Amgen patents upheld in longstanding Enbrel biosimilar dispute

A District of New Jersey judge recently upheld two patents at issue for Amgen, handing a victory to the biopharma company in its long-running dispute against Novartis entity Sandoz. The decision, which found Sandoz infringed on seven claims in the asserted patents, will prevent the company from marketing its biosimilar version of Amgen’s blockbuster Enbrel product.

This case is one of the earliest litigations to play out under the new Biologics Price Competition and Innovation Act (BPCIA), a statute that governs disputes involving biosimilar entry.

With the current ruling, Amgen and its affiliate Immunex will now hold market exclusivity over the manufacture and sale of etanercept until 2029.

Representing Amgen was a team of Sidley Austin lawyers, including David Pritikin, Vernon Winters and Jeffrey Kushan. All three attorneys are recognized as LMG Life Sciences stars. Sidley Austin is ranked 'Highly Recommended" for general patent litigation.