Patents listed in FDA's Orange Book for Eli Lilly’s Evista invalidated

Sep 24 2009

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDA’s Orange Book for Eli Lilly’s Evista® (raloxifene hydrochloride) Tablets in litigation concerning Teva’s abbreviated new drug application to market a generic version. The court found these patents to be invalid for lack of written description.

In the same opinion, the Court rejected Teva’s challenges to four earlier expiring patents, which claim the use of raloxifene for the prevention or treatment of osteoporosis and the dosages of raloxifene for such treatment, and found that Teva’s generic raloxifene tablets infringe those other patents. Based on this ruling, the Court enjoined Teva from commencing the commercial launch of generic raloxifene hydrochloride tablets prior to the expiration date of those patents.

Teva plans to appeal the decision, which if affirmed, would prevent Teva from launching its product until March 2, 2014.