Will 2023 Be The Year Of ' 112 At The Supreme Court?

• Published date: 12 December 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Mr Kenneth S. Guerra and Mark Feldstein

The Supreme Court recently agreed to review the enablement standard for genus claims,¹ the first time the Court has considered 35 U.S.C. § 112 since evaluating the standard for indefiniteness in 2014.² This is especially notable considering the Court granted cert. contrary to the recommendation of the Solicitor General and also denied two additional opportunities to review section 112 this term.³,⁴ Of further interest, Juno, petitioner in one of the denied cert. petitions, is seeking rehearing, arguing that its case warrants consideration in view of the question presented in Amgen v. Sanofi.

Amgen v. Sanofi

Amgen first brought suit against Sanofi in 2014, alleging Sanofi's hyperlipidemia product Praluent® (alirocumab) infringed two Amgen patents that each claim a genus of antibodies by their function of binding a particular antigen.⁵ Sanofi stipulated to infringement but alleged invalidity. After two jury trials finding no invalidity,⁶ two Federal Circuit appeals finding invalidity,⁷ two denials of petitions for rehearing en banc,⁸ a 2019 denial of petition for cert.,⁹ and a recommendation by the Solicitor General to deny cert.,¹⁰ the Supreme Court granted cert. to address the 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,'" Pet. App. 14a.

The Solicitor General recommended cert. be denied.¹¹ Principally, the government explained that where a patentee purports to invent an entire genus, it must enable the entire genus. The government further argued the case is not a good vehicle to review the enablement standard because the degree of experimentation is just one Wands factor, the Federal Circuit enablement test that Amgen did not dispute during trial, and that Amgen does not provide an alternative test. On the other side, multiple amici wrote in support of Amgen's petition.¹²

Juno Therapeutics, Inc. v. Kite Pharma

Juno Therapeutics (now part of Bristol Myers Squibb) first brought suit against Kite Pharma (now part of Gilead Sciences) in 2017, alleging Kite's CAR-T cell therapy Yescarta® (axicabtagene ciloleucel) infringes a Juno patent. A jury found no patent...