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

C. U.S. 753 (D. Technology & Space of the Senate Comm.2d 143 (D. Biotechnology: History and Trends A. Science and Transportation. June 3. 756 F. April 14. Rev. Drugs. Biotechnology. Part IV.L. 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. Regulating the Environmental Release of Genetically Engineered Organisms: Foundation on Economic Trends v.D. the uses for the product.C. Finally. 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. Evolution of a 20th Century Industry 1. Cir 1985). C. 12 Fla. aff=d in part and vacated in part. 587 F. St.Supp. Part II.leading up to the development of the product. 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. Week of Mar 31 Reading Assignment: Principles of Biotechnology OTA. 103d Cong. Heckler. Additional Readings & Materials: Hearing on U. Course Outline I. of Science. 1984). Heckler. 2 . and public policy and ethical concerns (if any) raised during development. Part III. Biotechnology in a Global Economy (1991):1-33. Agricultural and Food Products 2. May 5.. Pesticides and Herbicides 3. 18 (1994) Stephen Pendorf. Biologics and Medical Products Commercial Expansion and Economic Growth Public Policy and Ethical Issues B. May 19. 265-272 Foundation on Economic Trends v. 2d Sess. On Commerce. Subcomm. 229-41. Due dates for each part of the case study will be as follows: Part I.

and Intellectual Property: Social and Ethical Dimensions. Johnson.131 (1989) Strachan Donnelley. Week of April 7 Reading Assignment: Foundation on Economic Trends. Administration Divided Over OECD Biotech Plan. 110.891 I. 661 F. et al. The Brave New World of Animal Biotechnology. 107 (1986) 57 Fed. in Owning Scientific and Technical Information. 24 Hastings Center Report S3 (Jan 1994) Marjorie Sun. Drugs. Reg 9753. Pesticides and Herbicides 3. Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products Into the Environment (Feb. 229 Science 842 (1985) 3 . Evolution of a 20th Century Industry 1. (1985) Biotechnology: History and Trends A.Supp. 1992) Frederick H Buttel & Jill Belsky. Plant Breeding. Biotechnology. Agricultural and Food Products 2. v. C. 27. Exploring Ethical landscapes. Biologics and Medical Products Commercial Expansion and Economic Growth Public Policy and Ethical Issues B.

256 PLI\Pat 107 (1988) Edward L. Carter. 123 (1995) Sandra H. Kessler.Accessing the Market A. Eric L.J. Ostrach. Human Biological Drug Regulation: Past. 133. Shalala. Bowen. 191 (1992\93) 61 Fed. Regulation of Biologics Manufacturing: Questioning the Premise. Present and Beyond the Year 2000. Reg.II. 8 J. 92 F. J. Biotechnology and the FDA Review Process. 895 F.J. The Environment and the Domestic Regulatory Framework for Biotechnology. Flamm & Linda S. 49 Food and Drug L. Supp 1178 (1995) International Dairy Foods Ass=n v. The Food and Drug Administration=s Regulation of Genetically Engineered Human Drugs. Elimination of Establishment License for Specified Biotechnology and Specified Synthetic Biological Products (May 14. 301 (1987) Additional Readings & Materials: Michael S. Amestoy. Novitch. 51 Food and Drug L. 2d 1356 (1985) Stauber v. The Safety of Foods Developed by Biotechnology. Envtl L. Pharmacy & L. Food and Drug Administration (FDA) Week of April 14 Reading Assignment: Linda Maher. Gamerman. 773 F. Korwek. James H Maryanski. 1996) 4 . Kahl. Taylor. J. 213 (1994) Martha J. & Litig. The Ability of Current Biologics Law to Accommodate Emerging Technologies. 50 Food & Drug L. 133-177 (1993) David A. 676 F. Regulation of Biotechnology . 256 Science 1748 (1992) Gary E. Cuttler. Supp. Michael R. 3d 67 (1996) Genentech v. 375 (1996) Community Nutrition Institute v.

139 (1996) 5 . Petricciani. Noguchi.J.J. 367 (1996) John C. From Jim to Gene and Beyond: An Odyssey of Biologics Regulation.Philip D. Reinventing the Biologics Approval Process. 51 Food & Drug L. 51 Food & Drug L.

