On Monday, the Supreme Court will hear oral arguments in Amgen Inc. v. Sanofi, Aventisub LLC, a case addressing patent law’s enablement requirement. The Supreme Court granted review to consider 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.’” This is our argument preview.
In its opening merits brief Amgen makes three arguments. First, it argues that the Federal Circuit imposes a different enablement standard for certain patent claims which is inconsistent with the text of Section 112. Second, Amgen argues that the text of Section 112 supplies the controlling “make and use” standard. Third, Amgen argues that its patents satisfy any proper formulation of Section 112’s enablement standard.
Amgen’s first argument centers on the assertion that the Federal Circuit’s decision “imposes a different [enablement] standard for certain patent claims, requiring that skilled artisans be able to ‘reach the full scope of claimed embodiments’—i.e., to cumulatively identify and make all, or nearly all, possible variations of the invention—without ‘substantial time and effort.’” According to Amgen, this heightened standard “has no basis in § 112’s text.” Amgen explains:
In ordinary understanding, [“make and use the invention”] means being able to produce and employ physical versions of the invention as needed. It would not ordinarily mean that one can ‘make and employ every possible variation of the invention in succession’ without expending much time or effort in the process.
Amgen maintains the Supreme Court “has never suggested that enablement turns on the cumulative ‘time and effort’ that would be required to make all, or virtually all, of a claimed invention’s potentially numerous embodiments.” Moreover, it contends, the fact that “two centuries of courts never articulated a reach-the-full-scope test ‘tends to negate the existence of’ any such standard.”
Amgen then transitions to argue that “Section 112 itself supplies the controlling standard.” It argues that “Congress provided that a patent’s description must be sufficient ‘to enable any person skilled in the art to make and use’ it.” Amgen maintains that “[a]pplication of the statutory standard reflects a practical inquiry into what skilled artisans can do using the patent’s specification—not a theoretical inquiry into hypothetical applications.” Amgen contends that the statutory “make and use” standard addresses concerns about overbroad claims. It argues that “challengers will always be able to show, through evidence, that skilled artisans cannot reasonably ‘make and use’ large areas of the claimed invention by following the patent’s teachings.”
Finally, Amgen argues that its patents are enabled under any reasonable formulation of the statutory standard. According to Amgen:
While the Federal Circuit deemed this ‘an unpredictable field of science,’ . . . Amgen’s patents gave those skilled in the antibody arts entirely predictable methods for actually producing the claimed antibodies. Mountains of evidence supported the jury’s determination that skilled artisans can make individual antibodies across the claims’ scope ‘without having to conduct undue experimentation.’ Sanofi-Regeneron did not present any evidence of failed efforts to generate antibodies, much less evidence so overwhelming that every reasonable juror would be compelled to find that it had proved non-enablement by clear-and-convincing proof.
In its responsive brief, Sanofi argues three main points: the Federal Circuit’s enablement standard is supported by Section 112, Amgen provides no reason to establish a new enablement standard, and Amgen’s claims are not enabled under any test for enablement.
Sanofi first argues that the Federal Circuit followed precedent “built on § 112’s text and this Court’s decisions,” specifically precedent involving genus claims with functional limitations. Sanofi explained:
The court noted that an enabling disclosure ‘must be at least commensurate with the scope of the claims.’ Accordingly, it explained, an inventor that ‘claims with broad functional language’ faces ‘high hurdles’ in ‘fulfilling the enablement requirement.’ These observations are fully consistent with the requirement of §112’s text that a specification enable the ‘invention’ claimed and the commonsense principle that the more that is claimed, the more that must be enabled.
Sanofi then transitions to argue that Amgen “attack[s] a straw man, adding its own language to a passage in the decision below to claim that the Federal Circuit adopted a novel enablement standard.” This assertion, Sanofi contends, “egregiously mischaracterizes the decision, which neither endorses nor relies on any such cumulative-effort standard—and in fact, expressly rejects it.” It maintains that, “[d]espite Amgen’s sky-is-falling lamentations, innovation has not been harmed by the decision below.”
Finally, Sanofi argued that “under any reasonable formulation” of the enablement standard, Amgen has not satisfied it. According to Sanofi, the reason is “simple.” It argues:
[T]he Amgen specification leaves skilled artisans seeking undisclosed embodiments exactly where they were before reading the specification: knowing from published research that certain undisclosed antibodies could be medically useful, and left to use well-known techniques to produce those potentially useful antibodies through trial and error. That is not a patent bargain at all, but a recipe for preempting useful research.
In sum, Sanofi argues that “the statutory text [of § 112], this Court’s cases, and a whole line of Federal Circuit precedents guard against what Amgen has done here: claim a lot and disclose a little, such that skilled artisans . . . must engage in undue experimentation.”
