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Pfizer wins UK Lipitor court battle

Published on 14/10/05 at 11:35am

Pfizer has won an important legal battle to maintain its UK patent on best-selling cholesterol drug Lipitor.

The UK High Court ruling secures the main patent on Lipitor's active ingredient (atorvastatin) until November 2011 and protects Pfizer revenues, expected to exceed 400 million pounds in England this year.

Indian generics company Ranbaxy failed in its challenge to Lipitor's main patent, but teamed up with another company, Arrow Generics, and succeeded in overturning a secondary patent on the calcium salt of atorvastatin.

Pfizer and its opponents have all pledged to appeal the decisions that went against them, but most analysts believe the case has secured Pfizer's exclusivity on the drug.

"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's chief executive Hank McKinnell.

He said Lipitor was one of the most important medical breakthroughs of our era and pointed to its continuing expansion in patients treated and new licences for prevention of heart disease and stroke.

"This court decision is consistent with the fundamental principle that patent laws exists to support and encourage medical innovators, not undermine them," he added.

Ranbaxy is also challenging the Lipitor patent in the US, where Pfizer earned $6.6 billion from the drug in 2004, the lion's share of the drug's global sales of $10.8 million.

The challenge to Lipitor's patent could signal a new, more aggressive approach from generic companies, who have tended to concentrate on lesser products.

Dr Tim Andrews, partner at UK patent and trade mark lawyers Marks & Clerk, commented: "This was a relatively unusual and quite bold challenge from two much smaller generic manufacturers to what is a giant of the pharmaceutical industry.

"Generic manufacturers normally seek to invalidate weaker patents rather than going for the jugular with primary patents, although some earlier examples do exist  such as the successful challenge to Eli Lilly's Prozac patent by Barr."

The loss of Prozac's patent in 2001 left a gaping hole in Lilly's revenues, producing four consecutive quarterly drops in earnings, before the company could start to recover.

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