Genes, Patents, and Bioethics — Will History Repeat Itself?

First published in September 2000, Scope Note 39 is an annotated bibliography with links to electronic texts where possible. It is updated on a periodic basis.

Introduction

Gene patenting — the very notion sounds absurd! How can anyone claim to have invented the genes with which one is born? To make matters worse, genetic makeup precedes birth, meaning the existence of the invention predates the existence of the inventor. So, do we really own our genes, or do they belong to our parents, or our governments, or a Supreme Being? Ownership is only one bioethical issue involved in gene patenting. But before looking at the issues, some essential and basic terms must be understood, namely genes and patents.

Genes

In his book On the Origin of Species, published in 1859, the biologist Charles Darwin proposed a theory called "natural selection," whereby living things changed over time or evolved through generations due to competition and variation. By experimenting with the garden pea in the 1860s, Gregor Mendel, a monk and accomplished horticulturalist, provided the mechanism of inheritance supporting the natural selection theory of his contemporary Darwin. That mechanism is the gene, or, as Mendel described it, a discrete "factor." The gene has also been defined as "the fundamental unit of heredity" (United States 1987, p. 157). Each individual has two copies of a gene, one from each parent, but that individual passes down to offspring only one of the two copies. Because of Mendel, the gene has become a scientific concept and the basis of a new scientific field: genetics.

David C. Page (2000) of the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology explained today's terms for genetics structures using an analogy taken from the home. In his view, the cell is a kitchen, the genome is a shelf in the kitchen, the chromosome is a cookbook on the shelf, the gene is a recipe in the cookbook, and a base-pair (either adenine with thymine or guanine with cytosine) is a single letter in the recipe. A protein, the working molecule blueprinted by a gene, is a dish ready to eat, and an ingredient in the dish is an amino acid, which is a building block of the protein as specified by a string of base-pairs.

Colin Tudge (1993), a British science journalist, would disagree with Page's description of the gene as a recipe. A recipe is like a blueprint: both are directions that precede the work. But a gene is not passive according to Tudge; it actively administers the cell's work, and it also responds to cellular events (Aldridge 1996).

The current focus of scientific research and funding is on the gene and the completion of the sequencing of all the genes that comprise the human genome, portrayed in the press as a race between the U.S. government's Human Genome Project and the private corporation Celera Genomics. The real action, however, is at the protein level. The gene only holds the information to produce a protein; it is the three-dimensional shaped protein that does the work. In order to produce energy, eliminate waste, and perform other functions specific to a cell or tissue, proteins must bind, thus creating "biological pathways." Proteins bind (or not) and detach as a function of their shapes, which are determined by their precise chemical composition as spelled out in their genetic code. IBM will spend the next five years making one computer, Blue Gene, that will then take an entire year to come up with the chemical map for only one protein (Gillis 2000). It is estimated that there are about 40,000 proteins in the human body.

Despite these overwhelming numbers, modern biology has been able to achieve significant results within the Human Genome Project's 15-year time frame, from 1990 to 2005. The genetic map was completed in 1993; the physical map was completed in 1995; and the genetic sequence is expected to be completed in 2002, with 97 to 99 percent completed as of 26 June 2000. This was accomplished thanks to computers and robots, in short, high-throughput automation. The mechanization of the laboratory has moved the rate of scientific discovery and progress far ahead of that achieved by humans alone in the nineteenth century, the time when Darwin theorized about evolution, Mendel experimented with inherited traits, and the U.S. Patent Office came into being.

Patents

Patents are more properly called "letters patent"--i.e., documents from a sovereign, directed to all and entered into the open rolls so that all might be bound. In contrast, "writs close" were documents directed to particular persons, for particular purposes, sealed, and not open for public inspection.

The general contours of the present U.S. Patent and Trademark Office (PTO) were established by statute in 1836. Less than 50 years earlier, in 1790, Congress had enacted the first patent act under Article I, Section 8 of the Constitution. Common law, which is all the statutory and case law derived from England and the colonies before the American Revolution, influenced that seminal legislative act. The Statute of Monopolies had been passed under James I in 1623, because the awarding of patents by the sovereign, who granted monopolies either to royal favorites or as a reward for service, had become an abusive practice and restricted free trade. The Statute made all monopolies illegal except those granted by parliament and, more importantly, those granted to the "true and first inventor" of "any manner of new manufacture." This latter exception is the basis for the English, and subsequently American, patent system.

The system survives today in that a patent can only be granted to the original — i.e., the first — inventor. In exchange for a monopoly for a limited number of years, the patent holder must disclose to the government's PTO in a patent application sufficient detail of the invention so that others may use that knowledge when the patent expires and the application is made public. In the U.S., where priority goes to the first to invent, not the first to file, a one-year grace period is allowed between the date of publication and the date of the patent application, in order to facilitate sharing of information among the scientific research community. The essence of a patent, then, is the exchange of disclosure for monopoly, public knowledge for private gain.

A patent can be seen as government-sanctioned protection from competition. A patent creates an exclusionary right of ownership of property, specifically the possession of intellectual property. Thus, the patent confers not a positive right, but a negative one, namely, the right to exclude. The patent holder profits from use of this property in one of three ways: (1) use by the patent holder; (2) authorized use by another (licensing); and (3) protection from unauthorized use by another (infringement). Use means manufacture, actual use, importation, sale, and offer for sale. The patent holder is under no legal requirement or moral obligation, however, to use the patented property; in fact, the patent holder may choose not to use it, but just to prevent others from using it.

