USA's GPhA calls on FDA to support Supreme Court review of 'case that threatens generic competition'

The USA’s Generic Pharmaceutical Association (GPhA) has written a letter to Food and Drug Administration Commissioner Margaret Hamburg urging the agency to support Supreme Court review of Caraco Pharm Labs (CPD:US) versus Danish insulin giant Novo Nordisk A/S (NVO: N).

The GPhA explained that Supreme Court review of Caraco is needed because the Federal Circuit’s ruling in that case threatens to eliminate a critical check on brand-name drug manufacturers’ ability to block generic competition by providing FDA with misleading and overbroad descriptions of their patents.

Specifically, the Caraco case involves the Hatch-Waxman Act’s counterclaim provision, which complements “Section VIII” of the act and facilitates generic competition by permitting generic drugmakers to market their products for FDA-approved uses not covered by any patent. When a generic drug maker seeks marketing approval for only a drug’s unpatented uses, Section viii allows FDA to grant a “carve-out” label that permits the generic to market the drug for those uses alone, thus avoiding litigation over patent infringement.