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Transformation of a Research Platform into Commercial Products

The Impact of United States Federal Policy on Biotechnology

  • Chapter
The Commercialization of Genetic Research

Abstract

The 20th Century, a century of accomplishment in the life sciences, has ended with a deluge of discovery and established a footing for innovation that will bridge well into the next millennium. The impact of biotechnology has been particularly profound. An entire industry of companies and a generation of innovative drugs have reached the market more quickly than the average bench-to-market time frame—roughly 14.9 years, and at a cost of $500 million (PhRMA 1998, 20, 24–25). Today, there are approximately 1,300 US biotechnology companies, and 93 biotech drugs have reached the market, 58 of those since 1995 (PhRMA, New Drugs Jan. 1999; Med Ad News, “Bursting with Innovation” Dec. 1998, 44–45 ; see also BIO 1998). While only 10 percent of pharmaceutical product launches were attributable to the biotechnology industry in 1996 and 1997, that number reached 25 percent of launches in 1998 (Dorey 1999, 128; Med Ad News, “New Drugs”. Feb. 1999, 11 (descriptive identification) of all new drug products approved in 1998). The biotech family of drugs includes breakthrough products such as Avonex for multiple sclerosis (Biogen, Inc.), Ceredase/Cerezyme for Gaucher’s disease (Genzyme Corp.), Herceptin for metastasized breast cancer (Genentech, Inc.), and Pulmozyme for cystic fibrosis (Genentech, Inc.). Moreover,Herceptin, approved by the Food and Drug Administration on Sept. 25, 1998, marks a new era of applied pharmacogenomic therapeutics—drugs that intercede in disease pathways at the molecular level to impact cellular funcation and disease eapression with extreme precision, and that can be matched to patients genetically predisposed to respond (Carey 1999, 98–100; Hoyle 1998, 887; Med Ad News, “Biological Warfare” Dec. 1998, 3 & 44–47; Editorial, “Pharmacogenomics” 885)

“Public demand for these biotechnology products has created a worldwide industry that has spread across all developed nations with advanced medical science programs. Researchers on all continents are part of this dynamic enterprise because the scientific and fiscal rewards for cutting-edge technology are substantial.

And the world is awaiting new developments. Chronic conditions like AIDS, cancer, hypertension, arthritis, Alzheimer’s disease, and asthma are at the heart of biotechnology research. In the U.S. alone, there will be around 50 million baby boomers entering the elderly age phase by 2010. Increased life percentage of retirees, relative to workers, will demand an unparalleled transformation in health care and its delivery.”

Foley, Hoag & Elliot

(Source: Pellerito 1999)

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References

  • 1986. “Coordinated Framework for Regulation of Biotechnology” Fed. Reg., Vol. 51, pp. 23, 302–93.

    Google Scholar 

  • 1987. Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues (National Academy Press).

    Google Scholar 

  • Abbott, A. 1999. “Science Moves up Europe’s Aid Agenda” Nature, Vol. 397, pp. 8–9.

    Article  Google Scholar 

  • Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round vol. 31; 33 I.L.M. 1197 (1994).

    Google Scholar 

  • Associated Press. Sept. 26, 1998. “Census: Number of Uninsured Rising” (taken off wire service; reporting on findings of Census Bureau report).

    Google Scholar 

  • Bayh-Dole implementation: Chapter IV: Assistant Secretary for Technology Policy, Department of Commerce, codified at 37 CFR pts. 401, 404 (1987).

    Google Scholar 

  • Biotechnology Industry Organization (BIO), Biotech Therapies: Approved Biotechnology Drugs Summer 1998, at <http://www.bio.org/whatis/approved98>

    Google Scholar 

  • Biotechnology Industry Organization. 1996. Editors’ and Reporters’ Guide (1996).

    Google Scholar 

  • Biotechnology Industry Organization. 1998. Industry Survey: 1997–98.

    Google Scholar 

  • Blumenthal, D. et al. 1997. “Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty” JAMA, Vol. 15, p. 1223.

    Google Scholar 

  • Blumenthal, D. et al. 1996a. “Relationships Between Academic Institutions and Industry in the Life Sciences—an Industry Survey” New England GMAT, Vol. 334, p. 368.