The scope of patents has broadened considerably from the days when they referred to "any manner of new manufacture." In the United States, there are currently three kinds of patents: design, plant, and utility, with utility patents being the most common and the most economically important. Design patents cover "any new, original and ornamental design" for "articles of manufacture" (35 U.S.C. 101). Plant patents cover the invention or discovery of "any new and distinct plants" asexually reproduced, other than by tuber reproduction, or a plant found in its uncultivated state (35 U.S.C. 161). Utility patents cover "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvements thereof" (35 U.S.C. 171).

The right to a patent is granted by the PTO, a federal government administrative agency under the Department of Commerce within the Executive Branch. A patent officer examines the patent application for the legal criteria of novelty, utility, and nonobviousness, provided the invention or discovery falls under the patentable subject matter of one of the three kinds of patents. Also, a patent must be enabled, meaning the patent applicant must include sufficient disclosure in the patent application so that others can "make or use" the invention or discovery upon expiration of the patent (35 U.S.C. 111, 112). Currently the statute creates a monopoly of 20 years; the earlier law limits protection to 17 years for patent applications filed prior to 8 June 1995. Examination of a patent application, award of a patent to the inventor, and dissemination of information contained within an expired patent are the main functions of the PTO. The PTO also registers patent attorneys and patent agents, individuals who are permitted to represent applicants for patents before the PTO in the preparation and prosecution of applications.

Although patent attorneys and patent agents both may appear before the PTO Board on Patent Appeals and Interferences, only patent attorneys may appear before the federal district courts. In patent cases, the courts share trial jurisdiction with the administrative agency. The U.S. Court of Appeals for the Federal Circuit hears all appeals in patent cases, and an appeal from that court goes to the U.S. Supreme Court.

The Supreme Court has the final word on patent law, because it is the highest court in the U.S. Some would argue that the final word rightfully belongs not to the Supreme Court, but to the Supreme Being. The familiar Constitutional split between church and state did not exist in the common law beginnings of American patent law. Under the doctrine of the divine right of kings, all authority, both temporal and spiritual, belongs to the sovereign and is granted to the sovereign by God. Thus it is God's agent, the sovereign, who grants patents. The award of a patent for a living thing arguably constitutes the government sanction of the human invention of life, a notion at odds with the divine creation of life. The issue of whether life should be patented--in legal terms, whether it should be patentable subject matter--is probably the key bioethical issue concerning patents.

An annotated time line of selected events involving U.S. patent law, its origins, and its application to genetics, follows.

200     Athenaeus notes in his Deipnosophistae that several centuries B.C. cooks in the Greek city of Sybaris were granted exclusive rights for one year to prepare any "peculiar and excellent" dish which they invented "in order that others might be induced to labor at excelling in such pursuits" (Frumpkin 1945).

1474     The first patent law is passed in the republic of Venice on 19 March. As Venetians spread throughout Europe during the sixteenth century, the idea of exclusive rights for manufacture, in this case glass, follows (Belcher and Hawtin 1991; Price 1906).

1623     England passes the Statute of Monopolies, making all patents illegal except those granted by parliament or those granted to inventors. Because of abuse, patents are no longer granted by the sovereign (Price 1906).

1790     U.S. Congress enacts the first patent statute under the Constitution on 10 April 1790. The right to a patent now exists in the United States (II Stat. 7 (1790)).

1836     U.S. Patent Office is created under the third patent statute on 4 July 1836 (I Stat. 357 (1836)).

1873     Louis Pasteur is awarded the first patent on a microorganism, for a yeast "free from organic germs of disease," as an article of manufacture (U.S. Patent No. 141,072).

1930     Patent protection is extended to asexually reproduced ("cloned") plants (Plant Patent Protection Act of 1930 (46 Stat. 376 (1930), 35 U.S.C. 161-164)).

1940     The Plant Patent Protection Act does not encompass bacteria. The interpretation of statutory language is controlled by law, not science. The common use of the word plant applies, not the scientific one. Scientists classify bacteria as a plant despite the fact it has both animal and plant characteristics (In re Arzberger, 112 F.2d 834 (C.C.P.A. 1940)).

1948     Patent protection is denied to products of nature, because the packaging of various kinds of bacteria into one plant is an "aggregation of species" and the product of skill, not invention. "If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end" (Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S. Ct. 440, 92 L.Ed. 588 (1948)).

1970     The breeding of sexually reproduced plants is allowed patent-like protection from the Department of Agriculture, not the PTO of the Department of Commerce. Plant Variety Protection Act of 1970 (Pub.L. 91-577 (1970), 84 Stat. 1542, 7 U.S.C. 2321-2583).

1974     Patent law does not require that new starting material be patentable itself. Pre-existing naturally occurring products can be patented as processes, in this case a microorganism cultivated for use in the process of making an antibiotic, because new processes are distinguished under patent law from new products (Application of Mancy, 499 F.2d 1289 (C.C.P.A. 1974)).

