Petitions / Supreme Court Activity
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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 brief were filed in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case concerning the enablement patentability requirement. With respect to petitions, three new petitions were filed with the Court, one in a veterans case, one in a patent case, and one in a pro se case. Here are the details. 

Granted Cases

Amicus Briefs

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.’”

Nine of these fourteen 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.”

Five of these fourteen 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.” 

Petition Cases

New Petitions

Three new petitions were filed with the Court.

In Military-Veterans Advocacy Inc. v. McDonough, the petitioner asked the Court to review the following questions:

  1. “Whether under the United States v. Munsingwear 340 U.S. 36 (1950) [holding that where mootness prevents appellate review, the decision below should be vacated] the Court should grant certiorari and vacate the decisions below in this case that became involuntary moot following the Court of Appeals’ opinion?”
  2. “Whether the Federal Circuit contravened SEC v. Chenery, 318 U.S. 80 (1942) by sustaining the Secretary’s rulemaking denial on a ground other than the one adopted by the agency?”

In Janke v. Vidal, the petitioner asked the Court to review the following questions:

  1. “Can a known patentable product become ineligible for patenting when it is claimed to be made by applying a mathematical model of the product on a 3D printer, as no one is disputing follows from Parker v. Flook?”
  2. “And, can it be too much patent ‘monopoly’ to pre­-empt (in practical effect) a mathematical model of a product, as no one is disputing follows from Gottschalk v. Benson, when it is known that it is not too much pa­tent monopoly to pre-empt the real product itself?”

In Smith v. United States, a pro se petitioner asked the Court to review one question.