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Published on: August 9, 2011

Why Gene Patents Are Bad for Patients and Science

ERIC HOFFMAN

The information contained in our shared [genome] is so fundamental, and

requires so much further research to understand its utility, that patenting it at
the earliest stage is like putting up a whole lot of unnecessary toll booths on the
road to discovery, said National Institutes of Health Director and former head
of the Human Genome Project Francis Collins in his 2010 book The Language of
Life: DNA and the Revolution in Personalized Medicine.
Unfortunately such toll booths were just given the go-ahead by a Federal
appeals court. In a 2-1 decision issued on July 29, the Court of Appeals for the
Federal Circuit overruled a lower courts decision in Association for Molecular
Pathology et al. v. U.S. Patent and Trademark Office et al. holding that private
companies and researchers could in fact patent genes and DNA sequences. If
not overturned by the Supreme Court, this decision could have harmful impacts
on patient health and could limit future genomic and scientific discoveries.
To get a better sense of what this case means and where it is going, we must
take a step back and look at the history of gene patenting and the case against
it. These patents harm patients and researchers, and they go against years of
legal precedent holding that one cannot patent a fact of nature.
A Brief History of Gene Patents
Most people are shocked to learn that more than 20 percent of the human
genome is patented.1 Corporations and researchers own patents on genes that
correlate diseases such as breast cancer, Alzheimers and Huntingtons disease,
among others. The U.S. Patent and Trademark Office started granting patents
on human genes in the 1980s and has since granted more than 4,300 of them.
In May 2009, the American Civil Liberties Union filed a lawsuit against Myriad
Genetics, which owned genes (BRCA1 and BRCA2) that correlate with increased

risk for breast cancer and ovarian cancer. The ACLU named the Patent Office as
a defendant, too, since it had granted these patents. The lawsuit was filed on
behalf of researchers, genetic counselors, women patients, cancer survivors,
breast cancer and womens health groups, and scientific associations
representing 150,000 geneticists, pathologists and laboratory professionals.
The plaintiffs claimed that genes are facts of nature and are therefore not
patentable. Additionally, they argued that Myriads patents limited patients
access to potentially life-saving genetic diagnostic tests and prevented
researchers from looking at those genes to help their patients or to develop
more effective and affordable tests.
The defendants argued that patents are necessary to protect the time and
money invested in identifying disease-gene correlations. Myriad Genetics also
claimed that its patents are on isolated genes and DNA sequences, and this
act of isolating a gene from the genome is an inventive step and worthy of a
patent. These patents, the industry claims, are necessary to bring expensive
tests and products to market and improve patient health.
In March 2010, a Federal judge agreed with the ACLU and decided that DNA
sequences are facts of nature and are therefore no more patentable than
isolated gold from a mine or isolating a natural element. Myriad Genetics
quickly appealed the decision.
Do Gene Patents Harm Patients and Innovation?
Contrary to industry claims that gene patents are necessary to bring tests and
products to market, such patents are actually detrimental to patient health and
researcher access to genetic information. Gene patent holders often use their
exclusive control to charge excessive fees for diagnostic testing and to prevent
other researchers from utilizing specific genes for research.2
Myriad Genetics, for example, charges up to $4,000 for its breast cancer
diagnostic test, a price too steep for many patients and health insurance
providers. If allowed, labs could run the same genetic test for only a few
hundred dollars.3 Myriad also sent cease-and-desist letters to researchers who
were looking at the BRCA1/2 genes in their labs, providing diagnostic tests to
patients and even providing patients second-opinion tests to confirm the test
provided by Myriad.
Gene patents have a detrimental impact on health care and research.4 Gene
patents can prevent more accurate, affordable and complex diagnostic tests
from being developed.5 A survey of genetics labs found that 53 percent stopped
doing research due to concerns about patented genes,6 and there has been a
significant decline in published material on patented genetic information.7 The

future of personalized medicine may be crushed by the weight of gene patent

thickets if a company must ask permission from hundreds of patent holders to
scan a single patients genome.
Gene patents also drive research towards gene-to-disease correlations and away
from factors that actually cause disease, such as exposure to toxic chemicals.
Most genetic tests offer only an estimate of the chances for developing a
particular disease and fail to account for the influence of other genes and
environmental factors that cause disease.8 The predictive power of the test for
BRCA breast cancer mutations is high for persons from families with a history of
particular kinds of breast or ovarian cancer, but very low for women without a
family history of breast cancer; many women who test positive for a BRCA1
mutation do not get the disease.9 Gene patents lock-in our knowledge on these
DNA sequences to only their potential correlation to a disease while preventing
others from looking at how that gene may interact with other genes or the
outside environment.
Are Genes Patentable?
This brings us to the recent verdict, in which the judges were not asked to rule
on whether gene patents are harmful but whether they are patentable. In this
respect, the appeals court largely agreed with Myriad Genetics when it
determined that isolated DNA is patentable since it is not found in nature and
is the result of a human process. The appellate court did agree with the lower
court on one point when it said the act of comparing two DNA sequences
(comparing a normal gene with a mutated gene sequence to identify said
mutation) was not patentable since it was simply a mental process.
The majority opinion stated that, since isolated DNA is not found in nature, the
act of isolating said DNA is an inventive step worthy of a patent. Since the
bonds between the specific gene and the rest of the DNA had been broken, they
argued, the isolated DNA is no longer a fact of nature but a man-made
invention.
This view fails to take into account the unique nature of DNA. As Judge Sweet
said in the lower courts decision originally invalidating the BRCA1/2 genes, the
essential characteristic of DNA is its nucleotide sequence, which is defined
by nature and central to both its biological function within the cell and its
utility as a research tool in the lab.10 In other words, DNA sequences have
naturally evolved over millennia and are important not simply for their
chemical construction but for the information they code for. If the genetic code
and its information were different than that found in nature, Myriads and
others genetic diagnostic tests would be worthless. That is why Judge Sweet
called attempts to define patented genes as novel as merely a lawyers trick.

