Biotechnology and the Law LAW E570 Spring, 1997 Course Outline and General Information

Patricia Kuszler Condon 630; 616-1756 Office Hours: By Appointment Summary of Course This seminar course will address the dynamic biotechnology industry and the law affecting it. The course will begin with an overview of the history and trends within the industry considering biotechnologic products and methods in the production of food, in pesticides and in the drugs and biologics used in medicine. Part II of the course will consider the regulatory framework applicable to these new products and how it has been modified to address the special issues presented by use of biotechnologic methods, focusing on FDA, EPA and USDA regulations. Part III will turn to protection of and property rights in new biotechnology products including Aownership@ and patentability. The course will conclude with study of the risks and liability faced by the biotechnology, especially in the context of products liability and toxic torts. During the course, the student will research and write a four part case study on a biotechnologic product assigned by the professor. Required Texts The Course Materials include several recent cases, articles, excerpts from books and other texts, and legislative/regulatory materials. The Course Materials will be available in two sets. Set I will include materials for the first five weeks of class and Set II will cover the last four weeks of class. In addition to the assigned reading materials, there is a listing of additional readings available in the library that may prove useful for researching the cases studies. Class Participation The course will be conducted in lecture\discussion format.. Active participation by students is strongly encouraged. Course Grade The course grade will be based upon a four part case study researching the development and use of a biotechnology product. The class sessions will serve to provide the student with a general overview of the law to serve as the underpinning for the more detailed and product-oriented research necessary for the case study. Part I of the case study (5-10 pages) will describe the biotechnologic and scientific advances

leading up to the development of the product, the uses for the product, and public policy and ethical concerns (if any) raised during development. Part II of the study (10-12 pages) will trace the product=s journey through the regulatory maze and what specific regulations had to be complied to bring the product to market. Part III of the study (1012 pages) should focus on the intellectual property protections available to and chosen by the manufacturer or inventor of the product. Finally, part IV of the study (10-12 pages) will consider the potential liability associated with the product and means by which the manufacturer might protect against that liability. Due dates for each part of the case study will be as follows: Part I, April 14; Part II, May 5; Part III, May 19; Part IV, June 3. Course Outline I. Biotechnology: History and Trends A. Evolution of a 20th Century Industry 1. Agricultural and Food Products 2. Pesticides and Herbicides 3. Drugs, Biologics and Medical Products Commercial Expansion and Economic Growth Public Policy and Ethical Issues

B. C.

Week of Mar 31 Reading Assignment: Principles of Biotechnology OTA, Biotechnology in a Global Economy (1991):1-33; 229-41; 265-272 Foundation on Economic Trends v. Heckler, 587 F.Supp. 753 (D.D.C. 1984), aff=d in part and vacated in part, 756 F.2d 143 (D.C. Cir 1985). Additional Readings & Materials: Hearing on U.S. Biotechnology, Subcomm. of Science, Technology & Space of the Senate Comm. On Commerce, Science and Transportation, 103d Cong., 2d Sess. 18 (1994) Stephen Pendorf, Regulating the Environmental Release of Genetically Engineered Organisms: Foundation on Economic Trends v. Heckler, 12 Fla. St. U.L. Rev. 2

891 I.

(1985) Biotechnology: History and Trends A. Evolution of a 20th Century Industry 1. Agricultural and Food Products 2. Pesticides and Herbicides 3. Drugs, Biologics and Medical Products Commercial Expansion and Economic Growth Public Policy and Ethical Issues

B. C.

Week of April 7 Reading Assignment: Foundation on Economic Trends, et al. v. Johnson, 661 F.Supp. 107 (1986) 57 Fed. Reg 9753, Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products Into the Environment (Feb. 27, 1992) Frederick H Buttel & Jill Belsky, Biotechnology, Plant Breeding, and Intellectual Property: Social and Ethical Dimensions, in Owning Scientific and Technical Information, 110- 131 (1989) Strachan Donnelley, Exploring Ethical landscapes; The Brave New World of Animal Biotechnology, 24 Hastings Center Report S3 (Jan 1994) Marjorie Sun, Administration Divided Over OECD Biotech Plan, 229 Science 842 (1985)

II.