    Article  Google Scholar 

  • Blumenthal, D. et al. 1996b. “Participation of Life-Science Faculty in Research Relationships with Industry” New England J. Med., Vol. 23, p. 1734.

    Article  Google Scholar 

  • Campbell, E. et al. 1998. “Looking a Gift Horse in the Mouth: Corporate Gifts Supporting Life Sciences Research” JAM, Vol. 13, p. 279.

    Google Scholar 

  • Carey, J. Jan. 18, 1999. “This Drug’s for You: Genetically Tailored Treatments Could Transform Medicine” Bus. Wk., p. 98.

    Google Scholar 

  • CenterWatch, <http://www.centerwatch.com> (international listing of clinical research trials).

  • Charski, M. Sept. 28, 1998. “A Healthy Trend Ends: New Report Predicts Rising Medical Costs” U.S News & World Rep., 1998 WL 8127297 (reporting on findings of the Health Care Finance Administration (HCF).

    Google Scholar 

  • Convention on Biological Diversity (“CBD”), June 5, 1992, 31 I.L.M. 818 (entered into force Dec. 29, 1993).

    Google Scholar 

  • Cook-Deegan, R. 1994. The Gene Wars: Science, Politics and the Human Genome, New York: W.W. Norton & Company.

    Google Scholar 

  • Dep. of Health and Human Services, Office of Inspector General. Mar. 1998 (Draft). Institutional Review Boards: The Emergence of Independent Boards.

    Google Scholar 

  • Dep. of Health and Human Services, Office of Inspector General. Mar. 1998 (Draft). Institutional Review Boards: Promising Approaches.

    Google Scholar 

  • Dep. of Health and Human Services, Office of Inspector General. Mar. 1998 (Draft). Institutional Review Boards: A System in Jeopardy, Overview and Recommendations.

    Google Scholar 

  • Dep. of Health and Human Services, Office of Inspector General. Mar. 1998 (Draft). Institutional Review Boards: Their Role in Overseeing Approved Research.

    Google Scholar 

  • Diamond v. Chakrabarty, 47 U.S. 303 (1980) (recognizing intellectual property rights in the invention of microorganisms capable of breaking down oil).

    Google Scholar 

  • Dorey, E. 1999. “Will Investors Return to Biotechnology?” Nature Biotechnology, Vol. 17, p. 128.

    Article  Google Scholar 

  • Editorial. 1999. “Can Physics Deliver Another Biological Revolution?” Nature, Vol. 397, p. 89.

    Article  Google Scholar 

  • Editorial. 1998. “Editorial: Pharmacogenomics at Work” Nature Biotechnology, Vol. 16, p. 885.

    Google Scholar 

  • Editorial. 1998. “Surviving Misconduct is One Thing, Accountability is Another” Nature, Vol. 395,p. 727.

    Article  Google Scholar 

  • Ernst & Young. 1996. Biotech 97: Alignment.

    Google Scholar 

  • Ernst & Young. 1996. European Biotech 97: A New Economy.

    Google Scholar 

  • FDA/CFSAN. Jan. 8, 1998. FDA’s Policy for Foods Developed by Biotechnology (available at <http://vm.cfsan.fda.gov/-1rd/biopolcy.html>).

    Google Scholar 

  • Fox, J. 1997. “EPA Issues, USDA Amends Respective Biotech Rules” Nature Biotech, Vol. 15, p. 503.

    Article  Google Scholar 

  • Garwin, L. 1999. “US Universities Create Bridges Between Physics and Biology” Nature, Vol. 397, p. 3.

    Article  Google Scholar 

  • General Accounting Office. May 7, 1998. Report to Congressional Committees: Technology Transfer—Admin-istration of the Bayh-Dole Act by Research Universities GAO/ACED 98–126, 1998 WL 403–207.

    Google Scholar 

  • General Agreement on Tariffs and Trade-Related Aspects of Intellectual Property Rights (TRIPS),§ 5, Art. 27.

    Google Scholar 

  • Hodgson, J. 1998. “A Genetic Heritage Betrayed or Empowered?” Nature Biotechnology, Vol. 16, p. 1017.

