Gene Patents: A Brief Overview of Intellectual Property Issues
Gene Patents: A Brief Overview of Intellectual
Property Issues
Wendy H. Schacht
Specialist in Science and Technology
Resources, Science, and Industry Division
Summary
The courts have upheld gene patents that meet the criteria of patentability defined
by the Patent Act. However, the practice of awarding patents on genes has come under
scrutiny by some scientists, legal scholars, politicians, and other experts. Gene patenting
may raise ethical, legal, and economic issues; a short discussion of these issues follows.
Patents
The Patent Act of 1952, codified in Title 35 of the United States Code, defines
current patent law. According to section 101, one who “invents or discovers any new and
useful process, machine, manufacture, or any composition of matter, or any new and
useful improvement thereof, may obtain a patent therefore, subject to the conditions and
requirements of this title.” To be patentable, an invention must be useful, novel, and
nonobvious. The requirement of usefulness, or utility, is satisfied if the invention is
operable and provides a tangible benefit. To be judged novel, the invention must not be
fully anticipated by a prior patent, publication, or other knowledge within the public
domain. A nonobvious invention must not have been readily within the ordinary skills
of a competent artisan at the time the invention was made. The invention must be fully
described. Once the United States Patent and Trademark Office (USPTO) issues a patent,
the owner enjoys the right to exclude others from making, using, selling, offering to sell,
or importing into the United States the patented invention. Generally, the term of a patent
is 20 years from the date the application was filed. In the process of obtaining a patent,
the information associated with the patent is published and made available to the public.
Gene Patents
Genes are chemical compounds and, as such, they qualify as compositions of matter
with respect to patent criteria. Within the parameters of patentability delineated by the
Patent Act, there are several exceptions as interpreted by the courts. Products of nature
(a preexisting substance that is found in the wild) may not be patented, per se. However,
the courts have also determined that such a product of nature may be patentable if
significant artificial changes are made. By purifying, isolating, or otherwise altering a
naturally occurring product, an inventor may obtain a patent on the product in its altered
form.1 Thus, “one cannot patent a naturally occurring gene or protein as it exists in the
body, but one can patent a gene or protein that has been isolated from the body and is
useful in that form as a pharmaceutical drug, screening assay or other application.”2
Research indicates that by 2005, 20% of human genes were claimed by patents in the
United States.3 According to the U.S. Patent and Trademark Office, as of the end of
FY2007, over 49,000 patents issued relate to genes (including method of use). This
practice of awarding patents on genes, while upheld by the courts, has come under
scrutiny and criticism by some scientists, legal scholars, and politicians. The subject of
gene patenting involves various ethical, legal, and economic components. While not
mutually exclusive, a short discussion of several issues follows.
Ethical Issues
An often held belief is that gene patents permit outsiders ownership of another
person’s genetic makeup, often without their knowledge or consent.4 This concern has
led to complaints that patients no longer control their own bodies and doctors are being
constrained from testing for various diseases.5 Professor Lori Andrews argues that patents
hinder access to testing procedures because “... gene-patent holders can control any use
of ‘their’ gene; they can prevent a doctor from testing a patient’s blood for a specific
genetic mutation and can stop anyone from doing research to improve a genetic test or to
develop a gene therapy based on that gene.”6 This perceived constraint on research and
testing options is an issue to opponents of gene patents.7 According to Dr. Debra
Leonard, patents on “... specific genetic information limits the medical use of the
information and impedes or prevents widespread research on the disease, the traditional
pathway by which medical knowledge is advanced and shared.”8
However, other experts disagree. As noted by Dr. Jorge Goldstein and Attorney
Elina Golod, the courts have consistently “... taken the position that a person does not
1 Scripps Clinic and Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991).
2 Biotechnology Industry Organization, Primer: Genome and Genetic Research, Patent
Protection and 21st Century Medicine, available at [http://www.bio.org/ip/primer].
3 Kyle Jensen and Fiona Murray, “Intellectual Property Landscape of the Human Genome,”
Science, October 14, 2005, 239-240.
4 Michael Crowley, “They Own Your Body,” Readers Digest, August 2006, available at
[ ht t p: / / www.r d.c om] .
5 Debra G.B. Leonard, “Medical Practice and Gene Patents: A Personal Perspective,” Academic
Medicine, December 2002, 1388.
6 Lori B. Andrews, “Genes and Patent Policy: Rethinking Intellectual Property Rights,” Nature
Reviews, October 2002, 804.
7 John F. Merz, “Disease Gene Patents: Overcoming Unethical Constraints on Clinical
Laboratory Medicine,” Clinical Chemistry, 45:3, 1999, 324.
