Procter & Gamble (CINCINNATI, Ohio) announced that the US District Court of Delaware ruled in its favor in the patent infringement lawsuit the company filed against Teva Pharmaceuticals USA, Inc. Teva had submitted an Abbreviated New Drug Application (ANDA) to the US FDA to market a generic version of P&Gs Actonel^® (risedronate sodium tablets). The positive ruling protects P&Gs’ rights in the US to exclusively market the osteoporosis therapy. Teva intends to appeal the decision.

In August 2004, P&G filed a patent infringement lawsuit against Teva to enforce its US composition of matter patent (US Patent No. 5,538,122) for risedronate, the active ingredient in Actonel. Teva was seeking to market a 5mg, 30mg, and 35mg generic version of the drug in the US under the assertion that the Actonel patent was not valid due to obviousness of the invention. The court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.

The Actonel patent life extends through the end of 2013, excluding any potential extensions. The drug was FDA approved in 2000 for the prevention and treatment of osteoporosis in postmenopausal women; it is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures in just 1 year.