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Ranbaxy loses Lipitor case — US court favours Pfizer on `patent infringement'

Our Bureau

New Delhi , Dec. 17

IN yet another setback to Ranbaxy Laboratories Ltd, the US District Court of Delaware ruled that the generic company's product infringes the two patents covering Pfizer Inc's cholesterol lowering drug, Lipitor. This follows a ruling in October by a UK High Court delaying an early launch of atorvastatin (generic) in that market.

Mr Justice Joseph J. Farnan of the US District Court ruled that Ranbaxy's atorvastatin infringes US company Pfizer's patent covering the main molecule and also upheld the validity of the patent covering the calcium salt of Lipitor, which Ranbaxy had claimed was invalid. The main patent covering Lipitor expires in March 2010, while the patent covering the calcium salt of the drug expires in June 2011.

To appeal: Ranbaxy has decided to appeal against the decision and will be beginning the process immediately. In a statement, Mr Malvinder Mohan Singh, President and Executive Director of Ranbaxy, said, "We remain undeterred in our resolve on this issue, and we will press our case in the US Court of Appeals for the Federal Circuit. We are committed to bringing lower cost, reliable medicines to healthcare systems, worldwide."

According to the US company, "Pfizer will be entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for or marketing its generic version of atorvastatin until 2011. The injunction against Ranbaxy will remain in place during the appeals process."

Defending jurisdiction: The Pfizer Chairman and Chief Executive Officer, Mr Hank McKinnell, said, "Together with the decision in October by the UK High Court of Justice, we have now successfully defended our Lipitor patent rights in two important jurisdictions. We will continue to defend against any and all patent challenges that seek to undermine our mission of finding new therapeutic innovations for the patients we serve."

This is the second major market where Ranbaxy has not been able to get a favourable court ruling. It has been using legal challenges to overturn Pfizer's atorvastatin patents in the US and many other markets.

In October this year, the UK High Court of Justice upheld the exclusivity of the basic patent covering atorvastatin, which will prohibit Ranbaxy from introducing a generic version of the drug in the UK until the patent expires in November 2011. The British court ruled that the calcium salt patent, which expires in the UK in 2010, was invalid. Both the companies have stated that they would file appeals at a higher court.

Winning patent challenges difficult: Analysts tracking the sector said that it would be increasingly difficult for generic companies such as Ranbaxy to win patent challenges in the US.

"The decision on Lipitor is a huge setback for Ranbaxy as it will not be able to launch the generic version of the drug early. This is indicative that going forward patent challenge battles against the US companies are only going to be tougher," said an analyst.

The market for Lipitor globally is estimated at $10 billion with the US markets accounting for over 70 per cent share.

Ranbaxy has seen a steady increase in share price this week, from Rs 383.60 on December 12 to Rs 390.25 on December 16.

The stock, however, is trading considerably lower than its 52-week high of Rs 1,300.

Related Stories:
Ranbaxy wins process patent verdict on Pfizer drug in Norway
UK court restricts launch of Ranbaxy's cholesterol drug — Pfizer says ruling will protect UK turf from generic competition

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