1979     The fact that the microorganism is alive is not legally significant under patent law. Like Mancy, a patent is awarded for a microbiological process to make an antibiotic where a microorganism is used in the process (Application of Bergy, 596 F.2d 952 (C.C.P.A. 1979)).

1980     U.S. patent law applies to new life forms created by recombinant DNA technology as manufacture or composition of matter. Patents can be awarded to "anything under the sun that is made by man." The inventor and plaintiff in the case, Chakrabarty, claimed patents to three things: the production of a type of bacterium, the material carrying that bacteria, and the bacteria themselves. The PTO examiner allowed the patent claims on the process and the vector, but rejected the claim to patent the bacteria; the PTO Board affirmed the rejection under the rationale that living organisms are not patentable per se; the U.S. Court of Customs and Patent Appeals overturned the Board by allowing the patent for the bacteria as a purified sample and process under Bergy; and the U.S. Supreme Court ruled on the issue of subject matter patentability that living matter is irrelevant as long as the invention results from human interference and results in a genetically altered or manipulated product (Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144 (1980)).

1980     Nonprofit organizations, which include educational institutions, can apply for patents for federally funded inventions. The federal agency, however, will keep the nonexclusive worldwide license. The patent holder must share royalties with the inventor and use its own share for research, development, and education purposes (Patent and Trademark Amendment Act (Pub.L. 96-517 (1980), 94 Stat. 3015- 3027), amended 1984 (Pub.L. 98-620 (1984), 98 Stat. 3362-3364)).

1982     On 1 October, the U.S. Court of Appeals for the Federal Circuit, a specialized court with exclusive jurisdiction over the patent system, came into existence through an act of Congress under Article I of the Constitution (Federal Courts Improvement Act of 1982 (Pub.L. 97-164 (1982), 96 Stat. 25, 28 U.S.C. 1295)).

1985     Patent protection is extended to plants, in addition to the more limited protection already provided under the 1930 and 1970 laws (In re Hibberd, 227 U.S.P.Q. (BNA) 443 (PTO Bd. App. & Int.)).

1987     The award of a patent on polyploid oysters (oysters having more than the usual number of chromosomes) by the U.S. PTO is upheld in court because such oysters are not naturally occurring (In re Allen, 2 U.S.P.Q. (BNA) 1425 (PTO Bd. App. & Int.)). On 7 April, four days after the Allen decision, the Commissioner of Patents gives notice in a ruling that "nonnaturally occurring non-human multicellular living organisms, including animals, are patentable subject matter under 35 U.S.C. 101." He also advises that "[t]he grant of a limited, but exclusive property right in a human being is prohibited by the Constitution" (Patent, Trademark & Copyright Journal 33 (827): 664-65, 23 April 1987).

1988     The U.S. PTO awards a patent for a transgenic mouse, a nonhuman animal genetically modified to carry "any oncogene or effective sequence thereof" (U.S. Patent No. 4,736,866).

1990     The California Supreme Court, en banc, decides that a patient has a cause of action for breach of fiduciary duty or lack or informed consent against his physician, a university researcher, the university regents, and licensees of rights to a patented cell line and its products because the physician failed to disclose "preexisting research and economic interests" in a patient's cells before obtaining possession of them. Using recombinant DNA techniques on the cells, the physician and a researcher established a cell line containing the modified genetic material, which was needed to manufacture proteins, and then they were awarded a patent as the inventors (Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990)).

1994     New plants are protected from patent infringement in other countries. The right to save seed under 7 U.S.C. 2541 gives way to patent protection (Plant Variety Protection Act Amendments of 1994 (Pub.L. 103-349 (1994), 108 Stat. 3136)).

2000     Three years after the birth of the cloned sheep Dolly, patents covering the methods of producing cloned non-human animals, human cell lines, and early human embryos, and also covering such animals, cell lines, and embryos as the products of cloning, are awarded in Britain on 19 January. Patents on the same are pending in the U.S. (Wadman 2000).

NHGRI Policy and Legislation Database, National Human Genome Research Institute (NHGRI), National Institutes of Health [United States].

This database contains the full-text of Federal and State laws/statutes, legislative materials, and administrative and executive materials (including regulations, institutional policies, and executive orders) on a number of genetic issues including patenting.

Bioethics

The bioethical issues concerning gene patenting are complex and interwoven with other bioethical issues-e.g., informed consent, the body as property, animal rights, and xenotransplantation. The Asilomar conference on the safety of various types of recombinant DNA research was held in February 1975; it is considered "a landmark of social responsibility and self-governance by scientists" (Barinaga, p. 1584). Since 1975, the government has taken a more prominent role in addressing and regulating biotechnology as issues have emerged, such as labeling allegenes and the food safety of genetically engineered crops with an inserted peanut gene.

Recognizing that bioethics discourse might not keep pace with genetic advances, James Watson, the co-discoverer of the double helical nature of DNA in 1953 and the first head of the Human Genome Project in 1990, directed that a part of the Project's federal funding, currently 5 percent, would be set aside to study the ethical, legal, and social implications (ELSI) of human genetics research. Today ELSI has become the largest federal supporter of bioethics research with an annual budget over $10,000,000. Even with such financial support, human reflection, analysis, and discussion of the issues involving bioethics, genetics, and patents cannot keep up with the machines and people doing the genetics research.

