In 2006, the American Intellectual Property Law Association passed a resolution supporting, in principle, legislation to codify an exemption from patent infringement for uses of a patented invention related to scientific research or experimental inquiries. The resolution explicitly provided that, under the proposed legislation, it would not be considered an act of infringement to make or use a patented invention solely to discern or discover:
• The validity or scope of the patent;
• Features, properties, inherent characteristics or advantages of the patented invention;
• Methods of making or using the patented subject matter; or
• Alternatives to, improvements on or substitutes for the patented invention.
The intellectual property section of the American Bar Association had passed a similar resolution 18 years earlier.
Such legislation would be a direct response to one of the shortcomings in the patent system identified in the 2004 National Academies’ monumental study of the system. That study’s final report, and many other publications, have criticized patents as impediments to innovation, directly contrary to the constitutional purpose of patents, i.e., to promote progress in science and the useful arts, at least to the extent that they inhibit research. While the validity of that criticism may be challenged, it would be far easier to blunt it with a legislative solution to which there would likely be little opposition, i.e., a legislatively created exemption from patent infringement for research of the type referred to in the AIPLA resolution.
Among coincidental indicators of the merit of such legislation is that the patent systems of virtually every other major country in the world include such an exemption. While the need for this legislation seems to have escaped the attention of Congress, not so, the courts.
Indeed, a judicially created research exemption to patent infringement with roots in the early 19th century has been progressively narrowed to the point of irrelevancy by the U.S. Court of Appeals for the Federal Circuit. As critics of the patent system invariably cite the inhibition of research by patents as one of their main objections to patents, proponents of a strong and effective patent system should move this proposed legislative fix to the front burner.
Nowhere has the need for this fix been clearer than in the media publicity and private briefing urging invalidation of Myriad Genetics’ patent claims covering certain genes isolated from their native environment. A number of researchers gave testimony, in support of those urging invalidation, that they in fact limited or discontinued their research in view of the possibility that they could be sued for patent infringement. Those pursuing this line of attack have ignored completely Myriad’s public disclaimer of any interest in asserting the patent against research activities. Whether or not these activities are vulnerable to a charge of patent infringement, the reality is that inhibition of research has been one of the most publicized and possibly most effective, though arguably irrelevant, arguments to invalidate the patents in question.
With the Supreme Court’s grant of certiorari to review the Federal Circuit’s decision in the Myriad Genetics case (Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (2012)), it would not be surprising if the court’s decision on the patent eligibility of isolated genes is impacted by its concern for the inhibition of related research. In the earlier case of Laboratory Corp. of America Holdings v. Metabolite Laboratories. 548 U.S. 124 (2006), Justice Stephen G. Breyer, in dissenting from vacation of a prior grant of certiorari, explicitly found the inhibition of research by patents justification for his view that the patent claims at issue in that case should be examined by the Supreme Court lest those claims pre-empt others from applying a law of nature. Breyer reasoned that when a patent claim covered an abstract idea, as he characterized the claims in issue in that case, they, in effect, claim an exclusive right in a law of nature. Breyer revisited this logic in his opinion for the court in Mayo Collaborative Services v. Prometheus, 132 S.C. 1289 (2011). That reasoning conflates the issue of patent eligibility with the entirely different issue involving the alleged inhibition of research caused by the vulnerability of researchers to claims of patent infringement.
Entirely absent from Breyer’s reasoning is any consideration of whether the inhibitive effects of the patent differ when the hypothetically inhibited research involves use of the claimed invention as opposed to research on the claimed invention. Contentions that a research exemption should apply to the former would render meaningless the patent protection of research tools, such as a radically improved centrifuge. More in point, with reference to the Myriad Genetics case, would a valid patent claim on a gene isolated from its native environment preclude use of that gene in research on an alternative gene for diagnosing breast cancer, as opposed to use of that gene to actually diagnose a patient for breast cancer? In its preferred form, as proposed in the policy resolutions of the AIPLA and the IP section of the ABA, the research exemption would find the latter, but not the former, an infringement.
Among those who have studied or written about a possible research exemption, none have opposed such an exemption.
