Running Head: IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
Is it Ethical for Companies to Patent Human Genes?
Shontrice C. Barnes
Virginia Commonwealth University
Author Note
This paper was prepared for Univ 112, taught by Professor Corner
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IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
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Nearly 30,000 human genes have been patented in the United States. A gene patent is a
patent claiming a protein encoding DNA sequence. The term is mostly used loosely to describe
patents for gene-fragments, expressed sequence tags, or single nucleotide polymorphisms. The
Patent Act permits exclusive control for a limited amount of time, which is currently twenty
years. The DNA patents prohibit other entrepreneurs from selling less expensive tests based on
the same genes. Kluge (2003) states that as recently as the 1970’s, medical researches, legal
scholars, and members of the U.S. Patent Trademark Office all shared the view that DNA
sequences were not patentable because DNA was a “naturally occurring substance” rather than a
human invention. However, this belief changed in 1982 following the Supreme Court case of
Diamond v. Chakrabarty, which opened the door to patenting biotechnology discoveries. The
Diamond v. Chakrabarty case was a dispute over the patentability of a microbe that dissolves oil
and that had been specially designed to include a DNA plasmid in which the Court held that
while the Patent Act didn’t authorize ownership of laws by nature, “anything under the sun made
by man” was patentable, therefore the human-made bacterium was patentable (p. 119-130).
Recently, the Supreme Court has ruled in Junes 2013 in the Association for Molecular
Pathology v. Myriad Genetics to ban the patenting of naturally occurring genes, but allows for
artificially created DNA to be patented (Little, “Invalidating Human Gene Patenting: The U.S.
Supreme Court Rules in Association for Molecular Pathology v. Myriad Genetics”). The core of
the debate concerning gene patents has been whether or not the discovery of gene sequence of
DNA rises to the level of invention required by the Title 35 of the United States Code. According
to the Code, a patent may be granted on "any new and useful process, machine, manufacture, or
IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
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composition of matter, or any new and useful improvement thereof." Laws of nature, natural
phenomena, and abstract ideas cannot be patented (http://www.genome.gov/19016590).
In the case of gene patents, critics have pointed out that gene patents do not meet the
requirements of Title 35. They are naturally occurring, the Human Genome Project of 2003 made
all the human gene sequences available in a public domain, and are therefore prior art, and
finally the discovering of the location of a gene has become more common. Prior art means that
it has already been discovered, therefore it cannot be duplicated. With that stated, it can be
understood that gene patents are not only unethical, but fail to meet the requirements of Title 35,
therefore it is not, and should not be legal.
Many countries grant gene patents and this includes Commonwealth countries, such as
Canada and Australia. Pacific Rim, African and Asian countries grant patents as well. Similarly
for those European countries that follow EC BiotechnologyDirective No. 98/44/EC, it states in
Article 5(2) that “An element isolated from the human body or otherwise produced by means of
a technical process, including the sequence or partial sequence of a gene, may constitute a
patentable invention, even if the structure of that element is identical to that of a natural
element.” However, these countries also recognize that something patentable has to meet three
conditions: it must be a “novel” or new, it must not be obvious, and it must have utility. These
three conditions are very similar to the ones stated in Title 35 by the United States (Kluge,
“Patenting Human Genes: When Economic Interests Trump Logic and Ethics”).
Kluge (2003) then goes on to discuss the contradiction. Human genes are not the result of
human manufacturing or intervention. However, the United States Patent Office and the
European Patent Office Technical Board of Appeal, reject this fact. They maintain the idea that
the particular chemical units that are individual genes are not obvious, but only identifiable after
IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
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“sophisticated” biomedical and micro-biological research. Individual genes never occur on their
own, but are obtainable as “the products of deliberate human activity” which then produces
something that did not exist before and anyone that wants to patent a human gene must identify
the protein that it is coded for by that gene. With this reasoning, the agencies consider
themselves justified in granting gene patents (p.119-130).
