United States Court of Appeals for the Federal Circuit ruled in favour of the Procter & Gamble Company (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals USA, Inc. The positive ruling protects P&G's rights in the US to exclusively market the osteoporosis therapy Actonel (risedronate sodium) tablets. Actonel is commercialised through a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis.
On August 13, 2004, P&G filed a patent infringement lawsuit against Teva to enforce P&G's US composition of matter patent for risedronate, the active ingredient in Actonel. Teva sought to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. On February 28, 2008, the Court ruled in favor of P&G, expressly rejecting Teva's validity challenge. Shortly afterwards, Teva filed an appeal of the decision. Oral arguments for the appeal were heard in December, 2008.
"We are very pleased and not surprised that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G president, Global Health Care. "P&G pioneered the use of bisphosphonates in humans almost 30 years ago. We specifically selected Actonel for development versus a stable of many other bisphosphonates because our extensive R&D efforts suggested Actonel had many important, distinguishing characteristics including its potency and favourable safety profile. We will continue to invest in Actonel and continue to pursue development of future Actonel initiatives in the years to come."
TThe Actonel patent life extends through June 2014, including a pediatric extension, which was granted last month. Actonel was approved in 2000 by the U.S. Food and Drug Administration for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral monthly postmenopausal osteoporosis therapy approved to reduce the risk of both spine and non-spine fractures (non-spine fractures were measured as a group, not separately).
Actonel is indicated for the treatment and prevention of osteoporosis in post-menopausal women. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes.
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel (risedronate sodium) tablets, Asacol (mesalamine) delayed-release tablets, Enablex (darifenacin) extended-release tablets, Prilosec OTC, Metamucil, Fibersure, Align, Pepto-Bismol, Vicks, PUR, Crest and Oral-B.