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 lower court’s ruling and concluded that a third-party manufacturer’s sale to the inventor of services to manufacture the product, where title to the product never passed to the manufacturer, does not constitute an invalidating sale under § 102(b). The Medicines Company v. Hospira, Inc., 119 U.S.P.Q.2d 1329 (Fed. Cir., July 11, 2016) (O’Malley, J.)

The case concerned whether the on-sale bar was triggered when The Medicines Company (MedCo) paid a third-party contract manufacturer, Ben Venue, to manufacture improved Angiomax® (bivalirudin), the brand name drug that is an embodiment of the patented claims before the critical date. MedCo does not have its own manufacturing facilities and cannot make its products in-house. MedCo therefore contracted with Ben Venue to make commercially saleable improved Angiomax. The transaction was confidential in nature, and title to the Angiomax batches was never transferred to Ben Venue.