    Article  Google Scholar 

  • House Committee on Science. Sept. 24, 1998. Report to Congress: Unlocking Our Future, Toward a New National Science Policy.

    Google Scholar 

  • Hoyle, R. 1998. “Genentech is Poised for an Anti-Cancer Breakthrough” Nature Biotechnology, Vol. 16, p. 887.

    Article  Google Scholar 

  • International Convention for the Protection of New Varieties of Plants (“UPOV”), Dec. 2, 1961, as revised at Geneva Nov. 10, 1972, Oct. 23, 1978, and Mar. 19, 1991.

    Google Scholar 

  • July 30, 1998. Directive 98/ /EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions, OJ L 213, 30.7.98, p. 13.

    Google Scholar 

  • Katz-Stone, A. Aug. 28—Sept. 3, 1998. “High Court Paves Path for Biotech” Wash. Bus. J., p. 21. (Special Report).

    Google Scholar 

  • Katz-Stone, A. Aug. 28—Sept. 3, 1998. “Professional Services: Burgeoning Biotech” Wash. Bus. J., p. 21 (Special Report).

    Google Scholar 

  • Keller, G. 1988. “Biomedical Technology Transfer in the Government Sector” AMS NEWS, Vol. 64, p. 454.

    Google Scholar 

  • Krimsky, S. & Wrubel, R. 1996. Agricultural Biotechnology and the Environment: Science,Policy, and Social Issues (The Environment and the Human Condition), Urbana: Univ of Illinois Press, p. 251.

    Google Scholar 

  • Littlefield, N. 1999. “Foreword” Biotechnology: Law, Business and Regulation.

    Google Scholar 

  • Macilwain, C. 1999. “US Spirit is Willing, But Funds are Still Weak” Nature, Vol. 397, p. 7. Macilwain, C. 1998. “Lobbyists Elated s the NIH Wins $2b Budget Increase” Nature, Vol. 395, p. 734.

    Article  Google Scholar 

  • Malinowski, M. & O’Rourke, M. 1996. “A False Start? The Impact of Federal Policy on the Genotechnology Industry” Yale J. Reg., Vol. 13, 163.

    Google Scholar 

  • Malinowski, M. 1996a. “Capitation, Advances in Medical Technology, and the Advent of a New Era in Medical Ethics” Am. J. Law & Med., Vol. XXII.

    Google Scholar 

  • Malinowski, M. 1996b. “Globalization of Biotechnology and the Public Health Challenges Accompanying It” Albany L. Rev., Vol. 60, p. 127 & nn. 31–32.

    Google Scholar 

  • Malinowski, M. 1999. Biotechnology: Law,Business and Regulation (Aspen Law & Business).

    Google Scholar 

  • Masood, E. 1998. “Iceland Poised to Sell Exclusive Rights to National Health Data” Nature, Vol. 396, p. 395.

    Article  Google Scholar 

  • Masood, E. 1999. “World Bank Invests in Global Science Base” Nature, Vol. 397, p. 6.

    Article  Google Scholar 

  • McCabe, K. 1998. “Implications of the Cellpro Determination on Inventions Made With Federal Assistance: Will the Government Ever Exercise its March-In Right?” Public Contract L. J., Vol. 27, p. 645.

    Google Scholar 

  • Med Ad News Staff. Dec. 1998. “A New Clinical Environment” Med Ad News,p. 30.

    Google Scholar 

  • Med Ad News Staff. Dec. 1998. “Biological Warfare: In the Fight Against Breast Cancer, a Monoclonal Antibody Targets the Genetic Defect that Causes Disorder” Med. Ad News,p. 3.

    Google Scholar 

  • Med Ad News Staff. Dec. 1998. “Bursting with Innovation: Never Before Have the Pipelines of the Biotechnology Companies Held so Many Promising Products in Terms of Disease Management and Profitability” Med Ad News,p. 44.

    Google Scholar 

  • Med Ad News Staff. Dec. 1998. “Putting Life Back into Life Sciences” Med Ad News,p. 14.

    Google Scholar 

  • Med Ad News Staff. Feb. 1999. “New Drugs On the Decline” Med Ad News, p. 11.

    Google Scholar 

  • Med Ad News Staff. Dec. 1998. “Good Times Keep on Rollin” Med Ad News,p. 4.

