibody than one having an isoleucine at that position, wherein the difference in two molecules having tens of thousands of atoms is three atoms (-CH2-). While this should be addressed under the doctrine of equivalents there is inconsistent application of the doctrine under the best of circumstances.

Amgen's problem is that they claimed their antibody completely by function, which would have been fine 50 years ago because that was the only way to do it (and generally it would be antisera comprising a plurality of antibodies raised to an antigen rather than a monoclonal antibody). But the ability to define antibodies by amino acid sequence has actually reduced the scope of claims to antibodies, an attempted remedy for his being Amgen's claims.

Thanks for the comments.