Product-by-process claims: product or process claims?
Traditionally, the United States Patent and Trademark Office (USPTO) has allowed claims for a product to reference the process steps of its production only when the product cannot be defined in any other way. Product-by-process claims are most frequently used in chemical and biological technology. For example, a chemist may mix substances X, Y, and Z together, and then heat the mixture to a temperature to initiate polymerization (Process A). This polymerized mixture may contain XYZ, but also a variety of other combinations of those substances which are nearly impossible to identify. In such an instance, a product-by-process claim may be appropriate to describe the polymerized mixture (i.e., the chemist might seek protection for Product XYZ, obtained by Process A).
In 1991, the Court of Appeals for the Federal Circuit (CAFC) decided Scripps Clinic & Research Foundation v. Genentech, Inc., holding that a product-by-process claim was not limited to the product prepared by the process set forth in the claims, but rather to any product which was identical to the product of the process, regardless of whether the product was prepared by the process of the claims. Shortly thereafter, in 1992, the Federal Circuit decided Atlantic Thermoplastics Co. v. Faytex Corp., holding that the process terms in product-by-process claims serve as limitations in determining infringement. Since Atlantic Thermoplastics did not overrule Scripps Clinic, there have been 17 years of uncertainty in patent law over whether a product-by-process claim can be infringed by a product not produced by the claimed process.
The CAFC has resolved this conflict with its recent decision in Abbott Laboratories v. Sandoz, Inc., which combined two district court cases involving Abbott Labs. Abbott Labs is the exclusive licensee of U.S. Patent 4,935,507, under which it makes Omnicef, an antibiotic frequently used to treat ear infections in children. In one case, drug manufacturer Lupin sought a declaratory judgment that its generic form of Omnicef did not infringe the '507 patent, while in the other case, Abbott Labs accused generic drug manufactures Sandoz Inc, Teva Pharmaceuticals, Ranbaxy Laboratories, and Par Pharmaceuticals of infringing the '507 patent. At the district court level, Lupin's motion for summary judgment of non-infringement was granted, while Abbott Lab's motion for preliminary injunction was denied in the other case. Abbott Labs appealed both decisions to the CAFC, which chose to hear and decide the cases together.
The primary issue in both cases was proper interpretation of product-by-process claims. Citing seven Supreme Court cases, the opinion by Judge Rader reiterated that process terms in product-by-process claims serve as limitations in determining infringement, the position articulated by the earlier decision in Atlantic Thermoplastics. The court's logic behind this conclusion was illustrated by the following example:
Assume a hypothetical chemical compound defined by process terms. The inventor declines to state any structures or characteristics of this compound. The inventor of this compound obtains a product-by-process claim: "Compound X, obtained by process Y." Enforcing this claim without reference to its defining terms would mean that an alleged infringer who produces compound X by process Z is still liable for infringement. But how would courts ascertain that the alleged infringer's compound is really the same as the patented compound? After all, the patent holder has just informed the public and claimed the new product solely in terms of a single process. Furthermore, what analytical tools can confirm that the alleged infringer's compound is in fact infringing, other that a comparison of the claimed and accused infringing processes? If the basis of infringement is not the similarity of process, it can only be similarity of structure or characteristics, which the inventor has not disclosed.
Product-by-process claims: product or process claims?
Despite the fact that the CAFC has resolved the conflict in its product-by-process jurisprudence, the dissent by Judge Newman argues such claims will now be construed differently, for the first time, for infringement purposes at trial than for validity purposes during the patent application process. When attempting to secure a patent for a product-by-process claim, an applicant will need to show that the product is patentable, regardless of the process by which it is made. At trial, the claim for the product will only be infringed if it is produced by the same process in the claims. The impact of this distinction remains to be seen.
Ultimately, product-by-process claims comprise only a small portion of all issued patent claims. As analytical methods for evaluating complex chemical and biological compounds continue to improve, the necessity for claiming products by their method of production in product-by-process may diminish even further. Nevertheless, the new certainty regarding interpretation of product-by-process claims is a welcome change in light of the past 17 years of uncertainty.
Copyright 2009 Hahn Loeser & Parks LLP
Jason is an associate with the Akron office of Hahn Loeser. He is also a Registered Patent Agent (re. no. 61,120) with more than five years of manufacturing experience related to steelmaking and health and hygiene products. Jason also has experience prosecuting mechanical and materials science patent applications, including interviewing inventors, drafting patent applications, and responding to Patent Office actions.
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