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ANDA 180-Day "Triggering Period" Favored By FTC, Opposed By Industry

This article was originally published in The Tan Sheet

Executive Summary

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.

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Exclusivity ruling

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)

Exclusivity ruling

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)

Exclusivity ruling

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)

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