|Bioethics Research Library
The Joseph and Rose Kennedy Institute of Ethics
Box 571212, Georgetown University
Washington, DC 20057-1212
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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. Last updated: July 2010
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.
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
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.
(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
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.
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.
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.
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.
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.
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.
time line of selected events involving U.S. patent law, its origins, and its
application to genetics, follows.
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
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).
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).
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)).
U.S. Patent Office is created under the third patent statute on 4 July 1836
(I Stat. 357 (1836)).
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.
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)).
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)).
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)).
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
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)).
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)).
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)).
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)).
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)).
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.)).
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).
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
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)).
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)).
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).
on Biotechnology & the Human Future. "Gene Patents" under Topics.
This webpage belongs to an unincorporated entity affiliated with the Illinois Institute of Technology
and the Center for Policy on Emerging Technologies. The Resources page lists online webpage links of
organizations with interests and publications concerning gene patents. This includes the DNA patent
database of Georgetown University's Kennedy Institute of Ethics and the Foundation for Genetic Medicine.
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
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
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.
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.
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?
overlapping, these resources can be loosely categorized into three areas based
on their use in this Scope Note.
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,
- 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
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
- 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
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.
Ram, Natalie. Assigning rights and protecting interests: constructing ethical and efficient legal rights in human tissue research. Harvard Journal of Law and Technology 2009 Fall; 23(1): 119-177
- Ram offers an informational property rights model as a way of balancing interests between the individual tissue provider, the researcher, and society at large.
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.
“Testing time for gene patents” [editorial]
Nature 2010 April 15; 464(7291): 957
- On March 29, 2010, the U.S. District Court for the Southern District of New York invalidated patents on the BRCA1 and BRCA2 genes involved in assessing risk for breast and ovarian cancers ( http://www.patentlyo.com/files/myriad-opinion.pdf). The plaintiffs (including the Association for Molecular Pathology, the American College of Medical Genetics, the Boston Women’s Health Book Collection, as well as individual researchers) were represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation. Myriad Genetics, the exclusive licensee, aggressively defended its legal rights to the BRCA genes. The court determined that the patents hampered research. Myriad is expected to appeal.
Available online: http://www.nature.com/nature/journal/v464/n7291/full/464957a.html
United States. Department of Health & Human Services. Secretary’s Advisory Committee on Genetics, Health, and Society.
Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. 392 p. April 2010. Available online at: http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf
- Besides considering the impact of gene patents and licensing practices on patient access to genetic tests, the Committee also discusses the impact on clinical access, promotion of the development of genetic tests, the quality of genetics tests, and genetic testing innovations. Specific recommendations for changing the law are made. The report was acknowledged by DHHS Secretary Kathleen Sebelius, available online:
U.S. Congress. An Act to Promote the Progress of Useful Arts,
1st 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,
24th 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
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
Winickoff, David E.; Saha, Krishanu; Graff, Gregory D.
Opening stem cell research and development: A policy proposal for the management of data, intellectual property, and ethics.
Yale Journal of Health Policy, Law and Ethics 2009 Winter; 9(1): 52-127
- The authors point out the need for integration of data sharing, patents, and ethics. One part of the article focuses on the complexity of ethics and regulation.
- American College of
Obstetricians and Gynecologists. Patents, medicine, and the interests
of patients: applying general principles to gene patenting. International
Journal of Gynecology & Obstetrics 80(1): 93-98, January 2003. Also see
ACOG committee opinion number 364 published in May 2007, available at http://www.acog.org/from_home/publications/ethics/co364.pdf
- ACOG Committee on Ethics
and Genetics opinion number 277 was published in November 2002 and is reprinted
in full here. The committee deems patents on medical or surgical procedures
as ethically unacceptable. Patents on surgical or diagnostic instruments are
ethically acceptable and should be made available at a fair and reasonable
cost to patients. The committee supports legislation making composition-of-matter
patents on genes unenforceable; if there is no such legislation, then "patents
on genes with clinical applications should be subject to federal regulation
and oversight to ensure reasonable availability of the genes and their products
for research and clinical use."
Ashcroft, R. The ethics of reusing archived tissue for research.
Neuropathology and Applied Neurobiology. 26(5): 408-411, October 2000.
