CAFC: Genetic Tags Unpatentable Unless Function of Underlying Gene is Described

In re Fisher (Fed. Cir. 2005).

ESTs Unpatentable for Failure to Satisfy 35 U.S.C. § 101 Where Function of Underlying Gene is Unknown

by Sherri Oslick, PhD

In an opinion of great import to biotechnology patent law, the CAFC affirmed the decision of the Board of Patent Appeals that denied a patent to five expressed sequence tags (ESTs) — holding that in the absence of an identification of the function of the underlying genes, “the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.”  In its opinions, the CAFC endorsed the 2001 PTO Utility Examination Guidelines, holding that Brenner v. Manson applies broadly to the fields of chemistry and biology and that the PTO had not applied a heightened standard for utility of ESTs. 

Monsanto, the real party in interest, had asserted that the claimed nucleic acid sequences found their use as research tools, including use in monitoring gene expression by measuring the level of mRNA through microarray technology and in identifying the presence or absence of polymorphism.  The CAFC, however, dismissed this argument and affirmed that, without presenting a specific function for the underlying gene, the claimed invention lacked a specific and substantial utility and the application in question therefore also did not meet the enablement requirement of 35 U.S.C. § 112, as it incorporates the utility requirement of 35 U.S.C. § 101. 

Following the directive from the Supreme Court in Brenner, the CAFC noted that any invention must have a substantial and specific utility. 

Substantial Utility: “an asserted use must show that the claimed invention has a significant and presently available benefit to the public.” 

Specific Utility: “an application must disclose a use which is not so vague to be meaningless” and “an asserted use must [] show that the claimed invention can be used to provide a well-defined and particular benefit to the public.”

Applying these principles, the CAFC found that the asserted utilities met neither the substantial nor the specific test.  Rejecting Monsanto’s analogy that ESTs are like a microscope, a patentable research tool used to generate data about a sample of unknown properties, the CAFC found the ESTs to be merely a starting point for further research, providing no presently available benefit. 

[W]hile a microscope can offer an immediate, real world benefit in a variety of applications, the same cannot be said for the claimed ESTs. Fisher’s proposed analogy is thus inapt. Hence, we conclude that Fisher’s asserted uses are insufficient to meet the standard for a “substantial” utility under § 101.

The CAFC also held that the asserted uses were not specific.  Asserting that any EST from the maize genome could perform any of the recited utilities, the CAFC found that Monsanto had failed to assert any utilities setting the five claimed ESTs apart from the 32,000 plus ESTs disclosed in the application or any EST for that matter.  The disclosure of such general utilities was “nebulous” and not sufficiently specific.

In dissent, Judge Rader distinguished Brenner and argued that the majority, without supporting scientific evidence, was too quick to render a value judgment that the utility of the claimed ESTs would not provide enough valuable information, that the information gained through the ESTs was too “insubstantial” to merit patent protection.  Scientific research, noted Rader, is an incremental process, and ESTs, like a microscope, possess utility, albeit limited to the laboratory setting, as research tools useful in studying other compounds.  ESTs, therefore, provide an identifiable benefit to society. Rader argued that the majority failed to recognize the complex nature of scientific discovery, and that “only the final step of a lengthy incremental research inquiry gets protection” under the majority holding.  The decision to deny protection to inventions that contribute to the “useful arts” but not to an extent justifying the exclusive right afforded by a patent, contended Rader, is more properly founded in the nonobviousness requirement of 35 U.S.C. § 103 than in the utility requirement of 35 U.S.C. § 101.

This post was written by Sherri Oslick, PhD. Sherri studied chemistry as an undergraduate at Cornell University, bio-organic chemistry as a graduate student at MIT, and biochemistry and molecular biology as a postdoctoral associate at University of Chicago.  She practices biotech patent law as a law clerk at MBHB in Chicago.  She is an Hon. Howard T. Markey Distinguished Scholar at the John Marshall Law School and will graduate later this year. []