To say that the bioethical issues involving gene patenting generally follow a biological hierarchy, such as plant-animal-human, would be overly simplistic and miss the subtlety of the debates. The issues in the debates over plant patents concerned microorganisms and bacteria. These issues are precursors to similar concerns involving animal patents and the extension of patenting to humans.

Gene patents are essentially legal creations about science. The objects of patents need only be new and useful. In themselves, they are neither moral nor immoral; however, their use may be moral or immoral. So, what are the uses of genes? In biology, genes hold and transmit genetic information, in addition to organizing or administering the cell, for the purpose of reproduction. In patent law, genes that have been modified by man can be categorized as a process, a manufacture, or a composition of matter, or any improvement on such, in short, a means or an end. The patent holder has no legal or moral obligation to use the patent. The only right granted is the right to exclude others from its use. This exclusive right means that the use of genes is no longer held solely by the possessor of the genes. Furthermore, this right runs for most, if not all, of one's reproductive life, 20 years. The bottom line is that by allowing a legal entity like a corporation to hold a patent on genetic material creates sterilization de jure (in law) and in some cases, such as Monsanto's patented Terminator seed, which can produce only one crop because of genetic modification, sterilization de facto (in fact) (Feder 2000). Gene patenting is the unbundling of genetic property into rights, such as the right to possession, the right to use, the right to sell, the right to dispose. Gene patenting thus presents a challenge to society's definition of reproduction.

To multiply now means to clone, to amplify, to make the same in quantity, replication using only one "parent." To diversify means to recombine and it may be nonnaturally occurring, with two or more parents. What about genetic variation that occurs in the second or later generations? With traditional genetic engineering, genes are directly inserted. With transgenomics, genes are induced to activate genes not in use or enhance the function of already activated genes. What are the limits for credit or responsibility?

The limits on the U.S. patent system lie within the U.S. PTO and the U.S. Court of Appeals for the Federal Circuit, and those limits are personified as a patent examiner and as a judge. Both institutions have created a runaway patent system, a system that badly needs checks put in place to restore balance (Adelman 1987; Gleick 2000). For instance, controversy over a rush to patent gene sequences with no known or obvious use ended with public outcry against such action (Baird 1998; Peters 1997). The only way to bring about these necessary checks on the executive and judicial branches of federal government is through the remaining branch of the federal government, the legislative one. Without action on an institutional level, will history repeat itself? Will the power to grant patents, what once belonged to the sovereign and now is in the hands of an anonymous patent examiner and an independent judge, be taken away by our parliament, the U.S. Congress? Will 2023 be 1623 all over again?

Resources

Although sometimes overlapping, these resources can be loosely categorized into three areas based on their use in this Scope Note.

Genes

Aldridge, Susan. The Thread of Life: The Story of Genes and Genetic Engineering. New York: Cambridge University Press, 1996. 258 p.

In a well written explanation of the science of molecular biology, Aldridge opens with a recipe: "Take a large onion and chop finely. . . . It should collapse into a web of fibres that you can pull out of the glass. This is DNA (short for deoxyribonucleic acid)." She describes proteins as assembled one amino acid at a time by the RNAs (messenger, transfer, and ribosomal), which act as intermediaries for the DNA. Aldridge goes on to cover genetic engineering, the application of the broader biotechnology, and the effect of such knowledge on evolution.

Feder, Barnaby J. Monsanto to Bar a Class of Seeds. New York Times (5 October): A1, C2, 1999.

The Monsanto corporation will not market seeds, called "Terminator seeds," that produce infertile crop plants, but is expected to continue work on the technology, which balances the suppression and release of key genes, resulting in a sterilizing protein after the plant matures.

Feder, Barnaby J. New Method of Altering Plants Is Aimed at Sidestepping Critics. New York Times (29 February): F3, 2000.

Dr. Richard A. Jefferson of CAMBRIA (Center for the Application of Molecular Biology to International Agriculture) in Canberra, Australia, is changing genetic engineering techniques in agriculture by laboratory mutation called transgenomics. To introduce a new genetic trait, instead of inserting a gene, Jefferson inserts an on-off switch that changes the gene's self-regulation by freeing mobile DNA called transposons.

Gillis, Justin. IBM to Put Genetics on Fast Track; High-Speed Computer to Study Proteins. Washington Post (3 June): A1, A7, 2000.

Life: Patent Pending, 1980, VHS, 60 min., color, Time-Life Video, distributed by Ambrose Video Publishing, Inc., 381 Park Ave. South, New York, NY 10016

This NOVA show was produced at the time of the Supreme Court's Chakrabarty decision. It explains genetics terms and molecular biology science, such as the fact that bacteria were the first living things made of cells to be patented because it was easier to work on them in part because bacteria lack nuclei and the chromosomes are spread throughout the cell. Leroy Hood comments that the speed of doing the science, such as gene sequencing, has changed. The interviews with scientists reveal concerns over the commercial future of recombinant DNA technology and the looming change of research from academia--i.e., basic science in the universities-to industry--i.e., applied science for the corporation. The freedom of scientists to speak that was epitomized by Asilomar, when Chargaff and Sinsheimer opened the debate among scientists by their criticism of the lack of laboratory safety with recombinant DNA, is seen as passing.

Page, David C. Primer on Modern Biology. Lecture given prior to the conference "Genes and Society: Impact of New Technologies on Law, Medicine, and Policy," 10 May 2000, Cambridge, Massachusetts.

