Biotechnology and the Law

A Bibliography of Materials that Explore the Legality of Patenting Life Forms

Lisa McNamara
SLIS 5647
Spring 1998

Introduction:

Patenting living material has been a practice in the fields of agriculture and horticulture for many decades; plants have long been genetically altered to improve viability and to increase yield and desired characteristics. It is not surprising that Dolly, the sheep cloned by Scottish scientists, comes out of the agricultural world. For many people, though, there is a tremendous leap from cloning plants to cloning animals, and laws that were originally intended to protect agricultural and horticultural production processes and products may not seem adequate if extended into the domain of animal and, perhaps, human production or reproduction. With the birth of Dolly in March 1997, the world has been struggling to answer some of the social, legal, and ethical questions surrounding the issue of cloning animals.

What follows is a highly selective bibliography of resources on this topic. Selections have been made based on their significance and the perceived reliability of the source providing the information. Many highly informative materials had to be eliminated because of the narrow focus of this bibliography; only materials dealing directly with issues of patenting or copyrighting animal life forms have been included. For those who are interested, there is a tremendous amount of material available on plant patenting, and there is also much available on the uses of genetic information for reasons other than cloning, for instance: pre-selection of children, pre-selection of candidates by insurance providers, and so on. If these issues are touched on in the following bibliography, it is only briefly.

Judiciary Interpretation and Case Law

Supreme Court Case:

Diamond v. Chakrabarty, 447 US 303 (1980).

key points:

Supreme Court upheld that a live, man-made micro-organism is patentable under 35 USC Section 101.
Respondent filed for patent of human-made genetically engineered bacterium capable of breaking down crude oil, a property not known to exist in any other bacteria.
Micro-organism in this case constitutes a "manufacture" or a "composition of matter" under 35 USC Section 101.

case history and treatment:

Diamond v. Chakrabarty has been examined in --

Animal Legal Defense Fund v. Quigg, 710 F. Supp. 728, 731(N.D. Cal. 1989).
In re Grams, 888 F.2d 835, 838

followed in --

Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 923 (1991). This case concerns procedural issues and the requirement for public notice of changes in patent regulation and procedure.

and cited in dissenting view in --

Cumberland Reclamation Co. v. Secretary, Dept. of the Interior, 925 F.2d 164, 169 (1991).
State of Idaho v. Hodel, 814 F.2d 1288, 1298 (1987).

Annotations, Responses and Interpretations

William T. Goglia, Annotation, Supreme Court's View As To What Is Patentable Subject Matter Under Federal Law As "Process," "Machine," "Manufacture," or "Composition of Matter."
Additional articles are included in Secondary Sources (see below).

Other Resources:

CASOLM -- The Courts and Science On-Line Magazine

Legislative Materials and Statutes

Legislative: United States Code relevant section(s):

35 USC Section 101

35 USC Section 103, Conditions for Patentability; Non-Obvious Subject Matter

For information related to pending legislation and the "Human Cloning Research Prohibition Act"

Search: http://thomas.loc.gov/

Bills to look for from the 105th Congress include:

S.368 To prohibit the use of federal funds for human cloning research
S.1574 Human Cloning Prohibition Act
H.R.923 " "
S.1601 " "
H.R.922 " "
H.R.3133 " "
S. 1602 " " Prohibition Act of 1998
S. 1611 " " Prohibition Act of 1998
S. 1595 To establish commission to promote national dialogue on bioethics

Also look to the following accessed via http://wais.access.gpo.gov/:

Cloning Prohibition Act of 1997 -- Message from the President, Cong. Rec., June 10, 1997, H3638.
Human Cloning Prohibition Act, Cong. Rec., Feb. 10, 1998, S566-S580.
Human Cloning, Cong. Rec., March 4, 1997, H713-H714
Report of Draft Legislation Entitled -- "The Cloning Prohibition Act of 1997" -- Message from the President -- PM 46, Cong. Rec., June 9, 1997, S5412.
Cloning Ban Versus Partial Birth Abortion Ban, Cong. Rec., June 12, 1997, H3724.
Human Cloning Prohibition Act of 1998, Cong. Rec., Feb 11, 1998, S661.

