Use of Authorized Generic Challenged

Sanofi has become the latest company to be defending allegations that its use of an authorized generic violated the antitrust laws. In patent litigation commenced by Sanofi-Synthelabo and certain affiliates against Apotex relating to the drug Plavix – which was reinstated after the FTC rejected the parties’ proposed settlement – the judge has permitted Apotex to amend its Answer to assert counterclaims based on the allegation that “Sanofi entered into an agreement with a third party, Prasco Laboratories, ... to market an authorized generic with the goal of excluding Apotex from the market for [the generic form of Plavix].” In the order issued on November 2, 2006, Judge Stein did not appear to consider the legal sufficiency of the antitrust allegations, and decided only that the counterclaim would be severed from the patent litigation and stayed pending the resolution of the trial on Sanofi’s patent claims.

No court has yet held that the use of an authorized generic violates the antitrust laws, although plaintiffs have made such allegations before. See, e.g., Mylan Pharmaceuticals, Inc. v. FDA, 04 Civ 0242 (IMK) (Nov. 12, 2004 N.D. W.Va.) (complaint asserting antitrust claims against Proctor & Gamble in connection with P&G’s agreement to permit Watson Pharmaceuticals to sell an authorized generic of P&G’s product Macrobid).