Pfizer Inc., the world’s largest drugmaker, settled a patent-infringement lawsuit with the Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. over the cholesterol treatment Lipitor. The terms weren’t disclosed.
Pfizer, based in New York, sued Dr. Reddy’s in December 2009 to block generic copies of Lipitor from coming out before Pfizer’s patent for the tablets expires in 2017. The companies settled on Aug. 19, and U.S. District Judge Leonard P. Stark in Wilmington, Delaware, dismissed the case Aug. 29, according to court records.
“We have closed our litigation with Pfizer, but the date of entry into the market is not yet confirmed,” Kedar Upadhye, a spokesman for Dr. Reddy’s, said in a statement.
Dr. Reddy’s, of Hyderabad, India, announced the settlement today in a statement. The agreement is subject to review by the U.S. Justice Department and the Federal Trade Commission, the company said.
“We can confirm that we have reached an agreement with Dr. Reddy’s regarding a patent case involving Lipitor,” Christopher Loder, a Pfizer spokesman, said in an e-mailed statement. “Terms of the agreement are confidential.”
Teva Pharmaceutical Industries Ltd. and Mylan Inc. also have reached settlements with Pfizer to sell generic forms of Lipitor, known chemically as atorvastatin.
Ranbaxy Laboratories Ltd., the first company to seek regulatory approval for its version, had planned to enter the market on Nov. 30 -- with Teva, Mylan and other generic makers beginning sales six months later as part of its deal with Pfizer. A U.S. Food and Drug Administration investigation into quality standards at two Ranbaxy plans and a federal probe of its testing practices have delayed approval.
Analysts including Edward J. Kelly of Credit Suisse AG have said that Ranbaxy may have to sell its rights to be the only approved generic on the market if it can’t pass regulatory muster by November.
Watson Pharmaceuticals Inc. has a separate agreement with Pfizer that would let it sell Lipitor without the brand label as a so-called authorized generic beginning Nov. 30. The Watson-sold drug doesn’t require FDA approval and wouldn’t be affected by the Ranbaxy deal.
The case is Pfizer v. Dr. Reddy’s, 1:09-cv-00943, U.S. District Court, District of Delaware (Wilmington).
To see the patent, click: 5,969,156.
-- With assistance from Adi Narayan in Mumbai, Susan Decker in Washington and Catherine Larkin in Indianapolis. Editors: Charles Carter, Glenn Holdcraft