Bayer Healthcare Pharma, Inc. v. Watson Pharma, Inc.

First introduced in 1960, combined oral contraceptive (COC) “birth control pills,” deliver synthetic hormones that regulate the natural ovarian cycle and prevent pregnancy. Bayer filed an application directed to a low-dose, extended-regimen COC in 1993, which eventually led to the 564 patent. Bayer received final approval to market YAZ in the U.S. in 2006. Defendants filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of YAZ, with certifications asserting that the 564 patent is invalid (21 U.S.C. 355(j)(2)(A)(vii)(IV). Bayer responded with patent infringement actions. The district court entered summary judgment that the patent’s claims are not invalid for obviousness in view of numerous cited prior art references. The Federal Circuit reversed, finding that Bayer did not present evidence that overcomes the plain disclosures and express motivation to combine those disclosures in the prior art. View "Bayer Healthcare Pharma, Inc. v. Watson Pharma, Inc." on Justia Law