FDAnews Drug Daily Bulletin


Dec. 13, 2005

The FTC has filed an amicus brief asking a federal appeals court to rehear a case against AstraZeneca and Barr Laboratories that charged that the drugmakers violated antitrust laws with their patent settlement over AstraZeneca's breast cancer drug Nolvadex.

The move is the latest effort by the FTC to block so-called "reverse payment" agreements, where brand drugmakers pay generic rivals to keep less-expensive versions of branded products off the market.

In the brief, the FTC argues that "the Appeals Court's panel did not properly consider the Hatch-Waxman Act, which encourages challenges to pharmaceutical patents to facilitate the early entry of generic drugs into the market," the FTC said in a recent statement explaining the brief. "The Appeals Court's decision, if not corrected, would permit the holder of a challenged drug patent to harm competition, and thus consumers, by unjustifiably paying a would-be generic rival to stay off the market," the FTC added.

The FTC contends that the panel failed to give proper consideration to the Hatch-Waxman Act when it made its ruling. The agency asked the full court to rehear the case.

In early November, the U.S. Court of Appeals for the Second Circuit upheld the May 2003 dismissal of antitrust lawsuits filed by consumers and/or third party payors against Barr Pharmaceuticals and AstraZeneca. Plaintiffs in the case alleged that the companies' 1993 settlement, which gave Barr non-exclusive rights to produce an authorized generic of Nolvadex (tamoxifen citrate), artificially inflated prices for the drug.

The FTC in November sued Barr Laboratories and Warner Chilcott, seeking to nullify a $20 million agreement to keep a generic version of Warner's contraceptive Ovcon-35 off the market. The FTC in September petitioned the U.S. Supreme Court to review a similar case against Schering-Plough and Upsher-Smith Laboratories.