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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).

SmithKline Beecham Corp. is the holder of an NDA for the pharmaceutical Paxil', the active ingredient in which is paroxetine hydrochloride hemihydrate. On Dec. 29, 1992, the FDA approved SmithKline's NDA for the use of Paxil' to treat depression. Pursuant to 21 U.S.C. ' 355(b)(1), SmithKline referred in its NDA to its U.S. Patent No. 4,721,723 (the '723 patent), which claims crystalline paroxetine hydrochloride hemihydrate. Accordingly, the FDA listed the '723 patent in the Orange Book when it approved SmithKline's NDA.

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