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Product-By-Process Claim Construction: Conflict in Federal Circuit Precedent Remains Unresolved

By Jonathan S. Caplan and Mary W. Richardson
May 30, 2007

Construing claims that use the process by which a product is created to define the invention ' that is, product-by-process claims ' was not made any easier by the Federal Circuit's recent decision in SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312 (Fed. Cir. 2006). The Federal Circuit again declined to resolve the long-standing conflict between two decisions ' the 1991 decision in Scripps Clinic & Res. Foun. v. Genentech Corp., 927 F.2d 1565 (Fed. Cir. 1991), which held that product-by-process claims should not be limited by the process steps in the claims, (i.e., such claims cover an identical end-product regardless of the steps used) and the 1992 decision in Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992), which held that product-by-process claims should be construed to only cover the end-product if produced by the specifically claimed process steps. As explained below, this state of affairs warrants that patent applicants and litigants stay tuned to the case law and adjust their respective claim drafting and analysis strategies accordingly.

The SmithKline Case

In SmithKline, SmithKline Beecham Corporation's ('SmithKline') drug for treating depression, sold under the trade name Paxil', was subject to generic attack when Apotex Corporation ('Apotex') filed an Abbreviated New Drug Application with the FDA to market a generic version of the drug. SmithKline sued Apotex, asserting its patent claiming the active ingredient and defining the composition in terms of the steps required to make it in tablet form (instead of reciting the drug's structural characteristics). The district court granted Apotex's motion for summary judgment, holding that the patent was invalid because it was anticipated by SmithKline's earlier patent covering the active ingredient, paroxetine. In reaching its decision, the district court relied on the Federal Circuit's Scripps decision, finding that Scripps required evaluating the claims by reference to the products claimed, without considering the process steps as claim limitations. Because SmithKline's earlier patent disclosed tablets containing paroxetine, including the dosages specified in SmithKline's product-by-process patent claims, the district court found anticipation.

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