Today the United States District Court of Delaware ruled in favor of The Procter & Gamble (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharma. The positive ruling protects P&G's rights in the U.S. to exclusively market the osteoporosis therapy Actonel(R) (risedronate sodium tablets).
On August 13, 2004 P&G filed a patent infringement lawsuit against Teva to enforce P&G's U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking 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. Today's Court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.
"We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G President, Global Health Care. "We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures." Following patents are listed in orange book w.r.t Risedronate tablets
US5583122 (Expiry: DEC 10,2013)- Covers Formulation
US6096342 (Expiry: NOV 22,2011)- Covers Formulation
US6165513 (Expiry: JUN 10,2018)- covers Formulation
Innovator has earlier also sued Teva on infringement of US5994329 (Expiry: Jul 7, 2018)- which covers pharmaceutical kit. The court has decided on 122’ patent infringement. Teva has approved ANDA for Residronate tablets.The Actonel patent life extends through the end of 2013, excluding any potential extensions. The U.S. Food and Drug Administration approved Actonel in 2000 for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures with in a year
On August 13, 2004 P&G filed a patent infringement lawsuit against Teva to enforce P&G's U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking 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. Today's Court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.
"We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G President, Global Health Care. "We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures." Following patents are listed in orange book w.r.t Risedronate tablets
US5583122 (Expiry: DEC 10,2013)- Covers Formulation
US6096342 (Expiry: NOV 22,2011)- Covers Formulation
US6165513 (Expiry: JUN 10,2018)- covers Formulation
Innovator has earlier also sued Teva on infringement of US5994329 (Expiry: Jul 7, 2018)- which covers pharmaceutical kit. The court has decided on 122’ patent infringement. Teva has approved ANDA for Residronate tablets.The Actonel patent life extends through the end of 2013, excluding any potential extensions. The U.S. Food and Drug Administration approved Actonel in 2000 for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures with in a year
