The Medicines Co. v. Hospira, Inc.

E-Law Admin/ Juli 11, 2016/ Arzneimittelrecht Schweiz/ 0Kommentare

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

  • Argued
  • Submitted
  • Decided
  • Published 2016/07/11



  • United States Federal Circuit


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