Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC

 
DOCKET NO.
OP. BELOW
SUBJECT
Patent

Question(s) 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?”

Posts About this Case

Date
Proceedings and Orders
May 3, 2022
Application (21A677) granted by The Chief Justice extending the time to file until July 11, 2022.
July 26, 2022
Motion to extend the time to file a response is granted and the time is extended to and including September 12, 2022.
September 7, 2022
DISTRIBUTED for Conference of 9/28/2022.