In May the U.S. Court of Appeals for the Federal Circuit resolved a two-decade-plus internal split over the issue of product-by-process claims. Such claims involve patents that are defined, at least in part, by the process used to make the product in question. The decision left Abbott Laboratories and Astellas Pharma Inc. on the losing side, while handing a host of generic drug manufacturers—Lupin Ltd. chief among them—a judgment that stands to narrow some existing claims in various Big Pharma portfolios.
The underlying split on the court was the result of two decisions: 1992’s Atlantic Thermoplastics Co. v. Faytex Corp., authored by Judge Randall Rader, and 1991’s Scripps Clinic & Research Foundation v. Genentech, written by Judge Pauline Newman. The former decision held that product-by-process claims acted as limitations in determining infringement; the latter held that such claims are not limited solely to the product prepared by the process. In other words, Scripps allowed for much broader claims than Atlantic Thermoplastics did.
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