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Judge upholds Plavix patent

James Nurton, London

It may be the world's most controversial drug – attacked by generics in the US, the subject of an abandoned reverse-payment deal last year, and vulnerable to compulsory licensing in Thailand

It may be the world's most controversial drug – attacked by generics in the US, the subject of an abandoned reverse-payment deal last year, and vulnerable to compulsory licensing in Thailand.

But yesterday a New York judge provided some good news for Plavix, upholding the validity of the key US patent protecting the world's third biggest-selling drug until November 2011.

The decision will be welcomed by Sanofi-Aventis and Bristol-Myers Squibb. It means that generic producer Apotex cannot sell a rival version of the drug in the US, and may be liable for damages (to be decided at a future hearing).

Apotex initiated proceedings over the patent (US 4,847,265) covering clopidogrel bisulfate, the active ingredient in Plavix, by filing an Abbreviated New Drug Application (ANDA) in November 2001.

Sanofi retaliated in March 2002 with an infringement suit against Apotex. The Canadian generic company counterclaimed that the patent was invalid and unenforceable.

Apotex said the patent was invalid as it was anticipated, obvious and double-patented. It also alleged that there had been inequitable conduct before the USPTO.

During 2006, the two parties apparently discussed settling the dispute, prompting an investigation into whether BMS had tried to block generic versions of the drug from being made. The action led to BMS agreeing to a $1 million fine imposed by the Department of Justice, and chief executive Peter Dolan losing his job.

Apotex launched its generic version of clopidogrel bisulfate in August last year, but two weeks later Sanofi was granted a preliminary injunction – though it had to put down a $400 million bond.

A trial on the merits was finally held from January 22 to February 15 this year. In his judgment on June 19, Judge Sidney H Stein rejected Apotex's claims that the patent is invalid.

Specifically, he said that Apotex had not shown "by clear and convincing evidence" that the patent was anticipated by two earlier patents. In addition, he said: "Sanofi has effectively rebutted a prima facie case of obviousness by demonstrating that clopidogrel bisulfate – as a whole – possesses unexpected properties that could not have reasonably been viewed as a likely outcome of preparing the invention."

He also rejected the claims of double-patenting and inequitable conduct.

Plavix, a blood thinner, had annual sales of some $6.1 billion last year.

Apotex said it will appeal the decision.

Evan Chesler of Cravath, Swaine & Moore and Robert Baechtold of Fitzpatrick, Cella, Harper & Scinto advised Sanofi-Aventis and Bristol-Myers Squibb. Robert Silver of Caesar Rivise Bernstein Cohen and Pokotilow acts for Apotex.