Sanofi and BMS win Plavix infringement case

Sanofi and Bristol-Myers Squibb have been awarded more than $442 million in damages after Apotex was found to have infringed the patent rights on blockbuster drug Plavix (clopidogrel bisulphate).

The payment follows the decision of the US Court of Appeals for the Federal Circuit in October 2011 and ends a ten-year legal dispute between the companies.

French-based Sanofi, who will receive $270m of the settlement, and BMS say they are both “pleased” that their rights have been upheld and that Apotex has made a “reparation” of the harm it caused by the launch of the “at-risk” generic.

The two were also awarded $1.2 million in post-judgement interest and $900,000 in costs in addition to the damages award.

The settlement ends the final phase of patent litigation between Sanofi, Bristol-Myers Squibb and Apotex which dates back to March 2002. Canadian-based Apotex launched a cheaper generic version of Plavix in 2006 whilst the legal challenge to the patent was being decided in court.

Chris Viehbacher, CEO, Sanofi, says the ruling shows it “pays to defend your intellectual property”.

Plavix – which will become the world’s best-selling drug when Pfizer’s Lipitor loses its remaining patent protection – generated €7bn in sales last year. However, it will be exposed to generic competition when its own patent expires in the US in May 2012.

Mr Viehbacher said the company was considering its plans in the coming months for the loss of revenue on the blood-thinning drug. Protection has already been lost in Europe, but Sanofi will maintain exclusivity in Japan until 2015.