Recent U.S. Congressional hearings that examine scientific, legal, and ethical issues related to genetic cloning:

United States. Cong. House. Subcommittee on Investigations and Oversight. Human Genetic Engineering. Hearings. 97th Cong., 2nd sess. Washington: GPO, 1982.
United States. Cong. House. Subcommittee on Courts, Civil Liberties, and the Administration of Justice. Patents and the Constitution: Transgenic Animals. Hearings. 100th Cong., 1st sess. Washington, GPO: 1987.
United States. Cong. Office of Technology Assessment. New Developments in Biotechnology: Patenting Life. 5 parts. 100th Cong., 1st and 2nd sess. Washington: Nat'l Tech Info Service, 1987.
United States. Cong. House. Transgenic Animal Patent Reform Act. 100th Cong., 2nd sess. House Rpt. 100-888. 1988.
United States. Cong. House. Subcommittee on Courts, Intellectual Property, and the Adminstration of Justice. Transgenic Animal Patent Reform Act of 1989. Hearings. 101st Cong., 1st sess. Washington, GPO: 1989.
United States. Cong. Senate. Subcommittee on Patents, Copyrights, and Trademarks. Genome Project: The Ethical Issues of Gene Patenting. Hearing. 102nd Cong., 2nd sess. Washington, GPO: 1992.
United States. Cong. House. Subcommittee on Energy. Department of Energy's Human Genome Project Issues Arising from Research. Hearing. 103rd Cong., 2nd sess. Washington, GPO: 1994.
United States. Cong. Senate. Subcommittee on Public Health and Safety. Scientific Discoveries in Cloning: Challenges for Public Policy. Hearing. 105th Cong., 1st sess. Washington, GPO: 1997.
United States. Cong. House. Human Cloning Research Prohibition Act. 105th Cong., 1st sess. House Rpt. 105-239 pt 1. 1997.
United States. Cong. Senate. Subcommittee on Public Health and Safety. Ethics and Theology: A Continuation of the National Discussion on Human Cloning. Hearing. 105th Cong., 1st sess. Washington: GPO, 1997.
United States. Cong. House. Committee on Science, Subcommittee on Technology. Biotechnology and the Ethics of Cloning: How Far Should We Go? Hearing. 105th Cong., 1st sess. Washington: GPO, 1997.

Congressional Responses:

Congressman Lee Hamilton responds to Cloning Debate

Congressional-Related Materials:

Pro & Con: Should Congress Prohibit All Human Cloning Experimentation?, Cong. Digest, Feb 1, 1998. v.77, n.2, pp46+

J.S. Purdy, State of the Debate: Dolly and Madison, Am. Prospect May 1, 1998. no. 38, pp. 88+

More Congressional-Related materials can be found in Secondary Sources (see below).

Executive Rules and Regulations

National Bioethics Advisory Committee (NBAC) This advisory committee was established by the President and charged with examining the ethical, social, and legal implications of human cloning. The President issued his directive in March 1997 in response to the successful cloning of the sheep, Dolly. The committee published its report in June 1997.

Presidential Directive March 1997 -- President responds to the cloning of Dolly with request for a Prohibition of Human Cloning.

Various Responses to NBAC Recommendations

from the American Association for the Advancement of Science
Anonymous. "Report on Human Cloning Criticized." Issues in Science and Technology 14(1): 33. Fall 1997.
More responses are included in Secondary Sources (see below).

Legal Encyclopedias, Hornbooks, Outlines, and Related Monographs:

60 Am Jur 2d, Patents Sections 10, 11

69 C.J.S., Patents Sections 9, 10, 11, 12

G.P. Smith, III. Bioethics and the Law: Medical, Socio-Legal and Philosophical Directions for a Brave New World. UP of Am. 1993.

Ira H. Carmen, Cloning and the Constitution: An Inquiry into Governmental Policymaking and Genetic Experimentation, 1985.

