The United States District Court of Delaware 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).
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 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."
The Actonel patent life extends through the end of 2013, excluding any potential extensions. Actonel was approved in 2000 by the US Food and Drug Administration 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 in just one year.
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 vertebral and nonvertebral fracture risk.
Actonel (risedronate sodium tablets) is indicated for the treatment and prevention of osteoporosis in post-menopausal women. In clinical trials, Actonel was generally well tolerated. 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 may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint and/or muscle pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients receiving bisphosphonates. Most ONJ cases have occurred in cancer patients undergoing dental procedures. In the majority of cases reported, patients had received intravenous bisphosphonate therapy.
In clinical trials of up to 3-years duration, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).
In a clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).
In a clinical trial comparing Actonel 75 mg two consecutive days/month and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were arthralgia (Actonel 75 mg 10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain (8.8% vs 10.8%).