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ACLU patent case could have far-reaching consequences
March 2010
EDIT CONNECT
SHARING OPTIONS:
NEW YORK—Should biotech
companies like Salt Lake City, Utah-based
Myriad Genetics be allowed to patent a pair
of genes closely linked to breast
and ovarian cancer? Myriad claims it "owns" the genes and argues that without
the right to patent and profit,
biotechnology as we know it would vanish.
But Christopher A. Hansen, an American Civil Liberties Union
(ACLU) lawyer, argues, "Patenting a gene is
unconstitutional."
This is the crux of what could become a national debate in
2010, with deep ramifications to the
biotechnological, genetic, pharmaceutical,
medical and healthcare industries far into the future.
In The Association for Molecular Pathology, et al. v.
U.S. Patent and Trademark Office, et al.,
the plaintiffs challenged the right to
patent genes in a lawsuit filed May 12,
2009. A hearing was held in the U.S. District Court for the Southern District
of New York, with Judge Robert Sweet presiding. Sweet is expected to make a
decision within 60
days. If the case goes to trial, the fate of Myriad and all
companies holding gene patents would be in the hands of a jury.
The lawsuit was filed on behalf of breast cancer and women's
health groups, individual women and scientific
associations representing
approximately 150,000 researchers, pathologists and laboratory professionals,
says Hansen, lead counsel.
The named defendants include Myriad Genetics and the
University of Utah Research Foundation, which hold the patents on the genes
BRCA1 and BRCA2, which are associated with breast and ovarian cancer. The
lawsuit charges that patents on human genes violate the First Amendment and
patent law because genes are "products of nature," and therefore, cannot be
patented.
"Allowing patents on genetic material imposes real and
severe limits on scientific research, learning and the free flow of
information," Hansen says.
"Patenting human genes is like patenting e=mc2,
blood or air."
Mutations along the BRCA genes
are responsible for most
cases of hereditary breast and ovarian cancers, according to the lawsuit. Many
women with a history of breast and ovarian
cancer in their families opt to
undergo genetic testing to determine if they have the mutations on their BRCA
genes before deciding on a treatment plan
which includes undergoing preventive
mastectomies or ovary removal.
The patents granted to Myriad
provides the exclusive right
to perform diagnostic tests on the BRCA1 and BRCA2 genes, Hansen says, and he
argues that Myriad's "monopoly" on the
genes makes it impossible for women to
access alternate tests, or even get a second opinion about their results.
Furthermore, one diagnostic test costs
as much as $3,700—which is out of reach
to women without the means to pay for it.
Myriad is
hardly alone. Approximately 20 percent of all
human genes are patented, including genes associated with Alzheimer's disease,
muscular dystrophy, colon
cancer, asthma and many other illnesses, Hansen says.
Co-counsel Daniel B. Ravicher says, "Patents on human genes
should never
have been granted in the first place. Genes are identified, not
invented."
The U.S. Patent and Trademark Office (PTO) has granted
thousands of patents on human genes—in fact, about 20 percent of our genes are
patented, Hansen says. A gene patent prevents anyone from studying,
testing or
even looking at a gene that limits scientific research and genetic testing.
Several major organizations, including
the American Medical
Association, the March of Dimes, the American Society for Human Genetics and
Nobel Prize winners Joseph Stiglitz and Sir John Sulston, have
filed
friend-of-the-court briefs in support of the ACLU and the Public
Patent
Foundation's (PUBPAT) case.
"Without the patents, there wouldn't have been the financial
incentive to create the tests," says Richard M. Marsh, Myriad executive vice
president and general counsel.
Parties who
have filed amicus briefs in support of Myriad
include the Biotechnology
Industry Organization (BIO); BayBio; Celera;
Coalition for 21st Century Medicine; Genomic Health; the Genetic Alliance;
Rosetta Genomics;
and George Mason University.
"We believe we have a compelling argument that our isolated
DNA claims are patent-eligible under the Patent Act, and our method claims are
also patent-eligible based on the recent Federal Circuit Court decision in Mayo
v. Prometheus," Marsh says. "This case has little to
do with the
cost of testing. While Myriad is currently profitable, we spent many years
incurring substantial operating losses, and finally, in the
twilight of our
patent term, we are finally recouping our investment.
"However, this is exactly
how the patent system works,"
Marsh adds. "It gives companies an incentive to spend vast capital dollars
(which would not be done but for patent
protection), to promote the underlying
science and progress of the invention, and hopefully, by the end of the patent
term, the patent holder has been
able to obtain a return on its investment."
Once the patent expires, society then gets the
collective
benefit of all of the efforts to promote and increase general research,
insurance coverage, patient and physician knowledge and
understanding about
predisposition testing for hereditary cancers, he says.
"One thing Myriad is proud
of is the fact that due to our
efforts, 90 percent of our testing is now covered by insurance, so the test has
become accessible and affordable to
patients," Marsh says. "For those without
insurance and who cannot afford testing, Myriad has a financial assistance
program providing free testing.
"
The issue of gene patents took the national stage Feb. 4,
when 26 organizations representing
innovations in American life sciences sent a
letter to Kathleen Sebelius, secretary of the U.S. Department of Health and
Human Services, "to express grave concerns about certain recommendations in the
Secretary's
Advisory Committee on Genetics, Health and Society's (SACGHS)
Report on Gene Patents and Licensing Practices and Their Impact on Patient
Access to
Genetic Tests.
While the controversial report indicates that gene patents
and licensing practices
concerning such patents have not had an adverse impact
on patient access to genetic tests, it nevertheless includes a controversial
proposal to exempt
gene patents from infringement liability.
"By undermining the value of gene-based patents, these
recommendations would chill future investment and innovation in this area, and
would unfairly upset the investment-backed expectations of current
patent
owners and licensees," the letter states.
At a press conference held in Washington, D.C., on Feb. 3, BIO
President
and CEO Jim Greenwood stood with former Sen. Birch Bayh, co-author of the
Bayh-Dole Act; Dr. Brian Stanton, a member of the SACGHS Task
Force; Dr. Jim
Davis, executive vice president, general counsel an secretary of Human Genome
Sciences Inc.; and Dr. Jon Soderstrom, managing director of the Office of
Cooperative Research at Yale University. Greenwood said the recommendation to
exempt gene patents
"would undermine the U.S. patent system, and the Bayh-Dole
technology transfer system … would discourage investment in biotech innovation,
hobble the
transfer of federally-funded research, undermine university research
programs and harm patients who are waiting for life-saving therapies and
diagnostics yet to be developed."
Code: E031023 Back |
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