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Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.

Special Rule for Obviousness-Type Double Patenting Inquiry on Pre-URAA Patent

Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.909 F.3d 1355 (Fed. Cir. Dec. 7, 2018) (Prost, Wallach, CHEN) (D. Del.: Andrews) (2 of 5 stars)

Fed Cir reverses Hatch-Waxman judgment of invalidity as to Novartis’s patent. The patent relates to Zortress and Afinitor (everolimus), used to treat certain cancers and prevent rejection in kidney and liver transplantations. The district court erred in holding the patent invalid for obviousness-type double patenting over a later-filed patent in the same family that, due to a change in law from the Uruguay Round Agreements Act (“URAA”), had expired first. The case is not controlled by Gilead, 753 F.3d 1208 (Fed. Cir. 2014), because in Gilead both the patents in issue had been filed post-URAA. Because the asserted patent here was filed pre-URAA, its issue date—not its expiration date—is the appropriate reference point for obviousness-type double patenting.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS-TYPE DOUBLE PATENTING; URUGUAY ROUND AGREEMENTS ACT