8 Medical Practice and Gene Patents: A Personal Perspective, 1388.
own any tissues or cells once they are outside the person’s body.”9 Attorneys Lee
Bendekgey and Dr. Diana Hamlet-Cox found no evidence of patients unable to utilize
existing genetic tests because of patents. Instead, they maintain, it is a financial issue
associated with the cost of health care and/or an issue of profits for the doctor or clinical
geneticist wishing to administer tests patented by other inventors.10 Similarly, Professor
Iain Cockburn found “... there is little quantitative evidence thus far of a negative impact
of patents on scientific research activity....”11 From his perspective, the disclosure
obligations of the patent system may better serve the objective of encouraging the
diffusion of knowledge and raising social returns than the chief legal alternative, trade
secret protection.12
Legal Issues
Some commentators argue that genes are products of nature — discoveries, not
inventions — that do not meet the criteria necessary to obtain a patent.13 As stated by
Professor Andrews, “The useful properties of a gene’s sequence ... are not ones that
scientists have invented, but instead, are natural, inherent properties of the genes
themselves.”14 The fact that the gene has been isolated is considered a “technicality” by
experts who subscribe to this position.15
The courts have upheld gene patents if they meet the requirements of the Patent Act.
According to some experts, the law allows for patents on discoveries:
... despite what is repeatedly asserted by the opponents of gene patenting, patent law
applies equally to “discoveries” as to “inventions.” In fact, Article 1, Section 8 of the
U.S. Constitution ... explicitly refers to “discoveries,” as does the Patent Statute:
“Whoever invents or discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement thereof, may obtain a
patent therefor....” [Emphasis added.]16
As Bendekgey and Hamlet-Cox point out, many biotechnology products are built upon
compounds existing in nature including such therapies as interferons, interleukins, and
9 Jorge A. Goldstein and Elina Golod, “Human Gene Patents,” Academic Medicine, December
10 Lee Bendekgey and Diana Hamlet-Cox, “Gene Patents and Innovation,” Academic Medicine,
December 2002, Part 2, 1378.
11 Iain M. Cockburn, “Blurred Boundaries: Tensions Between Open Scientific Resources and
Commercial Exploitation of Knowledge in Biomedical Research,” April 30, 2005, 15, available
at [http://people.bu.edu/cockburn/cockburn-blurred-boundaries.pdf].
12 Ibid., 11.
13 “Owning the Body and the Soul,” The Economist, March 12, 2005, 77, and They Own Your
Body.
14 Genes and Patent Policy: Rethinking Intellectual Property Rights, 803.
15 They Own Your Body.
16 Gene Patents and Innovation, 1374.
insulin.17 Similarly, a patent on penicillin was awarded to Alexander Flemming who
isolated and purified the drug from mold, a “naturally occurring source.”18
The quality of the gene patents awarded by the USPTO is a concern for some
experts. A study by Professors Jordan Paradise, Lori Andrews, and Timothy Holbrook
found that 38% of the claims contained in 74 patents on human genetic material were
“problematic.”19 This research indicated that utility issues were identified as the most
prevalent problem, followed by the required written description of the invention.20 In
another paper, Andrews also argues “... gene patents do not meet the criteria of non-
obviousness, because, through in silico analysis, the function of human genes can now be
predicted on the basis of their homology to other genes.”21
This analysis is not without criticism, as questions have been raised regarding the
authors’ definition of “problematic” that is based upon the authors’ perspectives rather
than court decisions. In addition, the data include patents issued in the early 1990s when
gene patenting was in its infancy and there was little expertise and experience on which
to grant these patents.22 Such concerns over patent quality, however, are not limited to
gene patents. The debate over whether or not the USPTO is too lenient in awarding
patents is on-going and is particularly intense as new industries develop and seek patents.
The patent process is a “one size fits all” activity leading to claims that certain
technologies are not amenable to patenting or that patents granted do not meet the
requirements of the Patent Act. However, as patent examiners build up expertise in a new
field and develop prior art, the quality of patents typically increase.23
Economic Issues
Biotechnology industry leaders perceive patents as critical to protecting innovation.
Research by Professor Wesley Cohen and his colleagues found that patents were
considered the most effective method to protect inventions in the drug industry,
particularly when biotechnology is included.24 Other commentators note that patents are
17 Lee Bendekgey and Diana Hamlet-Cox, “Rebuttal: Why We Need Gene Patents,” Law.com
[web journal], December 30, 2002.
18 Q. Todd Dickinson statement in “The Human Genome Project, DNA Science and the Law: The
American Legal System’s Response to Breakthroughs in Genetic Science,” American University
Law Review, 2001-2002, 380.
19 Jordan Paradise, Lori Andrews, and Timothy Holbrook, “Patents on Human Genes: An
Analysis of Scope and Claims,” Science, 11 March 2006, 1566-1567.
20 Patents on Human Genes: An Analysis of Scope and Claims, 1567.
21 Genes and Patent Policy: Rethinking Intellectual Property Rights, 803.
22 Owning the Body and the Soul, 77.
23 See CRS Report RL31281, Patent Quality and Public Policy: Issues for Innovative Firms in
Domestic Markets, by John R. Thomas.