Tudge, Colin. The Engineer in the Garden; Genes and Genetics: From the Idea of Heredity to the Creation of Life. New York: Hill and Wang/Farrar, Straus and Giroux, 1993. 388 p.

Tudge explains genetics and genetic engineering and describes its effects on the global community of plants, animals, and humans. He reminds us of two religious concepts to keep in mind with this technology. The first is the Greek notion of hubris, that to usurp the power of the gods is to bring swift, certain retribution. The second concept is the Jewish one of blasphemy, that to offend God is beyond sin and beyond crime.

Patents

Adelman, Martin J. The New World of Patents Created by the Court of Appeals for the Federal Circuit. University of Michigan Journal of Law Reform 20 (4): 979-1007, Summer 1987.

Within a broader article on the United States Court of Appeals for the Federal Circuit, Adelman discusses the origin and power of the court. This new court was created in 1982, two years after the Chakrabarty decision, because of Congressional dissatisfaction going back to 1971, with the handling of certain areas of federal jurisdiction (tax, patents, and environmental) by the other federal appellate courts, both the regional circuits and the Supreme Court. In theory, the Federal Circuit remains under the U.S. Supreme Court, but in fact the Federal Circuit is actually in control of the patent system. Adelman offers three reasons for this dominance: (1) the difficulty in getting selected for Court review; (2) the Federal Circuit's ability to control precedence by being the sole court of appeal in patents at this level; and (3) Congressional resolution of a dispute between the two courts would likely favor the Federal Circuit over the Supreme. As Adelman concludes, the Federal Circuit "is in the unique position of controlling the law that it administers due to its exclusive appellate position and control of technical substantive law" and, because of this, "structural counterbalances of appellate criticism or distinction" needed for Supreme Court review are missing.

Ducor, Philippe. In re Deuel: Biotechnology Industry v. Patent Law? European Intellectual Property Review 18 (1): 35-46, January 1996.

Ducor writes that the Deuel decision by the Court of Appeals for the Federal Circuit protects the biotechnology industry at the expense of patent law.

Dyer, Owen. US Awards Patent for Tribesman's DNA. BMJ 311 (7018): 1452, 2 December 1995.

The U.S. government awarded to itself on 14 March U.S. Patent No. 5,397,696 on the DNA pattern of a Hagahai tribesman from Papua, New Guinea, infected with a leukemia that is progressively benign to the tribe, who will get a share of the royalties. Charges of "bio-colonialism" are made against the U.S.

Frumpkin, M. The Origin of Patents. Journal of the Patent Office Society 27 (3): 143-149, March 1945.

Frumpkin writes about the origin of the patent as "one of the most curious chapters in the history of civilisation." He starts with its beginnings in ancient Greece and Rome and ends with the American and French Revolutions.

Gleick, James. Patently Absurd. New York Times Magazine (12 March): 44-49, 2000.

Gleick starts, "When [twenty-first] century historians look back at the breakdown of the United States patent system, . . ." they will see a patent system in crisis, "entangled in philosophical confession of its own making." Not only is the PTO issuing patents at an unprecedented rate (10,000 every 3 weeks, compared to the 46 years it took to issue the first 10,000 patents), but it is expanding the scope of patentable subject matter to include the most basic and most trivial. The PTO has no checks on its system, because the performance is measured in terms of output and the agency lacks the competence in both time and expertise for proper examination. The PTO, according to Gleick, serves the patent applicant, not the citizen.

Hagmann, Michael. Stem Cells: Protest Leads Europeans to Confess Patent Error. Science 287 (5459): 1567-1568, 3 March 2000.

The European Patent Office admitted that it had mistakenly granted too broad a patent on a method of isolating genetically engineered stem cells. The claim referred to "a method of preparing a transgenic animal" using stem cells, and the term animal is used in the patent in its scientific sense to include humans.

Houser, David J. Patent.In Encyclopedia Americana, International ed. Danbury, CT: Grolier, 1999.

This encyclopedia entry is a succinct four pages covering what may be patented, obtaining a patent, the nature of patent rights, the U.S. Patent and Trademark Office, foreign patent protection, and historical background.

Knoppers, Bartha Maria, ed. Status, Sale and Patenting of Human Genetic Material: An International Survey. Nature Genetics 22 (1): 23-26, May 1999.

Knoppers, chair of the Ethics Committee of the Human Genome Organization (HUGO), opens with a recognition of the genome's dual legal nature as person and as property and the three definitions of the genome as universal (collective "common heritage"), familial (related membership), and individual (uniqueness). She presents an overview of various international, regional, and national positions on gene patenting through laws and policies as a review of the opinions that lead to the 6 July 1998 adoption by the European Parliament and the Council of the European Union of the European Directive on the Legal Protection of Biotechnological Inventions.

Moufang, Rainer. Patenting of Human Genes, Cells and Parts of the Body?-The Ethical Dimensions of Patent Law. International Review of Industrial Property and Copyright Law 25 (4): 487-515, 1994.

The author looks at the application of Article 53(1) of the European Patent Code to humans (beings, organs, cell lines, DNA sequences, germ cells, and embryos). Article 53(a) prohibits "the granting of patents for inventions the publication or exploitation of which would collide with the ordre public or with morality." (Ordre public equates to legal system.) Moufang calls Article 53(a) "a specific gate of entry for ethical considerations."

