MNCs seek deal with Dr. Reddy's for Plavix

Multinational drug companies Sanofi-Aventis and Bristol-Myers Squibb Company have initiated talks with Dr Reddy's Laboratories (DRL) for an out-of-court settlement on the multi-billion dollar blood thinner Plavix.

Confirming the move, sources close to the development said both the foreign companies were among the original patent holders for Plavix. Plavix recorded sales of $6 billion in 2005. The patent of the drug expires in 2011.

DRL officials were not available for comments.

DRL had filed an abbreviated new drug application (ANDA) for its own molecule of Clopidogrel Bisulfate, which is the chemical name for Plavix, with the US Food and Drug Administration (FDA) in May 2002. Following this, Sanofi filed a case against DRL alleging patent infringement.

Sources said the foreign companies' discussion with DRL follows their recent out-of-court settlement with Canada's Apotex over Plavix. Like DRL, Apotex had also filed a case seeking to invalidate the patent for Plavix.

Industry sources said in case of an out-of-court settlement, DRL could
end up with receiving a compromise payment of $100-200 million. "For a $6 billion drug like Plavix, patent holders would be willing to shell anything in the range of $100-200 million, and keep away the drug from generics
till 2011," a Mumbai-based pharma analyst said.

A trial involving the disputed Plavix patent is expected to come up in the US District Court in New York in the next three months. The court has suspended the trial date pending possible finalisation of the proposed settlement.

The proposed settlement is, however, subject to anti-trust review and
clearance by the US Federal Trade Commission (FTC). Should the deal be rejected by the FTC, the litigation would be reinstated in the same court.