Claims may be written as: (1) an apparatus claim that recites various structural elements, (2) a method claim that recites various steps or (3) a product by process claim that define the product by the process by which the product is made. The issue with product by process claims is whether the steps are limitations in determining infringement or not.  In construing the scope of protection afforded under product by process claims, the Federal Circuit has previously held that “process terms in product-by-process claims serve as limitations in determining infringement.” Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992). Conversely, the Federal Circuit has also held that “the correct reading of product-by-process claims is that they are not limited to product prepared by the process set forth in the claims.” Scripps Clinic & Research Foundation v. Genentech, Inc. 927 F.2d 1565, 1583 (Fed. Cir. 1991). The holding in Scripps Clinic provides broader protection since products made by a different process would still infringe the product by process claim, whereas, the holding in Atlantic Thermoplastics would only protect products made by the process recited in the product by process claim.

The following case clarifies the conflict in law with respect to holdings in Atlantic Thermoplastic and Scripps Clinic. In Abbott Laboratories v. Sandoz, Inc. 2007-1400 (May 18, 2009 Fed. Cir.), the patent at issue contained claims directed to a crystal defined by a certain process for forming the crystal. After the Federal Circuit reviewed various case opinions rendered by the United States Supreme Court and other sister circuits in relation to product by process claims, the Federal Circuit held that product by process claims are limited by and defined by the recited process. The Federal Circuit narrowed the scope of patent protection afforded under product by process claims to only the process recited in the product by process claim. A product manufactured by a different process is not protected by the product by process claim.

Other posts related to claim interpretation is:

Avoiding Patent Infringement

Stopping Infringement

The Federal Circuit had two cases with opposite holdings relating to whether steps in the product by process claim are limitations or not in determining infringement. In Atlantic Thermoplastics Co. v. Faytex Corp. (Fed. Cir. 1992), the Federal Circuit held that “process terms in product-by-process claims serve as limitations in determining infringement.” (emphasis added). In contrast, in Scripps Clinic & Research Foundation v. Genentech, Inc. (Fed. Cir. 1991), the Federal Circuit held that product-by-process “are not limited to product prepared by the process set forth in the claims.” (emphasis added). In Abbott Laboratories v. Sandoz (Fed. Cir. 2009), the Federal Circuit clarified that the steps recited in a product by process claim serve as limitations in determining infringement.

The patent in suit relates to a drag reducing agents injected into oil and gas pipelines such that more liquid may be pumped more efficiently. The claim recited a process of preparing a drug reducing agent … a suspending material selected from the group consisting of water and water-alcohol mixtures, whereby a stable nonagglomerating suspension of the solid friction reducing agent is obtained. The alleged infringer added MIBK which is a common impurity in industrial alcohols in order to prevent a liquor tax from being applied. The Court held that impurities that a person of ordinary skill in the relevant art would ordinarily associate with a component on the “consisting of” list do not exclude the accused product or process from infringement. In footnote 5 of the opinion, the court specifically stated that the added component must be related to the invention to avoid infringement (Norian) but specifically reserved the issue of whether impurities not normally associated with a component would exclude the accused process from infringement.

In summary, if the added component is not related to the invention such as in the Norian Case where a spatula was added to a chemical kit consisting of a specific list of chemicals, then infringement is not avoided. If the added component is related to the invention and is normally associated with a component on the “consisting of” list, then infrigement is still not avoided. However, the Court appears to have specifically reserved the question of whether a component related to the invention but not normally associated with a component on the “consisting of” list would avoid infringement.