United States Federal Circuit
The Medicines Co. v. Hospira, Inc., 14-1469
In a case arising from the submission of two Abbreviated New Drug Applications (ANDAs) for generic bivalirudin drug products before the expiration of the patents-in-suit, involving the circumstances under which a product produced pursuant to the claims of a product-by-process patent is 'on sale' under 35 U.S.C. section 102(b), the District Court's judgment that the transactions at issue did not render the asserted claims of a patent invalid under section 102(b) is affirmed where: 1) to be 'on sale' under section 102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to section 2-106 of the Uniform Commercial Code; and 2) no such invalidating commercial sale occurred in this case.
Appellate Information
- Published 2016/07/11
Judges
- O'MALLEY
Court
- United States Federal Circuit