David W. Plant, et al, eds. Patenting of Life Forms, 1982.

Roman Saliwanchik, Legal Protection for Microbiological and Genetic Engineering Inventions, 1982.

Miguel A. Santos, Genetics and Man's Future/ Legal, Social, and Moral, 1981.

Joseph Menditto and Debbie Kirsch, Genetic Engineering, DNA, and Cloning: A Bibliography in the Future of Genetics, 1983.

Karl Drlica, Understanding DNA and Gene Cloning: A Guide for the Curious, 1992.

Philip Reilly, Genetics, Law, and Social Policy.

Yvonne M. Cripps, Controlling Technology: Genetic Engineering and the Law, 1980.

Margaret O. Hyde, Cloning and the New Genetics.

Secondary Materials:

Stephen G. Whiteside, Patents Claiming Genetically Engineered Inventions: A Few Thoughts On Obtaining Broad Property Rights, 30 New Eng. L. Rev. 1019 (1996).
Rochelle K. Seide and Frank A. Smith, Intellectual Property Protection and Biotechnology. 67 N.Y. St. B. J. 52 (1995).
Jeremy Cubert, U.S. patent policy and biotechnology: growing pains on the cutting edge, 77 J. Pat. [&Trademark] Off. Soc'y, 151 (1995).
Margaret Llewelyn. Industrial Applicability/Utility and Genetic Engineering: Current Practices in Europe and the United States. 16 EIPR: Eur. Intell. Prop. Rev. 473 (1994).
Thomas Traian Moga. Transgenic Animals as Intellectual Property (Or the Patented Mouse That Roared.). 76 J. Pat. [&Trademark] Off. Soc'y 511 (1994).
David Urso. NIH loses in its attempt to patent genetic materials. (National Institutes of Health) . 22 J.L. Med. & Eth. 179 (1994).
Rebecca S. Eisenberg, A technology policy perspective on the NIH gene patenting controversy. (National Institutes of Health) (Symposium: Biotechnology Law) . 55 U. Pitt. L. Rev. 633 (1994).
Richard M. Mescher, Patent law: best mode disclosure - genetic engineers get their trade secret and their patent too? (reprinted from U. of Dayton L. Rev., vol. 18, no. 177, 1992) . 26 Intell. Prop. L. Rev.183 (1994).
Christine Collard, Limited patent protection for proteins. (Canada), 10 Can. Intell. Prop. Rev. 25 (1993).
Stephen Green, The great gene robbery; a federal agency vies to monopolize patents. (National Institutes of Health), 104 L.A. Daily J., Dec 3, 1991 @ pg 6.
Harold C. Wegner, Biotechnology process patents: judicial or legislative remedy, 73 J. Pat. [&Trademark] Off. Soc'y 24 (1991).
Richard M. Klein, Helpful insights to the new standards required for patent applications containing nucleotide and/or amino acid sequence data, 73 J. Pat. [& Trademark] Off. Soc'y 29 (1991).
Rachel E. Fishman, Patenting human beings, 26 Trial, July 1990 @ pg. 54.
Terence Moran, On the political frontiers of biotechnology; court fight over genetically engineered protein moves to Congress, 12 Legal Times, Jan 8, 1990 @ pg 1.
Rachel E. Fishman, Patenting human beings: do sub-human creatures deserve constitutional protection?, 15 Am. J. of L. & Med. 461 (1989).
Sean Johnston, Patent protection for the protein products of recombinant DNA, 4 High Tech. L. J. 249 (1989).
Dan L. Burk, Copyrightability of recombinant DNA sequences, 29 Jurimetrics J. L., Sci. & Tech. 469 (1989).
Janice A. Sharp, Of transgenic mice and men, 16 W. St. U. L. Rev. 737 (1989).
Frank Y. Tang, Recent development of patent law protection for products of genetic engineering in Great Britain: Genentech Inc.'s patent for TPA, 15 Syracuse J. Int'l L. & Commerce 125 (1988).
Marianne Lavelle, Just whose life is it, anyway? Genetic patents. (Animal Legal Defense Fund v. Quigg), 10 Nat'l L. J., Aug 15, 1988 @ pg 3.
