"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.
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.
Information from Industry
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.
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