Patents and the research exemption.

I read with great interest David Malakoff's article about the ruling in Madey v. Duke University ([1][1]) “(Universities ask Supreme Court to reverse patent ruling,” News of the Week, 3 Jan., p. [26][2]). Although I have a great deal of sympathy for the academic institutions that would like to avoid having to worry about patent infringement, the court probably delivered the correct legal opinion. The research (or experimental use) exemption to patent law has always been a very narrow exemption reserved for cases in which the use of the patented invention was for solely noncommercial purposes ([2][3]). Although the U.S. patent statute (35 U.S.C. 1–37) does not contain a research exemption, judges have created this narrow exemption in a line of cases interpreting the statute. Universities have for many years maintained that they and their employees are entitled to a research exemption because research conducted at the university is for noncommercial, i.e., academic, purposes. In an earlier era, this claim may have been substantially true, but it is no longer: The modern university serves academic and commercial purposes ([3][4]). Universities and university-based researchers now frequently conduct research for commercial purposes, hold patents and other intellectual properties, and also form start-up companies from new technologies. Universities also have their own technology transfer offices, which are designed to help researchers obtain patents, to encourage the development of useful inventions, and to protect the intellectual property interests of the university. It is probably the case that many (or even most) researchers at universities still conduct research for purely academic reasons, but a court would need to evaluate every case involving a researcher or a university on its own merits. Blanket assertions by universities like “all research conducted at universities qualifies for the research exemption” are false and self-serving. How should society respond to the Madey v. Duke University ruling? If the narrow research exemption found in case law no longer applies uniformly to the university setting, universities and university-based researchers will face two choices: (i) infringe patents and take a chance on litigation or (ii) negotiate licenses with patent holders. Both of these options would probably increase the administrative costs of conducting research because they would involve more work for attorneys and technology transfer offices. To reduce these costs and allow universities to continue business as usual, the patent statute could be amended to develop an explicit research exemption. Some commentators favor strengthening the research exemption in precisely this way ([4][5]). Although this sounds good in theory, it will probably meet stiff resistance in Congress, because private companies will certainly oppose any changes in current patent law that would undermine their intellectual property interests and create an uncertain legal environment. Furthermore, it may be very difficult to develop a clear and unambiguous definition in the statute that distinguishes between commercial and noncommercial research. One good thing that has come of this dispute is that the courts are now finally holding universities accountable for their own commercial activities. If universities want to receive the benefits of the patent system, i.e., financial gain, then they should also be prepared to bear the burdens, i.e., potential patent infringement. Justice and fair play demand that all of those who participate in the patent system play by its rules. 1. [↵][6] Madeyv. Duke University , 307 F.3d 1351 (2002). 2. [↵][7]1. J. Mueller , Wash. Law Rev. 76, 1 (2001). [OpenUrl][8][Web of Science][9] 3. [↵][10]1. A. Shamoo, 2. D. Resnik , Responsible Conduct of Research (Oxford Univ. Press, Oxford, 2002). 4. [↵][11]1. The Nuffield Council , The Ethics of Patenting DNA (Nuffield Council, London, 2002)(available at [www.nuffieldbioethics.org/patentingdna/index.asp][12]). [1]: #ref-1 [2]: /lookup/doi/10.1126/science.299.5603.26a [3]: #ref-2 [4]: #ref-3 [5]: #ref-4 [6]: #xref-ref-1-1 "View reference 1 in text" [7]: #xref-ref-2-1 "View reference 2 in text" [8]: {openurl}?query=rft.jtitle%253DWash.%2BLaw%2BRev.%26rft.volume%253D76%26rft.spage%253D1%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [9]: /lookup/external-ref?access_num=000167466300001&link_type=ISI [10]: #xref-ref-3-1 "View reference 3 in text" [11]: #xref-ref-4-1 "View reference 4 in text" [12]: http://www.nuffieldbioethics.org/patentingdna/index.asp