Barry Hoffmaster, The ethics of patenting higher life forms, 4 Intell. Prop. J. 1 (1988).
Reid G. Adler, Introduction: evolving and recombinant biotechnology law. (Biotechnology Law Issues), 16 AIPLA Q.J. 287 (1988).
Robert B. Kambic, Hindering the progress of science: the use of the patent system to regulate research on genetically altered animals, 16 Fordham Urb. L.J. 441 (1988).
Jerome L. Jeffers, Restriction of propagation of patented bacteria sold by patentee -- can it be done?, 70 J. Pat. [& Trademark] Off. Soc'y 137 (1988).
Jeffrey G. Sheldon & Denton L. Anderson, Genetic engineering and the U.S. Patent Office, 100 L.A. Daily J., Oct 8, 1987 @ pg4.
Charley Roberts, Bill would halt patents on animals, 100 L.A. Daily J., Aug 11, 1987 @ pg5.
Jerry Schaffer, Biotech raises host of questions in legal circles; Congress to debate patent law aspects, beginning today; uncharted territory, 100 L.A. Daily J., June 11, 1987 @ pg1.
I.A. Wilson & K.R. Wilson, Patenting new life forms: a dilemma in bioethics and the law. (Australia), 3 Queensland Inst. Tech. L.J. 99 (1987).
James V. Feinerman, Deposit procedures for patenting microorganisms. (China), 8 East Asian Exec. Rep., Oct 15, 1986 @ pg 11.
Rudolf E. Hutz, Patent protection for living organisms, 5 Del. Law. 30 (1986).
Berge Hampar, Patenting of recombinant DNA technology: the deposit requirement, 67 J. Pat. [& Trademark] Off. Soc'y 569 (1985).
Steven D. Schroeder, Patenting microorganisms: working the bugs out of the international depositary authority, 14 Cal. W. Int'l L.J. 49 (1984).
Stephen R. May, Everything a lawyer should know (and then some) about legal rights in living matter, 54 Okla. Bar J. 2457 (1983).
Bradford C. Auerbach, Biotechnology patent law developments in Great Britain and the United States: analysis of a hypothetical patent claim for a synthesized virus, 6 B.C. Int'l & Comp. L. Rev. 563 (1983).
Irving Kayton, Copyright in living genetically engineered works, 50 Geo. Wash. L. Rev. 191 (1982).
Leon R. Kass, Patenting life, 63 J. Pat. Off. Soc'y 571 (1981).
Allen Bloom, Designer genes and patent law: a good fit, 26 N.Y. L. Sch. L. Rev. 1041 (1981).
Suzanne Clark, Philosopher's paradise: should a microorganism the product of a microbiologist be patentable?, 4 Auckland U. L. Rev. 129 (1981).
John W. Behringer, Microorganism patents: United States Supreme Court opens door to patenting of "human-made" bacteria, 63 J. Pat. Off. Soc'y 128 (1981).
John A. Norris, Karen Carroll and Bruce L. Watson, Biomedical research - genetically engineered microorganisms - patents, 6 Am. J. L. & Med. 375 (1980).
Patents ... living organisms. 66 ABA J. 1003 (1980).
Ruth Hochberger, Justices rule patent laws cover living micro-organism. (includes various U.S. Supreme Court decisions), 183 N.Y. L. J., June 17, 1980 @ pg 1.

Secondary Sources con'd:

Resolving the dilemmas between the patent law and biotechnology: an analysis of three recent biotechnology patent cases. Shaoyi Alex Liao. Santa Clara Computer and High-Technology Law Journal, July 1995 11 n2 p229-260.

Issues and trends relating to the patenting of biotechnology inventions since Diamond v. Chakrabarty. George Likourezos. Adelphia Law Journal, Annual 1994 10 n1994 p73-97.

Patenting living matter in the European Community: diriment of the draft directive. David G. Scalise and Daniel Nugent. Fordham International Law Journal, Summer 1993 16 n4 p990-1032.

