Amgen Gains Favorable Ruling in Patent-Infringement Case for EnbrelBy
A federal appeals courts has ruled in favor of Amgen regarding a patent-infringement suit with Novartis’ Sandoz over Amgen’s Enbrel (etanercept), one of Amgen’s top-selling drugs with 2019 global sales of $5.2 billion. The court ruling keeps Sandoz from launching a biosimilar version of Enbrel in the US. Sandoz received approval of its biosimilar version of Enbrel, Erelzi, in 2016 but had not launched the product due to ongoing patent litigation with Amgen.
The decision upholds a prior ruling from the New Jersey District Court in 2019, which declared Amgen patents valid. Sandoz says it is evaluating its options, which may include an appeal to the US Supreme Court.
The patent-infringement action was brought against Sandoz by Amgen affiliates, Immunex Corporation and Amgen Manufacturing Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc.
The ruling by the appellate court affirmed an August 9, 2019 decision by the United States District Court for the District of New Jersey that had upheld the validity of two patents asserted against Sandoz. The two patents describe etanercept and methods for making it. In October 2019, by stipulation of Amgen and Sandoz, the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling, or offering for sale Sandoz’s etanercept product.