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Procter & Gamble Wins Patent Infringement Lawsuit for Osteoporosis Therapy Actonel
Thursday, May 14, 2009
Cincinnati, OH -- Today, the United States Court of Appeals for the Federal Circuit ruled in favor 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 U.S. to exclusively market the osteoporosis therapy Actonel (risedronate sodium) tablets. Actonel is commercialized 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 U.S. 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 favorable safety profile. We will continue to invest in Actonel and continue to pursue development of future Actonel initiatives in the years to come."
The 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).
Osteoporosis is a silent disease that affects millions of postmenopausal women, making their bones weak and more likely to fracture over time. In fact, in the U.S. today, 8 million women are estimated to already have osteoporosis, and almost 27 million more are estimated to have low bone mass, placing them at increased risk for fracture. Each year the incidence of osteoporosis-related fractures is greater than the incidence of heart attacks, strokes, and breast cancer combined. The good news is that there are prescription medications available that effectively reduce both spinal and non-spinal fracture risk.
About Actonel (risedronate sodium) Tablets
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. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur.
There have been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients treated with bisphosphonates. Most cases were reported in cancer patients receiving intravenous bisphosphonates, but some have been in patients treated orally for osteoporosis. Most cases were reported in patients undergoing dental procedures such as tooth extraction.
Most common adverse reactions reported in >10% of patients treated with Actonel and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.
Please see full prescribing information for Actonel for additional safety information. For a copy of the full prescribing information for Actonel visit the Actonel Web site at www.actonel.com.
About Procter & Gamble
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. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (Euronext: SAN) and in New York (NYSE: SNY) . For more information, visit: www.sanofi-aventis.us or www.sanofi-aventis.com.
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