Government support of translational science: a promising way to bridge the development gap and increase technology commercialization to support the American economy.

AuthorKeating, Leah Tenney

Cite as 13 J. High Tech L. 650

  1. INTRODUCTION

    The purpose of patent law is to promote innovation by granting inventors a period of exclusivity within which to exploit their rights in the marketplace. (2) Since 1990, over seventy-five percent of all issued U.S. industrial patents have cited academic research as a key source of new knowledge. (3) Universities derive a majority of funding for the research that leads to patents from the federal government. (4) Continued and targeted funding of university inventors is essential for continued innovation and building industries for the future. (5) American innovation is at the heart of the country's success and holds the key to the future. (6) Further, collaborations that bring together expertise from the public and private sectors hold great potential as vehicles for successfully translating research results into viable products. (7)

    Only since 1980 has technology transfer been likely to occur at Universities. (8) In the last thirty years, university activity in the field has grown exponentially--not simply in terms of the number of offices that exist but also in their productivity. (9) The mission of technology transfer offices and the universities that support them is to enhance access to research and ensure that society reaps the benefits of new inventions. (10) Too often though, early stage inventions are left to languish in the laboratory instead of being developed and launched into the market. (11) To overcome this roadblock to commercialization, university technology transfer offices can act as trusted partners for industry and investors, and serve as advisors to faculty members toward the conclusion of fair, mutually beneficial agreements aimed at driving research toward commercialization. (12) As part of that commercialization effort, a focus on targeted funding for proof-of-concept programs has emerged. (13) Proof-of-concept is a vital step toward attracting further investment in nascent technologies. (14) While private parties currently supply most of this funding, the federal government has initiated some programs in this area. (15)

    As a country driven by innovation, it is vital to increase the funding levels for focused translational science programs in order to increase the number of useful technologies that reach the market and benefit the public. Momentum in this area continued with the passage of the Proof of Concept Partnership Pilot Program as an amendment to the Small Business Act as part of government defense appropriations for the 2012 fiscal year. (16) Even more, the creation of the National Center for Advancing Translational Research (NCATS) and the Cures Acceleration Network hold the potential to significantly impact innovation in America. (17) The government has a duty to promote American competitiveness, which relies on innovation, and the NIH should quickly award the funding authorized by the Proof of Concept Partnership Pilot program. Universities that accept federal funding on behalf of Principal investigators for basic research likewise have an obligation to society to commercialize technology, with an eye toward advancing technologies to the stage where an investor or corporation could further develop them for the benefit of the public and the economy. This is the reason that early-stage proof-of-concept programs and effective technology transfer programs are so vital--to bridge what is commonly referred to as the 'development gap' and reach the end goal of creating products that benefit society.

    This Note supports current efforts to promote dedicated proof of concept funding programs, and suggests that initial institutional recipients of this targeted funding employ a strategic, results-oriented approach to commercialization to support future rounds of similar financing. More broadly, it sets forth the link between proof of concept programs, successful technology commercialization and the related competitiveness of the United States in the global innovation economy. (18) Section II begins with a brief history of the government's involvement in funding basic research and technology transfer, focusing on the post-WWII era. It then explains the significance of the Bayh-Dole Act and its affect on university technology transfer. Finally, it introduces and explains a modern model of university technology transfer focused on attracting skilled professionals to negotiate and enforce effective agreements. Section III explains the problem of the development gap and introduces the emergence of targeted proof-of-concept funding programs as a tool to bridge that gap and attract outside investment to develop new technologies. Section IV discusses benefits and criticisms of the government's translational science programs, and explains the role of technology commercialization as vital to the larger economy. The discussion supports these efforts as vital to improving the translational process and as fully in line with the appropriate role of government. Lastly, it suggests that success depends upon recipients working collaboratively in a goal-oriented manner in order to validate and promote further investment in translational science.

