Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With regard to granted cases, the Secretary of Veterans Affairs filed its merits brief in Arellano v. McDonough. With respect to petitions, four new petitions were filed with the Court, one in a patent case, one in a case addressing the jurisdiction of the Federal Circuit, and two in pro se cases; seven amicus briefs were filed in support of the petitions in two patent cases addressing the written description requirement; and the Court dismissed a petition in another pro se case. Here are the details.
The government submitted its merits brief in Arellano v. McDonough, a case raising questions about equitable tolling of a one-year filing deadline for retroactive veterans benefits. The government maintains that “[e]quitable tolling does not apply to the one-year grace period in [38 U.S.C. §] 5110(b)(1)” because the grace period is not a statute of limitations. Rather, the government contends, “the one-year grace period . . . is one factor the VA considers in determining the amount of benefits the veteran may receive.” According to the government, “[t]raditional statutes of limitations do not operate in that manner.” The government also argues that, “[e]ven if the one-year grace period were viewed as a statute of limitations, the statutory text and context would rebut any presumption of equitable tolling.” The government notes how “VA has long construed Section 5110 to preclude equitable tolling, and the Federal Circuit likewise has repeatedly adhered to that view.”
Four new petitions were filed with the Court.
In Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, the petitioner asked the Court to consider the following question:
- “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”
- “Whether the Federal Circuit, a court with limited jurisdiction that includes cases ‘arising under’ patent law, also has subject matter jurisdiction over a petition for writ of mandamus challenging a denial of a motion to transfer venue under 28 U.S.C. § 1404(a), a statute that does not arise under such law.”
In Adeyi v. McDonough, the pro se petitioner asked the Court to consider two questions.
Two amicus briefs were filed in support of the petitioners in Biogen International GmbH v. Mylan Pharmaceuticals Inc., a patent case raising a question about the written description requirement.
- The New England Legal Foundation (NELF) submitted an amicus brief explaining how “[t]he Federal Circuit’s decision concerns the three separate disclosure requirements set forth in 35 U.S.C. §112(a): the written disclosure requirement, the enablement requirement, and arguably the best mode requirement.” According to NELF, “long-standing Federal Circuit precedent holds that those requirements are to be considered separate and distinct, [but] the Federal Circuit decision conflates them.” Urging the Supreme Court to grant certiorari, NELF contends that the Federal Circuit’s decision has “caused uncertainty, lack of predictability, confusion and undue expense in this highly important area of property law.”
- The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) jointly submitted an amicus brief urging the Supreme Court to grant review to resolve the question of whether “innovators [must] defer pursuing patent protection for a new human therapeutic method until they have actually proven it is safe and effective in human patients.” According to the organizations, “patent law has never preconditioned patent grants on such proof, and doing so via the written description requirement not only conflicts with the statutory language of 35 U.S.C. § 112, but creates irreconcilable conflicts with other patent law standards.”
Five amicus briefs were filed in support of the petitioner in Juno Therapeutics, Inc. v. Kite Pharma, Inc., another patent case raising a question about the written description requirement.
- City of Hope submitted an amicus brief explaining how “[t]he Federal Circuit’s decision leaves City of Hope and like institutions with two bad options: (1) promptly disclose inventions while foregoing patent protection on the full scope of the enabled invention; or (2) delay disclosure in order to conduct routine testing that is unnecessary to allow others to use the invention, solely to meet the requirements imposed by the Federal Circuit.” According to City of Hope, “both options will slow the rate of biopharmaceutical research . . . [and] [n]either option serves patients.”
- St. Jude Children’s Research Hospital, Inc., Albert Einstein College of Medicine, the University of Texas M.D. Anderson Cancer Center, and other academic research institutions jointly submitted an amicus brief arguing that the Federal Circuit’s “decision morphs the written description requirement into an unfeasible standard—most deleteriously affecting cutting-edge innovations in the biotechnology and pharmaceutical fields—that significantly threatens the innovative lifesaving efforts of Amici and their partners.”
- Professors Mark D. Janis and Timothy R. Holbrook jointly submitted an amicus brief maintaining that “[t]he Federal Circuit’s written description requirement is not supported by the text of the patent statute, nor found in this Court’s precedent.” According to the professors, this “approach has thus created costly uncertainty about what content a patent applicant must include in a patent document, and, for some types of inventions in the life sciences, may make it nearly impossible to secure meaningful patent protection.”
- Amgen Inc., Association of University Technology Managers (AUTM), Instil Bio, Inc., Corning Incorporated, Bavarian Nordic A/S, and GlaxoSmithKline plc jointly submitted an amicus brief contending that “[t]he Federal Circuit’s ‘possession’ standard for written description strays far from the statutory standard and this Court’s precedent.” According to the organizations, “[i]t imposes extra-statutory barriers to patent protection, and results in a shifting array of uncertain subtests that destabilize the incentives and certainty needed to drive the development of breakthrough inventions.”
- REGENXBIO Inc. submitted an amicus brief arguing that “[t]he Federal Circuit’s ‘possession’-based written description test is the erroneous product of a 1997 Federal Circuit decision that does not comport with the text and purpose of 35 U.S.C. § 112.” REGENXBIO maintains that “[t]his misapplication lessens inventors’ likelihood of recouping the costly investments necessary for groundbreaking biotechnology and biomedical innovation, and it impedes the objective of the patent system to promote the progress of the useful arts.”
- Holland v. United States (pro se case)