The Supreme Court has repeatedly held that facts of nature are not patentable.
In the 1980 landmark case of Diamond v. Chakrabarty, the Court explained how
patents can be granted to:
Anything under the sun that is made by man . . . . [T]he laws of nature, physical
phenomena, and abstract ideas have been held not patentable . . . a new mineral
discovered in the earth or a new plant found in the wild is not patentable
subject matter. Likewise, Einstein could not patent his celebrated law that
E=mc2; nor could Newton have patented the law of gravity. Such discoveries are
manifestations of nature, free to all men and reserved exclusively to
none.11 [emphasis added]
The dissenting judge in the appeals court agreed that genes are not patentable
and that extracting a gene is akin to snapping a leaf from a tree. Since the
genetic information in isolated genes is identical to that in genes found in
nature, and in our bodies, it should be beyond the scope of patentability.
This case points out an interesting problem: We are asking our judges, who are
experts in legal jurisprudence, no doubt, to make decisions about basic facts of
biology and genetics. The two judges who supported gene patents, Judge Lourie
and Judge Moore, studied chemistry and electrical engineering, respectively,
before their legal careers.12 While they must have consulted experts on the
issue, we should not delegate the future of genetic research and access to our
common genetic heritage to engineers and chemists. Congress, which has
constitutional authority over what is patentable, should pass legislation making
it clear that genes are facts of nature and are therefore unpatentable. Such a
law would tear down the thicket of gene patent toll booths that are harming
patient health and scientific research.
The Next Battleground
This legal battle is far from over, since the case is expected to be decided by the
Supreme Court, and no matter which way the court rules, Congress will likely
step in.
As Joseph Stiglitz and John Sulston explained in the Wall Street Journal, the
patenting of human genes is wrong as a matter of science and as a matter of
economics. Lets hope Congress keeps with good science, good economics and
good public health policy by declaring, once and for all, that genes and DNA
sequences are facts of nature, part of our common genetic heritage, and
therefore unpatentable.
1

Kyle Jensen and Fiona Murray, Intellectual Property Landscape of the Human
Genome, Science, October 14, 2005. See also Human International Genome
Sequencing Consortium, Initial Sequencing and Analysis of the Human

Genome, Nature, February 15, 2001; J. Craig Venter et al., "The Sequence of the
Human Genome", Science, February 16, 2001.
2Mildred

K. Cho, Preparing for the Millennium: Laboratory Medicine in the 21st

Century (American Association for Clinical Chemistry Press, 2d ed., 1998), pp.
4758.
3

Joseph Stiglitz and John Sulston, "The Case Against Gene Patents", Wall Street
Journal, October 7, 2010.
4

See Jon F. Merz, Antigone G. Kriss, Debra G. B. Leonard and Mildred K. Cho,
Diagnostic Testing Fails the Test, Nature, February 7, 2002; David Blumenthal
et al., University-Industry Research Relationships in Biotechnology, Science,
June 13, 1986; David Blumenthal et al., Withholding Research Results in
Academic Life Sciences, Journal of the American Medical Association, April 16,
1997; David Blumenthal et al., Data Withholding in Academic Genetics,
Journal of the American Medical Association, January 23/30, 2002.
5

Gene Patents and Licensing Practices and their Impact on Patient Access to
Genetic Tests, report of the Secretarys Advisory Committee on Genetics, Health
and Society.
6

Mildred K. Cho, Samantha Illangasekare, Meredith A. Weaver, Deborah G.

Leonard and Jon F. Merz. "Effects of Patents and Licenses on the Provision of
Clinical Genetic Testing Services", Journal of Molecular Diagnostics (February
2003).
7Fiona

Murray, Scott Stern, Do Formal Intellectual Property Rights Hinder the

Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons
Hypothesis, prepared for the NBER Academic Science and Entrepreneurship
Conference (June 2005).
8

Michael J. Malinowski and Robin J.R. Blatt, "Commercialization of Genetic

Testing Services: The FDA, Market Forces, and Biological Tarot Cards", Tulane
Law Review, vol. 71, no. 4 (1997).
9

Wylie Burke, Genetic Testing, New England Journal of Medicine, December 5,

2002.
10

Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et
al., 132, U.S. District Court, Southern District of New York, March 29, 2010.
11
12

Diamond v. Chakrabarty, U.S. Supreme Court, June 16, 1980.

Andrew Cohen, "Like a Leaf From a Tree: The Gene Patent Ruling, The
Atlantic Online, August 1, 2011.

Eric Hoffman is biotechnology policy campaigner at Friends of the Earth.