US court rules patent for Yasmin is invalid

The US District Court for the District of New Jersey has ruled invalid a Bayer Schering Pharma patent for the oral contraceptive Yasmin (drospirenone/ethinyl estradiol) that was challenged by US generic manufacturer Barr Laboratories. Bayer disagrees with the decision on the drug, which saw full-year 2007 US sales of 321.0 million euros ($487.0 million), and says it is considering its legal options.

The Leverkusen, Germany-based firm is also evaluating the impact of the court's decision on another product in its line of oral contraceptives, Yaz, a low-dose variant of Yasmin, which was approved by the US Food and Drug Administration and launched in 2006 (Marketletter March 27, 2006). Bayer retains marketing exclusivity for Yaz in the USA until March 16, 2009. No generic manufacturer can lawfully market a copy version of the low-dose drug for an oral contraceptive indication until after this date, the company stressed.

Lowers 2008 margin for drug unit