BY OUR CORRESPONDENT
28 October,2006: India’s top drug maker Ranbaxy may seek review of the Court of Appeals decision upholding the exclusivity of Pfizer’s main patent covering atorvastatin, by the US Supreme Court.
Pfizer Inc has announced that the Court of Appeals for the Federal Circuit has denied Ranbaxy's petition for rehearing of an August 2 decision upholding the exclusivity of the patent which pertains to the active ingredient in Lipitor. That patent expires in March 2010.
The issues in this case were straightforward, the lower court's decision was consistent with prior law, and it raised no matters of exceptional importance requiring that they be revisited again, said Peter Richardson, Pfizer's senior vice president and associate general counsel.
In August this year, a panel of the Court of Appeals for the Federal Circuit ruled in a lawsuit brought by Pfizer against the generic manufacturer Ranbaxy Ltd that Ranbaxy's generic atorvastatin product would infringe the company's basic patent (U.S. 4,681,893) broadly covering atorvastatin. It upheld the exclusivity of the main patent covering atorvastatin, until March 2010.
The Appeals Court also ruled that a second patent (U.S. 5,273,995) at issue in the lawsuit covering the calcium salt of atorvastatin is invalid on technical grounds. That patent would have expired in June 2011.
The decision turned on a technical defect in the patent. There is a process for correcting such defects in the U.S. Patent and Trademark Office, and Pfizer plans to pursue that option.
"Pfizer now plans to go back to the US Patent office to seek to correct a technical defect in a second patent covering the calcium salt of atorvastatin,’’ Mr Richardson said.
In a similar case, the Austrian Patent Office has ruled that a claim in the company's basic patent covering the use of atorvastatin as valid, earlier this month. Lipitor is sold in Austria under the brand name Sortis.
The decision will allow Pfizer to take further legal action to prevent Ranbaxy from launching a competitor product before the expiration of Lipitor's basic patent on November 7, 2011.
Pfizer said it will continue to vigorously contest challenges to its Lipitor patents around the world.
BY OUR PHARMA CORRESPONDENT