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.
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