A US court has dismissed a lawsuit filed by Mylan Pharmaceuticals against health regulator USFDA seeking action against Ranbaxy Laboratories' application to sell the generic version of cholesterol drug Lipitor.
US-based Mylan had moved the court, mainly to ensure that it would be able to market Lipitor's generic version.
The District Court of Columbia has dismissed the plea saying that "Mylan's claims are not fit for review for the same reasons it lacks standing its own application has not even been tentatively approved".
When contacted, a Ranbaxy spokesperson said, "a decision has been rendered by the US District Court, and we concur with Judge Boasberg's decision supporting the US Food and Drug Administration".
According to Mylan's petition, the USFDA arbitrarily, unreasonably and unlawfully failed to decide whether it would enforce the terms of Application Integrity Policy (AIP) against the atorvastatin ANDA application submitted by Ranbaxy.
The American entity had also pointed that USFDA found Ranbaxy engaged in a pattern and practice of submitting to FDA drug applications containing false and unreliable data generated from Ranbaxy's Paonta Sahib" in India where it produces generic Lipitor.
Disposing off the petition, the court said that Mylan's own allegations reveal the "speculative and unripe nature of its claim," hinging on the contingency that Ranbaxy's ANDA contains unreliable data.
According to the court, Mylan has also failed to establish that it would suffer great loss if the injunction is not brought against Ranbaxy selling Lipitor's generic version.
"Mylan's speculative claim of potential monetary loss simply does not rise to the level of irreparable harm, sufficient to support a request for exigent equitable relief," the court said.
The patent for Lipitor, held by pharma major Pfizer, is to expire in June this year, following which other companies would be able to market the generic versions, subject to regulatory approvals.
A blockbuster drug, Lipitor had sales of over $7.2 billion for the year ended September, 2010.
"Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan's liking," the court said.
Further, it added that USFDA cannot be compelled to take enforcement action.