In its reply brief, Amgen argues that the Federal Circuit’s opinion “plainly turns on the effort required to identify and make all or nearly all the antibodies within Amgen’s patent claims.” It maintains that, while Sanofi “downplays the “‘cumulative-effort standard as a ‘straw man,’” it was Sanofi that “pressed that standard below.” Amgen contends that the Section 112(a) enablement requirement is “a practical test, focused on the ability of skilled artisans to do something concrete—to make the invention and to use it.” It argues that, in contrast to Sanofi’s “specific undisclosed embodiment” test, Section 112(a) “imposes no requirement that every ‘specific embodiment’ one can hypothesize be ‘predictably produced.’”
In response to the government’s contention that Amgen’s patents are not enabled because they cover more antibodies than the “exemplars” in the specification, Amgen argues “the government ignores the rule that it is ‘not necessary to describe in the specification all possible forms in which the claimed principle may be reduced to practice.’” Finally, Amgen maintains, “[n]o one defends the Federal Circuit’s reach-the-full scope test for enablement of genus claims as consistent with the patent ‘bargain.’”
Interested parties have submitted numerous amicus briefs to present their perspectives and arguments on the issues in this case.
Eight amicus briefs were filed in support of the petitioners:
- A group of intellectual property law professors filed an amicus brief in support of the petitioners. According to these professors, under the Federal Circuit’s “full scope” standard to evaluate enablement, “[a]ny genus claim covering a significant number of species in the chemical and life sciences fields, which typically come with built-in unpredictability even if the claimed technology is mature, is now in question.” Moreover, they contend, the “full scope” standard “is an impossible burden, and it is not one the law imposed until recently.” These professors maintain that “the right framing . . . is whether a PHOSITA would require undue experimentation to make and use the broader invention constituting the genus, not–as modern Federal Circuit cases frame things–whether the PHOSITA could make and use every possible species in the genus.”
- Instil Bio, Inc. filed an amicus brief in support of the petitioners. It maintains “[t]he full-scope enablement requirement discourages innovation by creating an obstacle to meaningful patent protection.” According to Instil, this obstacle is “especially a problem for clinical-stage pharmaceutical companies that lack the revenues of larger, more mature, pharmaceutical companies. Moreover, Instil contends, the “full scope” requirement “might incentivize companies to pursue less challenging therapeutics that are less risky, but also less innovative.” It urges the Court to “reject the ‘full-scope’ enablement requirement in favor of the long-established, more flexible, and more equitable ‘undue experimentation’ standard.”
- GlaxoSmithKline (GSK) PLC also filed an amicus brief in support of the petitioners. It argues “[t]he rationale behind enablement supports the ‘undue experimentation’ test, not the ‘full scope’ test.” GSK maintains that “[r]igid and inelastic tests like the Federal Circuit’s ‘full scope’ enablement test . . . leave no room for nuance and deny factfinders recourse to common sense.” It argues that “[s]omething has gone awry when the aims of a ‘full scope’ test, which polices the breadth of the exclusive rights claimed in a patent, is untethered to why the enablement requirement exists (i.e., to ensure that the patent’s contribution to the public domain allows others to use the invention when the exclusive term ends).” Moreover, GSK contends, the “atextual ‘full scope’ enablement test punishes innovators in the life sciences and usurps Congress’s role.”
- The Chemistry and the Law Division of the American Chemical Society filed an amicus brief in support of the petitioners. It maintains the Federal Circuit’s “full scope” test “represents a significant departure from [the undue experimentation standard] that fundamentally alters the balance of incentives by creating an impractical and inefficient enablement requirement that cuts against the reliability of the patent system in a way that stifles innovation and forces an inefficient allocation of resources that harms potential inventors and the public at large.” It urges the Court to return to “applying the enablement standard as Congress enacted.”
- The National Association of Patent Practitioners, Inc. (“NAPP”) filed an amicus brief in support of the petitioners. NAPP “agrees with Amgen and the law professors’ brief that the Federal Circuit goes too far by specifying exceptionally high barriers for inventors to satisfy the requirement.” It expresses concerns that “the Federal Circuit’s heightened enablement standard in this case will negatively impact the patent system as a whole, creating uncertainty for inventors to obtain adequate patent protection and reducing the incentive for inventors to disclose their discoveries publicly by filing patent applications.”
