Pfizer wins court challenge on Lipitor

Posted AtMSNBC.com

Pfizer, the world's largest pharmaceutical company, received an important boost on Wednesday when a British court rebuffed a legal challenge by a generic rival to break the patent on its blockbusting heart drug Lipitor.

Judge Nicholas Pumfrey in the High Court in London rejected claims by Ranbaxy of India that its patents on Lipitor were invalid, in a move that protects the Pfizer drug in the UK until 2011, subject to appeals. Hank McKinnell, Pfizer's chairman and chief executive, 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."

The decision - news of which pushed up Pfizer's share price by up to 5 per cent - had been closely watched by investors, at a time when multinational drugs companies are facing growing threats to their sales from the expiry of patents over the coming years.

The pressure has been further inflamed by growing aggression by generic companies in recent years to launch legal challenges to patents long before they expire in an effort to enter the market, forcing down prices and margins.

The London court ruling marked a significant victory after Pfizer lost a similar legal challenge on its drug earlier this year in Austria. It comes ahead of a far more important litigation launched by Ranbaxy on Lipitor in its largest market in the US, where a decision is anticipated by the end of this year.

Lipitor is the world's best-selling prescription drug, with sales estimated to reach $12bn this year, of which the UK represents 7 per cent of the market. It accounts for about one fifth of Pfizer's annual sales, and represented a powerful target for generics companies.

The High Court upheld Pfizer's defence that it held a valid "genus" patent until 2011 on the underlying chemical compound in Lipitor. However, in a partial victory for Ranbaxy and its co-litigation Arrow, the judge ruled that a second Pfizer "species" patent covering the calcium salt for the drug until 2010 was invalid.

Both companies said that they would appeal the judgement.

Pfizer said the UK ruling had no bearing on the forthcoming US judgement, and stressed that it would continue to uphold its Lipitor patents wherever they were challenged.

Lipitor, which was introduced in 1997, reduces cholesterol in the blood, and has been prescribed to 18m patients in the US alone. It is approved for use in more than 70 countries.

October 12, 2005