NEW YORK, Dec. 16 /PRNewswire-FirstCall/ -- Pfizer Inc said today that a federal court in Delaware has upheld the exclusivity of two U.S. patents covering atorvastatin, the active ingredient in Lipitor, prohibiting generic competition until June 2011.
Judge Joseph J. Farnan of the United States District Court for the District of Delaware ruled in Pfizer’s favor in a lawsuit brought by Pfizer against the generic manufacturer Ranbaxy Ltd. As a result of the decision, Pfizer will be entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for or marketing its generic version of atorvastatin until 2011. The injunction against Ranbaxy will remain in place during the appeals process.
“Today marks a major victory for medical innovators and the patients who depend on them for important new therapies,” said Pfizer Chairman and Chief Executive Officer Hank McKinnell. “Together with last month’s decision by the United Kingdom’s High Court of Justice, we have now successfully defended our Lipitor patent rights in two important jurisdictions. We will continue to defend against any and all patent challenges that seek to undermine our mission of finding new therapeutic innovations for the patients we serve.”
The U.S. decision marks Pfizer’s second major victory over Ranbaxy, which is using legal challenges in an attempt to overturn Pfizer’s atorvastatin patents in the U.S. and many other markets. On October 12, the United Kingdom’s High Court of Justice upheld the exclusivity of the basic patent covering atorvastatin, which will prohibit Ranbaxy from introducing a generic version of atorvastatin in the United Kingdom until the patent expires in November 2011. The British court ruled that the calcium salt patent, which expires in the United Kingdom in 2010, was invalid. Pfizer has stated it would appeal this decision, which has no bearing on rulings in other jurisdictions.
The patents at issue in the U.S. lawsuit are Lipitor’s basic patent (U.S. Patent No. 4,681,893), which expires in March 2010 and the patent covering the calcium salt of Lipitor (U.S. Patent No. 5,273,995), which expires in June 2011.
Jeffery B. Kindler, vice chairman and general counsel of Pfizer, said, “We are gratified that the court has affirmed the validity of our Lipitor patents. Lipitor is supported by an unprecedented clinical trials program that has involved more than 80,000 patients and a research investment of more than $800 million to better understand the safety, efficacy and potential additional benefits of Lipitor. No generic company would make this commitment, and research-based companies would have no incentive to pursue this work without a stable patent system.”
Since Lipitor’s introduction in the U.S. in 1997, it has become the world’s most-prescribed cholesterol-lowering medication. More than 18 million people in the U.S. have been prescribed Lipitor to lower their cholesterol, and the medicine is approved in more than 70 countries. Numerous clinical trials have demonstrated that Lipitor has a major impact on preventing cardiovascular events in a broad range of patients at risk for cardiovascular disease. Recently, the U.S. Food and Drug Administration approved a new indication for Lipitor to reduce the risk of stroke, including in the millions of people who suffer from diabetes.
Source: Pfizer Inc