- AbbVie Inc. filed an amicus brief in support of the petitioners. It argues the Federal Circuit “has improperly created a heightened enablement standard for genus claims with functional limitations.” It maintains the “full scope” requirement “destroys the basic ‘bargain’ of patent law, because it does not give pioneering inventors adequate range of patent protection for breakthrough inventions with broad applicability.” Moreover, AbbVie contends, the “full scope” test is “fatally flawed because it is not tied to the text or purpose of the enablement requirement.”
- Alliance of U.S. Startups (“USIJ”) and Innovation Alliance (“IA”) jointly filed an amicus brief in support of the petitioners. They argue “[t]he decision below rewrites the ‘enablement’ provision of Section 112, as enacted by congress, by adding a new requirement not found in either the patent statute or the decisional law of this court.” USIJ and IA contend this rewriting of the enablement requirement “is hardly a legitimate exercise of judicial power.” According to USIJ and IA, “if left standing, this arbitrary and unsupported ruling will have a devastating effect on innovation in the biopharmaceutical and pharmaceutical industry and certain other industries as well.”
- Diversified Researchers and Innovators filed an amicus brief in support of the petitioners. They argue the “full scope” requirement “turns the enablement inquiry into a counting exercise and fails to account for the perspective of the skilled artisan.” They contend, moreover, that “the Federal Circuit prejudges the enablement inquiry for claims employing functional language in any manner, declaring that such claims raise ‘special problems’ warranting a special test.” Furthermore, they say, the “full scope” test “upends the burden of proof in challenging issued patents.” They argue the Federal Circuit’s standard “skews the balance of incentives for continued innovation.”
- The Fynder Group, Inc. filed an amicus brief in support of the petitioners. According to Fynder, “[u]nder this [‘full scope’] standard, instead of focusing on creating more groundbreaking innovation, innovators will have to devote substantial time and resources to produce routine examples premised on their invention—merely to satisfy the Federal Circuit’s concern about the ‘time and effort’ needed to ‘reach the full scope of the claimed embodiments.’” And, Fynder contends, “the risk associated with a higher enablement burden will likely convince many pioneering innovators to maintain their innovation (or key aspects of it) as trade secrets.”
Fifteen 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).
Five amicus briefs were filed in support of neither party:
- The Intellectual Property Owners Association filed an amicus brief in support of neither party. It argues “[t]he enablement analysis under § 112(a) should be applied in a predictable and fair manner that is consistent with the statutory language and longstanding precedent and should not ‘disrupt the settled expectations of the inventing community.’” It also contends “it is important to maintain the appropriate burden of proof when assessing enablement under §112(a).”
- Regenxbio, IGM Biosciences, Inc., and Adaptive Phage Therapeutics, Inc. jointly filed an amicus brief in support of neither party. They argue the “full scope” standard “diminishes innovation by undermining the presumption of validity, limiting constructive reduction to practice, and stepping away from this Court’s guidance.” The group maintains that “all innovators will be pushed towards too-narrow claims that fail to capture innovations.” Accordingly, the contend, this push “limits the incentives in the Patent Act and rewards the copyist that can make and use the unclaimable embodiments as taught by the patent.”
- High Tech Inventors Alliance and the Computer & Communications Industry Associate jointly filed an amicus brief in support of neither party. They argue this case is “an exceptionally poor vehicle for the Court to disturb [the patent system’s] delicate balance.” They contend the Petitioners do not challenge the “longstanding mandate of full-scope enablement.” They urge the Court to “either to dismiss certiorari as improvidently granted or to expressly circumscribe its opinion to be limited to the peculiar procedural posture of this case in which the claims are assumed to have an illegitimate, purely functional claim scope.”
- The Intellectual Property Law Association of Chicago filed an amicus brief in support of neither party. It contends that “enablement . . . is to be decided by the statutory and time-honored standard that the specification teach artisans how to make and use the invention.” It maintains “[t]he decision should be made for reasons of stare decisis, settled expectations, and most, because enablement is not, because it never has been and never should be . . . a matter of whether the specification has catalogued all possible embodiments of invention and taught each of them; that is not the law.”
- The New York Intellectual Property Law Association (“NYIPLA”) filed an amicus brief in support of neither party. It proposes an approach that “involves limiting Section 112 to its statutory language and requiring an applicant to disclose a reasonable number of species sufficient to give the Patent Office examiner confidence that the genus is supported.” Under this approach, “at the time of a trial for infringement the court would use a claim construction that limits the scope of the patent to only those species that could have been obtained without undue experimentation using the specification and the state of the art at the time the application was filed.” According to NYIPLA, this proposal “reduces the burden on the applicant and Patent Office in preparing the application and examining it.”
We will continue to follow this case. After Monday’s argument, we will post an argument recap. As always, you can find all of the relevant documents and all of our coverage of the case on our “Supreme Court Cases” page.