On July 11, 2016, a unanimous Federal Circuit en banc affirmed that The Medicines Company’s (“TMC”) use of third-party contract manufacturing services did not invalidate U.S. Patent Nos. 7,582,727 and 7,598,343 (the “patents-in-suit”) under the on-sale bar, reverting back to the district court’s original ruling but on modified grounds. The Medicines Company v. Hospira, Inc., No. 2014-1469 (“Hospira”). The Court provided useful guidance for companies and patentees that have third-party agreements to ensure they do not run afoul of the bar.

The on-sale bar under pre-AIA 35 U.S.C. § 102(b) prohibits patentability if “the invention” was “on sale” more than one year before the effective filing date of the invention. Here, TMC contracted with a batch manufacturer, Ben Venue Laboratories (“BV”), to produce Angiomax®, a blockbuster blood thinning drug covered by the patents-in-suit. More than a year before the effective filing dates of the patents-in-suit, TMC contracted with BV to manufacture a new formula of Angiomax® that met FDA requirements. In a decision penned by Judge O’Malley, the Federal Circuit reached the opposite conclusion from last year’s 3-judge panel decision holding that the patents-in-suit were not invalid under the on-sale bar...