News & Analysis as of

Manufacturers Pharmaceutical Industry Inventors

McDermott Will & Emery

ANDA Update - Volume 2, Number 3

McDermott Will & Emery on

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

The Medicines Company v. Hospira - Preparation of validation batches by a contract manufacturer for FDA submission creates an...

On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more

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