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:

  1. 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;
  2. The dubious legal status of patent claims to such unpatentable discoveries; and
  3. 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

Click here for the full submission to the Secretary's Advisory Committee on Genetics, Health and Society

 


Image of DNA strand posted on flickr under a creative commons license by ghutchis.