Bayer Schering et al. v. Lupin Ltd. et al.

Docket No. 2011-1143, -1228

April 16, 2012

Subject matter: ANDA, generics

Brief Summary: An ANDA may not infringe an Orange Book method of use patent where the claims do not exactly track the use approved by the FDA.

Summary: Bayer appealed from two USDC SD NY dismissals against Watson et al. and Lupin et al. regarding the oral contraceptive product Yasmin®. Bayer’s Orange Book patent (US 5,569,652) encompasses “[a] method of simultaneously achieving, during premenopause or menopause a gestagenic effect, antiandrogenic effect, and an antialdosterone efffect”. The ANDAs were filed for the use of Yasmin® as an oral contraceptive (tracking the original NDA). The DC concluded that the FDA did not approve Yasmin® for contraception alone and, therefore, the ‘652 patent was not infringed. Bayer, however, argued that the FDA did approve the use of Yasmin® to obtain all three effects simultaneously, pointing to the pharmacodynamics section of the label which mentions potential anti-mineralocorticoid and anti-androgenic activity. Relying in part on AstraZeneca (FC 2010 (proposed label that removes or “carves out” the claimed method of use) and Warner Lambert (FC 2003 (“because an ANDA may not seek approval for an unapproved or off-label use of a drug under 21 U.S.C. § 355(j)(2)(A)(i), it necessarily follows that 35 U.S.C. 271(e)(2)(A) does not apply to a use patent claiming only such a use”), the majority concluded that the label does not “recommend[] or suggest[] to physicians that the drug is safe and effective for administration to patients for the purposes of inducing these effects” (e.g., such use would be “off label”). And the panel was not persuaded by expert testimony from a physician or a former FDA official who oversaw the approval of Yasmin®. Judge Newman’s dissent argued that the majority was incorrect because “the portion of the FDA label in which a product’s properties are described is irrelevant to whether the patent is infringed by sale or use of the product” (“infringement inquiry is whether the generic counterpart, when used in accordance with its proposed ANDA authorization, would infringe the patent”) and that Bayer “sufficiently alleged that an ‘intended use’ for Yasmin®, as approved by the FDA, is the simultaneous treatment of all three effects” (“the three properties recited in the patent claim are coextensive with the FDA-approved label”).

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