Appeals from the United States District Court for the District of Delaware in No. 1:09-CV-00750, Judge Richard G. Andrews.
EDGAR HAUG, Frommer Lawrence & Haug LLP, New York, NY, argued for plaintiff-appellant. Also represented by PORTER F. FLEMING, ANGUS CHEN.
BRADFORD PETER LYERLA, Jenner & Block LLP, Chicago, IL, argued for defendant-cross-appellant. Also represented by SARA TONNIES HORTON, AARON A. BARLOW.
Before DYK, WALLACH, and HUGHES, Circuit Judges.
Hughes, Circuit Judge.
The Medicines Company appeals the U.S. District Court for the District of Delaware's claim construction and non-infringement findings. Hospira, Inc. cross-appeals the district court's determination that the asserted claims are not invalid under the on-sale bar, obviousness, or indefiniteness. We conclude that the district court clearly erred in finding that the bivalirudin batches prepared by Ben Venue Laboratories before the critical date were not sold to The Medicines Company and were prepared primarily for an experimental purpose. Accordingly, we reverse the district court's validity determination and hold the asserted claims invalid under the on-sale bar.
The Medicines Company owns U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343. The patents relate to the drug bivalirudin, a synthetic peptide used as an anti-coagulant. Bivalirudin is generally mixed with saline or water and administered intravenously. Because bivalirudin's acidity in saline or water makes it undesirable for injection, its pH is adjusted during compounding to make it more alkaline.
The Medicines Company sells a bivalirudin drug for injection under the Angiomax® brand. From 1997 to October 2006, The Medicines Company purchased pharmaceutical batches of Angiomax® from Ben Venue Laboratories. In 2005, Ben Venue created a batch of bivalirudin with levels of Asp9-bivalirudin impurity that exceeded the Food and Drug Administration's approved maximum of 1.5%. Accordingly, The Medicines Company could not use the batch.
After another batch failure, The Medicines Company hired a consultant, Dr. Musso, to investigate and resolve the issue. Dr. Musso discovered that certain
methods of adding a pH-adjusting solution during the compounding process minimize the Asp9-bivalirudin 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.
Over one year before filing these applications, however, The Medicines Company hired Ben Venue to prepare three batches of bivalirudin using an embodiment of the patented method. Each invoice for these services identifies a " charge to manufacture Bivalirudin lot." See JA17177-79. Each invoice also states that the bivalirudin lot was or will be released to The Medicines Company. JA17177 (" Release pending final validation report." ); JA17178 (same); JA17179 (" Batch released and held at Ben Venue pending shipping instructions." ). Each lot was marked with a commercial ...