Patent Term Extension Under Hatch-Waxman Applies to Patents with Terminal Disclaimers

Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., [06-1401](March 29,. 2007)[LINN, Friedman, Plager] The Federal Circuit held that patent term extension under Hatch-Waxman (35 USC 156) may be applied to a patent subject to a terminal disclaimer under 35 USC 253.
BRIEF: Merck sued Hi-Tech for infringement of U.S. Patent No. 4,797,413 on TRUSOPT, a glaucoma medication. Hi-Tech moved to dismiss, conceding that its products were covered by the patent, but alleging that the patent had expired, because the Hatch-Waxman term extension does not apply to patents subject to a terminal disclaimer. Noting, among other things, the imperative language of Hatch-Waxman (the patent term shall be extended), the Court found that statute unambiguous, and that the legislative history was consistent with the interpretation under the plain meaning of the statute.