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Lipitor Free from Generic Competition Until 2011
World's most popular drug wins U.S. suit against
generic drug maker
Dec. 18, 2005 The most prescribed
cholesterol-lowering medication in the U.S., Lipitor, is now protected
from competition by a generic version until June 2011, according to an
announcement by Pfizer Inc, the company that holds the U.S. patents
covering atorvastatin, the active ingredient in Lipitor. Pfizer filed
suit against Ranbaxy Laboratories Limited that has developed a generic
version. Ranbaxy said it plans to begin the appeals process immediately.
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12/10/04*
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Judge Joseph J. Farnan held that Ranbaxy's
atorvastatin infringes Pfizer's U.S. Patent No. 4,681,893, and at the
same time upheld the validity of another, Pfizer U.S. Patent No.
5,273,995 which Ranbaxy had claimed was invalid.
The ruling followed a hearing in the U.S. District
Court of Delaware, which took place in December 2004.
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. Many say it is the largest selling drug in the world.
"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," said the
Pfizer news release.
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.
As a result of the decision, Pfizer says it 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."
Commenting on the decision, Malvinder M. Singh,
President and Executive Director of Ranbaxy, said, We remain undeterred
in our resolve on this issue, and we will press our case in the U.S.
Court of Appeals for the Federal Circuit. We are committed to bringing
lower cost, reliable medicines to healthcare systems, worldwide.
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."
Information Sources:
Pfizer Inc. - Web site:
http://www.pfizer.com/
Ranbaxy Laboratories Limited is headquartered in
India Web site:
http://www.ranbaxy.com/.
Note: Earlier this month Ranbaxy said "that if
called upon by the U.S. Government or by the innovator, Roche, the
Ranbaxy global organization is well prepared to provide oseltamivir
phosphate capsules (generic version of Tamifluฎ) to the U.S. healthcare
system to meet the threat of the Avian flu, that has now become a global
concern.
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