Proposed Regulation Under the Toxic Substances Control Act (Sept. Simplification of Requirements and Procedures for Genetically Engineered Organisms 59 Fed. 680 F. Microbial Products of Biotechnology. Lyng. 10 (1988) Cordes v. 48 Food & Drug L. 685 F. McGregor's Transgenic Vegetable Patch. L 1633(1994) Foundation on Economic Trends v. J. Reg. Madigan. United States Department of Agriculture Week of April 21 Reading Assignment: David J. 2d 1199 (1982) Additional Readings & Materials: Alan Goldhammer. Reg. 60 Fed.S. Supp. Calvo. 1992 U. Genetically Engineered Organisms and Products. Earp.B. 45526. 24 Envtl.Dist LEXIS 6250 Barusch v. The Regulation of Agricultural Biotechnology: An Industrial Perspective. 43567. The Regulation of Genetically Engineered Plants: Is Peter Rabbit Safe in Mr. 1 1994) 6 .

38 Ariz. A Need to Reinvent Biotechnology Regulation at the EPA. Out of the Lab & Into the Field: Harmonization of Deliberate Release Regulations for Genetically Modified Organisms.C. 763 (1996) Judy J. Chadwick. 16 Fordham Int=l L. L. 25 (1986) Foundation on Economic Trends v. Thomas. 809 F. Supp. 713 (1986) Additional Readings & Materials: Robin A. 2d 875 (1987) Foundation on Economic Trends v. Regulating Genetically Engineered Microorganisms Under the Toxic Substances Control Act. Supp. Kim. 1160 (1993) 7 . Rev. 637 F. Environmental Protection Authority Week of April 28 Reading Assignment: Henry Miller. 661 F. Thomas. Rev. Thomas. 24 Hofstra L. 266 Science 1815 (1994) Nat=l Coalition Against the Misuse of Pesticides v. J. FIFRA=s Preemption of Common Law Tort Actions Involving Genetically Engineered Pesticides. 223 (1995) Celeste Steen.

Chem. Faculty Generated Inventions: Who Owns the Golden Egg? 1992 Wisc. Anne T. Sept. Courtney S. 4 J. 259 (1992). Rev 565 (1992). Property Rights Technology Transfer Patents Week of May 5 Reading Assignment: Moore v. Additional Readings & Materials: Richard Gold. B. Body. Thomas N. & Health 1 (1990). Self.III. 42 Case Western Reserve L. Pat Chew. Hastings Center Report. 1992). Inc. An Alternative to Property Rights in Human Tissue. 12 F. v. Margaret Swain & Randy Marusyk. Service. Tissues and Organs. Warren Greenberg & Deborah Kamin. Owning Our Bodies: An Examination of Property Law and Biotechnology 32 San Diego L. at 12.\Oct. Rev. Regents of the University of California. Corrigan. L. 1167 (1995).. 22 Hastings Center Report 22 (Sept. A Paper Tiger: Lawsuits Against Doctors for Non-Disclosure of Economic Interests in Patients' Cells. and the Property Paradigm. University-Industry Research Relationships in Biotechnology: 8 . David Blumenthal et al. 36 Soc. Rev. 1993). Public-Private Partnerships in Biomedical Research: Resolving Conflicts of Interest Arising Under the Federal Technology Transfer Act of 1986. 3d 1256 (3d Cir. Environmental Monitoring Systems Laboratory-Cincinnati. Campbell. 793 P. Bulleit. C. Property Rights and Payment to Payments for Cell Lines Derived from Human Tissues: An Economic Analysis.L. Med. 1071 (1993).2d 479 (1990). Protecting Biotechnology Products A. 1990. Sci.

