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Contents and Introductions for proceedings published in Risk
Maximizing the Return from Genome Research
* Annotated Contents
* Introduction
Promoting and Managing Genome Innovation
* Annotated Contents
* Introduction
Maximizing the Return from Genome Research
(Annotated Contents)
Thomas G. Field, Jr., Introduction...... 5.95
["5.95" indicates both volume (5) and page (95) where the article appeared in Risk.]
Robert M. Cook-Deegan, Origins of the Human Genome Project
Dr. Cook-Deegan recounts some of the scientific and political history leading to controversy about the proper mix of private and public roles in pursuing genome research and bringing its fruits to bear, e.g., in preventing and curing disease...... 5.97
Kate H. Murashige, Overview of Potential Intellectual Property Protection for Biotechnology
Dr. Murashige compares the function and value of copyright, patent and trade secret laws in recovering investments in developing genome-related biotechnology...... 5.119
Lawrence Rudolph, Overview of Federal Technology Transfer
Mr. Rudolph reviews approximately thirteen years of legal and political developments that have contributed to laws governing the extent to which private firms may secure rights in technology at least partly developed with federal funds...... 5.133
Harvey Drucker, Technology Transfer: A View from the Trenches
Dr. Drucker, who has lab-wide responsibility for technology transfer at Argonne National Laboratory, argues that transferring rights in discoveries made through tax-supported research to private entities can contribute to public welfare in many ways...... 5.143
Christopher J. Harnett, The Human Genome Project and the Downside of Federal Technology Transfer
Mr. Harnett argues that emphasizing technology transfer at institutions such as the National Institutes of Health will interfere with what should be regarded as their primary mission, basic research...... 5.151
Rebecca S. Eisenberg, Technology Transfer and the Genome Project: Problems with Patenting Research Tools
Professor Eisenberg argues against a system providing for federally-sponsored inventions to be patented if any associated person so desires. She believes that the system does not adequately weigh the possibility that the greatest social return from genome research will require some discoveries to be in the public domain...... 5.163
Timothy P. Linkkila & Timothy E. Tracy, Biotechnology Process Patents: Is Special Legislation Needed?
Although this paper was not presented at the conference, its authors review administrative and court decisions prompting proposed changes to the patent law. After reviewing pros and cons, they argue that, on balance, pending bills can easily cause more problems than they solve....... 177
Introduction
Maximizing the Return from Genome Research*
Thomas G. Field, Jr.
Only fourteen years ago, the U.S. Supreme Court was asked to find the
fruits of genetic research unpatentable:
"...The briefs present a gruesome parade of horribles. Scientists, among them
Nobel laureates, are quoted suggesting that genetic research may pose a serious
threat to the human race.... We are told that genetic research... may spread
pollution and disease, ...result in a loss of genetic diversity, and... tend to
depreciate the value of human life. These arguments are forcefully, even
passionately, presented; they remind us that, at times, human ingenuity seems
unable to control fully the forces it creates -- that with Hamlet, it is
sometimes better "to bear those ills we have than fly to others that we know
not of." (1)
The Court concluded that such arguments were best addressed to
Congress. Congressional failure to take the action urged upon the Court,
coupled with major support for the human genome project, seems to indicate,
e.g., belief that potential benefits outweigh potential hazards and that
inappropriate uses of genetic technology can be foreclosed as they arise.(2) The last is buttressed by considering, e.g., that, as copyrights do not permit sale of obscene books, patents do not permit illegal uses of inventions -- nor is one engaged in forbidden types of research apt to admit it in a patent application. Thus, these papers reflect a shift to R&D policy management to achieve positive health, safety and environmental objectives.
As Dr. Cook-Deegan notes in the lead article,(3) we lack knowledge that may be necessary to fine tune the intellectual property system.(4) Yet, these papers may make some things clearer to people unfamiliar with intellectual property or private and public technology transfer, e.g., that private firms will not invest in R&D, or anything else, without confidence of being able to recoup investments when they succeed. The symposium should therefore be useful in other attempts to fashion public incentives for private firms to contribute to reducing the risks of natural and artificial hazards.
Basic Information about Intellectual Property
Notes to 1993 introduction
* Gianna Julian-Arnold, J.D., M.I.P., Franklin Pierce Law Center, played a critical role in organizing the July 1993 conference. Also, the Department of Energy played a critical role in covering, e.g., the expenses of several speakers. Also, with regard to publishing this symposium, Timothy S. Odykirk, J.D., FPLC, and others named on the inside front cover of the issue made important contributions.
1. Diamond v. Chakrabarty, 447 U.S. 303, 315 (1980). See also ,
Animal Legal Defense Fund v. Quigg, 18 U.S.P.Q.2d 1677 (Fed. Cir. 1991). Risk has reviewed books raising similar issues. See, e.g.,
Sheldon Krimsky Biotechnonics and Society..., (1991), reviewed 3
Risk 185 (1992); The Code of Codes: Scientific and Social Issues in
the Human Genome Project, (Daniel J. Kevles and Leroy Hood eds. 1992),
reviewed 3 Risk 261 (1993) and Elaine Draper, Risky Business:
Genetic Testing and Exclusionary Practices in the Hazardous Workplace
(1991), reviewed 3 Risk 267 (1993).
