The petition of Ranbaxy Laboratories Ltd., generic drug maker and India's largest pharma company by sales, has been denied a hearing by the US Court of Appeals in the ongoing Lipitor patent litigation.
This implies that the Indian player will have to either go to the US Supreme Court or wait till 2010 to launch the cholesterol-lowering drug atorvastatin, sold by the innovator Pfizer as 'Lipitor'.
The patent challenge on the world's largest prescription drug has become a prototype of conflict between innovator pharma and the generic challengers.
The petition was against an August 2 decision this year, in which Ranbaxy had won the fringe patent covering the calcium salt of atorvastatin - the generic version of Lipitor which clocked $ 8.5 billion US sales last year - but lost the main patent which was expiring in March 2010.
However, as the invalidated fringe patent was running till June 2011, the windfall gain - of $1-1.5 billion, claim analysts - for Ranbaxy is the preponement of the launch of the drug by 15 months.
"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, senior vice president & associate general counsel, Pfizer in a release on the Pfizer website.
The US innovator was planning to go back to the US Patent office to seek correction of the technical defect in the fringe second patent that had been ruled invalid by the court on technical grounds, the release added. It was decision on this patent that Ranbaxy was counting on for the preponed launch.
A Ranbaxy spokesperson, while declining to comment if the company will move the US Supreme Court, said, "This isn't a setback as it doesn't change our position at all as we'll get to launch the drug a year sooner."
Ranbaxy's managing director & chief executive officer, Malvinder M Singh could not be reached for comments.
Ranbaxy had challenged Pfizer's patent on atorvastatin in 17 countries including US, UK, Canada, Australia, Germany, Austria, Belgium, Italy, Spain, Romania and Norway.
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