This article was originally published in The Tan Sheet
A firm's 180 days of Waxman/Hatch marketing exclusivity begins with the first court ruling on the invalidity of a patent, not the final appeal decision, Washington, D.C. federal court Judge Richard Roberts rules in Mylan v. Shalala. FDA's current interpretation specifies 180-day exclusivity begins after the ruling of a court "from which no appeal can or has been taken." Roberts finds FDA's stance inconsistent with the language of the Waxman/Hatch Act, stating the statute's reference to "a court" includes a district court. FDA is reviewing the opinion and may not appeal it, although it would supersede a recent proposed rule on 180-day exclusivity trigger periods (1"The Tan Sheet" Nov. 22, 1999, p. 8)
You may also be interested in...
FDA's proposed implementation of a 180-day "triggering period" for ANDA exclusivity is supported in comments submitted by the Federal Trade Commission, but opposed by Bristol-Myers Squibb, the Pharmaceutical Research & Manufacturers of America and the Generic Pharmaceutical Industry Association.
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
Perrigo promotes in pricing, planning