Noiville, Christine. Patenting Life-Trends in the US and Europe. In The Life Industry; Biodiversity, People and Profits, ed. Miges Baumann, Janet Bell, Florianne Koechlin, and Michel Pimbert, pp. 76-86. London: Intermediate Technology Publications, Ltd., 1996. 206 p.

The author, a lecturer in law at the University of Paris, notes that a European Patent Office ruling on the Harvard transgenic mouse charted a course in patent law different from that in the United States. European patents now require a benefit to humanity that must outweigh the harm to the animal and the risk to the environment. This brings societal and political considerations of environmental law and animal rights into the economic patent system. The author introduces intellectual property rights using "A brief chronology of the patent debate in the North" taken from People, Plants and Patents, International Development Research Centre, Ottawa, 1994.

Price, William Hyde. The English Patents of Monopoly. Boston: Houghton, Mifflin, 1906. 261 p.

In his first chapter, Price covers the political history of monopolies, the larger economic context of patents. He writes that few places in the sixteenth century had the economic and political conditions necessary for development of a patent system, which requires "[a]dequate guaranty of monopoly over a wide industrial area. Isolated industrial centres . . . , whether autonomous or not, could not protect an inventor against infringement beyond their own borders, so that the advantages of an extended market were not sufficiently attractive to encourage the divulging of a secret of manufacture." Such conditions are still lacking in many Third World countries today. In Appendix A, the entire English Statute of Monopolies (21 Jac.I, cap. 3. A.D. 1623-24) is reprinted.

Renton, Alexander Wood, and Ingram, Thomas Allan. Patents. In Encyclopaedia Britannica, 11th ed., pp. 903-910. New York: Cambridge University Press, 1911.

In addition to the entry on patents referenced here, this edition also covers the topic of patents under the entries on Letters Patent and on Monopolies, unlike the current edition, which subsumes the topic under Property. The main entry, although dated, has the best coverage on the beginning history of patents and the differences between the British and American patent systems.

U.S. Congress. An Act to Promote the Progress of Useful Arts, 1^st Congress, Statute II, Chapter 7, 10 April 1790. In Public Statutes At Large of the United States of America , vol. 1, ed. Richard Peters, pp. 109-112. Boston: Little, Brown, 1845.

This digital document is the first patent act passed by Congress. It establishes the right to patent in the U.S.

U.S. Congress. An Act to Promote the Progress of Useful Arts, and to Repeal All Acts and Parts of Acts Heretofore Made for That Purpose, 24^th Congress, Statute I, Chapter 3570, 4 July 1836. In Public Statutes At Large of the United States of America, vol. 5, ed. Richard Peters, pp. 117-125. Boston: Little, Brown, 1856.

Another digital document, this one is the third patent act passed by Congress. It outlines the U.S. Patent Office.

Wadman, Meredith. Issue of Patents on "Dolly" Technology Stirs Controversy. Nature 403 (6768): 351-352, 27 January 2000.

Britain has granted the first patents on cloning or nuclear-transfer technology and the growth of a human embryo to the blastocyst stage, and the U.S. patents on the same are pending. Critics are concerned over the control of medical research. Arthur Caplan commented that once the patents are lawfully granted, discussion should be on responsible patent ownership.

 

Bioethics

Baird, Patricia. Patenting and Human Genes. Perspectives in Biology and Medicine 41 (3): 391-408, Spring 1998.

Baird categorizes opposition to patenting human genes into two perspectives, one a world view about living things that opposes any patenting of life and the other a distributional view about the concentration and inequities of power and wealth in corporations and in developed countries of the northern hemisphere. She concludes that in order to get realistic and balanced policy, discussion and analysis of the broad ethical, social, and distributional implications of patenting human genes need be done in publicly elected bodies, not in the patent offices or in the courts.

Barinaga, Marcia. Asilomar Revisited: Lessons for Today? Science 287 (5458): 1584-1585, 3 March 2000.

Asilomar, the meeting of a scientific research community working in recombinant DNA, addressed only the safety issues of the technology and not ethical ones. Barinaga highlights the differences in social concerns over genetic engineering back in 1975 and now, along with the change of scientific research from academic to corporate.

Belcher, Brian, and Hawtin, Geoffrey. A Patent on Life: Ownership of Plant and Animal Research. Ottawa, Ontario: International Development Research Centre (IDRC), 1991. 40 p. (Searching Series, No. 2)

Although funded by the Canadian government, IDRC is autonomous in its policies and activities. This series looks at broad issues of international development that affect both the northern and southern hemispheres. In this short pamphlet, three questions are examined: "Biotech: The Commodity," "Who's Life Is It?," and "Research: Public or Private." In conclusion, the authors note that effective patent laws require the support of "a legal system (with a fair and impartial court system), and a political and economic system that is conducive to private business and to the protection of private property in general," which developing countries generally lack. Developing countries may have problems getting recombinant DNA technology because of no patent protection. Meanwhile, in the U.S., the PTO grants patents on living organisms under patent laws not designed for that purpose, and the courts are making decisions in large part based their interpretation of whether patent laws prohibit patents on living organisms.