Controversy does arise, however, regarding an extension of this exemption that would exempt not only research on the patented invention, but also research using the patented invention. That would encompass research using patented research tools. For the most part, proponents of this extension argue that genetic research in particular is inhibited by a common necessity in that research to use patented research tools, such as reagents, antibodies, DNA sequencing instruments, genetically modified animals, etc. Whether anyone would develop such research tools, in the absence of patents to protect their investment in that development, raises much larger questions. At least one writer urges that research tools developed in the course of government-sponsored research should be made available to the research community free of patent protection. The merit or demerit of these proposals may be debated separately, but that debate should not be permitted to delay consideration of the otherwise uncontroversial pure research exemption that does not include use of research tools for their intended purpose.
One may ask, if the justification for a practical research exemption is so clear and so consistent with the constitutional underpinnings of the patent system, why have court decisions apparently failed to realize that justification? The simple answer, of course, is that a literal reading of statutory patent law admits of almost no exceptions to the definition of what constitutes patent infringement. The one notable exception is that found in 35 USC §271(e)(1) for certain pre-patent expiration activities necessary for FDA approval to market a patented invention post-patent expiration. In contrast, copyright law, which, like patent law, is based on the constitutional imperative to promote progress by granting exclusive rights for a limited period of time in the copyrighted (as compared to patented) subject matter, includes a number of explicit exclusions from what would otherwise be copyright infringement. Most notable among these explicit exclusions, 17 USC §107 statutorily excludes, from copyright infringement, “fair use” of copyrighted subject matter.
Courts have faced this conundrum and the result is a very limited, judicially created research exemption. Numerous academics have analyzed the history of this exemption. These academics have generally concluded that the constitutionally based incentivization of progress in science and the useful arts is best served if it is clear that the information in a patent can be used to improve on or substitute for the subject matter of a patent claim or to evaluate and possibly challenge the validity of that claim. In its present form, the judicially created research exemption does not satisfy that need and is not likely to do so with any modification in the near future.
To do so would require the Federal Circuit to overrule a number of its prior decisions, most notably Madey v. Duke University, 307 F. 3d 1351 (Fed Cir. 2002). The court, in that case, could have based its decision on the fact that Duke was using the patented laser for its intended purpose, i.e., to study the physical properties of materials, not to improve on or substitute for the patented laser. Instead, it found the judicially created research exemption did not apply because Duke was using the laser in the course of its “business,” i.e., “educating and enlightening students and faculty … [and] pursuing an aggressive patent licensing program.” The Madey decision was in turn based on earlier Federal Circuit decisions that found a commercial purpose in the alleged infringing activity inimical to the research exemption that earlier courts had granted for activities performed “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.” While these Federal Circuit decisions were not inconsistent with justifications for the research exemptions found in earlier decisions of other courts, the enhanced emphasis on the commercial purpose of the activities charged as infringements seems to leave little room for the Federal Circuit to reverse itself. One judge of that court, Judge Pauline Newman, has dissented from this general view, but the court has not otherwise shown itself inclined to revisit its emphasis on commercial purpose to preclude recognition of a practical research exemption.
Under these circumstances, Congress may be the best, if not the only, source of a practical response to the concern expressed by Breyer and echoed repeatedly in the media and in legal arguments, such as those seen in the Myriad Genetics case. That concern, that research is meaningfully inhibited by patents, would be greatly ameliorated by a research exemption such as that favored by the AIPLA resolution. At the same time, progress in the development of inventions covered by valid patents would continue to be promoted and protected. If Breyer wishes to find that a patent claim is nothing more than an expression of a law of nature and therefore patent ineligible, so be it. But this should not preclude patent coverage on a new and unobvious use of the that law of nature. Nor should that patent preclude further research on that use. More importantly, it should not be invalidated because it precludes research on the law of nature itself.
A meaningful discussion of the proposed research exemption would make this clear. •
Paul F. Prestia is senior counselor and strategic adviser at RatnerPrestia, the firm he co-founded and led as CEO for many years. His current practice is focused largely on IP counseling for risk management due diligence, strategic IP protection and IP value realization.