Amgen v Sandoz: marketing exclusivity under the BPCIA

On February 16, 2016, Sandoz filed a petition for a writ of certiorari asking the US Supreme Court to review the case Amgen v Sandoz, in which the US Court of Appeals for the Federal Circuit interpreted key provisions of the Biologics Price Competition and Innovation Act (BPCIA) (codified at 42 USC §262[k]).

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

More on this story

Americas

Appeals court eases Teva’s headache with reversal

17 April 2026 A ruling that invalidated three of Teva's headache treatment patents has been thrown out, sending a long-running case back to the lower court.

Americas

Cancer drug researcher hit with suit over mutation-targeting tools

16 April 2026 The Cambridge biotech is accused of infringing six patents covering technologies used to target drug-resistant cancer mutations.

Americas

Court narrows Mylan’s Copaxone suit but key claims survive

14 April 2026 A US district court has allowed key elements of the generic drugmaker’s case against a rival to move forward, while drawing clear limits on how far the complaint can reach.

More features

Appeals court eases Teva’s headache with reversal

Cancer drug researcher hit with suit over mutation-targeting tools

Novo Nordisk and OpenAI strike AI deal to boost drug discovery

Court narrows Mylan’s Copaxone suit but key claims survive

Oracle retaliates with lawsuit to laid-off staff member’s ‘demands’

Patent office fee increases: What applicants must know

LSPN Awards USA: Meet the judges

Faegre Drinker boosts FDA regulatory practice with two senior hires

Amgen v Sandoz: marketing exclusivity under the BPCIA

More on this story

Editor's picks

Editor's picks

More features