Abbot Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009)
In a consolidated case on appeal from two separate jurisdictions, the Federal Circuit overruled an earlier decision to resolve a conflict regarding product-byprocess infringement claims. The seventeen-year conflict was the result of two conflicting opinions in the Federal Circuit. In one of those opinions, Scripps Clinic & Research Foundation v. Genentech, Inc., the court refused to limit product-by-process claims to the product prepared by the process claimed in the patent. In the other, Atlantic Thermoplastics Co. v. Faytex Corp., the court held that process terms that define the product of a product-by-process claim serve as enforceable limitations to a patent claim. The court in Sandoz overruled Scripps and, citing several U.S. Supreme Court decisions, adopted the holding in Atlantic Thermoplastics. Specifically, the court noted that even if the products of an alleged infringer and a patentee are similar, they are not sufficiently defined until it can be shown that they are made by the same process. In Sandoz, the patentee argued that the language “obtainable by” in the process claim introduced merely an optional process. The court found that it did not, as to find otherwise would mean that the patent could claim a product obtained by a process other than those explicitly recited in the claims. Therefore, the court found, even though the accused product was bioequivalent to the patentee’s product, the process described was a limitation to the asserted claims that must be applied in the infringement analysis. Because of this limitation, the patent was not broad enough to encompass the alleged infringers’ products produced using an alternate process.