Ranbaxy Labs plays safe on generic Lipitor

Davos, Jan 26 | Updated: Jan 27 2005, 05:30am hrs
Ranbaxy Laboratories is confident of its case to overthrow patent protection on Pfizer Incs Lipitor the worlds biggest-selling drug but will not launch a generic until the legal situation is finalised.

Chief executive Brian Tempest told Reuters on the sidelines of the World Economic Forum (WEF) that he would await the outcome of any appeal before introducing a copycat version of the cholesterol-lowering medicine in the US. He expects a ruling in the US patent case to come around July this year. If it loses, Pfizer will certainly appeal a process which could take about 12 months. We wouldnt launch at risk. We are a conservative company. We will wait until the appeal at the federal level, Mr Tempest said.

Overturning Pfizers patents on Lipitor, which sells $10 billion a year, would be a transforming event for Ranbaxy which currently has revenues of only around $1.2 billion. Ranbaxy put its case at a two-week trial in the US district court of Delaware last month.

It is trying to break two patents that currently protect Lipitor from generic competition until 2009 and 2011.

Ranbaxy charged that Pfizer withheld crucial scientific data that may have influenced the patent-review boards decision to grant an extension on the original patent and award the second patent.

Until recently, most commentators thought Ranbaxy had little chance of success. But Mr Tempest said attitudes had started to change. A number analysts originally said we had the flimsiest of cases. I think now they see that this is a serious case, he said.

Ranbaxy is busy getting ready for a generic Lipitor launch ahead of the legal ruling, something it has already warned shareholders will weigh on earnings in 2005. Weve already started to buy raw materials, Tempest said.

The Indian company is also challenging patents on Lipitor in around a dozen other countries, with a decision expected in a case in Austria in April, he added.