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

    By Sherri Oslick —

In an opinion of great import to biotechnology patent
law, the Federal Circuit 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 opinion, 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.

In re Fisher (Fed. Cir. 2005)
Panel: Chief Judge Michel and Circuit Judges Rader and Bryson
Opinion by Chief Judge Michel; dissenting opinion by Circuit Judge Rader

For additional information regarding this case, please see:

• "In re Fisher: EST Utility Redux,"  October 27, 2006

This article was originally published on Patently-O on September 8, 2005.