News & Analysis as of

Generic Drugs Leave to Amend

Smart & Biggar

Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

Smart & Biggar on

This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more

Wilson Sonsini Goodrich & Rosati

Federal Court Challenges FTC’s Litigation Authority in FTC v Shire ViroPharma

In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...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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