ISIS Report 11/11/10
Death of Gene Patents?
It took more than a decade to expose this legal
monstrosity; all patents on DNA sequences natural or synthetic should be banned
on the ground that they usurp the ‘laws of nature’ embodied in the DNA coding
mechanisms that have evolved through billions of years of evolution Dr. Mae-Wan
Ho
US Government rejects gene patents
The US federal government dropped a bombshell on 29 October
2010 when it reversed a longstanding policy. It said that patents should not be
granted for genomic DNA as it is a product of nature even when isolated from
the organism [1]. However, recombinant DNA, or new combinations for DNA for
making genetically modified organisms, or gene therapy, or ‘synthetic life’
(see[2] Synthetic Life? Not
By a Long Shot, SiS 47) remain patentable.
The opinion was expressed in the amicus
(friend of the court) brief from the Justice Department in response to the
ongoing legal battle over US patents for the breast and ovarian
cancer-predisposing genes BRCA1 and BRCA1.
“The chemical structure of native human genes
is a product of nature, and it is no less a product of nature when that
structure is ‘isolated’ from its natural environment than are cotton fibers
that have been separated from cotton seeds or coal that has been extracted from
the earth,…
“We acknowledge that this conclusion is
contrary to the longstanding practice of the Patent and Trademark Office, as
well as the practice of the National Institutes of Health and other government
agencies that have in the past sought and obtained patents for isolated genomic
DNA,” the brief said.
Is this a major reversal of
policy?
“It’s major when the United States, in a
filing, reverses decades of policies on an issue that everyone has been focused
on for so long,” said Edward Reines, a patent attorney who represents
biotechnology companies.
Dr. James P. Evans, a professor of genetics and
medicine at the University of North Carolina and head of a government advisory
task force on gene patents, referred to the government’s brief “a bit of a
landmark, kind of a line in the sand.” He pointed out that although gene
patents had been issued for decades, the patentability of genes had never been
examined in court.
As of 2010 approximately 40 000
US patents exist that relate to an estimated 2 000 human genes, or about 20
percent of the human genome [3]. Patents have been issued for isolated genes,
methods of using the isolated genes, and methods to diagnose a disease based on
an association between a gene and a disease.
Legal battle over breast cancer genes
This major reversal in US policy came in the midst of a
legal battle over patents on the breast cancer genes. In March 2010, a US
District court ruled that claims in seven patents supporting a widely used
genetic test for breast and ovarian cancer susceptibility are invalid [4]. This
was in stark contrast to a 2008 decision by the appeals board of the European
Patent Office, which supported the patents. The US ruling was delivered as the result
of a lawsuit brought in May 2009 against Myriad Genetics, Salt Lake City, Utah, and the University of Utah Research Foundation, which hold the patents on the BRCA1
and BRCA2 genes.
The company charges more than US$3
000 for a test. In 2009, Myriad’s revenues from molecular diagnostics grew by
47 percent to $326.5 million, with BRCAnalysis accounting for the lion’s share
of the revenues.
The
plaintiffs in the case included individual physicians and patients as well as
the Association for Molecular Pathology and the American College of Medical
Genetics; they were represented by the American Civil Liberties Union (ACLU)
and the New York–based Public Patent Foundation.
The
plaintiffs called the patents illegal on the basis that they restrict both
scientific research and patients’ access to medical care, and claim that
patents on human genes violate patent law because genes are products of nature.
In his written opinion, Judge Robert Sweet of the US District Court for the
Southern District of New York ruled that both Myriads' composition and method
claims are invalid under the law, disagreeing, for instance, with Myriad’s
argument that the purification of a natural product like a gene necessarily
renders it patentable,
“The
summary judgment is a first step but a very important one," says
Mary-Claire King, a geneticist at the University of Washington in Seattle, who discovered BRCA1 in 1990. “Opening genetic testing for BRCA1 and
BRCA2 to the competitive marketplace of new genomic technologies would
be good for breast and ovarian cancer patients, their families, and their
physicians.”t
Apart from the
steep price of the test, the plaintiffs raised of the points raised in the
Myriad case, was that Myriad made efforts to prevent clinical trials on their
test and the patents denied patients from receiving second opinions on their
test results [3].
Specific claims, though
not all claims, in seven of Myriad’s 23 patents on BRCA1 and BRCA2 were
challenged in the complaint, covering the isolated genes as well as diagnostic
methods.
In his decision
handed down March 29, 2010, the judge rejected the legal equivalency between
'chemical compositions such as purified adrenaline and DNA.