Kluge (2003) continues to explain that this reasoning is false though. Scientist do not
manufacture or construct genes out of more basic chemical constituents, but instead these genes
are found from naturally occurring genes. The scientists’ sole contribution resides in the
identification and separation of individuals genes from the other genes that make up the overall
strand of DNA in which the genes naturally occur. This DNA is also not manufactured. It is
found in—and extracted from—the human cells in which it functions as the master template for
the biological construction of the human being whose DNA it is. Individual genes contribute to
this construction by coding for the assembly of specific proteins. From this, it can be understood
that patenting human gene is to gain the right to the pattern, nature, or code of the material
substance itself, but this pattern has not been produced by a researcher. Basically, the researcher
has just produced a sample of something that has that nature, in which that nature has pre-existed
in the chemical compound when it part of the DNA from which the original sample was
extracted. With this stated, it seems ethical to permit someone to patent the particular isolating
process itself, this is extremely different from recognizing intellectual or other property rights in
the individual genes as pieces of structural biological code (p.199-130).
Patenting human genes can hinder research. The patent gives the owner the intellectual
property rights on the patented genome sequence for 17-20 years. Patents give their owners
exclusive rights to conduct diagnostic test on these genes, which means that other companies are
IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
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not allowed to work with these genes causing them to miss out on the potential to make
important discoveries on these patented genes. Sometimes a patent owner is unwilling to license
gene patents necessary for genetic testing to other researchers, which diminishes the quality of
genetic tests and interfere with access to health care by limiting research and development to the
patent owner. This then leads to the monopolization of gene patents. Since companies hold
exclusive rights to gene patents, they can decide to not allow other companies to look at these
genes, which can result in only a few companies conducting research on certain genes.
Chuang (2010) us the example of the case with Myriad Genetics, the company that
obtained exclusive rights to testing BRCA1 and BRCA1 genes, which accesses a woman’s
likelihood of developing breast and ovarian cancer. In the case Association for Molecular
Pathology v. Myriad Genetics, mentioned briefly previously, the company defended its right to
patent those genes by arguing that gene-related patents provide financial incentives for medical
research. This means that patents provide security for investors to invest their money into the
research of the gene that has been patented. However, women’s advocates have stated that
Myriad’s aggressive use of its patent rights have made it more difficult for women to have
genetic testing (p. 2054-2056).
Chuang (2013) continues to state that patents are company specific which means there is
an associated cost that each patient must pay in order to use a patented product. This increases
overall healthcare costs for everyone even in a free market healthcare system. Gene patents are
relevant to the provision of healthcare in two broad categories: medical genetic testing and novel
therapies. Since a patent grants exclusive rights to exploit the patented invention, this enables the
patent holder to charge higher prices and make greater profits. Gene patents may also increase
healthcare costs if restrictions on access to medical genetic testing mean that preventable or
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treatable genetic diseases are not identified, or if gene patents on research tools contribute to time
and expense involved in developing new healthcare products or services. For example, Myraid
Genetics had created an expensive $3,000 Myriad BRACAnalysis test for breast and ovarian
cancer that prohibited most women from accessing this important genetic information and from
getting second opinions. While Myriad states that the cost issue is not a big deal as most
insurances cover the cost for eligible patents, this is untrue as only about 40 percent of the
population is eligible for insurance coverage for the testing (p. 2054-2056).
.
Those in support believe that it gives companies time to look at a gene without
competition and encourages research and development in the private industry. The companies
that are in ownership of a gene patent do not have to worry about other companies competing
with them for new discoveries. This is especially important for smaller companies that may not
have the financial support to compete with larger, more established companies. Patents support
innovation and invention by giving companies rights to gene sequences, as it lures potential
patent drives and pushes researchers to think more creatively and work harder in order to obtain
a patent for their work. Patents provide opportunities for investment in research and
development. Companies and individuals can invest in a patented gene and this financial support
provides for the development of useful innovations. Most companies do not have the finances
needed and rely heavily on these investments to further their research (Intellectual Property).
Marcer (2002) explains that patented information may also be used in the study of a
particular disease. Article 27 of the Universal Declaration of Human Rights states that everyone
has the right to “share in scientific advancement and it’s benefits,” therefore rewarding an
inventor with a gene patent would create positive and open environment for research, which
results in the “betterment of society” (p. 361).
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Caulfield (2003) asserts, however, that patenting human genes harms the “research
environment” (p.101-103). Arnold and Ogielska-Zei (2002) support this assertion by stating that
the granting of gene patents may actually stifle innovation by discouraging researchers from
pursuing particular avenues of research for fear of being sued for patent infringement As
mentioned previously, a DNA patent prohibits others from conducting their own research on a
specific gene (p. 415-432). This only allows for one company to study that gene, which is not all
that smart because there’s a possibility that another company would be able to discover
something from that gene. This right is taken away from them and therefore that discovery would
be lost to us because it would never happen.