24 Wesley M. Cohen, Richard R. Nelson, and John P. Walsh, Protecting Their Intellectual Assets:
Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not), NBER Working
(continued...)
particularly important in this sector because of the relative ease of replicating the finished
product. Costs associated with imitating a product “... are extremely low relative to the
innovator’s costs for discovering and developing a new compound.”25
Opponents of gene patents argue that they restrain additional research because “...
there are no alternatives to a patented gene in diagnosis, treatment, and research,”26 and
owners require licensing fees.27 However, despite what some experts claim to be a
negative result of financial considerations in the biomedical research community,28 others
maintain that, at most, gene patents “... prevent the doctors and clinical geneticists from
performing these tests for profit, or in a way that competes with the patent holder, without
reimbursement to the inventors of those tests.”29
Some analysts assert that certain patents, particularly those on research tools30 in
biotechnology, hinder the innovation process. Professors Rebecca Eisenberg and Richard
Nelson state that ownership of research tools may “... impose significant transaction
costs” that result in delayed innovation and possible future litigation.31 They argue that
patents also can stand in the way of research by others:
Broad claims on early discoveries that are fundamental to emerging fields of
knowledge are particularly worrisome in light of the great value, demonstrated time
and again in the history of science and technology, of having many independent minds
at work trying to advance a field. Public science has flourished by permitting32
scientists to challenge and build upon the work of rivals.
Professor Arti Rai argues that “the most important research tools are fundamental
research platforms that open up new and uncharted areas of investigation” that need
further development by researchers in the field.33 While acknowledging that patent
protection on research tools has stimulated private investment in biotechnology and the
development of new products and processes, Eisenberg writes that:
24 (...continued)
Paper 7552, Cambridge, National Bureau of Economic Research, February 2000, available at
[http://www.nber.org/ papers/w7552].
25 Henry Grabowski, “Patents and New Product Development in the Pharmaceutical and
Biotechnology Industries,” Duke University Economics Working Paper, July 2002, available at
[http://www.econ.duke.edu/Papers/Other/Grabowski/Patents.pdf], 4.
26 Patents on Human Genes: An Analysis of Scope and Claims, 1566.
27 They Own Your Body.
28 Medical Practice and Gene Patents: A Personal Perspective, 1390.
29 Gene Patents and Innovation, 1378.
30 A biotechnology research tool is a cell line, reagent, or antibody used in research.
31 Rebecca S. Eisenberg and Richard R. Nelson, “Public vs. Proprietary Science: A Fruitful
Tension?,” Daedalus, Spring 2002.
32 Ibid.
33 Arti Rai, “Genome Patents: A Case Study in Patenting Research Tools,” Academic Medicine,
December 2002, Part 2, 1369.
Patents on research tools threaten to restrict access to discoveries that, according to
the firm beliefs of scientists trained in the tradition of open science, are likely to have
the greatest social value if they are widely disseminated to researchers who are taking34
different approaches to different problems.
Other commentators dispute these assertions. Professor F. Scott Kieff maintains that
there was no such “norm” regarding open scientific access as opposed to intellectual
property protection in the basic biological science community.35 He notes that “...
experience shows that patents on inputs generally do not prevent the production of
outputs” and that the availability of intellectual property protection has expanded the36
resources available in the biotechnology community and led to its success. Bendekgey
and Hamlet-Cox agree that there is no evidence that gene patents have caused a decrease37
in research as a whole in the biomedical arena or in gene therapies.
A study by Professors John Walsh, Ashish Arora, and Wesley Cohen found little
evidence that work has been curtailed due to intellectual property issues associated with38
research tools. Scientists are able to continue research by “... licensing, inventing around
patents, going offshore, the development and use of public databases and research tools,
court challenges, and simply using the technology without a license (i.e., infringement).”
According to the authors, private sector owners of patents permitted such infringement
in academia (with the exception of those associated with diagnostic tests in clinical trials)
“... partly because it can increase the value of the patented technology.”
A later analysis by Professors Walsh, Cohen, and Charlene Cho concluded that
patents do not have a “substantial” impact upon basic biomedical research and that “...
none of [their] random sample of academics reported stopping a research project due to
another’s patent on a research input, and only about 1% of the random sample of
academics reported experiencing a delay or modification in their research due to39
patents.” However, obtaining “tangible” research inputs (e.g., actual materials) appear
to be more difficult because of competition, cost, and time issues.40
As genes continue to be patented and research in the field of biotechnology proceeds,
the discussion surrounding the ethical, legal, and economic issues of gene patenting
remains on-going in the public policy arena.
34 Rebecca Eisenberg, “Why the Gene Patenting Controversy Persists,” Academic Medicine,
December 2002, Part 2, 1383.
35 F. Scott Kieff, “Facilitating Scientific Research: Intellectual Property Rights and the Norms
of Science – A Response to Rai and Heisenberg,” Northwestern University Law Review, Winter
36 Ibid., 704.
37 Gene Patents and Innovation, 1377, 1378.
38 John P. Walsh, Ashish Arora, Wesley M. Cohen, “Working Through the Patent Problem,”
Science, February 14, 2003, 1021.
39 John P. Walsh, Charlene Cho, and Wesley Cohen, “Patents, Material Transfers and Access to
Research Inputs in Biomedical Research,” September 20, 2005, 37, available at
[http://tigger.uic.edu/~j walsh/WalshChoCohenFinal050922.pdf].
40 Ibid., 2.