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Firms move to block generic Plavix

Sanofi-aventis and Bristol-Myers Squibb seek preliminary injunction against generics company

Sanofi-aventis (S-A) and Bristol Myers-Squibb (BMS) have moved to block sales of a generic version of the blockbuster blood-thinning drug, Plavix (clopidogrel), saying it violates their US patent.

The two companies have filed for a preliminary injunction against Canadian generics firm, Apotex, in a US District Court in New York, where ongoing patent litigation against Apotex is pending. The Court has scheduled a hearing on the motion on Friday (August 18) but has stressed that there can be no assurance it will be granted.

ìSanofi-aventis and Bristol Myers-Squibb continue to believe that the Apotex generic product infringes their intellectual property rights, which are currently the subject of the pending patent litigation,î said the two companies in a statement. ìThe companies intend to continue to vigorously defend their patent rights against infringement.î

In the court filings seeking the preliminary injunction, the two firms said the launch of a generic version of Plavix by Apotex could lead to permanent price erosion on their most important product. With $5.9bn in sales, Plavix is the world's second-best selling drug after Pfizer's Lipitor, representing up to 30 per cent of BMS' profits, and 10-15 per cent of S-A's earnings.

Analysts and traders appeared to be split on the French and US firm's chances of success in gaining an injunction, although most agreed that their share prices would not be negatively affected as the Apotex threat had already been priced in.

Some expressed surprise at how long it had taken the two firms to file the injunction motion.

Apotex launched its version of Plavix last week, after a proposed settlement with S-A and BMS that would have delayed market entry for the generic version until 2011 failed to gain US regulatory clearance in late July.

The Canadian firm is taking advantage of terms it negotiated with S-A and BMS in a revised settlement agreement, which allowed it to sell generic Plavix for five business days before the pharma firms could seek a court order to stop it.

If a court does eventually uphold S-A and BMS' patent claims, Apotex would have to pay damages, although these were capped as part of the settlement agreement.

At the end of July, BMS disclosed that the antitrust division of the US Department of Justice had begun a criminal investigation into the Plavix settlement. FBI agents seized document from the Manhattan office of BMS chief executive, Peter Dolan, as part of the investigation.

30th September 2008

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