By Audrey Millemann

In an interesting decision in the biotechnology area, the Court of Appeals for the Federal Circuit recently held that certain nucleic acid sequences had no utility and were not enabled. In re Fisher (Fed. Cir., September 7, 2005).

The owner of the patent at issue is the biotechnology giant, The Monsanto Company. The patent application claimed five purified nucleic acid sequences known as expressed sequence tags (ESTs) that encode certain proteins in maize plants. Although the inventors identified the ESTs, they did not know the function of the genes or the proteins. The application described several uses for the ESTs, including gene mapping in maize, providing primers to use in polymerase chain reaction processes to duplicate genes, determining the presence of polymorphisms, isolating promoters, controlling gene expression, and locating genes in other plants.

The examiner rejected the claim under 35 U.S.C. ��101 on the grounds the ESTs had no specific and substantial utility. The examiner found that the uses described by Monsanto were not specific as they were no different from the uses of any EST, and were not substantial as the proteins encoded by the ESTs had no identifiable function. The examiner also rejected the claim on the grounds that it was not enabled under 35 U.S.C. ��112, first paragraph, finding that the application could not teach how to use the ESTs because they had no specific and substantial utility.

The Board of Patent Appeals and Interferences affirmed on both grounds. The Board considered the uses asserted by Monsanto, but found that each use was either of insubstantial or non-existent utility. The Board agreed that the utility rejection required an enablement rejection.

On appeal to the Federal Circuit, Monsanto argued that the Board had applied an impermissibly strict test for utility. According to Monsanto, section 101 is to be construed broadly. Monsanto contended that an invention has utility as long as it is not “frivolous or injurious to the well-being, good policy, or good morals of society”. Monsanto argued that the application passed this test because several uses for the ESTs had been described, ESTs in general are commercially successful, and it was irrelevant that the function of the genes was not known.

The PTO argued that the uses identified by Monsanto were generic to any EST, and were so non-specific as to be meaningless. At best, the enumerated uses were future research goals. The PTO was supported by amicus curiae briefs filed by several universities and industry heavy hitters (Baxter, Dow, Eli Lilly, and Genentech). The amici viewed Monsanto’s ESTs as merely speculative research plans.

The court upheld the Board’s decision on both utility and enablement grounds. The court held that the “not frivolous” test proposed by Monsanto is not the proper test for utility under section 101. The test is set forth in Brenner v. Manson, 383 U.S. 519, 534-5 (1966):

“The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point – where specific benefit exists in currently available form – there is insufficient justification for permitting an applicant to engross what may prove to be a broad field.”

The court held that “an application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public.” The court further stated that a “specific utility” is one that is particular to the claimed invention, rather than to a broad class of inventions, and has “real world” value. The court further explained that the seven uses described by Monsanto were “merely hypothetical possibilities” as there was no data (or other evidence) showing that the claimed ESTs could in fact be used for the stated purposes. In concluding, the court stated that granting a patent to Monsanto “would amount to a hunting license because the claimed ESTs can be used only to gain further information.”

One judge dissented, stating that the claimed ESTs are research tools, and are patentable like any other research tool. In sharp criticism of the majority, the dissent stated: “this court, oblivious to other challenges of complex research, discounts these ESTs because it concludes (without scientific evidence) that they do not supply enough information.”