NEW YORK - Pfizer Inc. won a crucial court ruling Friday that will allow it to exclusively sell the top-selling drug worldwide, the cholesterol-lowering drug Lipitor, until 2011. Shares of Pfizer, the world's largest drug company, soared more than 11 percent on the news.
District Judge Joseph J. Farnan Jr. ruled in Delaware federal court that Indian pharmaceutical company Ranbaxy Laboratories Ltd.'s generic version of Lipitor infringes on two Pfizer patents. He said the New Delhi-based company failed to prove Pfizer's patents were invalid or unenforceable.
The ruling heads off the chance that Ranbaxy will be able to launch a cheaper version of Lipitor before Pfizer's patents expire in 2010 and 2011.
Lipitor was introduced in the United States in 1997 and its sales totaled $10.9 billion last year in the United States and more than 70 other countries.
More than 18 million Americans have been prescribed the drug as a means of reducing elevated levels of cholesterol in the blood that can lead to heart attacks, strokes and other cardiovascular ailments.
The ruling is "a victory for innovation" and good for patients, said Jeffery B. Kindler, vice chairman and general counsel of New York-based Pfizer. The company said it spent more than $800 million on clinical trials alone for Lipitor involving more than 80,000 patients. It needs the benefit of patent-protected sales of its medicines to fund the research needed to find other new and promising drugs, Kindler said.
Pfizer sued Ranbaxy after the Indian drugmaker applied to make its own version of Lipitor, a compound of the atorbvastatin calcium pharmaceutical composition. Ranbaxy's defense was that its generic version wasn't covered by Pfizer's Lipitor patents, or that the patents themselves were invalid.
Malvinder M. Singh, Ranbaxy's president and executive director, promised to continue the legal fight at the U.S. appeals court level. "We remain undeterred in our resolve on this issue," he said in a statement. "We are committed to bringing lower cost, reliable medicines to health care systems, worldwide."
Friday's ruling was Pfizer's second major victory over Ranbaxy. In October, British Judge Nicholas Pumfrey upheld the patent covering atorvastatin, Lipitor's active ingredient, in the United Kingdom through November 2011, though it did rule for Ranbaxy on a secondary patent challenge.
In the Delaware court case, Ranbaxy accused Pfizer of hoodwinking the U.S. Patent and Trademark Office with tailored versions of test results. Farnan, however, found Ranbaxy's proof of the claim wanting.
"Pfizer has advanced reasonable and credible grounds for the non-production of certain data that weigh against a conclusion that … scientists and employees were intentionally deceiving the PTO," he wrote.
Judge Farnan upheld Lipitor's basic patent, which expires in March 2010, and one covering the formulation of the calcium salt of Lipitor that runs through June 2011.
Pfizer's shares fell 21 cents to $22.58 in regular trading Friday on the New York Stock Exchange. After news of the court ruling circulated late in the day, the shares jumped $2.56, or 11.3 percent, to $25.14 in after hours trading.