Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, fourteen amicus briefs were filed in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case addressing the enablement patentability requirement. With respect to petitions, although no new petitions were filed with the Court, three new amicus briefs were filed in patent case. Here are the details.
Fourteen amicus briefs were filed in in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case raising questions related to the enablement patentability requirement. The Court granted review of the following question:
- “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed 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.’”
All of the fourteen amicus briefs were filed in support of the respondents:
- Professor Robin Feldman filed an amicus brief in support of the respondents. Professor Feldman, maintains the Supreme Court’s “precedent holds that the correct standard here is not undue experimentation but rather any experimentation.” She argues that “the conflict between undue and any experimentation is not squarely presented because the parties’ arguments accept the ‘undue experimentation’ standard.” According to Feldman, “[i]t would be pointless and misleading for this Court to rule on whether the standard’s extension is valid when the standard itself is arguably invalid.” If the Court were to reach the merits, Feldman contends, the Federal Circuits decision should be affirmed. She argues that “the Federal Circuit made clear that ‘exhaust[ion]’ of a genus is not required and that only a ‘reasonable’ set of embodiments is needed.”
- A group of intellectual property law professors filed an amicus brief in support of the respondents. These professors argue the Court “needs to provide guidance on both aspects of the enablement standard in order to support its further refinement.” One aspect, they contend, is “how much of a structural-functional relationship must be disclosed to validly support a genus claim.” The second aspect is, “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.” According to the professors, the case at hand is an “easy case” in view of the “complete lack of disclosure connecting structure to function.” They urge the Court to affirm the decision below while “providing the required guidance for the lower courts to further develop the law of enablement.”
- Sir Gregory Paul Winter and interested scientists filed an amicus brief in support of the respondents. They maintain “Amgen’s claimed ‘invention’ is simply a hindsight characterization of that which existed naturally.” The group contends that “simply knowing an antibody’s function . . . does not tell an antibody scientist about its structure.” Amgen’s patents, they argue, “are not directed to a narrow class of specific antibodies.” Moreover, they maintain, “Amgen has actually increased the burden on scientists, forcing them to engage in undue experimentation in order to make, test, and characterize each one of potentially billions of antibodies to determine whether they are covered by Amgen’s claims.” Finally, they argue, “using this case to vitiate the Federal Circuit’s long-standing enablement standard would permit an applicant to effectively patent a natural interface on a target of interest.”
- Another group of intellectual property law professors filed their own amicus brief in support of the respondents. They maintain this case is “a classic example of a narrow invention that is coupled to overbroad claims.” According to these professors, Amgen’s argument that it disclosed a “roadmap” that teaches how to make all the claimed antibodies “cannot support enablement.” They contend Amgen’s “roadmap” “categorically does not enable the making of something that was already invented.” Accordingly, the professors argue, “Amgen has improperly tried to claim well beyond what it had invented and its patent claims were properly invalidated.”
- Pfizer filed an amicus brief in support of the respondents. Pfizer argues “[t]he Federal Circuit . . . properly considered the overreaching broad scope of the purely functional claims that Amgen chose . . . and the comparatively limited number of examples and guidance in the patent specification.” It contends that the problem in this case is not the enablement test that the Federal Circuit applied, but, rather, “the overbroad, functionally-defined patent claims that are not commensurate with the inventors’ contribution to the art.”
- Eli Lilly and Company, Ipsen Bioscience, Inc. and Innovent Biologics, Inc. jointly filed an amicus brief in support of the respondents. They take the position that “the boundaries of Amgen’s claim are unbounded, both in terms of size as well as biological and molecular diversity.” They argue “Amgen seeks the Court’s endorsement of an exception to the requirements of § 112 for antibodies—permitting them to be claimed by reciting their naturally-occurring therapeutic target and their effect on that target instead of by their structure.” Accordingly, they contend, “[t]he Court should affirm the decision below and make clear that claims like Amgen’s—limited solely by functional results with no structural limitations whatsoever— are invalid under § 112.”
- Genentech, Inc., AstraZeneca Pharmaceuticals LP, Bayer AG, Gilead Sciences, Inc., and Johnson & Johnson jointly filed an amicus brief in support of the respondents. They maintain that, “[b]y limiting patentees’ monopolies based on the extent of their inventive contributions, the Federal Circuit’s [enablement] approach provides the right incentives for both pioneering research and continued innovation.” In contrast, they contend, Amgen’s approach “would vastly overreward the first entity to secure patent rights within an unpredictable field of research, preempting innovation in that area.” Moreover, they argue, “[l]owering the bar to enablement would only exacerbate . . . problems by allowing patentees to claim more than they have invented, prematurely monopolizing innovations that have not yet been discovered.”
- Small and medium-sized biotechnology companies jointly filed an amicus brief in support of the respondents. They argue “[t]he longstanding enablement standard is consistent with text and precedent.” According to these companies, “[t]he balance [the enablement standard] strikes promotes innovation and saves lives.” Departing from the enablement standard, they contend, would “unleash harmful consequences for industry participants like Amici, for patients, and for the public.”
