In a breather to Ranbaxy Laboratories, a US court has dismissed the petition by Mylan Inc seeking to block the Indian drug maker's exclusive rights to sell a generic version of blockbuster anti-cholesterol drug Lipitor.
Mylan, in a complaint filed on March 18 in a federal court in Washington, had said it and other generic-drug makers should be allowed to enter the market as soon as Lipitor's patent expires in June. It contended that the United States Food and Drug Administration (USFDA) should take immediate decision on Ranbaxy's application.
The US drug company said in its petition that Ranbaxy was not eligible for marketing exclusivity because of false and unreliable data from its manufacturing site in Paonta Sahib, from where copies of Lipitor would be produced.
The FDA countered that Mylan lacked standing to file the lawsuit, the complaint was premature, and that the agency's enforcement discretion was not reviewable by a court.
Siding with the FDA, US District Judge Mr James Boasberg ruled that drug makers cannot sue over pending applications filed by their competitors. He also said Mylan's lawsuit is premature, since an application from its subsidiary to sell a copy of the cholesterol-lowering drug is still pending. “Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan's liking,” Mr Boasberg said in the ruling.
The ruling comes as a relief to Ranbaxy, which is expecting to earn revenues of over $1.5 billion starting 2011 from this product. Reacting to the US court's verdict a Ranbaxy spokesperson said, “We concur with Judge Boasberg's decision supporting the US Food and Drug Administration.” Despite the favourable ruling, Ranbaxy's share price was down 2.52 per cent at Rs 446. 45 on the Bombay Stock Exchange at close on Tuesday.
Lipitor is Pfizer's product and is world's largest selling drug with global sales of over $10 billion last year. Nearly 50 per cent of the global sales came from the US market alone.
In 2008 Ranbaxy had reached an agreement with Pfizer to sell generic version of the drug in the US market beginning November 30, 2011. Ranbaxy had said it is entitled to 180 days of marketing exclusivity as a reward for agreeing to withdraw all litigation contesting the validity of Pfizer's patents in specified countries, including the US.
Mylan wanted the court to force the FDA to say publicly whether Ranbaxy's application was tainted and therefore the 180-day exclusivity void. If the court had ruled in favour of Mylan then it would have been able to enter the market eleven months ahead. That would have been a blow to Ranbaxy's US strategy where it is already fighting a ban on 30 drugs imposed by the USFDA. But with the court rejecting Mylan's plea, the Indian pharma major can hope to launch its version of Liptior ahead of anyone else if the USFDA approves its application.