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.