Pfizer Prevails in Challenge to Basic Lipitor Patent in British High Court
Lipitor Protected from Generic Competition in United Kingdom until 2011
CEO McKinnell: ’An Important Victory for All Innovators Pursuing High-Risk Medical Discoveries That Benefit Current and Future Generations of Patients’
NEW YORK, October 12 -- Pfizer Inc said today the United Kingdom’s High Court of Justice has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in Lipitor, until November 2011.
“This is an important victory not only for Pfizer but for all innovators pursuing high-risk medical discoveries that benefit current and future generations of patients around the world,” said Pfizer Chairman and Chief Executive Officer Hank McKinnell.
“Lipitor is one of the most important medical breakthroughs of our era, and millions of patients have used it to lower their cholesterol. Recently, Lipitor has been approved in the United States to reduce the risk of stroke and heart attacks in a broad range of patients,” McKinnell said. “This court decision is consistent with the fundamental principle that patent laws exist to support and encourage medical innovators, not undermine them.”
The ruling is the result of a lawsuit brought by the generic manufacturer Ranbaxy Ltd., which challenged two patents protecting Lipitor. The court ruled that a Ranbaxy generic would infringe on Pfizer’s basic Lipitor patent (EP 247,633). If upheld on appeal, this will prohibit Ranbaxy from introducing a generic version of atorvastatin in the United Kingdom before the expiration of that patent in November 2011.
The court ruled that a second patent covering the calcium salt of atorvastatin (EP 409,281) is invalid. Arrow Generics Ltd. joined Ranbaxy in the lawsuit on this patent. Pfizer said that it will appeal the decision on this patent, which expires in July 2010.
The court’s decision was based entirely on British law and has no bearing on Lipitor patent litigation between Pfizer and Ranbaxy in the United States or other countries. Pfizer said it will continue vigorously to defend its Lipitor patents wherever they are challenged.
Jeffrey B. Kindler, vice chairman and general counsel for Pfizer, said, "For nearly a decade, Pfizer has invested $800 million in high-risk research to better understand the safety, efficacy and potential additional benefits of Lipitor. This includes one of the most extensive clinical trials program in history, involving more than 80,000 patients worldwide. This important clinical information has enhanced our understanding of cholesterol management and helped physicians better treat their patients.
"Our 12,000 scientists work to discover and develop new medicines, while in marked contrast, Ranbaxy and other generic companies invest in aggressive legal tactics. While Pfizer makes significant investments in research and development, generic companies focus on finding loopholes in patents that protect our innovations and those of other biomedical research companies.
“Ironically, many of these generic companies take advantage of the lack of adequate protection of intellectual property in their own markets to manufacture copycat versions of our medicines without any risk,” Kindler said.
Since Lipitor was introduced in the United States in 1997, it has become the world’s most prescribed cholesterol-lowering therapy. More than 18 million people in the United States have been prescribed Lipitor for lowering their cholesterol, and it is approved in more than 70 countries. Clinical research has also shown that Lipitor provides unique benefits that go beyond LDL cholesterol reduction, such as reducing cardiovascular events and halting the progression of atherosclerosis, or hardening of the arteries. Most recently, the U.S. Food and Drug Administration approved a new indication for Lipitor for the millions of people who suffer from diabetes.
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