News & Analysis as of

Jurisdiction Biosimilars Pharmaceutical Industry

Sheppard Mullin Richter & Hampton LLP

Biopharmaceutical Patent Litigation: Regeneron’s Defense Against Biosimilar Launches

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....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

McDermott Will & Emery

No Declaratory Jurisdiction Without Biosimilarity Application on File with FDA - Sandoz Inc. v. Amgen Inc.

McDermott Will & Emery on

Avoiding an interpretation of the Biologics Price Competition and Innovation Act (BPCIA), the U.S. Court of Appeals for the Federal Circuit invoked traditional case or controversy principles to affirm the dismissal of a...more

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