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 and biotechnology inventions and to 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; GlaxoSmithKline; 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).  It is the amicus brief filed by these law professors that is discussed in this post.

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].

The professors'* arguments, by lead author Mark Lemley of Stanford University, rely heavily on 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 central feature of patent law in the life sciences industries is the genus claim" is the first assertion in the brief.  The basis for the primacy of genus claims the brief explains is that without them, "a competitor could make a minor change to the chemical the patentee invented and avoid liability while capturing the heart of the invention."  Prior to the recent spate of Federal Circuit decisions, including this one, the Supreme Court, the Federal Circuit, the C.C.P.A., and the Patent Office had recognized the usefulness and upheld the validity of genus claims in complying with the enablement requirement of 35 U.S.C. § 112(a) under the statutory mandate that the specification teach the skilled worker to make and use a chemical compound (as with every other type of invention) without undue experimentation.  Recently however, the professors argue, the Federal Circuit had changed the law ("dramatically") to the extent that "it is no longer possible to have a valid genus claim in the chemical and biotechnology industries."  The basis for this change is that "the Federal Circuit now rejects claims as invalid because the genus contains thousands or millions of possible chemicals, unless the patent itself identifies exactly which of those myriad species will work."  This burden is impossible to satisfy, in the professors' view, and represents "a categorical shift in thinking away from teaching the PHOSITA and towards a precise delineation of the boundaries of the claim" they argue, citing the Karshtedt article.

Expounding on these arguments, the brief sets forth a brief history of the enablement requirement and how the Court has interpreted it, citing as examples The Telephone Cases, 126 U.S. 1, 539 (1888); Tilghman v. Proctor, 102 U.S. 707, 728-29 (1880); Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 437 (1902); Cont'l Paper Bag Co. v. E. Paper Bag Co., 210 U.S. 405, 419-20 (1908); and Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916).  These interpretations, the professors argue, uniformly held that "a patent for such a discovery is not to be confined to the mere means he improvised to prove the reality of his conception" (The Telephone Cases), and that where an invention is "susceptible of being applied in many modes and by the use of many forms of apparatus . . . [t]he inventor is not bound to describe them all in order to secure to himself the exclusive right to the process" (Tilghman).  And the law as it was had been sufficient to avoid the issues and uncertainties the Federal Circuit advanced as a rationale for its current jurisprudence, the brief stating that "a genus claim cannot survive if the patentee failed to provide any guidance on how to practice the claimed invention" (emphasis in brief), citing Wood v. Underhill, 46 U.S. (5 How.) 1, 4-5 (1846); Tyler v. Boston, 74 U.S. (7 Wall.) 327, 330 (1868); and Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895).

The brief further explicates that the CCPA, Federal Circuit, and PTO had complied with this Supreme Court standard until recently, citing several cases and most prominently In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), for the principle that a patent satisfies the enablement requirement even when the skilled worker must "engage in a reasonable amount of routine experimentation to figure out compounds that can achieve the claimed result."  The need for some experimentation ''does not preclude enablement" the professors argue, citing Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1576-77 (Fed. Cir. 1984).  Summarizing, the professors assert that "enablement has not traditionally turned merely on whether there are many compounds within the claimed genus or whether routine screening takes considerable time" under the Wands test.

In contrast, the brief asserts that the current course of Federal Circuit jurisprudence is a "massive shift" in the enablement doctrine as applied by the Federal Circuit.  That change is labeled the "full scope" standard, consistent with Amgen and other amici's positions.  It differs from the traditional requirement because it "gauges enablement not by whether the experimentation needed to make and test particular species is undue, but by how long it would take the PHOSITA to make and screen every species within the claimed genus—even if that work would be routine" the professors argue, again citing the scholarship in the Karshtedt article.  Under this new standard the brief argues that "'[a] chemical genus with any decently large number of species will never be able to satisfy' the Federal Circuit's new enablement standard" and it will become easy for defendants to prevail by arguing the "substantial time and effort" theory regarding satisfaction of the "full scope" test.  And the Federal protestations to the contrary in its opinion denying rehearing en banc "ring[] hollow" to these professors because "the Federal Circuit is rejecting essentially every large genus claim challenged on enablement grounds, suggesting that the Federal Circuit's proposed method is illusory."  The very basis for the Federal Circuit's distinction (structural differences) "misunderstands the science" because, the professors argue that in biological molecules, "[t]here might sometimes be a structural chemical difference that divides operative from non-operative species, but often there won't be," citing Mark A. Lemley & Jacob S. Sherkow, The Antibody Patent Paradox, Yale L.J.**

