Court says isolated human genes cannot be patented
JESSE J. HOLLAND, AP
WASHINGTON
(AP) — The Supreme Court on Thursday unanimously threw out attempts to
patent human genes, siding with advocates who say the
multibillion-dollar biotechnology industry should
not have exclusive control over genetic information found inside the
human body.
But
the high court also approved for the first time the patenting of
synthetic DNA, handing a victory to researchers and companies looking to
come up with ways to fight — and profit —
from medical breakthroughs that could reverse life-threatening diseases
such as breast or ovarian cancer.
The
decision "sets a fair and level playing field for open and responsible
use of genetic information," said Dr. Robert B. Darnell, president and
scientific director of the New York Genome
Center. "At the same time, it does not preclude the opportunity for
innovation in the genetic world, and should be seen as an important
clarifying moment for research and the healthcare industry."
The
high court's judgment, written by Justice Clarence Thomas, reverses
three decades of patent awards by government officials and throws out
patents held by Salt Lake City-based Myriad
Genetics Inc. involving a breast cancer test brought into the public
eye recently by actress Angelina Jolie's revelation that she had a
double mastectomy.
Jolie
said she carries a defective BRCA1 gene that puts her at high risk of
developing breast and ovarian cancers, and her doctor said the test that
turned up the faulty gene link led
Jolie to have both of her healthy breasts removed. Jolie's mother died
of ovarian cancer and her maternal grandmother also had the disease.
The
high court's ruling immediately prompted one of Myriad's competitors to
announce it would offer the same test at a far lower price.
Justice
Clarence Thomas, who wrote the court's decision, said Myriad's
assertion — that the DNA it isolated from the body for its proprietary
breast and ovarian cancer tests were patentable
— had to be dismissed because it violates patent rules. The court has
said that laws of nature, natural phenomena and abstract ideas are not
patentable.
"We
hold that a naturally occurring DNA segment is a product of nature and
not patent eligible merely because it has been isolated," Thomas said.
However,
the court gave Myriad a partial victory, ruling that while
naturally-occurring DNA was not patentable, synthetically-created DNA,
known as cDNA, can be patented "because it is
not naturally occurring," as Thomas wrote.
The
split decision mitigates potential damage to the multibillion-dollar
biomedical and biotechnological industries in the U.S., experts said. It
will affect companies like Myriad and
others doing similar work, said Courtenay Brinckerhoff, a lawyer at
Foley & Lardner.
"The
decision is likely to have the greatest impact on diagnostic/genetic
screening patents similar to those at issue in Myriad, but the ruling
will impact the patent-eligibility of other
newly discovered compounds that are 'isolated' from nature, such as
medicinal compounds isolated from plants, beneficial proteins isolated
from human or animal sources, and beneficial microorganisms isolated
from soil or the deep sea," she said.
For
the most part, biotech companies already have moved on from trying to
patent isolated DNA, instead looking at synthetic options and other ways
of protecting their multimillion-dollar
investments, said Matthew McFarlane of Robins, Kaplan, Miller &
Ciresi L.L.P.
"On
a day-in and day-out basis, I don't see this changing that part of the
industry," McFarlane said. "Isolated DNA itself is not something that
companies seek to protect anymore."
Patents
are the legal protection that gives inventors the right to prevent
others from making, using or selling a novel device, process or
application.
The
U.S. Patent and Trademark Office has been awarding patents on human
genes for almost 30 years, but opponents of Myriad Genetics Inc.'s
patents on the two genes linked to increased
risk of breast and ovarian cancer say such protection should not be
given to something that can be found inside the human body.
The
company used its patents to come up with its BRACAnalysis test, which
looks for mutations on the breast cancer predisposition gene, or BRCA.
Women with a faulty gene have a three
to seven times greater risk of developing breast cancer and also have a
higher risk of ovarian cancer.
Myriad
sells the only BRCA gene test, which costs around $3,000. Opponents
said the company has used its patents to keep other researchers from
working with the BRCA gene to develop other
tests. The challenged patents would have expired in 2015.
"Today,
the court struck down a major barrier to patient care and medical
innovation," said Sandra Park, a lawyer for the American Civil Liberties
Union Women's Rights Project. "Myriad
did not invent the BRCA genes and should not control them. Because of
this ruling, patients will have greater access to genetic testing and
scientists can engage in research on these genes without fear of being
sued."
American
Medical Association President Dr. Jeremy A. Lazarus agreed. "Removing
the patents on the building blocks of life ensures that scientific
discovery and medical care based on insights
into human DNA will remain freely accessible and widely disseminated,
not hidden behind a vast thicket of exclusive rights," he said.
Not
long after the ruling, DNATraits, part of Houston-based Gene By Gene,
Ltd., said it would offer BRCA gene testing in the United States for
$995 — less than a third of the current
price.
Thomas
noted there are still ways for Myriad to make money off its discovery.
"Had Myriad created an innovative method of manipulating genes while
searching for the BRCA1 and BRCA2 genes,
it could possibly have sought a method patent," he said. And he noted
that the case before the court did not include patents on the
application of knowledge about the two genes.
For its part, Myriad focused on what the ruling left intact.
"We
believe the court appropriately upheld our claims on cDNA and
underscored the patent eligibility of our method claims, ensuring strong
intellectual property protection for our BRACAnalysis
test moving forward," said Peter D. Meldrum, Myriad's president and
CEO. "More than 250,000 patients rely upon our BRACAnalysis test
annually, and we remain focused on saving and improving peoples' lives
and lowering overall healthcare costs."
Companies
had billions of dollars of investment and years of research on the line
in this case. Their advocates argue that without the ability to recoup
their investment through the profits
that patents bring, breakthrough scientific discoveries to combat all
kinds of medical maladies wouldn't happen.
"Some
genetic testing companies are going to realize their patent portfolios
are not as strong as they thought they were," said Tom Engellenner, a
patent lawyer at Pepper Hamilton. "However,
for most companies, the court's narrow conclusion that 'isolated DNA'
is unpatentable will be comforting because the court also went out of
its way to note that some types of DNA can be patented, the so-called
cDNA molecules."
The
original judge who looked at Myriad's patents after they were
challenged by the ACLU in 2009 threw them out. U.S. District Judge
Robert Sweet said he invalidated the patents because
DNA's existence in an isolated form does not alter the fundamental
quality of DNA as it exists in the body or the information it encodes.
But the federal appeals court reversed him in 2011, saying Myriad's
genes can be patented because the isolated DNA has
a "markedly different chemical structure" from DNA within the body.
The
Supreme Court threw out that decision and sent the case back to the
lower courts for rehearing. That came after the high court unanimously
threw out patents on a Prometheus Laboratories
Inc. test that could help doctors set drug doses for autoimmune
diseases like Crohn's disease. The justices said the laws of nature are
unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current case.
The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.
( a collective sigh of relief,no "repo man" nightmares, no clone armies, but then again why bother,making clones is expensive, labor is cheap, none the less nobody can patent my spleen )