Federal Circuit Resolves Controversy Regarding
Product-by-Process Claims
by Mark J. Cohen, Ph.D.
The Federal Circuit in Abbott Laboratories v. Sandoz Inc. (Fed Cir, No 2007-1400), in a decision dated May 18, 2009,
resolved the conflict between two earlier decisions, Scripps Clinic and Research Foundation v. Genetech, Inc.,
927 F2d 1565, 18 USPQ 2d 1001 (Fed Cir 1991) and Atlantic Thermoplastic Co. v. Faytex Corp., 970 F2d 834, 73 USPQ 2d 1481
(Fed Cir 1991), regarding infringement of product-by-process claims.
A product-by-process claim is a claim which recites process parameters in defining the product. Product-by-process claims
are used in situations where the product structure is not known and/or too complex to analyze; the process parameters are
used to aid in defining the product. Scripps, the earlier case written by Judge Pauline Newman, held that a product-by-process
claim is a product claim and that the process parameters are not considered for determining infringement. On the other hand,
Atlantic Thermoplastic, written by Judge Randall Radar, held that product-by-process claims were limited by the process.
In a sua sponte en banc decision, written by Judge Radar, the Court reaffirmed the Atlantic Thermoplastic holding that the process
terms in product-by-process claims serve as limitations in determining infringement.
The opinion cited several U.S. Supreme Court decisions including Warner-Jenkinson which held that each element contained in
a claim is deemed material to defining the scope of the patented invention. As the Court stated:
In the modern context, however, if an inventor invents a product whose structure is either not fully known or too complex to analyze . . . ,
this court clarifies that the invention is absolutely free to use process steps to define this product. The patent will issue subject to
the ordinary requirements of patentability. The inventor will not be denied protection. Because the inventor chose to claim the product
in terms of its process, however, that definition also governs the enforcement of the bounds of the patent right. This court cannot simply
ignore as verbiage the only definition supplied by the inventor.
This court's rule regarding the proper treatment of product-by-process claims in infringement litigation carries its own simple logic.
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 the 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 than a comparison of the
claimed and accused infringing process? 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. Why also would the courts deny others the right to freely practice process Z that
may produce a better product in a better way?
In sum, it is both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should
not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only
by reference to a process by which it can be made. Such a rule would expand the protections of the patent beyond the subject matter that
the inventor has "particularly point[ed] our and distinctly claim[ed]" as his invention, 35 U.S.C. §112 ¶6 . . .
In contrast, the patentability of the product-by-process claim is established independently of the process by which it is identified in the claim.
Thus, patentability is a much broader inquiry than infringement. This decision defines an exception to the rule that patent claims are
construed the same way for validity and infringement.
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