    Google Scholar 

  • Miller, H. 1997. Policy Controversy in Biotechnology: An Insider’s View, Academic Press Inc., p. 198.

    Google Scholar 

  • NIH, Bioengineering Funding, <http://www.nih.gov/grants/becon/becon/htm>.

  • North American Free Trade Agreement (“NAFTA”), Dec. 17, 1992, U.S.-Can.-Mex., 32 I.L.M. 605 (entered into force Jan. 1, 1994).

    Google Scholar 

  • Organization for Economic Cooperation and Development (OECD). 1993. Safety Evaluation of Food Derived by Modern Biotechnology: Concepts and Principles.

    Google Scholar 

  • Orphan Drug Amendment of 1988, Pub. L. No. 100–290, § 3, 102 Stat. 90 (1988) (codified at 21 U.S.C. §§ 301, 360aa, 360ee (1988).

    Google Scholar 

  • Patient Protection Act of 1998, H.R. 4250.

    Google Scholar 

  • Pellerito, P. 1999. “Industry Overview” Biotechnology: Law, Business and Regulation (forthcoming 1999, Aspen Law & Business).

    Google Scholar 

  • Pharmaceutical Research and Manufacturers of America (PhRMA). Jan. 1999. New Drug Approvals in 1998.

    Google Scholar 

  • Pharmaceutical Research and Manufacturers of America (PhRMA). July 1998. 1998 Industry Profile.

    Google Scholar 

  • Piercey, L. Dec. 1998. “Technology Transfer Goes Professional” BioVenture View, p. 9.

    Google Scholar 

  • Reier, S. Nov. 18, 1998. “New Biotech Drugs Transform Market: Small Companies Proliferate” Herald Tribune,p. 20.

    Google Scholar 

  • Sacane, S. & Swank, D. 1996. Biotechnology 1997: Poised to Harvest the Fruits of a Decade’s Labor (a Montgomery Securities publication; internal citations omitted).

    Google Scholar 

  • Scarlett, J. Supp. 1999. “Biotechnology’s Emerging Opportunities: Lessons from the Bauhaus” Nature Biotechnology, p. BE13.

    Google Scholar 

  • Seachrist, L. Mar. 20, 1998. “Patients, Researchers Urge Doubling NIH Budget in 5 Years” Bio World Today, Vol. 9, No. 53, at p. 1 (Coalition of patient and research organizations proposed increasing federal funding of NIH 15 percent every year for the next 5 years, thereby doubling the NIH budget in 5 years).

    Google Scholar 

  • Shultz, D. 1996 “Interactions Between Universities and Industry” Biotechnology—Science, Engineering, and Ethical Challenges for the 21“ Century, pp. 131–46 (Frederick B. Rudolph and Larry V. McIntire eds., 1996).

    Google Scholar 

  • Spragins, E. Sept. 28, 1998. “Does Managed Care Work?” Newsweek (1998 WL 17010517).

    Google Scholar 

  • The Patient Bill of Rights Act, S. 2330.

    Google Scholar 

  • United States National Center for Health Statistics, 1998. Report.

    Google Scholar 

  • US Patent Act, 35 U.S.C. §§ 101–103, 112.

    Google Scholar 

  • Witholt, B. “The European University as a Startup Generator” Nature Biotech, Vol. 17, BE7 (Supp: “Bioentrepreneurship”).

    Google Scholar 

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Authors and Affiliations

  1. Foley, Hoag & Elliot, USA

    Michael J. Malinowsk & Nick Littlefield

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  1. Michael J. Malinowsk
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  2. Nick Littlefield
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Editors and Affiliations

  1. Health Law Institute, University of Alberta, Edmonton, Alberta, Canada

    Timothy A. Caulfield

  2. Centre for Applied Ethics, University of British Columbia, Vancouver, British Columbia, Canada

    Bryn Williams-Jones

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Malinowsk, M.J., Littlefield, N. (1999). Transformation of a Research Platform into Commercial Products. In: Caulfield, T.A., Williams-Jones, B. (eds) The Commercialization of Genetic Research. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-4713-6_3

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  • DOI: https://doi.org/10.1007/978-1-4615-4713-6_3

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