Pfizer's cholesterol-lowering drug Lipitor will maintain exclusivity in the U.K. until November 2011 under a ruling from the Court of Appeals.

The firm announced June 28 that the appellate court upheld an October ruling from the U.K. High Court of Justice that found that Ranbaxy's generic atorvastatin infringes Pfizer's European patent no. 247,633 (¹ Also see "One Of Two Pfizer Lipitor Patents Upheld By U.K. Court" - Pink Sheet, 12 October, 2005.). It is the primary patent covering the statin, Pfizer said.

Separately, the court found in favor of Ranbaxy's claim that Pfizer's European patent no. 409,281 is invalid, Ranbaxy noted in same-day comments.

However, according to Pfizer, the '281 patent - which covers the calcium salt of atorvastatin - expires in July 2010 "and therefore has no commercial relevance in the U.K." given the later expiration date for the '633 patent.

Ranbaxy said it is evaluating this decision and will decide on a course of action shortly.

Ranbaxy's plan to introduce generic Lipitor in the U.S. was similarly sidelined in December when a Wilmington, Del. federal court upheld Pfizer's two main U.S. patents (² Also see "Pfizer Lipitor Patents Valid, Infringed By Ranbaxy, Court Says" - Pink Sheet, 16 December, 2005.). That ruling allows Pfizer to maintain U.S. exclusivity through June 2011, although Ranbaxy is appealing.

Lipitor already faces generic pressure in the U.S., however, due to the June 23 patent expiration of Merck's Zocor (simvastatin). Pfizer has tried to counter patient switches from atorvastatin to generic simvastatin through a study that found Lipitor to be more cost-effective than Zocor, even when the price of the latter is reduced 50% (³ Also see "Lipitor Is Pound-Wise Versus Generic Zocor, Pfizer IDEAL Cost Study Says" - Pink Sheet, 16 May, 2006.).

-Kathleen Michael

Lipitor’s U.K. Exclusivity Affirmed In Appellate Decision

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