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The Medicines Company v. Hospira, Inc.

United States Court of Appeals for the Federal Circuit

827 F.3d 1363 (2016)

Relevant factsFree

The Medicines Company (MedCo) (plaintiff) paid Ben Venue Laboratories roughly $350,000 -- about 1% of the resulting product's $20+ million market value -- to manufacture batches of an improved form of its drug Angiomax in late 2006, with invoices describing the charge as being for manufacturing services; Ben Venue never held title to the product and could only deliver it to MedCo. MedCo filed for patents on the improved formulation in July 2008 and had begun selling the product in August 2007. When Hospira, Inc. (defendant) sought approval to sell a generic version before MedCo's patents expired, it argued the 2006 manufacturing transactions with Ben Venue triggered the on-sale bar under 35 U.S.C. section 102(b), which would have barred MedCo's later patent as filed too long after the invention was first offered for sale. The trial court ruled the Ben Venue transactions did not trigger the bar, and Hospira appealed.

IssueFree

Whether the on-sale bar of 35 U.S.C. section 102(b) is triggered when a contract manufacturer produces a patented product for the patent holder, without any commercial sale or offer for sale of the product itself.

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