Bayer Schering Pharma v. Barr Labs
By Aaron Dulles – Edited by Evelyn Breithaupt
Bayer Schering Pharma AG and Bayer Healthcare Pharm., Inc. v. Barr Labs., Inc., No. 2008-1282 (Fed. Cir. Aug. 5, 2009)
On August 5, 2009, a Federal Circuit panel affirmed the decision of the District of New Jersey, which had found Bayer’s U.S. Patent No. 6,787,531 (“’531 Patent”) invalid because of obviousness. The ’531 Patent concerns a formulation of the well-known contraceptive drug drospirenone. The patent previously protected Bayer’s formulation of a daily oral contraceptive product, marketed as the drug Yasmin. When Barr Labs sought approval from the FDA to market a generic version of Yasmin, Bayer filed a patent infringement suit. The district court found that under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the formulation of drospirenone in the Yasmin product was obvious. The sole issue of appeal was obviousness, and by a 2-1 vote the Federal Circuit affirmed the district court’s decision.
Passino PLLC suggests that the majority’s application of the In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) standards was too rigid, and thus appeared to go against warnings in KSR concerning rigid application of tests. Patent Docs agreed, asserting that the judges both at the trial and appellate levels disregarded important evidence and emphasizing that the “common sense” of obviousness is that of the practitioner, not the judge. AboutLawSuits.com noted the ruling, but focused on known potential negative side effects of the drospirenone-based contraceptives such as Yasmin. (more…)