Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc.
By Erica Larson – Edited by Suzanne Van Arsdale
Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc., No. 12-1397 (Fed. Cir. Apr. 16, 2013)
The Court of Appeals for the Federal Circuit reversed the judgment of the Nevada District Court, which ruled that claims 13 and 15 of Bayer Healthcare Pharmaceuticals, Inc. and Bayer Schering Pharma AG (“Bayer”) U.S. Patent RE37,564 were not invalid for obviousness. The patent claimed a combination of synthetic hormones and dosing regimens used by Bayer in the Yaz birth control pill. Three generic manufacturers—Watson Pharmaceuticals, Inc., Sandoz, Inc., and Lupin Ltd.—filed Abbreviated New Drug Applications (“ANDAs”) with the FDA, including Paragraph IV certifications, 21 U.S.C. 355(j)(2)(A)(vii)(IV), asserting that the patent was invalid.
The Federal Circuit held, first, that the patented combinations were obvious in view of prior art: two foreign patent applications and four scholarly articles. Bayer Healthcare Pharm., Inc. at 11. A person of ordinary skill in the art would have been motivated by the knowledge disclosed in the prior art to craft Bayer’s combination and would have had a reasonable expectation of success. Id. at 11–12. Second, the court rejected Bayer’s arguments on secondary indicia of non-obviousness relating to unexpected results, expert skepticism, industry praise, and copying. Id. at 10, 15.
Reuters and Bloomberg put this ruling into context by describing Bayer’s continuing legal troubles with Yasmin, the precursor to Yaz; the company faces thousands of legal claims that Yasmin increases the risk of blood clots. (more…)