product-by-pass claims : CAFC Alert

The “on-sale” bar is triggered by a commercial sale that bears the general hallmarks of a sale pursuant to the Uniform Commercial Code

| July 18, 2016

The Medicines Company v. Hospira, Inc.

July 11, 2016

En Banc Decision by O’Malley.


Hospira submitted two Abbreviated New Drug Applications (“ANDA”) to seek approval of Food and Drug Administration (“FDA”) for selling generic bivalirudin drug products before the expiration of patents-in-suit: the ‘727 patent and the ‘343 patent. The two patents-in-suit cover Angiomax, the trade name of a form of bivalirudin that MedCo markets in the United States. On August 19, 2010, MedCo sued Hospira in the district court of Delaware alleging that Hospira’s two ANDA filings infringed the two patents-in-suit. The district court found the patents-in-suit not invalid and not infringed. MedCo appealed and Hospira cross-appealed. The original three-judge panel of the Federal Circuit agreed with Hospira and held that the patents-in-suit are invalid. MedCo petitioned for panel rehearing or rehearing en banc. The en banc panel affirmed the district court’s holding and remanded the appeal to the original three-judge panel for further proceedings.

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