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BPCIA Amgen Regeneron

Venable LLP

Samsung Bioepis and Formycon’s EYLEA® IPRs Discretionarily Denied Institution Among Wave of Fintiv Denials; Regeneron Files Second...

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On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims 1–12, 14–17, 19, 20, 22–36, 39–42, 44, 45, and...more

Goodwin

Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation

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On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...more

Goodwin

Federal Circuit Affirms Denial of Injunction Against Amgen in Aflibercept BPCIA Litigation

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On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more

Goodwin

Are Reference Product Sponsors Asserting More Patents in BPCIA Litigation?

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On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more

Goodwin

Preliminary Injunction Denied Against Amgen in Aflibercept BPCIA Litigation

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In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. ...more

Goodwin

Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders

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As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more

Goodwin

MDL Panel Grants Transfer of Aflibercept BPCIA Case

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As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

Goodwin

Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents

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As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial...more

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