Bristol-Myers Squibb and Sanofi-Aventis reached a tentative settlement with Apotex over the Canadian generic-drug maker’s patent challenge to widely used, jointly marketed blood thinner Plavix, The Wall Street Journal reported.
The settlement, which must clear antitrust hurdles, allows Bristol-Myers and Sanofi to continue selling the drug until 2011 without competition from Apotex.
Under the terms of the settlement, Apotex, of Toronto, will receive undisclosed payments from Bristol-Myers and Sanofi in exchange for delaying the launch of its generic version of Plavix until eight months before the patent runs out. The Plavix patent is scheduled to expire in November 2011. Bristol-Myers and Sanofi have filed a request to extend it until May 2012.
In a statement announcing the deal, Bristol-Myers and Sanofi said there was “significant risk that required antitrust clearance will not be obtained,” in which case litigation against Apotex would resume. The case was set to go to trial June 12 in US District Court in New York.
The Federal Trade Commission has voiced opposition to branded-drug companies’ frequent settlements of patent challenges with generic makers, contending that they stymie competition and hurt the consumer. The agency has aggressively pursued some cases in which it claimed that branded-drug makers had paid a generic company to keep a copycat off the market. In recent court decisions, judges seem to have concluded that such settlements aren’t by definition anticompetitive.
Bristol-Myers and Sanofi face another challenge from Indian generic-drug maker Dr. Reddy’s Laboratories over the Plavix patent. Though that case is separate, it is scheduled to be heard in New York District Court. Bristol-Myers and Sanofi told the Journal they had approached Dr. Reddy’s about a settlement, but those discussions “cannot be assured.”