- Ashcroft describes two ethical tensions of pathologists
concerning tissue archiving. Those issues are "the public interest in research
and the moral rights to autonomy and respect for persons." He notes that "consent
cannot, by its nature, normally be specific to a research project, if archiving
is intended - since re-use is foreseen for unforeseen purposes." He distinguishes
research and teaching use from commercial use and exploitation.
Bahadur, G.; Morrison, M.
Patenting human pluripotent cells: balancing commercial, academic, and ethical interests. Human Reproduction 2010 January; 25(1): 14-21
- The authors examine the ethical issues using human pluripotent cells in the contexts of biotechnology and a global economy. They examine the positions of the European Patent Office and the U.S. Patent and Trademark Office in handling intellectual property rights with these cells.
Baird, Melanie. When and why does what belong to whom? A proposed
model for the international protection of human donors of biological material.
Canada-United States Law Institute 32: 331-352, 2006.
- Baird proposes using
current legal protection methods to address the problems as "to how much information
must be given regarding the donation of genetic material and to provide a
satisfactory method to ensure the benefits of developments stemming from such
donations are fairly and justly allocated." She examines two models, one a
donative/liability one and the other a property rights/liability one, before
proposing a third hybrid model, an individual/community property rights one.
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
Gene patenting. In her: Genetics and Christian
Ethics, chapter 7, pp. 160-190. Cambridge, UK: Cambridge University
Press, 2006. ISBN 10-0-521-53617-5.
- Deane-Drummond takes
a virtue ethics perspective on gene patenting, and the four virtues are prudence,
justice, temperance, and fortitude. She presents theological arguments both
for and against it. Then she looks to broadening the theological arguments
with justice issues, which include benefit-sharing and the public good.
Dickenson, Donna. The
gender politics of genetic patenting. In her: Property
in the Body; Feminist Perspectives, chapter 5, pp. 108-124.
Cambridge, UK: Cambridge University Press, 2007. ISBN 10-0-521-68732-2.
- Dickenson's concern
is not to concentrate on pragmatic arguments, but "to analyze the way in which
more theoretical objections such as human dignity or public morality typically
incorporate an element of fear of feminization."
Eisenberg, Rebecca S.
How can you patent genes? In: Genetics: Science,
Ethics, and Public Policy; A Reader, ed. Thomas A. Shannon,
chapter 9, pp. 131-145. Lanham, Md: Rowman & Littlefield, 2005. ISBN 0-7425-3237-2.
- Eisenberg argues for
maintaining a distinction between computer- or cell-readable (as opposed to
human-readable) DNA sequence information and DNA molecules within the present
patent system. To do otherwise would overturn the precedents formed in the
prior twenty years. She believes "it would be foolish to assume that we can
meet the changing needs of the information economy simply by expanding the
categories of subject matter that are eligible for patent protection."
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.
Everett, Margaret. The
social life of genes: privacy, property and the new genetics. Social
Science & Medicine 56(1): 53-65, January 2003.
- The author reviews the
legal, philosophical, scientific and anthropological literature on genetic
privacy and gene patenting. Everett, an anthropologist, was on the committee
that proposed the Oregon Genetic Privacy Act of 1995. In that law was a controversial
"property clause" that stated, "An individual's genetic information is the
property of the individual.". She relates three years later after her son
died of a rare genetic disorder, she ultimately supported eliminating that
clause because it encouraged commodification and objectification.
Garforth, Kathryn. Life
as chemistry or life as biology? An ethic of patents on genetically modified
organisms. In: Patenting Lives; Life Patents, Culture
and Development, ed. Johanna Gibson, chapter 3, pp. 27-52. Burlington,
VT: Ashgate Pub. Co., 2008. ISBN 978-0-7546-7104-6.
- Garforth analyzes the
conflict between the materialists and the vitalists, in genetics as distinguished
by "structural genes" and "regulator genes", before she considers an ethical
framework suggested by three pairs of antonyms: antonomy and control; uniqueness
and fungibility; sanctity and violability. She then looks at patent law concepts,
contrasting American and Canadian patent law cases.
Goldberg, Steven. Gene Patents and the Death of Dualism.
Southern California Interdisciplinary Law Journal 5 (1): 25-40, Winter
- "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.
