In re Fisher
421 F.3d 1365 (2005)
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Rule of Law:
To satisfy the utility requirement of 35 U.S.C. § 101, a patent application must disclose a specific and substantial utility for the invention. A utility is not substantial if it requires further research to identify or confirm a real-world use, and it is not specific if it is a general utility applicable to a broad class of inventions.
Facts:
- Dane K. Fisher and Raghunath Lalgudi (collectively “Fisher”) identified five purified nucleic acid sequences, known as expressed sequence tags (ESTs).
- The ESTs were derived from a cDNA library generated from maize plant leaf tissue harvested during anthesis (the flowering stage).
- At the time of the patent filing, Fisher did not know the precise structure or function of the genes from which the ESTs were transcribed, nor the proteins encoded by those genes.
- The patent application asserted seven potential, general uses for the claimed ESTs, including serving as molecular markers, measuring mRNA levels, providing primers for PCR, identifying polymorphisms, isolating promoters, controlling protein expression, and locating genes in other organisms.
- The seven asserted uses were general research applications potentially applicable to any EST, not just the five specific ESTs claimed in the application.
Procedural Posture:
- Fisher and Lalgudi filed patent application Serial No. 09/619,643 with the U.S. Patent and Trademark Office (PTO).
- The patent examiner issued a final rejection of the application's single pending claim for lack of utility under 35 U.S.C. § 101 and lack of enablement under § 112.
- Fisher appealed the examiner's rejection to the PTO Board of Patent Appeals and Interferences ('Board'), which is an administrative appellate body within the PTO.
- The Board affirmed the examiner's final rejection on both grounds.
- Fisher (appellant) appealed the Board's decision to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does a patent application for expressed sequence tags (ESTs) satisfy the utility requirement of 35 U.S.C. § 101 if the application discloses several potential research uses for the ESTs but does not disclose a known function for the underlying genes or proteins they represent?
Opinions:
Majority - Chief Judge Michel
No. The patent application for the claimed expressed sequence tags (ESTs) does not satisfy the utility requirement of 35 U.S.C. § 101 because it fails to disclose a specific and substantial utility. Following the Supreme Court's precedent in Brenner v. Manson, an invention must have a utility that provides a specific, well-defined benefit and a substantial, real-world benefit that is presently available, not merely a potential for future use after further research. Fisher's seven asserted uses are not 'substantial' because they are merely starting points for further research on genes and proteins of unknown function; they represent a 'hunting license' rather than the successful conclusion of a search. The uses are also not 'specific' because they are general functionalities applicable to any EST, not just the five claimed. The claimed ESTs are merely research intermediates to study other materials of unknown use, which, like the chemical intermediates in In re Kirk, lack patentable utility.
Dissenting - Circuit Judge Rader
Yes. The patent application for the claimed expressed sequence tags (ESTs) satisfies the utility requirement of 35 U.S.C. § 101 because the ESTs have a clear utility as research tools. The majority incorrectly applies a heightened standard that fails to recognize the incremental nature of scientific advancement. The claimed ESTs are analogous to a microscope; both are valuable research tools that allow scientists to take a step closer to understanding a previously unknown structure, thereby providing an immediate benefit to the research community. The majority's value judgment that the ESTs do not provide 'enough' information is improper for a § 101 utility analysis and is better suited for the obviousness inquiry under § 103. The ESTs have a clear, specific, and unquestionable utility in analyzing and studying other molecules, which is sufficient to meet the statutory requirement.
Analysis:
This decision significantly clarified and raised the utility standard for biotechnological inventions, particularly for genomic discoveries like ESTs. By requiring a specific and substantial 'real world' utility, the Federal Circuit effectively prevented the patenting of gene fragments and other 'upstream' research tools where their practical, end-use application was unknown. This holding was intended to prevent a 'patent thicket' or 'tragedy of the anti-commons,' where basic scientific research could be hindered by numerous patents on foundational discoveries of uncertain function. The ruling forces inventors in the biotechnology field to conduct further downstream research to identify a concrete function before they can secure patent rights, thereby keeping fundamental genetic information in the public domain for a longer period.
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