Bayer Healthcare Pharmaceuticals, Inc. et al. v. Watson Pharmaceuticals, Inc. et al.

Docket No. 2012-1397, -1398, -1400

April 16, 2013

Brief summary: Bayer’s claims relating to its contraceptive product YAZ® were found invalid for obviousness in view of several prior art references.

Summary: Defendants appealed DC entry of SJ that Bayer’s patents directed to its combined oral contraceptive (“COC”); low dose progestin and estrogen (brand name YAZ®) was not invalid for obviousness. Prior COCs included a 7-day drug free time period but Bayer’s patent encompass combinastions of “23 or 24 daily dosage units” and “5 or 4, respectively, active ingredient-free placebo pills”. SJ rulings are reviewed without deference and turn on “whether there are any genuine issues of material fact…viewing the evidence in the light most favorable to the nonmoving party” (Dealertrack, FC 2012). The defendants alleged obviousness in view of six prior art references. It was alleged that the references described 23/5 or 24/4 dosing regimens and the motivation to combine those with low-dose COCs in one of the references. The FC agreed, finding the only question to be “whether a person of ordinary skill in the art would have been motivated to combine those teachings to derive the claimed subject matter with a reasonable expectation of success” (Unigene, FC 2011 (“Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination. Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements”)). The panel also found that one of references “expressly propose[d] the claimed solution” (noting, however, that under KSR “any need or problem known in the field of endeavor at the time of the invention and addressed by the patent can provide a reason for combining the elements in the manner claimed”). Bayer’s arguments that the references addressed a different patient population were not accepted becuase “the product claims at issue do not distinguish between target patient populations”. Bayer’s teaching away arguments were also rejected because “a finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed…is the preferred, or most desirable, combination” (In re Fulton, FC 2004). And, finally, Bayer’s evidence regarding secondary considerations (FDA request for clinical data, “”bare journal citations and self-referential commendation”, copying in the ANDA context) was not persuasive. Thus, the disputed claims were found obvious and the DC judgment reversed.

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