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The Medicines Company v. Hospira, Inc.

United States Court of Appeals for the Federal Circuit
827 F.3d 1363, 119 U.S.P.Q.2d 1329 (Fed.Cir.2016) (en banc)


Facts

The Medicines Company (MedCo) (plaintiff) was a pharmaceutical company that marketed a drug named Angiomax, the trade name of a form of bivalirudin. MedCo contracted with Ben Venue Laboratories to manufacture Angiomax. Ben Venue completed the first batch of Angiomax on October 31, 2006. Ben Venue completed two more batches in late 2006. The three batches had a combined market value of well over $20 million. MedCo paid Ben Venue approximately $350,000 to manufacture the batches. Each invoice stated: “Charge to manufacture Bivalirudin lot.” MedCo was granted two patents covering an improved form of Angiomax. The patents were filed on July 27, 2008. MedCo made Angiomax available for sale in August 2007. Hospira, Inc. (defendant) sought approval to sell generic bivalirudin before the expiration of MedCo’s patents. Hospira argued that by manufacturing the patented product for MedCo, Ben Venue put the invention on sale. Thus, Hospira argued, the on-sale bar of 35 U.S.C. § 102(b) was triggered and MedCo was barred from patenting the later version of Angiomax. Hospira also argued that finding the bar inapplicable here would improperly permit an inventor to stockpile his invention. Additionally, Hospira argued that a number of similar cases applied to the on-sale bar. The trial court ruled that the transactions between Ben Venue and MedCo did not trigger the on-sale bar. Hospira appealed.

Rule of Law

Issue

Holding and Reasoning (O’Malley, J.)

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