Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2009)

A product-by-process claim is limited by process terms when determining infringement, according to the Federal Circuit sitting en banc sua sponte.

Astellas Pharma, Inc. is the owner of U.S. Patent 4,935,507 (the ’507 patent) regarding the formulation of crystalline cefdinir. Abbott Laboratories is the exclusive licensee of the ’507 patent. Two disputes reached the federal courts surrounding the ’507 patent. In the Eastern District of Virginia, Lupin Pharmaceuticals sought a declaratory judgment of non-infringement after its Abbreviated New Drug Application for a generic version of the drug was approved. In the Northern District of Illinois, Abbott sued Sandoz and others for infringement of the ’507 patent. The Eastern District of Virginia granted-in-part Lupin’s motion for summary judgment of non-infringement, and the Illinois court denied Abbott’s request for a preliminary injunction. Since the claim construction of the ’507 patent was at issue in both appeals, the Federal Circuit addressed both cases together.

The ’507 patent contains five claims. Claim 1 describes crystalline cefdinir using its chemical name and defining its characteristics using powder X-ray diffraction angle peaks. Claims 2 to 5, however, do not define any powder X-ray diffraction peaks, but describe the process by which the compound can be created by using the phrase “obtainable by.” The Virginia court’s claim construction, which was also used by the Illinois court, found these claims to be product-by-process claims. The Virginia court followed the rule set forth in Atlantic Thermoplastics Co., Inc. v. Faytex Corporation, which holds that a product-by-process claim is limited by the process that is described in the claims. Following this claim construction, the Virginia court granted-in-part summary judgment of non-infringement for Lupin, and the Illinois court denied Abbott’s request for a permanent injunction.

Abbott and Astellas appealed the district courts’ decisions, arguing that product-by-process claims are not limited to the process described in the claim. Abbott and Astellas relied on Scripps Clinic & Research Foundation v. Genentech, Inc. to support their position regarding this interpretation of product-by-process claims. The Federal Circuit, sitting en banc on this issue, adopted the rule from Atlantic Thermoplastics, stating “process terms in product-by-process claims serve as limitations in determining infringement.” Agreeing with the claim construction of the Virginia court, the Federal Circuit affirmed the district courts’ decisions.

Practice Tip:

Product-by-process claims should be used carefully because infringement can be limited to those process terms used in the claims.