Thompson (2003) argues that the idea of patenting human genes seems to “violate”
humanity as the human genome is “common humanity.” In an individual’s case, gene patents
may profiteer off the personal nature of a gene. An example of this was the Moore v. Regents of
University of California case where cell line from John Moore was manipulated, patented and
commercialized, unknowing to Moore, and the defendant received substantial royalties from
licensing the technology, including cash and stock options. This shows that those with unique
genetic characteristics have the possibility of being exploited, which then makes it clear that
patenting a person’s genes violates the “value and sanctity” of human life (29) Kluge (2002)
continues by explaining that it violates human dignity because it turns the life-code of the
individual into a piece of property and causes the individual to feel alienated by estranging them
from their own genetic image. It removes human genes from the collective humanity and assigns
it to a private party. These patents legitimize the claim of ownership and control over something
that the person who is claiming it, did not invent as no work went into the construction of the
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gene itself, but instead the material substance that expresses the gene-nature was removed from
the DNA matrix in which it is naturally embedded (p.473-496).
In conclusion, gene patents are not legitimate under the Title 35 Code as they are
naturally occurring and do not fit the requirements of being something new that the claimant has
invented. While, naturally occurring genes are now illegal to patent, artificial genes are
patentable. This is more logical because the claimant actually creates this gene, it is actually
manufactured, which is different from just discovering the gene. Now, this does not invalidate
the way in which the gene was discovered. Mentioned previously was a proposal that it would
make more sense to have the patent be put on the isolating process, as once again that is
something that the company created themselves. Little (2013) believes that it is possible that
now because patents on naturally occurring genes are illegal, there will be an increase in
competition, with more companies an-d healthcare providers offering genetic testing for their
patients, without fear of litigation (p.680-681) . This is more important than the profits and
monopoly that companies get from patenting human genes, because people lives and health
should hold more importance when discovering new genes. The people whose lives are affected
should come first when discovering and studying a particular gene. Gene patents tend to forget
about this people and make situations harder for them, which is why it is unethical practice.
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References
Kluge, E.-H. W. (2003). Patenting Human Genes: When Economic Interests
Trump Logic and Ethics. Health Care Analysis, 11, 119-130. doi: 10.1023/A:1025648928691
Jost, K. (2013). Patenting Human Genes. CQ Researcher Online, 23(20), 473-496
Chuang, C. S. (2010) Patenting Human Genes: The Myriad Controversy. 32(12), 2054-2056. doi:
10.1016/j.clinthera.2010.11.013
Marcer, D.R.J. (2002). Patent or Perish? An Ethical Approach to Patenting Human Genes and
Proteins. Pharmacogenomics Journal, 2, 361
Kesselheim, A.S., Mello, M.M. (2010) Gene Patenting – Is the Pendulum Swinging Back. The
New England Journal of Medicine, 362, 1855-1858. doi: 10.1056/NEJMp1004026
James, K., Little, A. S. (2013) Invalidating Human Gene Patenting: The U.S. Supreme Court
Rules in Association for Molecular Pathology v. Myriad Genetics. World Neurosurgery, 80, 680681. doi: 10.1016/j.wneu.2013.10.029
Caulfield, T. A. (2003) From Human Genes to Stem Cells: New Challenges for Patent Law?
Trends in Biotechnology, 21, 101-103. doi: 10.1016/S0167-7799(03)00006-4
Thompson, R.E. (2003) Does Patenting Genes Change the Meaning of Life? Physician
Executive, 29, 40.
Arnold, B.E., Ogielska-Zei, E. (2002) Patenting Genes and Genetic Research Tools: Good or
Bad for Innovation? Annual Review of Genomics and Human Genetics, 3, 415-432. doi:
10.1146/annurev.genom.3.032102.170635
IS IT ETHICAL FOR COMPANIES TO PATENT HUMAN GENES?
Intellectual Property. (n.d.). Retrieved December 4, 2015, from
http://www.genome.gov/19016590
Moore v. Regents of the University of California – Case Brief Summary. (n.d.). Retrieved
December 4, 2015, from http://www.lawnix.com/cases/moore-regents-california.html
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