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news.The UK's High Court of Justice has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in Pfizer's blockbuster cholesterol drug Lipitor until November 2011.
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The ruling is the result of a lawsuit brought by the generic manufacturer Ranbaxy, which challenged two patents protecting Lipitor. The court ruled that a Ranbaxy generic would infringe on Pfizer’s basic Lipitor patent.
If upheld on appeal, this will prohibit Ranbaxy from introducing a generic version of atorvastatin in the UK before the expiration of the patent in November 2011. However, Pfizer is yet to secure a similar ruling that would protect its exclusivity on Lipitor in the US, the world’s biggest pharmaceutical market.
“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 CEO Hank McKinnell. “This court decision is consistent with the fundamental principle that patent laws exist to support and encourage medical innovators, not undermine them.”
The court ruled that a second patent covering the calcium salt of atorvastatin is invalid. Arrow Generics joined Ranbaxy in the lawsuit on this patent. Pfizer said that it will appeal the decision on this patent, which expires in July 2010.
Since Lipitor was introduced in the US in 1997, it has become the world’s most prescribed cholesterol-lowering therapy, earning revenues of nearly $11 billion last year. More than 18 million people in the US have been prescribed Lipitor for lowering their cholesterol, and it is approved in more than 70 countries.
Most recently, the FDA approved a new indication for Lipitor for the millions of people who suffer from diabetes.