By Donald Zuhn --
On Tuesday, the Federal Circuit will hear In re Fisher, in which the Court will address the utility requirement for the first time since the Patent Office set forth revised Utility Examination Guidelines in January 2001. Specifically, in Fisher, the issue of patentable utility is being raised with respect to nucleic acid molecules. In commenting on the possible importance of this case, Harold Wegner has described Fisher as having "the potential of being either the single most important pharmaceutical patent case in recent years - or a yawn." Amicus briefs filed by such well-known biotech and pharmaceutical companies as Affymetrix, Eli Lilly, and Genentech in support of the Board's decision in Ex parte Fisher suggest that it may be the former as opposed to the latter.
The particular controversy presented in Fisher can be
traced back as far as 1991, when a group of NIH investigators led by J. Craig
Venter sought to protect thousands of
While the withdrawal of these applications temporarily quieted the debate surrounding EST patentability, the Patent Office again stoked the fires of controversy in 1995, when it published new Utility Examination Guidelines. The new Guidelines removed some of the obstacles to EST patenting by only requiring that an applicant assert a utility that was "specific" and "credible." The new Guidelines had thus omitted the requirement that the assertion of utility also be "substantial," as set forth by the Supreme Court in 1966 in Brenner v. Manson. In 1997, the Patent Office further declared that since ESTs were acknowledged to have utility apart from the full-length sequences from which they were derived, an applicant would no longer be prevented from securing protection for an EST by the failure to specify the function of the full-length sequence from which that EST was derived.
The Patent Office reversed course again in 2001 when it publishing revised Utility Examination Guidelines, reinstating the Brenner substantial utility prong. The revised Guidelines now required that an applicant assert a specific and substantial utility for the claimed invention that would be considered credible by a person of ordinary skill in the art. The Patent Office also issued Revised Interim Utility Guidelines Training Materials, which provided Examples indicating how the revised Guidelines were to be applied to thirteen different types of biochemical subject matter, including ESTs, as well as definitions of the three utility prongs. In particular, the Training Materials defined "specific utility" as utility that is specific to the subject matter claimed, as contrasted with a general utility that would be applicable to the broad class of the invention; "substantial utility" as utility having a "real world" use; and "credible utility" as utility that is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided.
In the appeal to be heard Tuesday, Appellants Dane Fisher
and Raghunath Lalgudi (employees of Monsanto Co., the real party in interest)
seek to reverse the Board's decision affirming the final rejection of a claim
directed to five ESTs isolated from maize leaf tissue. The five ESTs constitute only a small portion
of the 4,013 sequences that Appellants originally claimed and an even smaller
portion of the 32,236 sequences that Appellants disclosed in their
application. Appellants also asserted a
number of utilities for the claimed ESTs in their application, including the
use of the ESTs to identify polymorphisms (i.e., alternate forms, or alleles,
of the claimed sequences), to design oligonucleotide probes or primers for use
The Board, in Ex parte Fisher, analyzed Brenner and subsequent CCPA and CAFC decisions in In re Kirk, In re Ziegler, In re Jolles, Cross v. Iizuka, and In re Brana, and determined that "[r]ather than setting a de minimis standard, Section 101 requires a utility that is 'substantial'," or in the words of the Brenner court, "one that provides a specific benefit in currently available form." The Board then examined Appellants' asserted utilities and determined that none of the claimed ESTs provided a specific benefit in its currently available form. In particular, with regard to Appellants' assertion that the claimed ESTs could be used to measure mRNA expression levels in plant cells using microarray technology, the Board declared that "the asserted utility of the claimed nucleic acid - as one component of an assay for monitoring gene expression - does not satisfy the utility requirement of Section 101."
In briefing the issues before the Federal Circuit, Appellants argue that the Board erred in concluding that an EST is "subject to a heightened standard of utility . . . that hinges upon some undefined 'spectrum' of knowledge about the function of the gene that corresponds to the EST." Appellants also contend that the Board erred in concluding that the claimed ESTs lack patentable utility "despite the undisputed existence of eight scientifically useful applications for the claimed ESTs and a commercially successful industry built upon the sale and licensing of ESTs corresponding to genes of unknown function, just like those at issue here." In arguing against the Patent Office's application of a "heightened standard" of utility in this case, Appellants note that the Patent Office has set forth "three substantially different constructions of the utility standard over the last decade alone," and that the Board has adopted a test "so ambiguous and impracticable that even the PTO cannot articulate with any reasonable certainty when the claimed ESTs - or any other EST - might be entitled to patent protection." Appellants also contend that the Patent Office has applied the wrong test in determining whether there is an assertion of specific utility, since "the specific utility prong only requires the existence of an identifiable benefit for the claimed invention; it does not require a benefit that is unique to the claimed invention."
The Patent Office, on the other hand, denies that Appellants' ESTs have been subjected to a heightened standard, arguing instead
that Appellants merely failed to assert a specific and substantial utility for
the claimed ESTs that would be considered credible by a person of ordinary
skill in the art. In its brief, the Patent
Office often focuses on Appellants' failure to satisfy the specific utility
prong, arguing, for example, that Appellants' asserted utilities "would
apply not only to the over 32,000 ESTs Fisher discloses, and to the over
600,000 ESTs disclosed in Monsanto's [six] related appeals, but also to any
ESTs derived from any organism." In
particular, the Patent Office counters Appellants' argument that because each
EST only specifically binds to its complement, the specific sequence of each
EST makes its use as a probe or primer specific, by stating that "there is
no specific reason for using the EST to bind its complement," and
therefore, "[t]o the extent that more sequence data could be acquired by
using the ESTs as probes, that result would likely be true for any scrap of
Dr. Zuhn's article "
DNA Patentability: Shutting the Door to the Utility Requirement," which was published in the summer 2001 issue of the John Marshall Law Review, contains a more thorough discussion of the history of the utility requirement, particularly with respect to DNA sequences.
This article was originally published on Patently-O on May 2, 2005.