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The Medicines Company v. Hospira, Inc. | 827 F.3d 1363, 119 U.S.P.Q.2d 1329 (Fed.Cir.2016) (en banc)

Section One-Oh-Two B of the Patent Act states that patents can’t be granted for inventions that were on sale more than a year before the filing of the patent claim. In The Medicines Company versus Hospira, the Federal Circuit clarified the application of this ban to pharmaceutical claims.

In nineteen ninety-seven, the Medicines Company, or MedCo, contracted with Ben Venue Laboratories to manufacture Angiomax, an anticoagulant drug used in heart surgery. The active ingredient in Angiomax was a synthetic peptide known as bivalirudin. In two thousand five, MedCo developed a pH-adjusted version of Angiomax. It started paying Ben Venue to produce this improved version in two thousand six, contracting for three batches of commercially salable Angiomax worth over twenty million dollars. Each batch was to be placed on quality hold until all testing was completed. Ben Venue released each batch to MedCo for commercial and clinical packaging. The batches were then placed in quarantine until MedCo made them available for sale in August, two thousand seven.

MedCo filed two patent claims on the improved Angiomax on July twenty-seventh, two thousand eight. The critical date for purposes of the on-sale ban was, therefore, July twenty-seventh, two thousand seven.

Hospira sought approval from the Food and Drug Administration to sell generic bivalirudin. MedCo sued Hospira, alleging that its filings infringed its patents. Hospira argued that the patents were invalid because MedCo paid Ben Venue to manufacture Angiomax and offered Angiomax for sale before the critical date. MedCo countered that the on-sale bar isn’t triggered by an inventor’s hiring a third party to manufacture the claimed invention confidentially and under the inventor’s control.

The district court found that the invention wasn’t commercially offered for sale before the critical date and thus wasn’t invalidated by the on-sale bar. Hospira appealed to the Federal Circuit. It argued that the on-sale bar should be triggered by any commercialization, such as Medco’s requesting that Ben Venue fill the batches for commercial use and releasing them for commercial and clinical packaging. Hospira also argued that failing to find that the on-sale bar applied could allow a manufacturer to improperly stockpile an invention.

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