Smithkline Beecham Corp., et al. v. Apotex Corp., et al.

April 25, 2004 on 9:41 pm | In Caselaw |

Smithkline Beecham Corp., et al. v. Apotex Corp., et al.
Opinion by Rader, concurring opinion by Gajarsa
Federal Circuit, April 23, 2004
Following a bench trial, the United States District Court for the Northern District of Illinois determined that the paroxetine hydrochloride anhydrate product produced by Apotex Corp., Apotex, Inc., and TorPharm, Inc. will not infringe claim 1 of U.S. Patent No. 4,721,723 owned by SmithKline Beecham Corp. and Beecham Group, P.L.C. Claim 1 of the ’723 patent recites, in its entirety, “Crystalline paroxetine hydrochloride hemihydrate.” The Federal Circuit reversed the claim construction of the district court and held that claim 1 covers any amount of crystalline paroxetine hydrochloride hemihydrate without further limitation. Based on the factual findings of the district court, the Federal Circuit affirmed the district court’s finding that Apotex’s PHC anhydrate product will infringe claim 1 under that broad construction. Notwithstanding that conclusion, the Federal Circuit held, based on the undisputed facts, that SmithKline’s clinical trials constituted a public use under § 102(b) rendering claim 1 invalid. Apotex was thus not liable for infringing claim 1 of the ’723 patent. This Federal Circuit thereby affirmed the district court’s judgment.

UPDATE (April 29, 2004): Errata here: http://www.fedcir.gov/opinions/03-1285e.doc

UPDATE 2 (May 13, 2004): Errata updated (same file name/link as the April 29, 2004 errata).

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