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CEO McKinnell: A Major Victory for Medical Innovators and the Patients Who
Depend on Them
NEW YORK, Dec. 16 /PRNewswire-FirstCall/ -- Pfizer Inc said today that a
federal court in Delaware has determined that two Pfizer U.S. patents covering
atorvastatin, the active ingredient in Lipitor, are both valid and are both
infringed by a generic manufacturers product, thus protecting Lipitors
exclusivity until June 2011.
Judge Joseph J. Farnan of the United States District Court for the
District of Delaware ruled in Pfizers 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 the decision in October by
the United Kingdoms 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 Pfizers second major victory over Ranbaxy, which
is using legal challenges in an attempt to overturn Pfizers atorvastatin
patents in the U.S. and many other markets. On October 12, the United
Kingdoms 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 Lipitors 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 Lipitors introduction in the U.S. in 1997, it has become the
worlds 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.
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