News & Analysis as of

FDA Approval Mylan Pharmaceuticals Hatch-Waxman

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. § 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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