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Product-by-Process Claims Not Limited by Claimed Process Steps for Purposes of Anticipation

June 22, 2006

Decision icon Decision

Last Month at the Federal Circuit - July 2006

Judges: Newman (dissenting), Schall, Dyk (author)

In SmithKline Beecham Corp. v. Apotex Corp., No. 04-1522 (Fed. Cir. Feb. 24, 2006), the Federal Circuit affirmed a district court’s SJ holding that product-by-process claims were anticipated by a previously disclosed product

In 1992, SmithKline Beecham Corporation and SmithKline Beecham, P.L.C. (collectively “SmithKline”) obtained FDA approval to market a pharmaceutical composition (“paroxetine”) sold under the trade name Paxil®. SmithKline applied for and was granted U.S. Patent No. 6,113,944 (“the ’944 patent”). Claims 1 and 2 of the ’944 patent are product-by-process claims reciting paroxetine tablets made by certain processes.

In March 1998, generic drug manufacturer Apotex Corporation, Apotex, Inc., and Torpharm, Inc. (collectively “Apotex”) filed an ANDA to the FDA seeking to market a generic version of Paxil®. Apotex also filed a “paragraph IV certification” in connection with its ANDA, stating, among other things, that the ’944 patent was invalid. Pursuant to 35 U.S.C. § 271(e)(2), which makes submitting an ANDA an act of infringement, SmithKline sued Apotex for infringement of the ’944 patent in the Eastern District of Pennsylvania. Apotex counterclaimed that the ’944 patent was invalid and moved for SJ of invalidity. Apotex argued that an earlier SmithKline patent, U.S. Patent No. 4,721,723 (“the ’723 patent”), anticipated the ’944 patent. The ’723 patent disclosed tablets containing a crystalline form of paroxetine, paroxetine hydrochloride hemihydrate.

The district court held that it was bound to follow the Federal Circuit’s decision in Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991), which required the district court to evaluate the validity of the ’944 patent claims without reference to any process limitations in the product-by-process claims. Because the ’723 patent disclosed tablets containing paroxetine, the district court held that the product disclosed in the ’723 patent anticipated the product-by-process claims of the ’944 patent. In so holding, the district court did not consider any differences in the products because any such differences were caused by the process limitations, which the court held it could not consider.

On appeal, SmithKline argued that if the district court had treated the process steps recited in claims of the ’944 patent as claim limitations, the district court would have held that the ’723 patent did not anticipate the ’944 patent, or that there was a genuine issue of fact over whether the ’723 patent disclosed those process limitations. The Federal Circuit rejected SmithKline’s arguments, holding that “once a product is fully disclosed in the art, future claims to that same product are precluded, even if that product is claimed as made by a new process.” Slip op. at 5.

The Federal Circuit noted a potential conflict between Scripps, where the court construed product-by-process claims without reference to process steps, and Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992), where the court read process steps in a product-by-process claim as claim limitations. Although the Federal Circuit declined to directly address the conflict between the two cases, it nevertheless stated that a product-byprocess claim is “always to a product, not a process.” The Court stated that while the process set forth in a product-by-process claim may be new, that novelty can only be captured by obtaining a process claim. Accordingly, the Federal Circuit affirmed the district court’s finding of anticipation.

The Federal Circuit also held that SmithKline waived any argument regarding the differences between the products claimed in the ’723 patent and the ’944 patent by not including the argument in its opening brief.

Judge Newman dissented, arguing that Federal Circuit precedent requires that all claim limitations limit a claim, and therefore, process limitations cannot be ignored. In Judge Newman’s view, process limitations may distinguish an invention as a whole from prior art. Accordingly, a mere product disclosure could not anticipate the product-byprocess claims at issue. Additionally, Judge Newman argued that the issues not briefed in SmithKline’s appeal should not be deemed waived, because the appeal related solely to the question mentioned in the SJ, i.e., whether the process limitations in the product-byprocess claims should be read as limiting the claim. She added that “when the appellant sticks to the issues on appeal he risks a waiver of the non-issues; and when he argues non-issues he risks a scolding.”