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Venable LLP

Spotlight On: Biosimilar Litigations - August 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

Samsung Bioepis Files IPR Petition Challenging Regeneron Aflibercept Patent

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​​​​​​​On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron...more

Goodwin

Aflibercept IPRs Update

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​​​​​​​On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in...more

Goodwin

Celltrion and Samsung File IPR Petitions on Aflibercept Patents

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​​​​​​​Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions...more

Goodwin

Year in Review: Top 5 Biosimilars Deals of 2017

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Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more

Goodwin

Pfizer files two IPR petitions on Genentech’s Patent Directed to Methods of Making Humanized Antibodies

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Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized...more

Goodwin

Year In Review: Top Five Biosimilars Deals of 2016

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After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an...more

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