Singh: Undaunted

New Delhi, Dec. 17: Pharmaceutical major Ranbaxy has suffered another blow with a US court ruling against its challenge for non-infringement and invalidation of two patents of American drug company Pfizer on atorvastatin.

Atorvastatin is the core ingredient of Lipitor ? a cholesterol-lowering drug, marketed and manufactured by Pfizer. Lipitor is the largest selling drug in the world.

Judge Joseph J. Farnan held that Ranbaxy?s atorvastatin infringes on Pfizer?s US patent no. 4,681,983 and at the same time upheld the validity of another, Pfizer US patent no. 5,273,995, which Ranbaxy had claimed was invalid. The patents expire in 2010 and 2011, respectively.

The ruling followed a hearing in the U.S District Court of Delaware, which took place in December 2004.

Ranbaxy plans to begin the appeals process immediately.

The latest ruling by the US court effectively means that unless its appeal receives a favourable ruling, Ranbaxy will be prohibited from introducing a generic version of atorvastatin in the US before the expiration of the patent in November 2011.

The term generic drug refers to a copy of an original product whose patent has expired. Generics are sometimes also defined as medicines for which the patent of the active substance has expired.

?We remain undeterred in our resolve on this issue, and we will press our case in the US Court of Appeals for the Federal Circuit. We are committed to lowering cost and providing reliable medicines to healthcare systems, worldwide,? said Malvinder M. Singh, president and executive director of Ranbaxy.

This is the second major unfavourable ruling against Ranbaxy in the last two months on its patent challenges against Pfizer.

In October, the UK High Court of Justice had ruled in favour of Pfizer?s patent on Lipitor. Ranbaxy, which is also challenging Pfizer?s patents on Lipitor in several other European countries, was seeking to invalidate two British patents on the drug.