2. Those interested in more integration of ethical and intellectual
property issues should consider The Genetic Frontier: Ethics, Law and
Policy (Mark S. Frankel & Albert Teich, eds. 1994) -- a 259 pp.
paperback published by AAA Press in January ($22.95) -- also containing papers
by Dr. Cook-Deegan and Dr. Murashige.
3. Infra, at 118.
4. See generally, Industrial Innovation: Joint Hearings Before the
Senate Comm. on Commerce, Science and Transportation, and Select Comm. on Small
Business, and House Comms. on Science and Technology, and Small Business,
96th Cong., 1st Sess., Parts 1 and 2 (1979). As part of a lively exchange, Dr.
Frank Press stated, "For 25 years the question of innovation and Americans'
ability to innovate has been... around; it's been studied to death." Part 1,
at 40. This suggests too much; see, e.g., J. G. Tewksbury et al.,
Measuring the Societal Benefits of Innovation, 209 Science 658
(1980) "A sample which was as representative as possible... would have been
desirable.... [I]nformation... was so difficult to obtain that availability of
data became dominant in the selection of cases."
Promoting and Managing Genome Innovation
(Annotated Contents)
Suzanne A. Sprunger & Gianna Julian-Arnold, Introduction.... 7.197
["7.97" indicates both volume (7) and page (197) where the article appeared in Risk.]
Elaine Alma Draper, Social Issues of Genome Innovation and Intellectual
Property
Dr. Draper's focus is the use of personal information derived from genome research. She identifies several potential problems, including access to and control of genetic information, employment discrimination and social stratification. She also recommends possible solutions.... 7.201
Kate H. Murashige, Genome Research and Traditional Intellectual Property
Protection -- A Bad Fit?
Dr. Murashige addresses the need for a patent system more closely tailored to the needs of biotechnology. For example, the obviousness requirement may interfere with using patents to recoup high costs of work when it could arguably be done by researchers of ordinary skill.... 7.231
Phillip K. Russell, Development of Vaccines to Meet Public Health Needs:
Incentives and Obstacles
Dr. Russell explains how such matters as high costs of regulation, lack of an effective plan for delivery (particularly abroad) and politics can interfere with providing globally needed vaccines.... 7.239
Brian C. Cunningham, Impact of the Human Genome Project at the Interface between Patent and FDA Laws
Mr. Cunningham stresses the broad scope of biotechnological innovations. Besides endorsing the need for a new oversight commission to deal with potential social issues, he suggests, for example, that some products should be treated like biologics rather than new drugs.... 7.253
Jeffrey N. Gibbs, The Human Genome, FDA and Product Liability
Mr. Gibbs describes the risks to innovators associated with FDA regulations.
He also points out how developers and marketers of products based on human
genome research face such risks both before and after marketing.... 7.267
Susan J. Timian & D. Michael Connolly, The Regulation and Development
of Bioremediation
The authors describe how federal statutes regulating hazardous wastes create both incentives and disincentives for exploiting the large potential of bioremediation. Ultimately, they argue for regulation attending more to comparative risks and costs.... 7.279
Introduction
Promoting and Managing Genome Innovation
Suzanne A. Sprunger & Gianna Julian-Arnold*
What is the appropriate balance between encouraging biotechnological innovation while protecting the public from risks that accompany any new technology? A conference was convened1 to address a concern that, as biotechnology develops at breakneck speed, even rapidly adapting legal systems2 neither promote genome-related innovation effectively, nor adequately address public worries about product safety and control of genetic information. The conference was a sequel to an earlier one that focused on intellectual property and technology transfer.3
Presentation topics included societal issues raised by genomic innovation, the role of intellectual property in promoting research and development, and the effects of legal regulation of pre- and postmarket testing -- as well as case studies of vaccine development, bioremediation and genome sequence database creation.
Elaine Draper made the first formal presentation, pointing out that not all innovation is necessarily good. She identified possible employment discrimination and social stratification as undesirable consequences of genome research. Among other things, Dr. Draper suggested that statutes designed to protect employees from discrimination be extended to cover those with genetic predispositions for disease.4
Kate Murashige followed, acknowledging that some technologies present problems, as patents themselves sometimes do. She nevertheless stressed the importance of private risk capital in supporting research and development and patents in attracting it. She also discussed several ways the patent system fails to provide adequate incentives for certain types of inventions.5
Phillip Russell focused on a technology with little if any downside. He discussed how biotechnology can meet a global need for more effective vaccines. He also addressed several compelling obstacles, including various kinds of bureaucratic and logistical problems. In passing, he noted that while patent protection provides an investment incentive, it may interfere with commercial availability of logistically optimal combinations of proprietary vaccines.6
Brian Cunningham illustrated how policies for regulating the use of biotechnology develop in practice. From his experience, he endorsed a suggestion for a federal bioethical commission. He found such an institution to be potentially helpful in reassuring the public and shrinking the gap between the rapid development of biotechnology and the slow develoment of guidelines for its use.7
Karin Gregory8 discussed Institutional Review Boards (IRBs) as a means for protecting clinical subjects in premarket testing of new medical products, however derived. She suggested that one reason IRBs are needed is because investigators can have several roles: scientist, agent of the drug sponsor and treating physician. She explained how IRBs, made up of both health-care professionals and lay citizens, must ensure, for example, that patients are advised of significant side effects in informed consent forms that can be understood. She also noted that IRBs may even play a role in designing or redesigning clinical studies.
