U.S. Court: "Human Genes Cannot be Patented"

Washington, U.S. - The Supreme
Court ruled Thursday that
companies cannot patent parts of
naturally-occurring human genes,
a decision with the potential to
profoundly affect the emerging
and lucrative medical and
biotechnology industries.
The high court's unanimous
judgment reverses three decades of
patent awards by government
officials. It throws out patents held
by Salt Lake City-based Myriad
Genetics Inc. on an increasingly
popular breast cancer test.
Justice Clarence Thomas, who wrote
the court's decision, said that
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
could be patented. The court said
that synthetically created DNA, known
as cDNA, can be patented "because
it is not naturally occurring," Thomas
said.
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 company has used its patent to
come up with its BRACAnalysis test,
which looks for mutations on the
breast cancer predisposition gene, or
BRCA. Those mutations are
associated with much greater risks of
breast and ovarian cancer. 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.
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.
Myriad sells the only BRCA gene test.
Opponents of its patents say the
company can use the patents to
keep other researchers from working
with the BRCA gene to develop other
tests.
Companies have 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.
But "genes and the information they
encode area not patent eligible ...
simply because they have been
isolated from the surrounding
genetic material," Thomas said.
In a concurring opinion, Justice
Antonin Scalia said "the portion of
the DNA isolated from its natural
state sought to be patented is
identical to that portion of the DNA in
its natural state."
The case is 12-398, Association for
Molecular Pathology v. Myriad
Genetics, Inc.