The Hindu Business Line : Ranbaxy wins process patent verdict on Pfizer drug in Norway

THE patent battle for Pfizer Inc's cholesterol-lowering drug, Lipitor (atorvastatin), took an interesting turn with the Oslo District Court in Norway ruling that Ranbaxy Laboratories Ltd's proposed generic version of the drug did not infringe the key process patent.

The Delhi-based company will, however, appeal against the Court's second ruling, which found that its product would infringe another patent covering a particular intermediate compound.

Mr Malvinder Mohan Singh, President - Pharmaceuticals, Ranbaxy, told Business Line , "I think we have a significant win in the process patent verdict. We will appeal against the second ruling on the intermediary soon. We believe we have a strong case as we have won a favourable decision on a similar patent dispute surrounding the intermediary in Finland."

He said that if Ranbaxy manages to get a favourable verdict on appeal, the company could launch the drug by late 2006 or early 2007. If it lost on appeal, then it would be able to launch in 2009, when the patent for the intermediate compound of the drug expires.

"In the worst case scenario we should be able to launch the atorvastatin product in Norway in 2009 after getting the regulatory approvals," said Mr Singh.

In an official release, Mr Jeffrey B. Kindler, Vice-Chairman and General Counsel, Pfizer, said, "We are pleased with the court's decision, which is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries."

Ranbaxy can appeal the decision, but it will not be able to market a product made using the patented intermediate compounds unless it prevails on appeal, it said.

Ranbaxy has challenged Pfizer's patent for Lipitor in various countries, including the US and the UK. The total market for atorvastatin in Norway is estimated to be $50 million and has been growing at 7.8 per cent. The global sales for Lipitor touched $11 billion in 2004.

Analysts tracking the sector felt that the Norway market is relatively small and, therefore, the upside may not be much.

The shares of Ranbaxy today rose 0.60 per cent to close at Rs 376.10 on the Bombay Stock Exchange.

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