Jeffrey Gibbs discussed the role of the Food and Drug Administration (FDA) in premarket testing and sanctions that it can bring to bear on those who fail to conform to legal requirements. He also discussed how action by the FDA, both before and after marketing, can have a major effect on manufacturers' potential civil liability to those who suffer adverse consequences.9
Michael Connolly,10 presented a paper recounting how hazardous waste regulation both encourages and discourages biotechnological development. As he explained, despite the very large apparent promise of bioremediation,11 it is projected to represent only about 3% of the $ 1.7 trillion market in technologies used to clean up hazardous sites over the next twenty years. He also suggested ways bioremediation might be more fully exploited to improve the environment.
Finally, Robert Benson12 related the experience of Human Genome Sciences (HGS) in attempting to recoup the costs of data generated by its affiliate, The Institute for Genetic Research (TIGR). TIGR currently concentrates on cDNA sequences that represent approximately 4% of the human genome actively used by cells to produce proteins. The information developed for human cDNAs includes both the DNA sequence and the pattern of cDNA expression in different tissues and developmental stages. He explained that much more information is generated than can be protected effectively by patents. Thus, while HGS files patent applications on commercially valuable cDNAs, it also licenses proprietary databases of genome sequence information -- with special efforts to make it available for scientific research in non-profit institutions.
Conclusion
Discoveries in biotechnology are made at an extraordinary rate. As noted by several speakers whose papers appear here, such discoveries have the potential to improve our environment, health, food supply and, indeed, our world. As noted by others, these discoveries also are subject to abuse and, even when helpful, can create ethical or social problems.
The following papers offer many suggestions for promoting useful biotechnological innovation and avoiding the downside of some discoveries. The challenge is to encourage the technology and harvest its many manifestly valuable fruits while avoiding possible physical and societal damage. To that end, it is hoped that readers will find them valuable.
Notes to 1995 introduction
* Dr. Sprunger received her B.S. (Biology) from Cornell University, a Ph.D. (Genetics) from the University of Wisconsin-Madison and J.D. degree from Franklin Pierce Law Center (FPLC).
Ms. Julian-Arnold is an Associate with Roberts & Brownell, Tysons Corner, VA. She received her B.S. (Chemistry) from Northern Arizona University and her J.D. and M.I.P. from FPLC).
1 October 1995. Organized by Professor Thomas G. Field, Jr. and Gianna Julian-Arnold, the conference was funded in part by the Ethical, Legal and Social Issues component of the - http://www.er.doe.gov/production/oher/hug_top.html - Human Genome Program of the U.S. Department of Energy; Nixon, Hargrave, Devans & Doyle L.L.P., Rochester, N.Y.; and Human Genome Sciences. We are grateful for that support.
2 Recent changes include, e.g., an amendment to 35 U.S.C. §§ 103 & 282, PL 104-41 § 1111, Nov. 1, 1995, (facilitating the patenting and protection of biotech processes) and amendments to FDA regulations to eliminate some hurdles for approval of biotechnology products. With regard to the latter, see Lauran Neergaard, FDA Eases Rules for Biotech Drugs, AP, Nov. 9, 1995, 1995 WL 4413545.
3 July 1993. Human Genome Symposium, 5(2) Risk (1994) (at 95-188).
4 Elaine Alma Draper, Social Issues of Genome Innovation and Intellectual Property, 7 Risk 201 (1996) (includes brief biographical information).
5 Kate H. Murashige, Genome Research and Traditional Intellectual Property Protection -- A Bad Fit? 7 Risk 231 (1996) (includes brief biographical information).
6 Phillip K. Russell, Development of Vaccines to Meet Public Health Needs: Incentives and Obstacles, 7 Risk 239 (1996) (includes brief biographical information).
7 Brian C. Cunningham, Impact of the Human Genome Project at the Interface between Patent and FDA Laws, 7 Risk 253 (1996) (includes brief biographical information).
8 Ms. Gregory, a lawyer who also holds an M.P.H., practices in Boston.
9 Jeffrey N. Gibbs, The Human Genome, FDA and Product Liability, 7 Risk 267 (1996) (includes brief biographical information).
10 Susan J. Timian & D. Michael Connolly, The Regulation and Development of Bioremediation, 7 Risk 279 (1996) (includes brief biographical information).
11 The use of biological organisms or substances to convert hazardous waste into reusable or nontoxic products.
12 Dr. Benson is Vice President, General Counsel and Secretary, Human Genome Sciences. He received his B.S. (Chemistry) and Ph.D. (Molecular Biology) from the University of Florida.
Risk Articles Index
Modified 11/17/96
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