Supreme Court of the United States · Official docket →
Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, et al.
Paid petition · United States Court of Appeals for the Federal Circuit, No. 2018-1976, 2018-2023 · judgment August 5, 2021
Before the decision, about 1.9× the 4.1% base rate. The model weighted this up for counsel who has won certiorari before, a dissent in the court below (flagged in the petition), and a Federal Circuit decision below, and down for a business respondent.
Question presented
Congress passed the Hatch-Waxman Act to “speed the introduction of low-cost generic drugs to the market.” Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012). The Act embodies a carefully crafted legislative compromise. On the one hand, Congress bolstered patent terms for brand-name drug companies. On the other, it ensured that once a brand drug is no longer patented, the fact that some of the drug’s uses remain patented “will not foreclose marketing a generic drug for other unpatented [uses].” Id. at 415. Instead, a generic manufacturer can sell its product with a “skinny label” that “carves out” any patented uses found in the brand drug’s labeling— and thereby avoid inducing infringement of the brand manufacturer’s patent rights. See 21 U.S.C. § 355(j)(2)(A)(viii). To aid in this process, brand manufacturers must provide a sworn statement to FDA identifying “the specific section(s)” of their labeling “that describes the method of use” claimed by their patents. 21 C.F.R. § 314.53(c)(2)(i)(O)(2), (c)(2)(i)(P)(2). Those are the sections that generic manufacturers then carve out of their labeling in order to obtain FDA approval despite the brand manufacturer’s remaining patents. The question presented is: 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?
Counsel of record
For petitioner
William McGinley Jay
Goodwin Procter, LLP
For respondent
Juanita R. Brooks
Fish & Richardson
Proceedings
- May 15 2023Petition DENIED. Justice Kavanaugh would grant the petition for a writ of certiorari.
- May 08 2023DISTRIBUTED for Conference of 5/11/2023.
- Apr 12 2023DISTRIBUTED for Conference of 4/28/2023.
- Apr 11 2023Supplemental brief of respondents GlaxoSmithKline LLC, et al. filed. (Distributed)
- Mar 29 2023Brief amicus curiae of United States filed.
- Oct 03 2022The Solicitor General is invited to file a brief in this case expressing the views of the United States.
- Sep 07 2022DISTRIBUTED for Conference of 9/28/2022.
- Sep 07 2022Reply of petitioner Teva Pharmaceuticals USA, Inc. filed. (Distributed)
- Aug 19 2022Brief of respondents GlaxoSmithKline LLC, et al. in opposition filed.
- Aug 12 2022Brief amicus curiae of Alvotech filed.
- Aug 12 2022Brief amicus curiae of Mylan Pharmaceuticals Inc. filed.
- Aug 12 2022Brief amicus curiae of Association for Accessible Medicines filed.
- Aug 10 2022Brief amici curiae of 42 Professors of Law, Economics, Business, and Medicine filed.
- Jul 26 2022Motion to extend the time to file a response is granted and the time is extended to and including September 12, 2022.
- Jul 25 2022Motion to extend the time to file a response from August 12, 2022 to September 12, 2022, submitted to The Clerk.
- Jul 11 2022Petition for a writ of certiorari filed. (Response due August 12, 2022)
- May 03 2022Application (21A677) granted by The Chief Justice extending the time to file until July 11, 2022.
- Apr 29 2022Application (21A677) to extend the time to file a petition for a writ of certiorari from May 12, 2022 to July 11, 2022, submitted to The Chief Justice.