-- E.J. Mundell
THURSDAY, June 13 (HealthDay News) -- In a decision that could
have far-reaching implications for medicine, the U.S. Supreme Court
on Thursday ruled that human genes cannot be patented.
The ruling could be a blow to drug companies such as Myriad
Genetics, whose effort to patent an isolated form of a gene that
might foretell cancer risk was at the center of the case. The high
court decided that, unlike drugs or medical devices, human genes
are not "created" by companies and therefore cannot be patented,
"Myriad did not create anything," Justice Clarence Thomas wrote in the unanimous decision. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
Still, the justices did say that Myriad or companies like it
might be able to patent forms of DNA that were not simply extracted
from genes taken from the human body.
USA Today, the judges' nine-to-zero decision was in line
with past decisions that have ruled that forces of nature are not
patent-eligible, while products of human invention are.
The decision may have a profound impact on the bottom line of
companies that sell genetic tests. According to
USA Today, more than 40,000 patents linked to genetic
material have been issued by the U.S. Patent and Trademark Office
since 1984. Myriad's gene tests for breast and ovarian cancer risk
have been used by almost 1 million women since the late 1990s.
But the newspaper noted that these tests aren't cheap: it costs
$3,340 for the breast cancer gene analysis, for example.
As is usual in cases over patents, Myriad and industry
representatives have long argued that losing patent protection
would lead to less investment in research and development.
On the other side, doctors and patient advocacy groups say loss
of patent protection for gene-based products would free up
competition, drive prices down and lead to more research and
development, not less.
In a statement released earlier this week, the National Society
of Genetic Counselors, argued against the patenting of genes.
"Exclusive licenses on patents create barriers that could stifle the development of innovative tests by restricting the access of researchers to gene sequences," the group said, "or requiring researchers to pay exorbitant licensure costs that will ultimately be passed on to the consumer."
An advocacy group for patients with ovarian cancer agreed.
"Many women we work with are concerned about their genetic risk of developing ovarian cancer, especially in the wake of Angelina's Jolie's announcement that she carries the BRCA1 mutation," Calaneet Balas, CEO of the Ovarian Cancer National Alliance, said in a statement. "Myriad's patent limited women's options for learning about their genetic risk."
The Supreme Court agreed that a gene is a preexisting entity
that is not subject to patent.
"In isolation, it has no value, it's just nature sitting there," Justice Sonia Sotamayor said, USA Todayreported.
To find out more about genes, head to the
Human Genome Project.
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