Ranbaxy's US launch of Lipitor drug only in 2010

NEW DELHI: With the US Supreme Court rejecting an appeal by Ranbaxy to launch a generic drug of Lipitor in the US before its patent expires in 2010, Ranbaxy’s last hope for an early launch of atorvastatin — the generic version of Pfizer’s blockbuster drug Lipitor – in the US appears to have squashed.

Last year, a federal court ruled a verdict against Ranbaxy, in the 893 patent, and had given the company two months time to appeal against the adverse decision in the Supreme Court. On Monday, the US Supreme Court declined to intervene in Ranbaxy’s appeal against the federal court’s verdict, which had uphold Pfizer’s exclusive market rights for Lipitor in the US. When contacted, a Ranbaxy spokesperson declined to comment.

“We are pleased to see that the Supreme Court has declined to intervene in the Appeals Court’s decision supporting our very strong basic patent for Lipitor,” a US TV channel said quoting a Pfizer statement.

As things stand now, Ranbaxy can launch its atorvastatin by on March 2010. However, Pfizer has approached the US Patent and Trademark office to re-examine its patent for Lipitor in an attempt to claim patent protection till 2011. A decision in this matter is pending. A favourable verdict for Pfizer may mean that Ranbaxy’s launch date will be pushed back to 2011.

Anti-cholesterol drug Lipitor is the world’s largest selling drug with sales worth about $13 billion last year. In the US, Lipitor’s market size is about $8.5 billion (two-third of its global sales). Ranbaxy’s launch of the atorvastatin is crucial in the company’s plan to generate nearly $2 billion in sales over the next five-six years.

In 2003, US-based world’s largest drug-maker Pfizer had sued Ranbaxy for alleged patent infringement over the latter’s plans to launch generic drug of Lipitor. In 2005, a court in the US held Pfizer’s two patents valid.

But following an appeal and subsequent favourable verdict in one of the patents last year, Ranbaxy can now launch atorvastatin by 2010. Ranbaxy has locked horns with the Pfizer in 17 countries over patent infringement of Lipitor.