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Case Briefing

By ALM Staff | Law Journal Newsletters |
December 01, 2003

FDA Not Required to Police Orange-Book Listings

The FDA does not have a duty under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the Hatch-Waxman Act) to review the substance of patents filed in its Orange Book to make sure that the patent holder has not, in contravention of 21 U.S.C.S. ' 355(c)(2), listed a patent unrelated to the subject drug. Apotex Inc. v. Thompson, No. 02-1295, 2003 U.S. App. LEXIS 21818 (Fed. Cir. 10/27/03).

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