US District Court rules in favour of Amgen on patent validity of Enbrel and against Sandoz biosimilar, Erelzi

Amgen announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz). Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid. Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018.

The company will appeal the ruling to the US Court of Appeals for the Federal Circuit, and the parties have agreed to an expedited appeal.