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.
A total of thirty-four amicus briefs were filed, wherein twelve support Petitioner Amgen, seventeen support Respondents Sanofi and Regeneron, and five were filed in support of neither party. One of the briefs in support of Respondents was filed by three law professors*, and it is this amicus brief 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].
In arguing in support of Respondents, these professors' thesis is that the quid pro quo of patent law embodied in Section 112 has two facets. The first, that an applicant must show possession of an invention, is commonly considered the province of the written description requirement. In addition, however, the law has a second requirement, the professors argue, which is to disclose sufficient information for the skilled worker to be able to make and use the invention, which is mandated by the enablement requirement. This second requirement necessitates disclosure of what the professors call "additional information," arrived at by inter alia a parsing of the language of the statute reminiscent of similar linguistic analyses performed by amici in Ariad v. Eli Lilly & Co. (see "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association" and "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al." and in particular the brief filed by Dr. Roberta J. Morris) with regard to written description. As a doctrinal framework this argument presents a reasoned basis for the statute containing both a written description and enablement requirement, which has been the law at least since the Federal Circuit's Ariad decision (there being both Federal Circuit judges and amici in that case who questioned this construction of the statute). Whether the statute supports this interpretation is the task undertaken in their arguments.
The distinction frames the entire argument both explicitly and implicitly; the introduction to the Summary of the Argument asserts that "[f]or over two hundred years, the Patent Act has consistently required that an applicant for a patent actually conceive an invention and disclose what they have invented, in a manner that also enables skilled practitioners to make and use the invention conceived and disclosed" (the memes "conceived and disclosed" or "invented and disclosed" being repeated throughout to reinforce the distinction). The invalidating deficiency in genus claims can arise from "the applicant [having] failed to disclose a sufficient structural-functional relationship" to satisfy the disclosure requirement, particularly where what is disclosed are members of the genus recited merely by their function, according to the professors. When this happens, what an applicant has done is "shift[ed] to the public the burden of 'inventing' the claimed genus" because the applicant has failed to "provide sufficient information for the public to 'make and use' a properly disclosed and claimed genus invention."
The professors further argue that while the Federal Circuit's decision is "clearly correct" under existing precedent (In re Wands), the Supreme Court needs to provide "guidance" on the two aspects of the proper standard for satisfying the enablement requirement, because "[t]he current 'undue experimentation' standard in Wands . . . does not provide any meaningful referent to guide such analysis ('undue' compared to what?), and improperly conflates these two required inquiries." The two aspects the professors believe the Court should address are:
First, how much of a structural-functional relationship must be disclosed to validly support a genus claim without improperly shifting the burden of inventing to skilled artisans? Second, for an already invented and properly disclosed genus, how much additional information must an applicant provide to "enable" skilled artisans to "make and use" the claimed genus? This second requirement must consider how much time, money, and effort can be imposed by applicants on skilled practitioners in regard to the scope of the invention actually claimed [emphasis in brief].
The policy reasons the professors set forth regarding the necessity for the Court to clarify these standards are that granting genus claims that do not disclose a "sufficient structural-functional relationship" between the species they encompass "provides a disproportionate reward to applicants." In their view, an applicant should be entitled to the species explicitly disclosed, functionally equivalent species according to the doctrine of equivalents, and if and only if the applicant can "identify a common structural-functional relationship that sufficiently assures that other structures will perform the required functions" should such an applicant be permitted to claim species that they have not individually identified. The professors also assert that granting genus claims that fail to satisfy these requirements is equivalent to permitting applicants to claim research plans, which "blocks sequential innovation and commercialization of additional structures that the applicant has not yet identified to possess the desired result or recited function, but has claimed using structural or functional language." This negative consequence is exacerbated because there is a "constrained" experimental use exception under Madey v. Duke Univ., 307 F.3d 1351, 1355, 1362 (Fed. Cir. 2002), that precludes the public or successor inventors from producing such species without potential infringement liability (paradoxically, a consequence less likely for antibody species falling within the scope of the claims at issue here due to the safe harbor provisions of 35 U.S.C. § 271(e)(1)).