Berg, Paul; Baltimore, David; Brenner, Sydney; et al. Summary Statement of the Asilomar Conference on Recombinant DNA Molecules. In The Ethical Dimensions of the Biological Sciences, ed. Ruth Ellen Bulger, Elizabeth Heitman, and Stanley Joel Reiser, pp. 263-82. New York: Cambridge University Press, 1993. 294 p.

Danish Council of Ethics. Patenting Human Genes: A Report. Copenhagen: The Council, 1994. 43 p.

The report highlights the legal, biological, and ethical issues that may arise with patenting the human genome and that should bring about changes in the Danish patent law. The Council's concept of gene is a dynamic one, divided into corporeal (the physical/chemical substance or object) and incorporeal (the immaterial performance or information contained within the structure). Ownership, proprietary rights, and the right to dispose of a particular object, are distinguished from patent rights, the right to prohibit others from commercial use or exploitation. Taking these definitions of gene and patent, the Council illustrates patent infringement using gametes. If a patented gene has been inserted into a person's sperm or eggs and that gene passes down to the next generation, no patent infringement occurs, but if the person were to sell the sperm or eggs, then patent infringement would occur.

Eisenberg, Rebecca S, and Rai, Arti K. Patenting Organisms and Basic Research. In: Encyclopedia of Bioethics. Third Edition. Stephen G. Post, editor. New York: Macmillian Reference USA, 2004, pp. 1980-1982.

The authors provide a concise overview of patenting organisms, and discuss the preemptive actions taken to maintain the completed human genome sequence in the public domain.

Goldberg, Steven. Gene Patents and the Death of Dualism. Southern California Interdisciplinary Law Journal 5 (1): 25-40, Winter 1996.

"We, the undersigned religious leaders, oppose the patenting of human and animal life forms. We are disturbed by the U.S. Patent Office's recent decision to patent human body parts and several genetically engineered animals. We believe that humans and animals are creations of God, not humans, and as such should not be patented as human inventions." That quotation is the text of the Joint Appeal Against Human and Animal Patenting issued in May 1995. The statement-and its press conference-were organized by Jeremy Rifkin's Foundation on Economic Trends and the United Methodist Church's General Board of Church and Society. Goldberg analyzes the 1992 Methodist report that is the rationale behind the Joint Appeal. He points out that the Methodist opposition to gene patenting "is based wholly on the idea that the genes themselves are vital to 'the sanctity of God's creation'" or, in short, on the idea that the gene is what humans are. Goldberg decries the loss of the dualism of body and soul and feels that the gene patenting debate is missing religion's distinctive contribution concerning the non-material when religion focuses on the material, in this case the gene.

Hanson, Mark J. Biotechnology and Commodification Within Health Care. Journal of Medicine and Philosophy 24 (3): 267-287, June 1999.

Hanson's thesis is that the intellectual property claims of the biotechnology industry "represent a measure of encroachment of commodification within health care." Informed consent is both a principle and practice needed to protect from exploitation of genetic resources, as in the Moore case, where a patient's cancer cells were taken with his consent, for research that researchers knew prior to the taking would lead to the development of a lucrative, patented cell line.

Jonsen, Albert R. The Birth of Bioethics. New York: Oxford University Press, 1998. 431 p.

Jonsen's book contains a chapter called "Splicing Life: Genetics and Ethics" that starts with the beginnings of the eugenics movement in 1865 with Darwin's cousin, Francis Galton, and ends with molecular biology and mapping of the human genome, under the human genome project that came into existence on 1 October 1989.

Kass, Leon R. Patenting Life. Commentary 72 (6): 45-57, December 1981. (Originally published in Journal of the Patent Office 63 (11): 571-600, November 1981.)

In discussing the Chakrabarty decision, Kass points out that patent decisions do not and cannot consider the broad social questions of use and abuse, because "the responsibility lies with the legislature."

Murray, Thomas H. On the Human Body as Property: The Meaning of Embodiment, Markets, and the Meaning of Strangers. University of Michigan Journal of Law Reform 20 (4): 1055-1099, Summer 1987.

Murray outlines the Moore case before discussing the moral significance of embodiment and commercialization of the body and the common good. He concludes that the body ought to remain as quasi property in the law and not be treated as a commodity property.

Peters, Ted. Should We Patent God's Creation? In his Playing God?, pp. 115-141. New York: Routledge, 1997. 218 p.

In this chapter, the author examines a landmark event between the religious and scientific communities, the 18 May 1995 press conference on a statement, signed by over 180 religious leaders representing 80 different faiths or denominations, that called for a ban on the patenting of human genes and genetically engineered animals. Bishop Kenneth Carder of the United Methodist Church in the Nashville area chaired the United Methodist Genetic Science Task Force, which produced a 1992 report. The statement actually read by Carder--"The patenting of genes, the building blocks of life, tends to reduce it to its economic worth. Life becomes a commodity whose value is determined by its commercial value." --differs from the reprinted version (p. 125). Peters clearly outlines the controversy over patenting DNA sequences. Only genes or genomic DNA, not junk DNA, codes for proteins by creating messenger RNA; the messenger RNA is cloned into copies called complementary DNA; the complementary DNA is then sequenced; and the resulting short, partial gene sequence with a length of 300-500 bases is called an "expressed sequence tag" or EST. Patenting ESTs, the copies of genomic DNA, without the knowledge of the genomic DNA's use (function of the gene) erupted into a controversy over premature patenting between the government and the private sector. In his concluding recommendations, on gene patenting Peters asks for precision in the use of the term gene. "Gene" can refer to what exists naturally in the genome, or to a cloned sequence of complementary DNA or an expressed sequence tag that matches that in the original genome, or to an altered or engineered DNA sequence that is legally novel, useful, and non-obvious.