Judge Sweet said: “The
information encoded in DNA is not information about its own molecular structure
incidental to its biological function, as is the case with adrenaline or other
chemicals found in the body...this informational quality (of DNA) is unique
among the chemical compounds found in our bodies, and it would be erroneous to
view DNA as ‘no different’ than other chemicals previously the subject of
patents....DNA, in particular the ordering of its nucleotides, therefore serves
as the physical embodiment of laws of nature - those that define the
construction of the human body…the preservation of this defining characteristic
of DNA in its native and isolated forms mandates the conclusion that the
challenged composition claims are to unpatentable products
of nature.”
Myriad
announced that it would appeal the decision, and did so 16 June 2010.
In September 2010,
Melissa Parke, a Member of Parliament in Australia, announced that she intends
to call for amendments to the Patents Act so gene patents would no longer be
recognized for reasons similar to those in the Myriad case.
Division within the US government
On 1November 2010, David Kappos, Undersecretary of Commerce
for Intellectual Property and Director of the United States Patent and
Trademark Office told the press [5]: “The USPTO at the present time is
maintaining the status quo. We’re continuing with current procedures as
they are.”
This presages a public policy
battle between the United States Department of Commerce and the United States
Department of Justice.
ISIS has called for a ban on gene
patents since 1999 (see [6] Open Letter from World Scientists to all
Governments Concerning Genetically Modified organisms (GMOs), http://www.i-sis.org.uk/list.php);
and argued time and again [7] Why
Biotech Patents Are Patently Absurd, ISIS-TWN Report). We are obviously
gratified by these new developments, and look forward to a ban on all patents
on DNA sequences, synthetic or natural on ground that humans are usurping the
laws of nature embodied in the DNA coding mechanisms (as Judge Robert Sweet had
pointed out in his ruling against Myriad), which have evolved through billions
of years of evolution.
References
1.
“ U.S. says genes should not be eligible for patents”, Andrew
Pollack, The New York Times, 25 October 2010, http://www.nytimes.com/2010/10/30/business/30drug.html?_r=1&ref=science
2.
Ho MW. Synthetic life? Not by a long shot. Science in Society 47, 16-17,
2010.
3.
Gene patents, Wikipedia, 1 November 2010, http://en.wikipedia.org/wiki/Gene_patent
4.
“Breast cancer gene patents judged invalid”, Meredith Wadman,
Nature News, 30 March 2010, http://www.nature.com/news/2010/100330/full/news.2010.160.html
5.
“Conflicting positions on gene patents in Obama Administration”,
Gene Quinn, IP Watchdog, 2 November,2010, http://ipwatchdog.com/2010/11/02/conflicting-positions-on-gene-patents-in-obama-administration/id=13085/
6.
Ho MW. Open letter from World Scientists to all Governments
Concerning Genetically Modified organisms (GMOs), ISIS, 1999, 2000, http://www.i-sis.org.uk/list.php
7.
Ho MW. Biotech patents are patently absurd. ISIS-TWN report,
February 2001, http://www.i-sis.org.uk/trips2.php;
also Journal of Intellectual Property Rights 2002, 7, 151-165.
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There are 2 comments on this article so far. Add your comment
| Rory Short Comment left 11th November 2010 16:04:20
This is really great news.
Allowing the patenting of the products of Nature is an obvious logical absurdity. Allowing the patenting of synthethic genes is however not so clearly absurd because in this case humans have changed the gene program in some way. It could perhaps be argued that in terms of the whole gene's information content the change introduced by humans is too small to warrant the granting of a patent. This in fact is the very argument against the need for GMO labelling put forward by the gene giants and it could be used in a call for the dismissal of GMO patents all together. What to do about larger scale genetic modification? Here I think one could argue that the gene manipulators are in their manipulations just using a mechanism evolved by Nature over billions of years and so it is logically absurd to have patents for any particular manipulations. | Lucian Coulson Comment left 12th November 2010 21:09:29
Dear Dr. Mae-Wan Ho,
I should like to express my gratitude for all the "good works" you "guys" are doing on behalf of humanity (though I can only speak for myself (not wishing to presume (though feel sure) etc.)). The unsullied integrity of your aim is of such great substance and significance(to me) that I feel so motivated as to invest (painfully unstudied)waking conscious "willpower" in support of an autopoetic outcome to what I anticipate, may become "our" (all life) mutual trajectory and benefit.
Yours sincerely,
Luke Coulson. |
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