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ARTICLE · 08 MARCH 2016

Amgen Launches Enbrel Biosimilar Patent Litigation

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Although Sandoz' application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act...

United StatesIntellectual Property
Courtenay Brinckerhoff
Courtenay Brinckerhoff
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Although Sandoz' application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act (BPCIA) to enforce five patents relating to that product and approved methods of use. Some of the BPCIA issues raised in Amgen's complaint are similar to those raised by Janssen Biotech, Inc. in its dispute with Celltrion Healthcare Co., Ltd. over Remicade® (infliximab), which I have written about here. Sandoz' previous attempts to invalidate two of the patents at issue and a potential IPR proceeding involving one of those same patents makes this case even more interesting to follow.

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