The U.S. Court of Appeals for the Federal Circuit held en banc on May 18, 2009 in Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, that infringement of a product-by-process claim requires showing that an equivalent process was used in making the alleged infringer’s product. Accordingly, the Court rectified a 17 year conflict between its decisions in Atlantic Thermoplastics Co. (970 F.2d 834 (Fed. Cir. 1992) and Scripps Clinic & Research Foundation (927 F.2d 1565 (Fed. Cir. 1991). Writing for the majority, Judge Rader stated that process terms in product-by-process claims serve as limitations in determining infringement, expressly overruling Scripps. With respect to situations where a product whose structure is not fully known or too complex to analyze, the decision explained that “the inventor is absolutely free to use process steps to define this product . . . [and] will not be denied protection. Because the inventor chose to claim the product in terms of the process, however, that definition also governs enforcement of the bounds of the patent right. This court cannot simply ignore as verbiage the only definition supplied by the inventor.” Judge Newman’s dissent noted that “[f]or the first time, claims are construed differently for validity and for infringement,” i.e., product-by-process claims are product claims for validity interpretations but process claims for infringement interpretations.
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