Biotechnology and animal patents: when someone builds a better mouse. Reagen Anne Kulseth. Arizona Law Review, Summer 1990 32 n3 p691-716.

Can patent law accommodate the novel challenges of the biotech industry? Jade Lynn Hlavinka. South Texas Law Review, Feb 1990 31 n1 p301-321.

Patent law: patenting animal life: another scapegoat for small interest groups. (case note) Jae H. Kim. Oklahoma Law Review, Spring 1989 42 n1 p131-144.

The evolution of patentable compositions of matter: the United States Patent Office accepts genetically altered animals as patentable subject matter under 3 5 U.S.C. section 101. (Case Note) Robert S. Wasowski. The Administrative Law Journal, Fall 1988 2 n2 p309-331.

Biotechnology patent law developments in Great Britain and the United States: analysis of a hypothetical patent claim for a synthesized virus. Bradford C. Auerbach. Boston College International and Comparative Law Review, Spr 1983 6 n2 p563-590.

Patentability of living multicellular life forms. (U.S. patent and trademark law developments) C. Bruce Hamburg. Patent and Trademark Review, Jan 1983 81 1 p28-30.

Patenting life. Leon R. Kass. Journal of the Patent Office Society, Nov 1981 63 n11 p571-6090.

Designer genes and patent law: a good fit. Allen Bloom. New York Law School Law Review, Fall 1981 26 n4 p1041-1057.

Patent law - Diamond v. Chakrabarty - The U.S. Supreme Court rules that living matter is patentable. Thomas J. Hefferon. North Carolina Law Review, June 1981 59 n5 p1001-1011.

Patent law - Patenting the microbe: Perspectives and limitations. (case note) Robert M. Novack. Suffolk University Law Review, April 1981 15 n2 p324-338.

Patents - a live, man-made micro-organism is patentable subject matter under 35 U.S.C. 101. (case note) Carol F. Fowler. Drake Law Review, Spr 1981 30 n3 p636-649.

Patent law - man-made, living microorganisms held patentable subject matter under section 101 of the Patent Act. (case note) Neil Faggen. Temple Law Quarterly, Spr 1981 54 n2 p308-330.

Man-made organisms receive patent protection. (case note) Washington University Law Quarterly, Spr 1981 59 n1 p261-271.

Oil eaters: alive and patentable. (patentable of living organisms) (case note) Dennis J. Walsh. Pepperdine Law Review, March 1981 8 n3 p747-781.

Innocuous inoculum or perilous parasite? Encouraging genetic research through patent grants: a call for regulation and debate. James F. Brashear. San Diego Law Review, March 1981 18 n2 p263-299.

The patentability of genetically engineered micro-organisms: a change in judicial attitudes. Yvonne Cripps. New Zealand Law Journal, Jan 20, 1981 n1 p13-16.

Building a better bacterium: genetic engineering and the patent law after Diamond v. Chakrabarty. (case note) Karen Goodyear Krueger. Columbia Law Review, Jan 1981 81 n1 p159-178.

Patent law - Life forms found to be within the ambit of Section 101 of the Patent Code. (case note) Carol H. Wolfe. Cumberland Law Review, Wntr 1981 11 n3 p775-798.

Patents - statutory interpretation - patentability of living microorganisms - the United States Supreme Court has held that a live, human-made, genetically engineered microorganism is patentable subject matter under 35 U.S.C. 101. (case note) Ronald M. Benrey. Duquesne Law Review, Wntr 1981 19 n2 p337-349.

Patent law - patent on life form - man-made modification of microorganism is patentable subject matter under 35 U.S.C. 101. (case note) Scott Vidas. Hamline Law Review, Jan 1981 4 n2 p341-350.

Patent law - human-made, genetically engineered, living microorganism constitutes a "manufacture" or "composition of matter" under title 35 U.S.C. 101. (case note) Ruth Rawls Harris. Mississippi College Law Review, Jan 1981 2 n2 p161-173.