  2. A BRIEF HISTORY OF TECHNOLOGY TRANSFER AND THE EMERGENCE OF PROOF-OF-CONCEPT PROGRAMS

    1. THE FEDERAL GOVERNMENT'S (EARLY) INVOLVEMENT IN RESEARCH AND DEVELOPMENT

      Historically, inventors were self-funded. (19) Some invented while others exploited the commercial potential of inventions. (20) During the First World War, government focused research on military applications. (21) But by the Second World War, while that focus continued, (22) the government recognized that scientific research was essential to the future of the United States. (23)

      The Federal government's involvement in the funding of modern science grew dramatically after World War ii when President Roosevelt challenged Vannevar Bush, Director of the Office of Scientific Research to answer the question: "what can the Government do now and in the future to aid research activities by public and private organizations?" (24) The answer took the form of a report titled: "Science: The Endless Frontier," which formed the basis for founding the National Science Foundation in 1950. (25) By this time, the National Institute of Health (NIH) had been in existence in various forms for 63 years. (26) In 1944, Congress passed the Public Health Service Act, which impacted the NIH in two important ways. (27) First is the commitment to the production of scientific research. (28) The NIH was elevated from a Division to a Bureau and the Surgeon General was allowed to conduct clinical research. (29) Second, the National Cancer Institute became a division of the NIH and its grant program became the model for the entire Institute. (30) In 1947, the NIH budget was $8 million, and it grew to more than $1 billion by 1966. (31) During the end of the 1960s, however, the NIH budget was reduced because of U.S. inflation as well as competition from Medicare and Medicaid for Congressional funding. (32) The debate over basic research versus goal-directed research then began in earnest. (33) Congress took a more focused approach by authorizing specific initiatives against cancer, heart disease, and AIDS. (34)

      A main goal of scientific research is to better human life by discovering therapies and curing disease, and ideas need to reach patients in order to reach that goal. Throughout the 1950s and 1960s, federally-funded, university-based research was rarely commercialized because the government owned the intellectual property rights to inventions stemming from federally funded research. (35) The Bayh-Dole Act, (36) called in 2002 "possibly the most inspired piece of legislation to be enacted in America over the past half-century," (37) set the country on a course to exploit university research as a major economic driver. (38)

    2. THE IMPACT OF THE BAYH-DOLE ACT

      The intent of the Bayh-Dole Act is to promote technology transfer by allowing universities, small businesses and other research institutions to retain ownership of intellectual property created through federally funded research. (39) Senator Bayh noted: "Unless universities and small businesses receive the right to retain the patent on these inventions, valuable discoveries wind up wasting away on the funding agency's shelves, benefitting no one." (40) In addition to enabling universities to obtain title to inventions, Bayh-Dole includes a mandate for universities to file patents on those inventions and to collaborate with the private sector to promote commercialization of inventions arising from federal funding. (41) There is no question that the Bayh-Dole created the current economy around university patenting. (42) In 1980, there were 495 issued patents to universities, and in 2005, there were 3,278--an increase of over 650%. (43) Universities have helped create 3,641 new products since 1980. (44) "Since enactment, more than 5,000 new companies have formed around university research; in fiscal year 2008, university research helped create 1.6 new companies a day." (45) AUTM Leadership commented to the Senate Committee on the Judiciary in 2007: It is not an exaggeration to say that ... universities have become important components of the economic development plans of their surrounding regions. They are rich sources of cutting edge discoveries, for the formation of venture capital, and the creation of technology clusters driving state and regional economies.... The conclusion is obvious. The Bayh-Dole Act is a success in terms of bringing new science to the public's benefit in the form of new products, jobs and companies. It has helped to restore U.S. competitiveness. (46)

      Major-market drugs have been born out of university research. The HIV drug Atripla came out of Emory University, and grossed approximately $2 billion dollars in 2010 for Gilead Sciences. (47) Stavudine, sold under the name Zerit, is a treatment for...

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