Bayer Sues Watson Over Generic Yaz Application

In response to Watson Pharmaceuticals submitting an abbreviated new drug application (ANDA) for a generic version of Yaz, Bayer HealthCare Pharmaceuticals sued the company in the U.S. District Court for the District of Nevada.

Yaz (drospirenone/ethinyl estradiol) is an oral contraceptive that was approved in 2006.

In its Nov. 5 complaint, Bayer noted that Watson’s ANDA contained Paragraph IV certifications for the ’564, ’838 and ’531 patents. The ’564 and ’838 reissue patents expire in 2014, and the ’531 patent expires in 2020. The patents cover the composition of Yaz and its use as a contraceptive.

Bayer claims Watson’s application constitutes an act of infringement, and its product, if approved, would infringe on Bayer’s patents.

The company asked the court to issue a permanent injunction preventing Watson from marketing its product until after the patents and exclusivity expire. Bayer said it is entitled to triple damages if Watson commercializes its product before then.