Patenting life forms under 35 U.S.C. 101: Diamond v. Chakrabarty. Debbie Mills. Northrop University Law Journal of Aerospace, Energy and the Environment, Wntr 1981 3 n1 p131-138.

Expanding patent coverage: policy implication of Diamond v. Chakrabarty. (case note) Frank P. Darr. Ohio State Law Journal , Wntr 1981 42 n4 p1061-1083.

Patent law - Statutory subject matter - Genetically engineered microorganisms. (case note) Larry C. Stephens. Tennessee Law Review, Wntr 1981 48 n2 p454-492.

Patenting life. William L. Hayhurst. Canadian Business Law Journal, Dec 1980 5 n1 p19-35.

Patentability of living microorganisms. (Supreme Court, 1979 term) Harvard Law Review, Nov 1980 94 n1 p261-270.

Scientist patents micro-organism - Life forms considered patentable subject matter under 35 U.S.C. 101. (case note) John M. Kiernan. Ohio Northern University Law Review, Oct 1980 7 n4 p1038-1051.

Patentability of micro-organisms. (case note) Ann Amer Brennan. Akron Law Review, Fall 1980 14 n2 p341-349.

Biomedical research - genetically engineered microorganisms - patents. John A. Norris, Karen Carroll and Bruce L. Watson. American Journal of Law & Medicine, Fall 1980 6 n3 p375-376.

New criteria for patentable subject matter: microorganisms and computer-related technology. Lorance L. Greenlee. Brooklyn Law Review, Fall 1980 47 n1 p43-66.

Life forms as proper subject matter under the Patent Act. (case note) Reginald R. Modlin. Detroit College of Law Review, Fall 1980 1980 n3 p939-956.

The patent system and the "new biology". (industrial microbiology) Iver P. Cooper. Rutgers Journal of Computers, Technology and the Law, Fall 1980 8 n1 p1-46.

Patent law - live, human-made microorganisms are patentable subject matter under 35 U.S.C. 101. (case note) Firooz T. Namei. University of Cincinnati Law Review, Fall 1980 49 n4 p902-913.

U.S. patent and trademark law developments. C. Bruce Hamburg. Patent and Trademark Review, Sept 1980 78 n9 p367-370.

Washington rediscovers the patent system. Herbert H. Mintz. Practical Approach to Patents, Trademarks & Copyrights, Sept 1980 1 n4 p237-253.

Patent decision fuels genetic research debate. James Podgers. ABA Journal, Aug 1980 66 p943-944.

Patents - patentable subject matter - living man-made organisms held to be patentable subject matter under 35 U.S.C. 101. (case note) Michael T. Day. Marquette Law Review, Summ 1980 63 n4 p711-730.

Patent law - Patentability of micro-organisms - What next? (case note) Garry Johnson. University of Florida Law Review, Summ 1980 32 n4 p820-828.

Live, human-made bacteria as patentable subject matter under 35 U.S.C. 101. (case note) Brent J. Jensen. Brigham Young University Law Review, Spr 1980 n3 p705-719.

Patents on microorganisms. Arthur P. Gershman and Joseph Scafetta Jr. Idea, Wntr 1980 21 n1 p1-36.

The patentability of living matter: hey waiter, what's Chakrabarty's pseudomonas bacterium doing back in the Supreme Court's soup? G. Scott Rayson. Washington and Lee Law Review, Wntr 1980 37 n1 p183-200.

Background Information and Other Pathfinders

Bioethics-Related Websites: Click on the following links to access additional bioethics materials, websites, and pathfinders.

Legislation Pertaining to Cloning - Website out of UCLA This site has information on state legislation as well as the relevant bills in Congress.

National Information Resources on Ethics and Human Genetics; website includes BioEthicsLine Database and Bibliography of Bioethics

NBAC's Links to Bioethics Sources and Bibliographies A good website for additional links to important bioethics sources many of which are not listed here.

BioTech Page from the Indiana Molecular Biology Institute at Indiana Univ Go to this site for technical information and additional molecular biology links.

Last Updated: May 12, 1998
Maintained by: Lisa McNamara

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