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 on-sale bar – even though the contract was for manufacturing and not for sale of the product – because the batches embodied the claimed invention. As bioprocessing and production patents have taken a role of increasing importance to protect compounds from biosimilar challenge, this decision in The Medicines Company v. Hospira highlights the risks of using CMOs to produce products without a recognition of triggering events for a bar under 35 U.S.C. §102(b).

The Medicines Company owns U.S. Patent Nos. 7,582,727 and 7,598,343, broadly directed to the drug bivalirudin, a synthetic peptide used as an anti-coagulant. The Medicines Company sells bivalirudin under the brand name Angiomax®. From 1997 to October 2006, The Medicines Company purchased pharmaceutical batches of bivalirudin from Ben Venue Laboratories. In 2005, Ben Venue created a batch of bivalirudin with levels of the Asp9-bivalirudin impurity that exceeded FDA’s approved maximum of 1.5%. After another batch failure, The Medicines Company hired a consultant to investigate and resolve the issue. The consultant discovered that certain methods of adding a pH-adjusting solution during the compounding process minimized the impurity to less than 0.6%. In July 2008, The Medicines Company filed applications for the ’343 and ’727 patents, which include product by-process claims describing this discovery.