Resnik, David B. The Morality of Human Gene Patents. Kennedy Institute of Ethics Journal 7 (1): 43-61, March 1997.

Resnik analyzes moral arguments for and against human gene patenting. Briefly he considers the backward-looking desert approach of just rewards for contribution, before he focuses on the forward-looking utilitarian approach of maximization of social outcomes. Nonutilitarian arguments against the morality of human gene patents are the Kantian perspective that patenting persons makes them property and treats them as ends, another perspective that patenting dehumanizes the human body with a loss of dignity and respect, and the last perspective that human genes are common property, belonging to no single individual or corporation.

Rifkin, Jeremy. Patenting of Genes: A Personal View. In: Nature Encyclopedia of the Human Genome, David N. Cooper, editor, Vol. 4, pp. 505-507.

Likening the argument against life patents to the abolitionists' stance on slavery, Rifkin calls for a "...global treaty to make the human gene pool, and the gene pool of our fellow creatures, a 'commons' that is administered jointly by every nation on behalf of all future generations - similar to the treaty that established Antarctica as a commons."

Sterckx, Sigrid, ed. Biotechnology, Patents and Morality. Aldershot, England: Ashgate Publishing Ltd., 1997. 324 p.

The International Workshop on "Biotechnology, Patents and Morality: Towards a Consensus" held 17-19 January 1996 in Ghent (this book being the workshop proceedings) was organized along the framework of a similarly named research project funded by the Commission of the European Communities (DG XII--Science, Research and Development--Biotechnology Unit). Article 53(a) of the European Patent Convention of 1973 is the "morality provision" grounds for rejection of a patent by the European Patent Office. Participants see patents as "ethically neutral" (Crespi, p. 220); believe that the American view "that morality should practically speaking have nothing to do with patents" should be the world view (Schapira, p. 172); and feel that in Europe, ecological and ethical matters should be addressed by the political (legislative and executive) branches of government and not by the judiciary, as is the case in the U.S. (Van Overwalle, p. 147).

Sung, Lawrence M., and Maisano, Claire M. Piercing the Academic Veil: Disaffecting the Common Law Exception to the Patent Infringement Liability and the Future of A Bona Fide Research Use Exemption After Madey v. Duke University. Journal of Health Care Law & Policy 2003, 6(2): 256-283.

Noting that it was a common misperception that university-based research was exempt from patent infringement liability, the authors review patent law jurisprudence pertinent to research exemptions and discuss the implications of Madey v. Duke University (307 F.3rd 1351 (Fed. Cir. 2002).

United Methodist Church. Genetic Science Task Force. Draft Report to Annual and Central Conference: An Invitation to Explore a Frontier, December 1990. Christian Social Action 4 (1): 17-28, January 1991.

In its Draft Report, the Task Force questions gene patenting by asking "should exclusive ownership rights apply to the gene pool?" A 1984 Methodist declaration stated that genes were "part of the common heritage of all peoples" and that no one had exclusive ownership rights over genes.

United States. Congress. Office of Technology Assessment [OTA]. The Human Genome and Patenting DNA Sequences [Draft]. Washington, DC: Office of Technology Assessment [OTA], 1994. 270 p.

United States. Congress. Office of Technology Assessment. Ownership of Human Tissues and Cells. Washington, DC: Congress of the U.S., Office of Technology Assessment, March 1987. 168 p.

The first report in a series called "New Developments in Biotechnology," this report looks at the legal, economic, and ethical considerations of "human biological materials." A separate chapter on informed consent covers the requirements for consent and for disclosure in medical care and research.

United States. Congress. Office of Technology Assessment. Patenting Life. Washington, DC: Congress of the U.S., Office of Technology Assessment, April 1989. 195 p.

This report focuses on subject matter patentability, as defined by legislative statute and judicial interpretation.

Wachbroit, Robert. Eight Worries About Patenting Animals. In Values & Public Policy, ed. Claudia Mills, pp. 66-75. Fort Worth: Harcourt Brace Jovanovich, 1992. 573 p.

Wachbroit looks at the arguments that arose against patenting animals in the wake of the Harvard transgenic mouse patent. He divides objections into intrinsic (morally wrong, concerned with values or ideals) and extrinsic (likely consequences, based on empirical or contingent assumptions).

This Scope Note was prepared by Susan Cartier Poland, J.D., Legal Research Associate at the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, Box 571212, Washington, DC 20057-1212.  It was first published in September 2000, and is updated periodically.

The National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, operates on Contract N01 LM73529 from the National Library of Medicine, National Institutes of Health. Additional support is provided by Grant P4 1 HG01115 from the ELSI Branch, National Human Genome Research Institute, National Institutes of Health, and by other public and private sources. Materials on this site are copyrighted and made available to individual researchers. Any redistribution or commercial use requires written permission of the Institute.

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