Generic Yasmin Lawsuit Appeal Invalidates Bayer Patent

A federal appeals court has invalidated Bayer’s patent for the birth control pill Yasmin, opening the door for Teva Pharmaceuticals to produce the generic version, Ocella, without licensing the drug.

The U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s finding that advances in the use of the progestin drospirenone that led to the creation of Yasmin were too obvious a pharmaceutical development for Bayer to patent.

Yasmin is an oral contraceptive that combines drospirenone with the estrogen component ethinyl estriadol to prohibit ovulation. While many birth control pills use ethinyl estriadol in combination with progestins, Yasmin was the first to use drospirenone.

Yasmin, Ocella and a reformulated version sold as Yaz, which contains slightly less ethinyl estriadol, are the only birth control pills currently available in the United States that contain drospirenone.

Bayer faces a number Yaz and Yasmin injury lawsuits filed by users of the drugs who allege that the use of drospirenone increases the risk of serious and potentially life-threatening injuries, such as heart attacks, strokes, gallbladder disease, deep vein thrombosis and pulmonary embolism.

Drospirenone impacts the body’s normal mechanism of regulating a balance between salt and water, elevating levels of potassium, which is known to cause serious heart problems and other health issues. The Yaz and Yasmin lawsuits allege that Bayer minimized the risk of problems while aggressively marketing the drugs and failed to provide adequate warnings to consumers or the medical community.

In April 2002, the consumer advocacy group Public Citizen listed Yasmin birth control on its list of “Do Not Use” drugs because of the problems caused by drospirenone and the lack of evidence that the drug is any better than older contraceptives that are available.

The generic Yasmin lawsuit centered on a patent dispute over the development of drospirenone particles small enough to be absorbed into the body before stomach acids destroy them. In June 2008, Bayer and Teva Pharmaceutical’s Barr subsidiary reached an agreement where Barr buys a generic version of Yasmin from Bayer and sells it under the Ocella name. The U.S. Court of Appeals ruling clears the way for Teva to sell its generic Yasmin without licensing it from Bayer.

Despite the known Yasmin side effects, the three birth control pills containing drospirenone have become best selling drugs. In 2008, Yaz accounted for 17.7% of the birth control market, with sales of $616 million and Yasmin had 11% of the market with $382 million in sales. Ocella birth control, which was launched in July 2008, generated $170.2 million in sales for that year.