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UK court restricts launch of Ranbaxy's cholesterol drug — Pfizer says ruling will protect UK turf from generic competition

Our Bureau

New Delhi , Oct. 12

THE United Kingdom High Court of Justice today restricted Ranbaxy Laboratories Ltd from launching early its generic version of Pfizer's cholesterol reducing drug, Lipitor, in the UK.

The court upheld the exclusivity of the main patent covering the active ingredient of the drug until November 2011. It also ruled invalid another patent, which covers the calcium salt of atorvastatin.

While for Pfizer, this victory would offer protection to its $12-billion drug (global sales) in the UK market from competition by generic companies, for Ranbaxy this would delay the launch of its version of the drug. Winning the challenge would have allowed Ranbaxy to begin sales of its version of Lipitor in 2006.

In an official statement, Ranbaxy said it would appeal against the decision. "Mr Justice Pumfrey ruled that one of Pfizer's patents is invalid but that Ranbaxy's atorvastatin (active ingredient) product infringed another patent. Mr Andrew Waugh QC, will represent the company on the appeal," it said.

"This is an important victory not only for Pfizer but for all innovators pursuing high-risk medical discoveries that benefit current and future generations of patients around the world," said Pfizer Chairman and Chief Executive Officer, Mr Hank McKinnell, in a communiqué posted on the company Web site.

He further added that Pfizer would appeal against the court's decision on the patent covering the calcium salt of atorvastatin, which expires in July 2010.

Meanwhile, in the US too a trial of issues similar to those heard in the UK took place in December 2004. A Delaware federal court is expected to release a ruling before the end of this year.

Analysts and investors, both in India and the US, have closely watched the litigation viewed by some as a prelude to the far more important patent battle in the US market. Pfizer however maintained that the Court's decision was based entirely on British law and had no bearing on Lipitor patent litigation between Pfizer and Ranbaxy in the US or other countries.

Analysts felt the development could act as deterrent for Indian companies fighting patent battles. "This just goes to show the high-risk nature of the pharma business," said an analyst. Last year, Dr Reddy's Laboratories was restrained from selling its version of Pfizer's hypertension drug, amlodipine maleate, in the US.

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