The brief characterizes as "a false dichotomy" the choice before the Court argued by Petitioners, between the statutory enablement standard under the strictures of "undue experimentation" and the Federal Circuit's putative "full scope" test. Because the Constitution grants the patenting power to Congress for inventions, what constitutes an invention they argue "requires [(1)] subjective mental comprehension by applicants of what they claim to have invented; (2) . . . the completed, objectively disclosed inventions that must be enabled for others to "make and use"; and (3) the claims (to be proper) must correspond in scope to the inventions subjectively recognized by the applicant (i.e., what is "regarded" as the invention)." (These categories correspond to the written description and enablement requirements of 35 U.S.C. § 112(a), respectively, and the "particularly point out and distinctly claim" requirement of 35 U.S.C. § 112(b).) The professors argue that there is no actual dichotomy here because the "statutory standard requires enabling the invention actually conceived, disclosed, and claimed." This is itself a "full scope" disclosure standard and not a new creation of the Federal Circuit in its opinion below. And the professors challenge the assertion that the current Federal Circuit standard requires actual reduction to practice (i.e., to "physically make") all species in a claimed genus (which courts have "never required"). The question comes down to sufficiency in disclosing structure-function relationships between the species that identifies the genus as the invention and provides "additional information" to enable the genus to be made and used by others (where the "degree of time, money, and effort" that does not amount to undue experimentation is "undefined") (here, the professors abandon, as have many, the conventional belief that the amount of "time, money, or effort" is not undue to the extent that the experimentation required is routine and the outcomes predictable).
The professors' brief recites a historical litany of cases illustrating the various ways the Court has attempted to limit the scope of claims depending on the sufficiency of a supporting specification's disclosure, including O'Reilly v. Morse, 56 U.S. 62 (1853); Corning v. Burden, 56 U.S. 252, 269 (1853); Risdon Iron & Locomotive Works v. Medart, 158 U.S. 68 (1853); and Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1, 12-13 (1946). The brief recognizes that Congress stepped in after the Halliburton decision by permitting functional claiming under a specific statutory provision, 35 U.S.C. § 112(f), but in doing so the statute "specified the permissible limits of structural genus claiming using functional language, limiting claim scope to equivalent species of embodiments actually invented by the applicant and disclosed in the specification."** The brief cites Brenner v. Manson, 383 U.S. 519 (1966), a decision usually appreciated as being directed to the utility requirement under Section 101, as being consistent with the proscription against claiming a research plan, which is what in their view claiming a genus unsupported by sufficient disclosure amounts to. (To be fair, Section 112(a) is also recognized as having a utility requirement; see In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).) The brief also acknowledges the application of the written description requirement to establish possession of an invention under Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), but asserts that "the Federal Circuit has not yet clearly articulated when sufficient species have been disclosed or when a sufficient structural-functional relationship is identified to justify that the applicant subjectively 'possess[ed]' the genus of a claimed species, and thus invented rather than just claimed that genus." And, according to the professors, the Supreme Court has also recognized a need for an applicant to identify and disclose "a sufficient structural-functional relationship of a claimed genus to qualify as an 'invention' under the 'enablement' doctrine," citing Consolidated Elec. Light Co. v. McKeesport Light Co., 159 US. 465 (1895) in support. The brief distinguishes the Court's decision in Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916), a case cited by Amgen and some amici writing in support of their position, stating that in that case the Court "merely held that applicants need not reduce to practice (i.e., physically create) and enumerate in the specification all of the generically claimed species embodiments in order to show what species within the claims work best, when and only when disclosure of a limited number of embodiments was sufficient to demonstrate that the applicant had identified the required structural-functional relationship" (emphasis in brief).
