“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?”
