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Pfizer and Sanofi battle challenges on patents

Published on 08/09/05 at 01:56pm

Two blockbuster drugs are facing key patent challenges on both sides of the Atlantic, with the outcome of the cases potentially having huge ramifications for the whole industry.

Generic firms are attempting to invalidate the exclusivity rights of Pfizer's Lipitor and Sanofi-Aventis' Plavix in the UK and US.

A successful challenge against either drug would have huge implications for the industry and could save the NHS and other healthcare providers billions of pounds a year.

Pfizer is awaiting court rulings in the UK and US following a challenge from Indian drug firm Ranbaxy, which is taking on the US company over the rights to produce a generic version of its $12 billion-a-year blockbuster Lipitor (atorvastatin).

Pfizer insists that its patents on Lipitor are valid until 2011 and is confident of seeing off the challenge, having fought such legal cases vigorously in the past.

"We maintain that our patents are valid and would be infringed by an atorvastatin calcium product marketed by Ranbaxy, and we believe that we vigorously defended our patents during the trial," said a Pfizer spokesman.

A victory for Ranbaxy, however, would have grave consequences for Pfizer, slashing its profits by around $6 billion while tripling the Indian firm's profits to about $1 billion a year.

In the UK, a ruling against Pfizer would result in enormous savings for the NHS - which spent in the region of 350 million on Lipitor last year - while sales of competing branded statins, like AstraZeneca's Crestor, would be dented by the arrival of generic competitors.

Both rulings are expected within the next month and will be eagerly awaited by the industry and in particular by manufacturers of cholesterol-lowering drugs.

Sanofi-Aventis, meanwhile, is defending the US patent on one of its most profitable drugs, the anti-stroke blood thinner Plavix.

Plavix, which is co-marketed with Bristol-Myers Squibb, represented nearly 10% of Sanofi's global revenues in 2004 and is facing a challenge from Dr Reddy's Laboratories of India and Canadian generics firm Apotex.

Sanofi has recently seen off a challenge in the UK after a Scottish company attempted to overturn the patent for clopidogrel bisulfate, the active compound in its Plavix.

The challenge came from Aircoat, a Scottish brass-plate firm, which Sanofi believed was acting as a shell company for a generic competitor.

The patent on Plavix's active compound expires in 2013 in the UK and Sanofi will be hoping that seeing off Aircoat will ward off further challenges.

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