In addition, the professors assert that the Federal Circuit's "full scope" standard "misunderstands the point of the enablement requirement."  This is because this "new approach . . . focuses on knowing exactly which species of a claimed genus will work instead of knowing how to make and use the invention" as required by the statute (as the CCPA recognized, a "certainty" standard makes any experimentation undue because by definition experimentation involves uncertainty; In re Angstadt, 537 F.2d 498, 503 (C.C.P.A. 1976)).  Moreover, the Federal Circuit's emphasis on certainty could, the professors predict, result in "less, not more, disclosure of new ideas to the public" because it "would delay disclosure and frustrate, rather than further, the interests of the public," citing In re Bundy, 642 F.2d 430, 434 (C.C.P.A. 1981).  Expanding on this theme, the brief argues that the "full scope" test "threatens patent protection for many inventions in the chemical and life sciences, where large genus claims are ubiquitous," which in turn "frustrates patenting and innovation."  The conundrum the test creates is that satisfying the enablement requirement makes inventors "carry out a prohibitive number of actual experiments" and will result in "discourage[ing] inventors from filing patent applications in an unpredictable area since the patent claims would have to be limited to those [working] embodiments which are expressly disclosed," citing In re Angstadt.  The reason the test cannot be satisfied for genus claims in the chemical and biotechnological arts is that "[n]o matter how much testing the patentee does, there will always be untested species, so courts cannot know whether they are properly included in the genus," a standard that is "fatal to genus claims."  As a consequence:

Patent protection is important in the pharmaceutical and biotechnology industries, perhaps more than anywhere else.  Given the importance of strong patent protection in these industries, the unwillingness of courts to permit chemical genus claims seems quite troubling as a policy as well as a doctrinal matter.  The new rule makes it unreasonably difficult for a pharmaceutical company that comes up with an innovative new class of drugs to protect that class against imitation.  That result threatens innovation.

For these reasons the professors advocate that the Court return enablement law to its "traditional moorings" because this interpretation of the doctrine "serves important purposes, including policing against overbroad and purely functional claims" while the current Federal Circuit standard "to teach or enable every possible species within the genus is unnecessary and unworkable."  The law prior to these recent changes was not in need of them according to the professors because "the 'undue experimentation' test articulated in Wands has offered a useful and practical way" to address the question of what constitutes a sufficient enabling disclosure.  This is because the focus of the standard was rooted in the understanding of the person of ordinary skill in the art, which provided a basis that was not in the application of "an arbitrary judicial rule."  Under this standard the professors maintain that not all genus claims need satisfy the requirement, citing two examples.  First, the brief asserts that "a genus claim must be accompanied by disclosure of some operable species within the claim" and "[i]t is doubtful a PHOSITA could 'make and use' a truly new and nonobvious invention without any working examples at all" (emphases in brief).  This proscription will avoid the concern understood by the Court regarding "pure functional claiming."***  Second, the brief argues that a genus must share "some identifiable characteristics in common that set it apart from other categories," citing the Court's Consolidated Edison decision.  These are instances of "improper generalization" the professors argue, wherein "the patentee defined a genus of things that don't have enough identifiable characteristics in common (something that can happen whether the genus is large or small).  These claims are ultimately (according to the professors) dependent on whether "the patentee possess[ed] a true genus or merely a random assemblage of features without identifying a relevant property in common among them"(in the latter case there being no enabled genus claim).

Applying these rubrics the professors argue that Amgen disclosed a sufficient number of species to satisfy the proper test for enablement:

In this case, Amgen disclosed a number of working embodiments of anti-PCSK9 antibodies, it identified the particular epitopes of PCSK9 to which their antibody invention bound, and it provided other detail in its specification about the antibodies constituting its invention, including listing partial amino acid sequences for the business end of twenty-six antibodies.  The claims are limited to antibodies that bind at least one of fifteen amino acids on the PCSK9 protein.  Amgen's patent therefore does not appear to present either of the concerns identified above –pure functional claiming without workable examples or improper generalization without common identifiable characteristics.

For these reasons the professors argue the Court should reverse the Federal Circuit and specifically reject the full scope enablement standard that was the basis for the decision below.

*Another group of professors have filed an amicus brief in favor of Respondent Sanofi's position.

**This article will be the subject of a future post.

***In a footnote the professors discuss briefly (and somewhat unnecessarily) "prophetic examples" and that applications and patents containing them should be "viewed with special caution."