Patent and Health Law Professors Submit Comments to NIH on Gene Patents, Licensing Practices, and Their Impact on Patient Access to Genetic Tests
June 01, 2009
CONTACT: Joshua Sarnoff
Professor of Law, WCL
202-274-4165
jsarnoff@wcl.american.edu
In response to the request for feedback on the Secretary’s Advisory
Committee on Genetics, Health, and Society’s (“SACGHS’s”) Public
Consultation Draft Report on Gene Patents and Licensing Practices and
Their Impact on Patient Access to Genetic Tests (“Draft Report”), the
undersigned law professors submit the following comments. (Our
affiliations are provided for identification only.) We believe our
comments will help the Committee to better understand the current state
of the law regarding genetic patents, how such patents have been
unjustifiably granted, and why they will continue to create serious
problems for innovation, health care, and society at large.
In
particular, our submission responds to three statements in the Draft
Report. The first, at page 26 of the draft (emphasis added), states
that: “"some legal scholars have called for the courts to conduct a
‘fact-specific inquiry into the materiality of the differences that are
created by the processes such as isolation, purification, and
synthesis.’ Whether or not courts decide to undertake this inquiry at
some point in the future, for the time being, isolated and purified DNA molecules are clearly patentable."
If this statement is meant to suggest by “patentable” only that such
DNA patents have issued, it is clearly correct. If this statement is
meant to suggest that any such issued DNA patents are valid,
it is clearly mistaken, given a proper understanding of the binding
Supreme Court interpretations of patentable subject matter.
Notwithstanding the fact that the U.S. Patent and Trademark Office
(“PTO”) has granted numerous patents on isolated and purified genetic
materials, a correct understanding of existing law reveals that all such patents are invalid as not patentable subject matter, and many also are invalid for obviousness.
The
fact that PTO practices (based on interpretations of the U.S. Court of
Appeals for the Federal Circuit (“Federal Circuit”)) have been at
variance with the applicable law for decades does not make this any
less true. As the Federal Circuit itself recognized last month, the
Supreme Court in a seminal case on obviousness in 2007 unambiguously
discredited the Federal Circuit’s 1995 decision on gene patents, which
Federal Circuit decision likely resulted in thousands of gene sequence
claims improperly being granted as non-obvious. There is every reason
to think the Supreme Court will similarly unambiguously discredit the
Federal Circuit’s patentable subject matter precedents in conflict with
binding Supreme Court precedents. No adequate justification has been
presented for extending patent law to permit the patenting of such
genetic materials.
The second statement, at page v of the draft,
confirms statements made earlier by the National Academy of Sciences
that: “the evidence to date suggests that the number of difficulties
created for researchers by human DNA and gene patenting is currently
small, the complexity of the patent landscape is worrisome and may
become ‘considerably more complex and burdensome over time.’” This
statement mistakenly conveys the impression that there is no sufficient
current problem that would warrant immediate action to change
applicable practices, and that further adverse developments should
occur before taking action. The seriousness of the current problem is
reflected in both the particular examples and survey evidence that our
comments discuss.
This statement is particularly problematic
given that human DNA and gene patents were never valid and that many of
them reflect insufficient creativity to have warranted the patent grant
even if they were patentable subject matter. Thus, the “difficulties”
such patents have caused should have been entirely avoided, and in most
cases such patents resulted in no, much less partially, offsetting
social benefits. Participants in the already-strapped health care
system—including patients, insurers and Medicare—have had to pay
unnecessarily for access to gene sequences and biological facts that
should never have been patented in the first place. The “difficulties”
caused by the patent system for scientific innovation and health care
practices relating to genetic tests are in fact serious problems that
warrant immediate governmental responses. Waiting for such problems to
become even worse will only make adoption of the necessary legal
responses more difficult and more costly.
The third statement,
at page 7 of the draft, notes “general agreement regarding the
importance of patents for innovation in therapeutics and lack of
evidence that patenting per se poses a problem with access to
DNA-based technology or the development of new technologies.” Not only
is there no such “general agreement,” but also (given the applicable
law that human DNA and gene patents have never been validly patented)
this statement improperly shifts the burden of justification to extend
the patent system to validly apply to such technologies. Given existing
incentives for gene-based science and medical discoveries, there are
good reasons to believe that patents are not needed to
incentivize DNA-based therapeutic (as well as diagnostic) innovations.
Further, the evidence suggests that the mere fact of patenting such
technologies, by threatening liability and by requiring costly
evaluations and licensing, may chill rather than promote further
innovation and may impose other social costs that should be avoided.
Again, waiting for these problems to become worse will make the
necessary responses more difficult and more costly.
Our submission addresses the following issues, around which the comments are organized:
- The questionable need for patent incentives and rights in genetic sequences and other derivatives of naturally occurring materials, certain diagnostic discoveries, and other discoveries of laws of nature and products of nature;
- The dubious legal status of patent claims to such unpatentable discoveries; and
- The serious current and future harms caused by granting patents on such unpatentable discoveries.
Our
submission is not an exhaustive treatment of these issues, but rather
is intended to highlight mistaken assumptions about the need for,
validity of, and effects of gene sequence patents and other patents
reflecting newly identified natural products and phenomena. The
submission focuses on the issue of the legal status of patent claims
that have issued for such discoveries of nature, and the need for
government agencies like the U.S. Department of Health and Human
Services (“HHS”) and the PTO to properly follow the binding Supreme
Court precedent in regard to patents that have issued for such natural
discoveries and for claims to such natural discoveries that are
currently pending. The submission also notes that even if the PTO does
not itself invalidate such patents or refuse to grant such claims,
other areas of law may be used to limit efforts to seek patents on such
unpatentable discoveries, and thus to restrict the adverse consequences
currently being imposed by the patent system in this area.
HHS
and the National Institutes of Health (“NIH”) have already done much to
encourage the broad exchange of research tools and materials, as the
Draft Report itself notes at v, to broadly license genomic inventions,
as the Draft Report notes at 45-48, and to discourage gene patenting.
But they can and should do more. HHS and NIH (and other federal
agencies) can draft their funding agreements to prohibit recipients
from taking title to the genetic sequences and other discoveries of
nature made with federal funding, and thus can prevent funding
recipients from seeking to patent those discoveries. The “exceptional
circumstances” required for such action (as discussed in the Draft
Report at 48-49), is demonstrated by the improper patenting of such
discoveries (under binding precedents) and by the adverse effects such
patents have caused. 35 U.S.C. § 202(a)(ii). The undersigned would be
happy to elaborate on any of the issues addressed.
Joshua D. Sarnoff
Professor
Washington College of Law
American University
Dr. Jonathan Kahn
Associate Professor
Hamline University
School of Law
Lori B. Andrews
Distinguished Professor of Law
Chicago-Kent College of Law
Illinois Institute of Technology
Image of DNA strand posted on flickr under a creative commons license by ghutchis.