Ex Parte Allen. 227 U. Soc=y 903 (1992). Rev. Eisenberg. Holland. Ex Parte Hibberd. App. 270 (1992). and the Frontiers of Science: Intellectual Property Protection in the Biotechnology Industry. Chakrabarty. D. Holden Foundation Seeds.S. U.Q. Rebecca E. Reid G. 35-166 (1989). 44 Am. 303 (1980). 39 Fed. General Overview of the Intellectual Property System in Owning Scientific and Technical Information.S.S. LEXIS 21 (1987). B.Chi. 1994). Diamond v. Biotechnology Patent Protection Act. Not Always the Best Medicine: Biotechnology and the Global Impact of U. Adler. 443 (1985). 3d 1226 (1993). U. Asgrow v.Implications for the University.2d 486 (Fed Cir. New Developments in Biotechnology: Patenting Life.P. Pioneer HiBred v. News & J. 1985 Pat. 173 (1991). L. Biotechnology as an Intellectual Property. Additional Readings & Materials: OTA. Carroll. David Beier & Robert H. Technology Transfer. Patents and Progress of Science: Exclusive Rights and Experimental Use. 1987 Pat. 147 (1989). 447 U. 35 F. Amy E. 74 Pat. Reid G. 17-40 (1989). 2433 (1995). 224 Science 357 (1984). Adler. 56 U. 982 F. Rev. 9 . 64 Den. Rev. 232 Science 1361 (1986). & Trademark Off. Can Product by Process Patents Provide the Protection Needed for Proteins Made by Recombinant DNA Technology. Week of May 12 Reading Assignment: Rochelle Dreyfus. R. App. L. Patent Law. LEXIS 11. L. Government Research. Benson. Winterboer.

927 F. Cir. Wellcome. Inc. Genentech.2d 1565. 984 F. 2d 1200 (Fed. Monoclonal Antibodies Inc. Cir. 1991). Imazio Nursery v. Genetech.Fiers v.Q. Dania Greenhouses. 3d 1560 (1995). Amgen v. Chugai Pharmaceuticals. U. Scripps Clinic v. 2d 1164 (Fed. 31 U. 69 F. 10 . 29 F3d 3d 1555.2d 1164 (Fed Cir. Genentech v. 902 F.2d 1338.2d 1367 (Fed Cir. Sugaro. 904 F. 1993). Trade Comm=n. 1986). 1994). Cir.S. Hybritech Inc.S. 802 F.P. 1990).. 927 F. Amgen v. Hormone Research Foundation v.2d 1532 (Fed. C.

2786 (1993). Causation. 11 . Additional Readings & Materials: Jackson v.. 1023 (1996). 889 (1994). Wyeth Laboratories... 1968). 1363 (1996). L. Inc. Pitt. Schwartz & Mark A. Supp. Rev. L. L. Products Liability Toxic Torts Week of May 19 Reading Assignment: Daubert v. 1985). Johns Manville Sales Corp. et al. Jean Macchiaroli Eggen. Supp. 750 F.. Rev. Rev. Garrett v. Razook. 277 (1985). 24 Seton Hall L. 943 F. 3d 620 (1996). 79 F. Rev. B. Jon Cohen. Bus. 1437 (1994). Jr. 113 S. 256 Science 168 (1992). & Scientific Evidence After Daubert. Ct. Is Liability Slowing AIDS Vaccines?. Peter Huber. Victor E. SmithKline Beecham Corp.IV. Lynnbrook Farms v. Behrens. W. 2d 1314 (5th Cir. Safety and the Second Best: The Hazards of Public Risk Management in the Courts .J. L. 1023 (9th Cir. Kip Viscusi.. Merrell Dow Pharmaceuticals. Legal and Extralegal Barriers to Federal Product Liability Reform 32 Am. Toxic Torts. 541 (1995). Davis v. Liability Risks A. SmithKline Beecham Corp. 399 F. The Effects of Products Liability on Innovation: Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense. Nim M. The Road to Federal Product Liability Reform. 55 Md. 55 U. 85 Colum.

Serious Flaws to Biotechnology Risk. Boczar. Ferretti. 791 (1993). Miller & Douglas Gunary. B. Pitt. L. 12 . Burk & Barbara A. Liability Risks A. Looking For the Big Picture . 711 (1993). Additional Readings & Materials: Henry I.Developing a Jurisprudence for a Biotechnological Age. Rev. 10 Pace Envtl. Dan L. 55 U.IV. Biotechnology and Tort Liability: A Strategic Industry at Risk. Products Liability Toxic Torts Week of May 26 Reading Assignment: Joan M. L. 262 Science 1500 (1993). Rev.

List of Products: Intron-A Protropin Neupogen Epogen Leukine Avonex Betaseron Activase Flavr Savr Tomato Posilac (rBST) Ceredase\Cerezyme Pulmozyme RespiGam Chymogen\ChyMax New Leaf Insect Protected Potato Humulin\Novolin Recombivax Orthoclone OKT3 Bollgard Insect Protected Cotton CIBA Maximizer Hybrid Corn 13 .

Sign up to vote on this title
UsefulNot useful