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news.The US Patent and Trademark Office is to confirm the validity of Pfizer's US patent covering the crystalline form of atorvastatin calcium used as the active ingredient in the cholesterol-lowering medicine Lipitor.
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The patent office undertook a review of the patent in response to a legal challenge to the crystalline form patent for atorvastatin which expires in 2017.
The patent office decision regarding the crystalline form of atorvastatin calcium used in Lipitor is separate from the ongoing patent litigation with Ranbaxy in the US, which involves the basic and enantiomer patents that provide market exclusivity for Lipitor through March 2010 and June 2011, respectively.
Since its introduction in the US in 1997, Lipitor has become the world’s most prescribed cholesterol-lowering therapy. 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.
“We are pleased that the patent office agreed with our arguments in this case which further confirms the strong patent position surrounding Lipitor,” said Jeffrey Kindler, vice chairman and general counsel of Pfizer. “We see this decision as affirming that important advances in medical innovation like Lipitor deserve strong patent protection under our laws.”