Supreme Court rejects Novartis Enbrel patent appeal

May 17, 2021

The U.S. Supreme Court declined to hear Novartis’ challenge to two patents on Amgen's rheumatoid arthritis blockbuster, crushing hopes of Novartis launching a biosimilar in the near future.

The court turned away a petition from Novartis' Sandoz that sought to challenge two Amgen patents which cover Enbrel’s active protein, etanercept, and a process to make the drug. The patents expire in November 2028 and April 2029, respectively. This means Sandoz won’t be able to sell its biosimilar version of the drug, called Erelzi, in the U.S. until 2029.

Enbrel, a biologic also known as etanercept, is used to treat adults with moderate to severe active rheumatoid arthritis and is Amgen’s top-selling drug. In 2016, an FDA review found there were no clinically meaningful differences between Enbrel and Novartis' Erelzi, in the studied condition of psoriasis, clearing the regulatory path for the biosimilar.

Read the press release