Supreme Court Refuses to Review Sandoz Appeal Over Enbrel Patent Ruling

Novartis subsidiary Sandoz failed to persuade the U.S. Supreme Court to review a federal circuit ruling that blocked the drugmaker from launching a copycat drug of Amgen’s autoimmune blockbuster Enbrel (etanercept).

Despite Sandoz’s hopes that the highest court in the land would rule in its favor and clear the way for Erelzi, its biosimilar version of Enbrel, to enter the U.S. market, the court denied the company’s petition for review this week. The decision means Amgen will continue to enjoy market exclusivity for Enbrel for approximately eight more years.

“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, president of Sandoz U.S. and head of North America. “Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029.”

In July 2020, the federal circuit ruled against Sandoz’s appeal regarding Amgen’s patents for the drug, moving to uphold them and the 2019 decision of a New Jersey federal district court. Now, Sandoz has run out of legal recourse and will have to wait for the Enbrel patents to expire before it can launch Erelzi, which has been FDA-approved since August 2016.