ANDAs for Generic Yasmin® do not Infringe Bayer Patent

The court granted defendant generic drug manufacturers' motion for judgment on the pleadings that their ANDAs did not infringe the patent-in-suit because the patent did not "claim a use for [plaintiff's name-brand oral contraceptive, Yasmin®] that has been approved by the FDA." While plaintiff's patent claimed "a simultaneous gestagenic, anti-androgenic, and anti-aldosterone effect," FDA approval of plaintiff's drug was for "the prevention of pregnancy in women who elect to use an oral contraceptive." Because defendants' ANDAs sought approval for use as an oral contraceptive and not the use claimed by the patent-in-suit, defendants were entitled to judgment on the pleadings of noninfringement. "Nothing in the proposed labels submitted in connection with Defendants’ ANDA filings indicates that they seek FDA approval to market their generic drugs for the . . . patented use. To the contrary, Defendants’ proposed labeling addresses only an indication for oral contraception."

Bayer Schering Pharma AG et al v. Sandoz, Inc. et al., 1-08-cv-03710 (NYSD September 28, 2010, Memorandum Opinion & Order) (Gardephe, J.)