- Unified Patents, LLC filed an amicus brief in support of the respondents. It argues “[t]he standard that the Court and Federal Circuit apply is one of ‘full scope’ enablement, where the patentee has kept its end of the ‘quid pro quo’ of the patent bargain by enabling its invention as broadly as its monopoly excludes.” Unified Patents contends the “undisputed facts showed a claim breadth (in an unpredictable art) encompassing many millions of antibodies, only a minute fraction of which were disclosed, where ‘substantial time and effort’ would be needed to experimentally determine on a case-by-case basis whether a non-disclosed antibody possessed the claimed function.”
- Fresenius Kabi USA, LLC, filed an amicus brief in support of the respondents. It argues “[t]he new, relaxed enablement standard espoused by Petitioners will negatively affect competition in the pharmaceutical industry.” Fresenius Kabi describes how “relaxing the standard for enablement carries with it an increased risk of abuse in the use of ‘continuation’ patents.” Furthermore, it contends, the petitioners “fail to grapple with recent changes to the patent system, changes that make a robust enablement standard essential to ‘promote the Progress of Science.’”
- The Association for Accessible Medicines filed an amicus brief in support of the respondents. It argues the Federal Circuit’s decision “correctly rejected Amgen’s effort to capture the rights to all PCSK9-inhibiting antibodies despite having invented just a small number of them.” The Association contends that, “if Amgen’s position prevails, a patentee could obtain a functional claim even without complying with Section 112(f).” Moreover, it maintains, the Supreme Court “has never held that by disclosing one structure that achieves a function, a patentee may obtain a monopoly over the entire class of structures performing that function.”
- The Public Interest Patent Law Institute filed an amicus brief in support of the respondents. Its brief argues that “[s]triking an appropriate balance between a patent owner’s exclusive rights and the public’s freedom to innovate, compete, and access knowledge is critical to the patent system’s ability to function effectively.” According to the Institute, the enablement requirement is “essential to maintaining an appropriate balance.” The Institute argues that “Amgen and Sanofi both have patents that give them exclusive rights, but they currently do not foreclose all innovation, competition, or access.” A reversal, according to the Institute, “would upend this beneficial balance.”
- Viatris Inc. filed an amicus brief in support of the respondents. Its brief argues that the Federal Circuit’s enablement precedent “is fully rooted in the text of § 112(a) and this Court’s precedents.” It maintains the Federal Circuit “did not forge a ‘new,’ ‘categorically different,’ or ‘exponentially more demanding [enablement] standard.’” In contrast, it contends, the Federal Circuit “simply held that broader claims typically require broader support, particularly where, as here, the art is less predictable —a conclusion that petitioners improperly attempt to challenge in this Court.”
- The American Intellectual Property Law Association filed an amicus brief suggesting affirmance. It argues that the Federal Circuit’s decision “did not rewrite or create a new test for determining the sufficiency of an enablement disclosure.” The finding that the disclosures in this case were inadequate, it contends, “was made with a time-tested method of analysis that has served the patent system well by balancing the disclosure burdens on the inventor against the public interest in providing access to the invention.” It urges the Court to confirm that the Federal Circuit’s Wands factors (eight factors that courts may apply to tailor findings to the particular claims and technology at issue) are “important considerations” in evaluating the sufficiency of disclosures under 35 U.S.C. § 112(a).
Three amicus brief were filed in Arthrex, Inc. v. Smith & Nephew, Inc., a patent case. The petitioner presented the following question for review:
- “The Federal Vacancies Reform Act of 1998 (‘FVRA’) establishes ‘the exclusive means for temporarily authorizing an acting official to perform the functions and duties’ of a vacant presidentially appointed, Senate-confirmed office . . . . The question presented is: Whether the Commissioner for Patents’ exercise of the Director’s authority pursuant to an internal agency delegation violated the Federal Vacancies Reform Act.”
All three of the amicus briefs support the petitioner.
- The Cato Institute filed an amicus brief in support of the petitioner. Its brief takes the position that the delegation to Commissioner Hirshfeld “sever[ed] the chain of accountability to the President that the FVRA was meant to protect.” It argues “the Federal Circuit held that the FVRA permits such an end-run around political accountability.” But that decision, according to the Cato Institute, was wrong. It contends “[t]he drafters of the FVRA knew better than to allow its restrictions to be so easily evaded.”
- Fair Inventing Fund filed an amicus brief in support of the petitioner. The Fund argues that the Court’s prior “decision in Arthrex recognized the importance of accountability and transparency.” Moreover, it contends, “[g]reater political accountability and transparency in the patent system would also help ensure greater PTO sensitivity to the needs of women and minority inventors.” The Fund argues the Court should grant review of the PTO’s “improper delegation of the Director’s authority to an inferior officer whose appointment did not comply with the requirements set forth in the FVRA.”
- Dr. Ron D. Katznelson filed an amicus brief in support of the petitioner. He argues the Federal Circuits conclusion is “fundamentally wrong.” He contends “not all the Director’s duties are delegable.” He also argues that the Federal Circuit “conflated the statutory provisions referring to the functions of the ‘Office’ (the PTO) with those of the Director herself, which are distinct from those of the ‘Office.’” Finally, Dr. Katznelson maintains, “the Federal Circuit misconstrued the legal meaning of a delegated authority and failed to recognize the scope, modality, and organic conditions under which such delegated authority remains in force and when it is rendered invalid.”