AAMC's Comment Letter to
the PTO on Revised Guidelines and Genetic Sequences
[In December 1999, the U.S Patent and Trademark Office issued
revised interim guidelines for patent reviewers on standards
of utility and written description. The AAMC's and other public
comments are accessible through the PTO's
website, posted in April 2000.]
March 16, 2000
Box Comments
Assistant Commissioner for Patents
Washington, D.C. 20231
Attention: Linda S. Therkorn
Re: Revised Interim Utility Examination Guidelines [64
FR 71440], and Revised Interim Guidelines for Examination
of Patent Applications Under the 35 U.S.C. § 112, 1 "Written
Description" Requirement [64 FR 71427].
I am writing as the President of the Association of American
Medical Colleges (AAMC), representing the nation's 125 medical
schools, some 400 teaching hospitals, and 91 academic medical
societies. Our institutions, at which approximately half of
all extramural research sponsored by the National Institutes
of Health (NIH) is performed, play a central role in the Human
Genome Project, including serving as host to numerous genome
centers and home to thousands of contributing investigators.
Medical schools and teaching hospitals also collaborate with
industry in the development of new drugs, diagnostics, and
innovative clinical procedures that integrate the outcomes
of genomic research into medical practice. Many of these institutions
are represented within the files of the Patent and Trademark
Office (PTO).
A central concern to the biomedical research community is
the extent to which claims on DNA, or polynucleotide, sequences
are recognized within the patent system. In particular, the
AAMC generally opposes the issuance of patents pertaining
to incompletely sequenced genes or those of unknown function,
as in the case of expressed sequence tags (ESTs). The principle
use of ESTs is as a research tool for identifying unknown
genes of yet-to-be-determined sequence and function. As in
the case of other research tools, the issuance of patents
on ESTs threatens to subject researchers to numerous and onerous
restrictions in their ability to use or apply information
entangled by these "inventions," and consequently
would impede the progress of this important area of research.
The posited use of ESTs for real world applications in forensics,
gene mapping, or other areas almost always requires significant
further research to enable a person of "ordinary skill
in the art" to use such inventions. Moreover, a profusion
of EST patents will effectively discourage researchers from
determining full-length expressed and genomic sequences and
isolating the protein(s) encoded by the gene for medical application
for fear that success in this endeavor would plunge them into
a morass of infringement claims and engender protracted litigation.
From this perspective, the AAMC has closely reviewed the
above referenced interim guidelines and their implications
for genomic research. In general, these guidelines make significant
strides toward addressing our concerns.
Our specific comments are noted below:
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Revised Utility Guidelines: The AAMC commends the PTO
for establishing a standard of "specific, substantial,
and credible" utility in its revised guidelines.
We agree that applicants for claims to expressed sequence
tags, single nucleotide polymorphisms, and other gene
fragments must demonstrate such utility, or their applications
should be rejected.
The AAMC strongly agrees with the NIH, representing the
Public Health Service, that the revised standard should
not be interpreted to embrace claims of a "theoretical
function" for polynucleotide sequences, such as a homological
description, as a sole basis for utility. Automated programs
and databases frequently enable researchers to infer, or
"guess," the identity and function of a protein
encoded by a gene based on the similarity of a fragment
to other known genes. Such suppositions of utility are technology
driven, require little scientific insight or creativity,
and do not characterize a specific, substantial and credible
utility.
The guidelines provide that an examiner should not reject
an application that is judged to have a well-established
utility, regardless of the quality of the assertion made
by the applicant. The PTO defines a utility as well established
if a person of ordinary skill in the art would immediately
appreciate that the invention would be useful based on its
applications and other characteristics. It implicitly follows
from the guidelines that a utility determined to be well
established should also meet the standard of "specific
and substantial" if an examiner decides not to impose
a rejection. The AAMC believes that, in instances where
the examiner perceives an invention to have a well-established
utility not explicitly asserted by the applicant, the written
record should clearly identify this utility and the rationale
for considering it specific and substantial. A clear explication
in the record will be invaluable as arguments regarding
the utility of polynucleotide sequences inevitably arise
in the future.
-
Revised Written Description Guidelines: The guidance
of the Court of Appeals Federal Circuit (CAFC), most recently
in Regents of the University of California v. Eli Lilly
and Co. (1997), has established the requirement that
claimed DNA sequences be identified by specific formulation,
as with claims on other chemical formulae. Several public
comments in response to the earlier proposed written description
guidelines argued that the inclusion of open-ended
claim language in EST claims would be contrary to
the CAFC's decision in Lilly, because a sequence
described by such language would not constitute a "substantial
portion of the genus." In its response, reported
within the revised interim written description guidelines,
the PTO has indicated that it would recognize open claim
language on a gene fragment. The AAMC strongly opposes
the inclusion of open claim language for an EST or other
gene fragment within the written description, and agrees
with the NIH's analysis that it could assist holders of
such patents to assert domination over later discovered
full length genes. Consequently, we urge the PTO to limit
the breadth of such claims to a scope commensurate with
the sequence structure actually disclosed by the applicant.
In conclusion, the AAMC acknowledges that the patent system
is a cornerstone of recent advancements in pharmaceuticals
and other products that have markedly improved medical care
and human health. But we also wish to stress that this progress
has been built upon open scientific discovery and communication.
The Association is deeply concerned about and strongly opposed
to the practice of awarding broad-reaching patents on claims
to DNA sequences that do not meet a rigorous, high standard
of specific, substantial, and credible utility. We believe
that the overly facile issuance of such patents in recent
years is inimical to the progress of science, as well as to
the practice of medicine, and not in the public's best interest.
Therefore, we urge that the utility and written description
guidelines be further strengthened and delimited, as recommended
by the NIH.
Sincerely,
Jordan J. Cohen, M.D.
President
Association of American Medical Colleges
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