Hoppe, Nils. Out
of touch: from corporeal to incorporeal, or Moore revisited. In:
Ethics and Law of Intellectual Property; Current Problems in
Politics, Science and Technology, ed. Christian Lenk, Nils Hoppe,
and Roberto Adorno, chapter 10, pp. 199-210. Burlington, VT: Ashgate Pub.
Co., 2007. ISBN 978-0-7546-2698-5.
- Hoppe's topic is that
of his doctoral thesis, which is expected to be published. He outlines a different
way of looking at the Moore case by using the law of equity to address issues
of fairness, justice and moral decision making, areas that the common law
cannot address. Hoppe terms this a "sublimation of the legal interest", when
the value no longer lies in the tangible tissues but in the intellectual property
derived from such.
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."
Koepsell, David. Who
Owns You? The Corporate Gold Rush to Patent Your Genes. Chichester,
West Sussex, UK: Wiley-Blackwell, 2009.
- Koepsell concludes that
we should stop the current process of granting patents over non-engineered
genes based on a commons argument, that genes are ethically "un-ownable" by
any one party and that genes are the duty of all to maintain and hold. He
notes "[w]here an artificially imposed scarcity is imposed through patents,
the tragedy of the anti-commons ensues." The tragedy of the anti-commons comes
about from underuse (or no use) of a resource by the patent-holder of the
monopoly on that resource.
When speed truly matters, openness is the answer.
Bioethics 2009; 23(7): 385-393
- Marturano analyzes the two main genomic research methods from an ethical point of view. The proprietary or patent-and-publish methodology is transactional, whereas the free and open source method is transformational. He notes that the open source philosophy recalls R.K. Merton’s "'four rules' for scientific practice aimed at ensuring the growth of certified knowledge" from 1942, which are universalism, 'communism', disinterestedness, and organized skepticism.
Macklin, Ruth. The
ethics of gene patenting. In: Genetic Information; Acquisition,
Access, and Control, ed. Alison K. Thompson and Ruth F. Chadwick,
chapter 12, pp. 129-137. New York, NY: Kluwer Academic, 1999. ISBN 0-306-46052-1.
- Macklin asks should
gene patenting be permitted if genes are part of the common human heritage.
She lays out the arguments for both sides, nonconsequentialists and consequentialists.
Her own view is that "commodification of human material for any purpose is
unsavory", but she admits that "it is hard to find a principled moral argument"
against gene patenting.
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,
- 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).
Suter, Sonia. Disentangling
privacy from property: toward a deeper understanding of genetic privacy.
George Washington Law Review 72(4): 737-814, April 2004.
- Suter argues against
property rights in genetic information. She develops a concept of genetic
privacy based on relationships, including the relationship one has with oneself.
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.
in Biotechnology: 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. New
Developments in Biotechnology: Patenting Life. Washington,
DC: Congress of the U.S., Office of Technology Assessment, April 1989. 195
- This report focuses on subject
matter patentability, as defined by legislative statute and judicial interpretation.
Vrtovec, Katja Triller,
and Vrotovec, Bojan. Commentary: Is totipotency of a human cell a
sufficient reason to exclude its patentability under the European Law?
Stems Cells 25: 3026-2038, 2007.
- The totipotent character
of human cells excludes such cells from patentability at the European Patent
Office and at the United Kingdom Patent Office. The authors believe that is
insufficient for this reason and for the reason that such cells are located
in a human body. They contend that exclusion from patentability applies to
"human totipotent cells that are created by natural process of fertilization
whether located outside the human body or isolated from the human body." Conversely,
human totipotent cells that are created by human beings alone and which nature
is incapable of creating, such as somatic cell nuclear transfer, are not excluded
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).
Weeden, Jeffery Lawrence.
Genetic liberty, genetic property: protecting genetic information.
Ave Maria Law Review 4(2): 611-664, Summer 2006.
- Weeden prefers that
genetic information be protected not by privacy law, but by property law.
He asserts that, "[g]enetic information is best protected as an incorporeal
thing" and treated as quasi property and as intellectual property.
Genes, Patents, and Bioethics – Will History Repeat Itself? was first prepared for publication in September, 2000 by Susan Cartier Poland, J.D., a Legal Research Associate at the Bioethics Research Library, and is updated periodically.
The Bioethics Research Library, Kennedy Institute of Ethics, Georgetown University is supported in part by grant P41 HG01115 from the National Human Genome Research Institute, National Institutes of Health.
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Last updated: July 2010