Ranbaxy could gain as Pfizer loses initial bid for Lipitor patent extension

17 August 2007

Mumbai: Pfizer Inc.has failed to secure reissuance of a US patent protecting its blockbuster cholesterol medicine Lipitor, opening the generic route open to its Indian rival Ranbaxy Laboratories after the patent for Lipitor expires in 2010.

An initial ruling by the US Patent and Trademark Office would open Lipitor to generic competition in March 2010, when the 'basic patent' for the drug expires, rather than in June 2011, when the 'patent at issue' would expire, the company said in its web site.

This means that Ranbaxy can start making generic versions of Lipitor in 2010. Ranbaxy will have 180-day exclusivity after the patent expires in March of that year, meaning that Ranbaxy will be the only generic drugmaker producing low-cost version of Lipitor. Ranbaxy has scored limited legal challenges in lawsuits initiated by Pfizer against it in several countries.

The rejection of the patent revision could cost the pharma giant at least $6 billion.
New York-based Pfizer still holds its basic Lipitor patent, which protects the world's top-selling drug until March 2010.

Pfizer spokesman Bryant Haskins said an initial rejection from the patent office is "non-final" and "not uncommon." He said Pfizer needed more information before the company could decide on its next move.