In re Fisher

Brief Fact Summary. Fisher (Plaintiff) stated that his claimed invention, relating to five purified nucleic acid sequences (genes), also known as expressed sequence tags (ESTs), that encoded proteins and protein fragments in maize plants, had a specific and substantial utility and that his patent application made it possible for someone of ordinary skill in the art to use the invention.

Synopsis of Rule of Law. A patent application that reveals general generic uses of a claimed invention, which simply assists research, lacks utility and lacks enablement.

Facts. Plaintiff submitted a patent application (the ‘643 application) that related to five purified nucleic acid sequences (genes), also known as expressed sequence tags (ESTs), that encoded proteins and protein fragments in maize plants.  When Plaintiff filed the ‘643 application, he did not know the precise structure or function of either the genes or the proteins encoded for by those genes.  The ‘643 application disclosed that the five claimed ESTs could be used in a variety of ways.  These included: (1) serving as a molecular marker for mapping the entire maize genome, which consists of ten chromosomes that together include about 50,000 genes; (2) measuring the level of mRNA in a tissue sample by way of microarray technology to provide information about gene expression; (3) providing a source for primers for use in the polymerase chain reaction (PCR) process to enable rapid and inexpensive duplication of specific genes; (4) identifying the presence or absence of a polymorphism; (5) isolating promoters by way of chromosome walking; (6) controlling protein expression; and (7) locating genetic molecules of other plants and organisms.  The patent examiner found that none of the stated uses for the ESTs satisfied the “substantial utility” standard and “enablement” standard required for patentability.  The board of appeals and interferences affirmed, and the court of appeals granted review.

Issue. Does a patent application that reveals general generic uses of a claimed invention, which simply assists research, lack utility and lack enablement?

Held. (Michel, C.J.)  Yes.  A patent application that reveals general generic uses of a claimed invention, which are simply assist research, lacks utility and lacks enablement.  Plaintiff’s argument that the claimed ESTs provide seven specific and substantial uses, regardless of whether the functions of the genes corresponding to the claimed ESTs are known is not convincing.  Basically, the claimed ESTs do no more than assist in research that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes.  The overall goal of such experimentation is presumed to understand the maize genome.  Therefore, the claimed ESTs are only “objects of use-testing,” meaning scientific research could be performed on the objects with no assurance that anything useful will be discovered in the end.  Plaintiff’s comparison of the ESTs to a patentable microscope is also not convincing.  A microscope can immediately reveal an object’s structure, but the claimed ESTs can only be used to detect the presence of genetic material which has the same structure as the EST itself.  It is not able to provide any information about the overall structure let alone the function of the underlying gene.  So while a microscope can give an immediate, real-world benefit in a variety of applications, the claimed ESTs cannot.  The claimed ESTs themselves are not an end of Plaintiff’s research effort, but only tools to be used along the way while searching for a practical utility.  Plaintiff’s claimed ESTs may add a noteworthy contribution to biotechnology research, but their utility is not sufficient to be eligible for patent because Plaintiff does not identify the function for the underlying protein-encoding genes.  Without sufficient identification, the claimed ESTs do not deserve a patent as they have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public.  Plaintiff’s claimed uses are not sufficient to meet the standard for a “substantial” utility under § 101.  The claimed inventions also lack enablement under § 112.  Affirmed.

Dissent. (Rader, J.)  The invention here, ESTs, has a utility as a research tool to isolate and study other molecules.  While the ESTs are only useful in a research context, they are still useful and patentable.  The Court determines the utility would not produce enough valuable information, but the existence of any information shows a utility.  The ESTs are similar to a microscope as they are a tool to enable a researcher to move one step closer to a discovery.  The Patent Office is in a difficult position because they have to distinguish between an incremental tool appropriate for patent protection and a tool that fails to provide enough advancement to justify patent protection.  The Patent Office must do this without the benefit of an obviousness requirement for genomic inventions.  The current law, however, includes research tools that provide a recognizable benefit and the ESTs have “utility” under § 101.

Discussion. Even though a research tool may not provide immediate benefit to the public at large, Judge Radar points out, and other scholars agree, that the incremental benefit offered to researchers should count as utility that deserves patent protection.  As it stands, the utility benefit is narrowly applied.