In an highly
anticipated decision, the Supreme Court has effectively invalidated the patents
held by Myriad Genetics for the BRCA1 and BRCA2 genes.
However, the ruling is not all bad news for Myriad.
The Court unanimously ruled that although naturally
isolated DNA is not patentable, synthetically created exon-only strands of
nucleotides — complementary (c)DNA — is patentable.
In essence, the Court ruled that 5 of Myriad's claims
covering isolated DNA are not eligible for patents. But according to Myriad,
the company holds more than "500 valid and enforceable claims in 24
different patents conferring strong patent protection for its BRACAnalysis
test."
The ruling was written by Justice Thomas, who was
joined by Chief Justice Roberts and Justices Kennedy, Ginsberg, Breyer, Alito,
Sotomayor, and Kagan; Justice Scalia concurred in part. The Court held that
"a naturally occurring DNA segment is a product of nature and not patent
eligible merely because it has been isolated, but cDNA is patent eligible
because it is not naturally occurring."
It notes that "Myriad's principal contribution
was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2
genes." Although this was an important contribution, "Myriad did not
create or alter either the genetic information encoded in the BCRA1 and BCRA2
genes or the genetic structure of the DNA."
In the decision, Justice Thomas notes that Myriad's
claims were not "saved by the fact that isolating DNA from the human
genome severs chemical bonds and thereby creates a non-naturally occurring
molecule." This is because the claims are "simply not expressed in
terms of chemical composition, nor do they rely in any way on the chemical
changes that result from the isolation of a particular section of DNA."
However, the decision leaves the door somewhat open on
gene patenting because it distinguishes natural from synthetic DNA. The Court
noted that "cDNA does not present the same obstacles to patentability as
naturally occurring, isolated DNA segments."
More specifically, Justice Thomas points out that
"cDNA retains the naturally occurring exons of DNA, but it is distinct
from the DNA from which it was derived." Thus, this form of DNA is
"not a 'product of nature' and is patent eligible under §101."
Long and Convoluted
Journey
Today's decision puts an end to what has been a long
and protracted case. Myriad acquired patents on the 2 genes in the mid-1990s.
Since that time, it has become the sole commercial provider of testing services
for BRCA1 and BRCA2 in the United States.
On May 12, 2009, the American Civil Liberties Union
and the Public Patent Foundation filed a lawsuit against the US Patent and
Trademark Office, Myriad Genetics, and the University of Utah Research
Foundation, which hold the patents on the BRCA1 and BRCA2 genes. It charged
that patents on human genes violate the First Amendment and patent law because
genes are "products of nature," and therefore cannot be patented.
The coplaintiffs in the case, including several
medical organizations, physicians, academic researchers, cancer survivors, and
patient advocates, represented 150,000 geneticists, pathologists, and
laboratory professionals.
On March 29, 2010, a New York federal court ruled
against Myriad, finding that patents on the BRCA1 and BRCA2 genes were invalid.
Myriad appealed the case, and it was heard by the US Court of Appeals for the
Federal Circuit in April 2011. Three months later, the appeals court ruled in
Myriad's favor, finding that companies can obtain patents on specific genes.
In March 2012, the US Supreme Court instructed the
appeals court to reconsider the case after a unanimous ruling invalidated 2
patents on a blood test that determines drug dosages, which had been licensed
to Prometheus Laboratories.
In August 2012, a divided federal appeals court (2 to
1) ruled in favor of Myriad and gene patents in general. However, the Court
invalidated patents on methods used to compare gene sequences. A month later,
the plaintiffs once again asked the Supreme Court to hear the challenge to
Myriad's patents. In November 2012, the Supreme Court agreed to hear it.
Today's decision is likely to have far-reaching
implications for the biotechnology industry, and will undoubtedly raise
questions about the validity of thousands of other patents that are currently
in force.
Victory for Both
Sides?
Both sides of the court battle see the ruling as a
victory. The American Society for Clinical Pathology (ASCP) and Breast Cancer
Action, both plaintiffs in the case, have expressed satisfaction with the
ruling in press releases.
"Isolated DNA is a product and law of nature, not
an invention, so it is not open to patent protection," said Steve Kroft,
MD, FASCP, president-elect of the ASCP, in a statement. "Gene patents
hinder advances in patient care and make the process slower and more expensive
for women to find out if they have certain gene mutations that could adversely
affect their health."
According to the ASCP, the cost of BRCA testing will
be considerably lower without patent protection, and laboratories nationwide
will be able to conduct the tests. In addition, patients will be able to obtain
a second opinion, which Myriad Genetics has not allowed.
Breast Cancer Action, a nonprofit advocacy group,
called the decision a "tremendous win for women's health — and for all our
health!" They echoed the sentiments of the ASCP, in that "Myriad's
monopoly is broken and other labs can conduct testing, perform vital research,
and develop treatments using the human BRCA1 and 2 genes."
Myriad also claimed victory because the Court upheld
its claims on cDNA, and pointed out that the Court noted that many of Myriad's
unchallenged claims are method claims applying knowledge about the BRCA1 and
BRCA2 genes.
"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, president and CEO of Myriad.
"More than 250,000 patients rely on our BRACAnalysis test annually, and we
remain focused on saving and improving peoples' lives and lowering overall
healthcare costs.
Roxanne Nelson
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