Generic Yasmin Lawsuit Over Patent Infringement Dismissed

A federal judge has rejected a patent lawsuit filed by Bayer Healthcare Pharmaceuticals against Watson Pharmaceuticals and Sandoz, a subsidiary of Novartis AG, which alleged that a recently approved generic version of Yasmin birth control infringed on Bayer patents.  

The lawsuit was dismissed late Tuesday by a judge in the U.S. District Court for the Southern District of New York, who ruled that Bayer’s patent fails to include an FDA-approved use for Yasmin.

Earlier this month, the FDA granted Watson approval for an Abbreviated New Drug Application (ANDA) for Zarah, which is the generic Yasmin equivalent. Bayer attempted to prevent Watson from filing the request, but a court denied that motion.

Bayer is currently involved in a similar lawsuit over generic Yaz, which is a lower dose version of the Yasmin birth control pill. Earlier this summer, Teva Pharmaceuticals introduced Gianvi, a Yaz generic version, which Bayer alleges violated an agreement between the two companies, as well as patent protections that should have prevented the introduction of a generic Yaz until 2014.

Yaz and Yasmin both contain a new “fourth generation” progestin, known as drospirenone, which is unique to these birth control pills and their generic equivalents. However, drospirenone has been cited as the likely cause of an increased risk of health problems from Yaz and Yasmin, such as strokes, heart attacks, pulmonary embolism, deep vein thrombosis, gallbladder disease and other potentially life-threatening injuries.

Thousands of women have already filed a Yaz birth control lawsuit or Yasmin birth control lawsuit against Bayer alleging that the drug maker failed to provide adequate warnings about the risk of side effects associated with the products. Since the label for Watson’s generic Yasmin will contain the same warnings as the name brand medication, the generic drug maker is likely to see a number of Zarah lawsuits filed if otherwise healthy women suffer injuries due to the inadequate warnings.

All federal Yasmin and Yaz litigation has been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), under Chief Judge David Herndon in the U.S. District Court for the Southern District of Illinois. It is likely that the generic Yasmin lawsuits would also be centralized as part of the same MDL.