News & Analysis as of

Hatch-Waxman FDA Approval Mylan Pharmaceuticals

Goodwin

Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation

Goodwin on

On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re:...more

Robins Kaplan LLP

Hatch-Waxman Venue Is Further Narrowed

Robins Kaplan LLP on

This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. ยง 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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