Having set forth their arguments for the enablement requirement having two aspects of what needs to be disclosed to support a genus claim, the professors ask the Court to provide guidance on the proper application of both. This requires guidance on how much of this structure-function relationship would be needed to satisfy the enablement requirement (a fact-specific question not apparently amenable to the type of broad pronouncements usually made by the Court for such principles). The professors provide their interpretation of what such a pronouncement would provide from earlier precedent: that species expressly not disclosed but falling within the scope of a genus claim be the product of "mechanical" rather than "inventive" skill; that the existence of any inoperative embodiments be per se invalidating; and the structure-function relationship must be a "'quality common to all of' the claimed species." As part of this exercise the professors urge the Court to correct the deficiencies they perceive in how the lower courts and Patent Office have implemented the Wands factors, to the extent that the undue experimentation standard conflates whether the disclosure permits species falling within a claimed genus to be identified with whether these species can be made and used without "too much time, money, and effort" (wherein the first requirement has generally been assessed under the written description requirement).
The professors assert that both the Wands calculus and the Court's precedent (Minerals Separation's "reasonable[ness]" standard) "provide no basis to draw the line between insufficient instruction and sufficient instruction that 'leav[es] something to the skill of persons applying the invention.'" That standard should depend on economic factors and "whether [it] promotes or restricts sequential innovation" in the professors' view, citing a variety of academic treatments of the question.
Finally, the professors argue the enablement requirement's importance in preventing applicants from obtaining claims to a mere "research plan." Much of their contentions in this regard, that confining the scope of genus claims too narrowly would not harm innovation, is based on a patentee's ability to rely on the doctrine of equivalents for species falling outside the literal scope of what is claimed (regardless of the unpredictability of such reliance and the limitations otherwise imposed on exercise of the doctrine). The policy (or doctrinal) position stems from the belief that overbroad claiming (to the extent the Court is persuaded by the argument) "blocks sequential innovation and commercialization of additional structures that the applicant has not yet identified to possess the required function," which was the Court's concern in Halliburton. And the professors in this context remind the Court of the "constrained experimental use" exception under Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. 2002), because under this interpretation of the law "no sequential innovator may seek to discover any additional, functional species within the scope of the claims by making and testing embodiments of the claimed genus." The professors use the history of antibody claiming, as explicated in S. Sean Tu & Christopher M. Holman, Antibody Claims and the Evolution of the Written Description/Enablement Requirement, 63 IDEA 84, 96 (2021), to illustrate how permitting claims based on function (antigen binding) would have stifled innovation into "the many medically useful alternatives and the variety of antibody options that were developed, some of which are at issue in this case" (although it must be borne in mind that the technology at the time prevented "better" disclosure of antibody species, inter alia, by amino acid sequence).
The brief ends with a call for the Court to decide this "easy case" by affirming the Federal Circuit, while also reiterating the professors' request for the Court's guidance on how to implement the enablement requirement to achieve the policy goals they advocate in their brief. Their argument boils down to where to draw the line on the scope given to genus claims, and the professors believe innovation is better served in preventing applicants from obtaining claims having a scope that is greater than what an applicant can reliably demonstrate at the time of filing, with invalidation being the price for inadvertent inclusion of inoperative embodiments, no matter how infrequent or easy to discern. Whether this level of stringency is consistent with innovation will become evident only if the Court were to adopt the standards proposed in the professors' brief, with equally deleterious consequences being possible in either event.
* Professor Joshua D. Sarnoff, DePaul University School of Law; Professor Sharon K. Sandeen, Mitchell Hamline School of Law; and Professor Ana Santos Rutschman, Villanova University, Charles Widger School of Law.
** The brief also notes that Graver Tank & Mfg. Co. v Linde Air Prods. Co., 336 U.S. 271 (1949), an earlier case related to its more famous relative that established the doctrine of equivalents, invalidated a patent to a genus "defined by structure that contained inoperative embodiments," thereby claiming a result rather than an invention (as the professors understand the Court's reasoning).