Regulation of Biotechnology - Accessing the Market A. Food and Drug Administration (FDA)

Week of April 14 Reading Assignment: Linda Maher, The Environment and the Domestic Regulatory Framework for Biotechnology, 8 J. Envtl L. & Litig. 133, 133-177 (1993) David A. Kessler, Michael R. Taylor, James H Maryanski, Eric L. Flamm & Linda S. Kahl, The Safety of Foods Developed by Biotechnology, 256 Science 1748 (1992) Gary E. Gamerman, Regulation of Biologics Manufacturing: Questioning the Premise, 49 Food and Drug L. J. 213 (1994) Martha J. Carter, The Ability of Current Biologics Law to Accommodate Emerging Technologies, 51 Food and Drug L.J. 375 (1996) Community Nutrition Institute v. Novitch, 773 F. 2d 1356 (1985) Stauber v. Shalala, 895 F. Supp 1178 (1995) International Dairy Foods Ass=n v. Amestoy, 92 F. 3d 67 (1996) Genentech v. Bowen, 676 F. Supp. 301 (1987)

Additional Readings & Materials: Michael S. Ostrach, Biotechnology and the FDA Review Process, 256 PLI\Pat 107 (1988) Edward L. Korwek, Human Biological Drug Regulation: Past, Present and Beyond the Year 2000, 50 Food & Drug L.J. 123 (1995) Sandra H. Cuttler, The Food and Drug Administration=s Regulation of Genetically Engineered Human Drugs, J. Pharmacy & L. 191 (1992\93) 61 Fed. Reg. Elimination of Establishment License for Specified Biotechnology and Specified Synthetic Biological Products (May 14, 1996)

Philip D. Noguchi, From Jim to Gene and Beyond: An Odyssey of Biologics Regulation, 51 Food & Drug L.J. 367 (1996) John C. Petricciani, Reinventing the Biologics Approval Process, 51 Food & Drug L.J. 139 (1996)

B.

United States Department of Agriculture

Week of April 21 Reading Assignment: David J. Earp, The Regulation of Genetically Engineered Plants: Is Peter Rabbit Safe in Mr. McGregor's Transgenic Vegetable Patch, 24 Envtl. L 1633(1994) Foundation on Economic Trends v. Lyng, 680 F. Supp. 10 (1988) Cordes v. Madigan, 1992 U.S.Dist LEXIS 6250 Barusch v. Calvo, 685 F. 2d 1199 (1982)

Additional Readings & Materials: Alan Goldhammer, The Regulation of Agricultural Biotechnology: An Industrial Perspective, 48 Food & Drug L. J. 60 Fed. Reg. 43567, Genetically Engineered Organisms and Products; Simplification of Requirements and Procedures for Genetically Engineered Organisms 59 Fed. Reg. 45526, Microbial Products of Biotechnology; Proposed Regulation Under the Toxic Substances Control Act (Sept. 1 1994)

C.

Environmental Protection Authority

Week of April 28 Reading Assignment: Henry Miller, A Need to Reinvent Biotechnology Regulation at the EPA, 266 Science 1815 (1994) Nat=l Coalition Against the Misuse of Pesticides v. Thomas, 809 F. 2d 875 (1987) Foundation on Economic Trends v. Thomas, 637 F. Supp. 25 (1986) Foundation on Economic Trends v. Thomas, 661 F. Supp. 713 (1986)

Additional Readings & Materials: Robin A. Chadwick, Regulating Genetically Engineered Microorganisms Under the Toxic Substances Control Act, 24 Hofstra L. Rev. 223 (1995) Celeste Steen, FIFRA=s Preemption of Common Law Tort Actions Involving Genetically Engineered Pesticides, 38 Ariz. L. Rev. 763 (1996) Judy J. Kim, Out of the Lab & Into the Field: Harmonization of Deliberate Release Regulations for Genetically Modified Organisms, 16 Fordham Int=l L. J. 1160 (1993)

III.

Protecting Biotechnology Products A. B. C. Property Rights Technology Transfer Patents

Week of May 5 Reading Assignment: Moore v. Regents of the University of California, 793 P.2d 479 (1990). Warren Greenberg & Deborah Kamin, Property Rights and Payment to Payments for Cell Lines Derived from Human Tissues: An Economic Analysis, 36 Soc. Sci. Med. 1071 (1993). Margaret Swain & Randy Marusyk, An Alternative to Property Rights in Human Tissue, Hastings Center Report, Sept.\Oct. 1990, at 12. Chem. Service, Inc. v. Environmental Monitoring Systems Laboratory-Cincinnati, 12 F. 3d 1256 (3d Cir. 1993). Pat Chew, Faculty Generated Inventions: Who Owns the Golden Egg? 1992 Wisc. L. Rev. 259 (1992). Additional Readings & Materials: Richard Gold, Owning Our Bodies: An Examination of Property Law and Biotechnology 32 San Diego L. Rev. 1167 (1995). Anne T. Corrigan, A Paper Tiger: Lawsuits Against Doctors for Non-Disclosure of Economic Interests in Patients' Cells, Tissues and Organs, 42 Case Western Reserve L. Rev 565 (1992). Courtney S. Campbell, Body, Self, and the Property Paradigm, 22 Hastings Center Report 22 (Sept, 1992). Thomas N. Bulleit, Public-Private Partnerships in Biomedical Research: Resolving Conflicts of Interest Arising Under the Federal Technology Transfer Act of 1986, 4 J.L. & Health 1 (1990).

