THOUSAND OAKS, Calif., July 1, 2020 /PRNewswire/ -- Amgen today announced that the United States Court of Appeals for the Federal Circuit has held in Amgen's favor on the validity of two patents that describe and claim Enbrel® (etanercept) and methods for making it.
Specifically, 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 Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz) based on Sandoz's biosimilar of Enbrel® (etanercept).
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. Before trial, Sandoz acknowledged its biosimilar etanercept infringes seven claims of U.S. Patent Nos. 8,063,182 and 8,163,522 (the '182 and '522 patents).
On October 8, 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.
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Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Trish Rowland, 805-447-5631 (media)
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