Duke University v. Biomarin Pharmaceutical Inc.

In enacting the Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 6(a), 125 Stat. 284, 299 (2011) (“AIA”), Congress created a powerful new mechanism for challenging patents called “inter partes review.” Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2136 (2016). Relying on this new procedure, a panel of the Patent Trial and Appeal Board, consisting of three administrative patent judges, revoked Duke’s patent claims despite unrebutted evidence of a long-felt but unsolved need, failure of others, industry praise, and commercial success. While Duke’s case was pending on appeal, the Federal Circuit decided in another case, Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019), reh’g denied, 953 F.3d 760 (2020) (en banc), that the administrative patent judges who conduct inter partes reviews hold office in violation of the Appointments Clause. The Federal Circuit has repeatedly refused to apply that ruling to cases like this one where the appellant did not challenge the appointments in its opening brief on appeal. The questions presented are:

1. Whether a court of appeals can invoke forfeiture to refuse to address an Appointments Clause violation in a pending appeal despite an intervening change in law.

2. Whether the U.S. Patent and Trademark Office Director’s delegation of authority to institute inter partes reviews to administrative patent judges acting