David Blumenthal et al., University-Industry Research Relationships in Biotechnology: 8

Implications for the University, 232 Science 1361 (1986). Reid G. Adler, Technology Transfer, Government Research, and the Frontiers of Science: Intellectual Property Protection in the Biotechnology Industry, 39 Fed. B. News & J. 270 (1992).

Week of May 12 Reading Assignment: Rochelle Dreyfus, General Overview of the Intellectual Property System in Owning Scientific and Technical Information, 17-40 (1989). Diamond v. Chakrabarty, 447 U.S. 303 (1980). Reid G. Adler, Biotechnology as an Intellectual Property, 224 Science 357 (1984). Ex Parte Hibberd, 1985 Pat. App. LEXIS 11, 227 U.S.P.Q. 443 (1985). Ex Parte Allen, 1987 Pat. App. LEXIS 21 (1987).

Additional Readings & Materials: OTA, New Developments in Biotechnology: Patenting Life, 35-166 (1989). Amy E. Carroll, Not Always the Best Medicine: Biotechnology and the Global Impact of U.S. Patent Law, 44 Am. U. L. Rev. 2433 (1995). Rebecca E. Eisenberg, Patents and Progress of Science: Exclusive Rights and Experimental Use, 56 U.Chi. L. Rev. 147 (1989). D. R. Holland, Can Product by Process Patents Provide the Protection Needed for Proteins Made by Recombinant DNA Technology, 74 Pat. & Trademark Off. Soc=y 903 (1992). David Beier & Robert H. Benson, Biotechnology Patent Protection Act, 64 Den. U. L. Rev. 173 (1991). Pioneer HiBred v. Holden Foundation Seeds, 35 F. 3d 1226 (1993). Asgrow v. Winterboer, 982 F.2d 486 (Fed Cir. 1994).

Fiers v. Sugaro, 984 F.2d 1164 (Fed Cir. 1993). Hybritech Inc. C. Monoclonal Antibodies Inc. 802 F.2d 1367 (Fed Cir. 1986). Amgen v. Chugai Pharmaceuticals, 927 F. 2d 1200 (Fed. Cir. 1991). Amgen v. U.S. Trade Comm=n, 902 F.2d 1532 (Fed. Cir. 1990). Hormone Research Foundation v. Genetech, Inc., 904 F.2d 1338. Scripps Clinic v. Genentech, 927 F.2d 1565. Genentech v. Wellcome, 29 F3d 3d 1555, 31 U.S.P.Q. 2d 1164 (Fed. Cir. 1994). Imazio Nursery v. Dania Greenhouses, 69 F. 3d 1560 (1995).

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IV.

Liability Risks A. B. Products Liability Toxic Torts

Week of May 19 Reading Assignment: Daubert v. Merrell Dow Pharmaceuticals, Inc. 113 S. Ct. 2786 (1993). Davis v. Wyeth Laboratories, 399 F. Supp. 1023 (9th Cir. 1968). Lynnbrook Farms v. SmithKline Beecham Corp., 79 F. 3d 620 (1996). Garrett v. SmithKline Beecham Corp., 943 F. Supp. 1023 (1996). Jon Cohen, Is Liability Slowing AIDS Vaccines?, 256 Science 168 (1992).

Additional Readings & Materials: Jackson v. Johns Manville Sales Corp., 750 F. 2d 1314 (5th Cir. 1985). Victor E. Schwartz & Mark A. Behrens, The Road to Federal Product Liability Reform, 55 Md. L. Rev. 1363 (1996). Nim M. Razook, Jr., Legal and Extralegal Barriers to Federal Product Liability Reform 32 Am. Bus. L.J. 541 (1995). Peter Huber, Safety and the Second Best: The Hazards of Public Risk Management in the Courts , 85 Colum. L. Rev. 277 (1985). Jean Macchiaroli Eggen, Toxic Torts, Causation, & Scientific Evidence After Daubert, 55 U. Pitt. L. Rev. 889 (1994). W. Kip Viscusi, et al., The Effects of Products Liability on Innovation: Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense, 24 Seton Hall L. Rev. 1437 (1994).

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IV.

Liability Risks A. B. Products Liability Toxic Torts

Week of May 26 Reading Assignment: Joan M. Ferretti, Looking For the Big Picture - Developing a Jurisprudence for a Biotechnological Age, 10 Pace Envtl. L. Rev. 711 (1993). Additional Readings & Materials: Henry I. Miller & Douglas Gunary, Serious Flaws to Biotechnology Risk, 262 Science 1500 (1993). Dan L. Burk & Barbara A. Boczar, Biotechnology and Tort Liability: A Strategic Industry at Risk, 55 U. Pitt. L. Rev. 791 (1993).

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