As noted in Part 1 of this report, the National Research Council (NRC) observed in 2010 that:

Discovery, learning, and societal engagement are mutually supportive core missions of the research university. Transfer of knowledge to those in society who can make use of it for the general good contributes to each of these missions. These transfers occur through publications, training and education of students, employment of graduates, conferences, consultations, and collaboration as well as by obtaining rights to inventions and discoveries that qualify for patent protection (intellectual property) and licensing them to private enterprises. All of these means of knowledge sharing have contributed to a long history of mutually beneficial relations among U.S. public and private universities, the private sector, and society at large.¹

The management of intellectual property derived from federally funded research is largely governed by the legal framework promulgated by the Bayh-Dole Act of 1980 (Pub. L. 96-517, Patent and Trademark Act Amendments of 1980). The act fostered greater uniformity regarding the manner in which agencies treat the inventions arising from sponsored research. In most instances, research institutions are permitted to take title to inventions derived from basic research supported with federal funding, and the act encourages universities to become much more active in seeking to commercialize their faculties' inventions.² However, the primary goal of academic technology transfer is the dissemination and development of scientific inventions for the public good. The costs associated with the development and maintenance of institutional capabilities for the transfer of intellectual property are borne by universities; only in rare instances are these costs recovered from patenting and licensing income.

As the result of increased university patent and licensing activity credited to the passage of the Bayh-Dole Act, questions were raised regarding which principles should govern this type of activity in a university setting. In 2006, representatives of a dozen major research universities met to draft a set of points for consideration by universities when making decisions about technology licensing. The resulting document, entitled “Nine Points to Consider in Licensing University Technology,”³ was subsequently endorsed by more than 100 other research universities and organizations, including a number of non-U.S. universities, the Association of American Medical Colleges and the Association of University Technology Managers. The document set expectations that:

• “Universities should reserve the right to practice licensed inventions and…allow other non-profit and governmental organizations to do so”;
• “Exclusive licenses should be structured in a manner that encourages technology development and use”;
• “Universities should anticipate and help to manage technology transfer related conflicts of interest”; and
• Universities should “be mindful of the implications of working with patent aggregators” and “consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world.”

The 2010 NRC report Managing University Intellectual Property in the Public Interest later examined the role and significance of the Bayh-Dole Act on technology transfer:

One purpose of the Act was to provide consistency within federal agencies with respect to inventions developed with federally funded research. The broader purpose of the Act was to ensure that publicly funded inventions should, whenever possible, enhance the public welfare through commercialization of technology to contribute to public health, government missions, job creation, international competitiveness, economic growth, and other public goods.⁴

The 2011 Leahy-Smith America Invents Act, the first major change in U.S. patent law in more than 60 years, also has significant implications for the management of university intellectual property. The act created a “first-inventor-to-file” system that harmonizes the U.S. patent system with that of trading partners across the globe; improved patent quality by strengthening the quality management and standards processes of the U.S. Patent and Trademark Office; and by creating more efficient alternatives to the courts for challenging patents, allows challengers an opportunity to eliminate weak patents and strengthen patents that survive a patent challenge;⁵ and provided mechanisms to reduce both the backlog of patent applications and patent litigation.

Footnotes

1

National Research Council. Managing University Intellectual Property in the Public Interest (Washington, DC: The National Academies Press, 2010), p. 1.

2

Recently, as the result of litigation regarding university versus university employee ownership of inventions (see, e.g., Stanford University v. Roche Molecular Systems, Inc.), universities have modified employment documents to indicate that university employees hereby assign to the university the rights to inventions and patents conceived or developed using university resources or facilities.

3

California Institute of Technology et al., “In the Public Interest: Nine Points to Consider in Licensing University Technology,” March 6, 2007. Available at: http://www​.autm.net/AUTMMain​/media/Advocacy​/Documents/Points_to_Consider.pdf.

4

National Research Council. Managing University Intellectual Property in the Public Interest (Washington, DC: The National Academies Press, 2010), p.16.

5

Association of American Universities, Association of American Medical Colleges, American Council on Education, and Association of Public and Land-grant Universities to Association Constituencies, June 4, 2011, available at: http://www​.acenet.edu​/news-room/Documents​/Memo-on-Patent-Reform-Reminder-to-Support-the-America-Invents-Act.pdf.

6

See https://era​.nih.gov/iedison/iedison.cfm.

7

NASA, for instance, does not utilize the system.

8

See, e.g., Council on Governmental Relations, “Meeting Report, October 27 and 28, 2011,” (November 18, 2011), available at http://www​.cogr.edu/COGR​/files/ccLibraryFiles​/Filename/000000000246/151875.pdf and Association of University Technology Managers, “Advanced Bayh-Dole Compliance Discussion'” (2016 Annual Meeting), available at http://www​.autm.net/2016-annual-meeting​/schedule​/filter/track-d​/d4-advanced-bayh-dole-compliance-discussion/.

9

National Institutes of Health. “iEdison Reporting Timeline.” See https://era​.nih.gov/iedison​/invention_timeline.cfm.

10

See Association of University Technology Managers, “AUTM U.S. Licensing Activity Survey: FY2014,” available at http://www​.autm.net/resources-surveys​/research-reports-databases​/licensing-surveys​/fy-2014-licensing-survey/.

11

National Research Council. Managing University Intellectual Property in the Public Interest (Washington, DC: The National Academies Press, 2010), p. 3.

12

The Director, National Institute of Standards and Technology, has authority over “functions relating to the promulgation of regulations pertaining to the ownership of inventions made with federal funding, the licensing of inventions owned by the Federal Government, and the ownership of inventions made by Federal employees under Section 6(a) of the Bayh-Dole Act (35 U.S.C. 206-209) and E.O. 10096, as amended by E.O. 10930.” See http://www​.osec.doc.gov​/opog/dmp/doos/doo30_2a.html.