Reversing a longstanding policy, the federal government said on Friday
that human and other genes should not be eligible for patents because
they are part of nature. The new position could have a huge impact on
medicine and on the biotechnology industry.
The new position was declared in a friend-of-the-court brief filed by
the Department of Justice late Friday in a case involving two human
genes linked to breast and ovarian cancer.
“We acknowledge that this conclusion is contrary to the longstanding
practice of the Patent and Trademark Office, as well as the practice of
the National Institutes of Health and other government agencies that
have in the past sought and obtained patents for isolated genomic DNA,”
the brief said.
It is not clear if the position in the legal brief, which appears to
have been the result of discussions among various government agencies,
will be put into effect by the Patent Office.
If it were, it is likely to draw protests from some biotechnology
companies that say such patents are vital to the development of
diagnostic tests, drugs and the emerging field of personalized medicine,
in which drugs are tailored for individual patients based on their
genes.
“It’s major when the United States, in a filing, reverses decades of
policies on an issue that everyone has been focused on for so long,”
said Edward Reines, a patent attorney who represents biotechnology
companies.
The issue of gene patents has long been a controversial and emotional
one. Opponents say that genes are products of nature, not inventions,
and should be the common heritage of mankind. They say that locking up
basic genetic information in patents actually impedes medical progress.
Proponents say genes isolated from the body are chemicals that are
different from those found in the body and therefore are eligible for
patents.
The Patent and Trademark Office has sided with the proponents and has
issued thousands of patents on genes of various organisms, including on
an estimated 20 percent of human genes.
But in its brief, the government said it now believed that the mere
isolation of a gene, without further alteration or manipulation, does
not change its nature.
“The chemical structure of native human genes is a product of nature,
and it is no less a product of nature when that structure is ‘isolated’
from its natural environment than are cotton fibers that have been
separated from cotton seeds or coal that has been extracted from the
earth,” the brief said.
However, the government suggested such a change would have limited
impact on the biotechnology industry because man-made manipulations of
DNA, like methods to create genetically modified crops or gene
therapies, could still be patented. Dr. James P. Evans, a professor of
genetics and medicine at the University of North Carolina, who headed a
government advisory task force on gene patents, called the government’s
brief “a bit of a landmark, kind of a line in the sand.”
He said that although gene patents had been issued for decades, the
patentability of genes had never been examined in court.
That changed when the American Civil Liberties Union and the Public
Patent Foundation organized various individuals, medical researchers and
societies to file a lawsuit challenging patents held by Myriad Genetics
and the University of Utah Research Foundation. The patents cover two
genes, BRCA1 and BRCA2, and the over $3,000 analysis Myriad performs on
the genes to see if women carry mutations that predispose them to breast
and ovarian cancers.
In a surprise ruling in March, Judge Robert W. Sweet of the United
States District Court in Manhattan ruled the patents invalid. He said
that genes were important for the information they convey, and in that
sense, an isolated gene was not really different from a gene in the
body. The government said that that ruling prompted it to re-evaluate
its policy.
Myriad and the University of Utah have appealed.
Saying that the questions in the case were “of great importance to the
national economy, to medical science and to the public health,” the
Justice Department filed an amicus brief that sided with neither party.
While the government took the plaintiffs’ side on the issue of isolated
DNA, it sided with Myriad on patentability of manipulated DNA.
Myriad and the plaintiffs did not comment on the government’s brief by
deadline for this article.
Mr. Reines, the attorney, who is with the firm of Weil Gotshal & Manges
and is not involved in the main part of the Myriad case, said he thought
the Patent Office opposed the new position but was overruled by other
agencies. A hint is that no lawyer from the Patent Office was listed on
the brief.
Reversing a longstanding policy, the federal government said on Fridaythat human and other genes should not be eligible for patents becausethey are part of nature. The new position could have a huge impact onmedicine and on the biotechnology industry.
The new position was declared in a friend-of-the-court brief filed bythe Department of Justice late Friday in a case involving two humangenes linked to breast and ovarian cancer.
“We acknowledge that this conclusion is contrary to the longstandingpractice of the Patent and Trademark Office, as well as the practice ofthe National Institutes of Health and other government agencies thathave in the past sought and obtained patents for isolated genomic DNA,”the brief said.
It is not clear if the position in the legal brief, which appears tohave been the result of discussions among various government agencies,will be put into effect by the Patent Office.
If it were, it is likely to draw protests from some biotechnologycompanies that say such patents are vital to the development ofdiagnostic tests, drugs and the emerging field of personalized medicine,in which drugs are tailored for individual patients based on theirgenes.
“It’s major when the United States, in a filing, reverses decades ofpolicies on an issue that everyone has been focused on for so long,”said Edward Reines, a patent attorney who represents biotechnologycompanies.
The issue of gene patents has long been a controversial and emotionalone. Opponents say that genes are products of nature, not inventions,and should be the common heritage of mankind. They say that locking upbasic genetic information in patents actually impedes medical progress.Proponents say genes isolated from the body are chemicals that aredifferent from those found in the body and therefore are eligible forpatents.
The Patent and Trademark Office has sided with the proponents and hasissued thousands of patents on genes of various organisms, including onan estimated 20 percent of human genes.
But in its brief, the government said it now believed that the mereisolation of a gene, without further alteration or manipulation, doesnot change its nature.
“The chemical structure of native human genes is a product of nature,and it is no less a product of nature when that structure is ‘isolated’from its natural environment than are cotton fibers that have beenseparated from cotton seeds or coal that has been extracted from theearth,” the brief said.
However, the government suggested such a change would have limitedimpact on the biotechnology industry because man-made manipulations ofDNA, like methods to create genetically modified crops or genetherapies, could still be patented. Dr. James P. Evans, a professor ofgenetics and medicine at the University of North Carolina, who headed agovernment advisory task force on gene patents, called the government’sbrief “a bit of a landmark, kind of a line in the sand.”
He said that although gene patents had been issued for decades, thepatentability of genes had never been examined in court.
That changed when the American Civil Liberties Union and the PublicPatent Foundation organized various individuals, medical researchers andsocieties to file a lawsuit challenging patents held by Myriad Geneticsand the University of Utah Research Foundation. The patents cover twogenes, BRCA1 and BRCA2, and the over $3,000 analysis Myriad performs onthe genes to see if women carry mutations that predispose them to breastand ovarian cancers.
In a surprise ruling in March, Judge Robert W. Sweet of the UnitedStates District Court in Manhattan ruled the patents invalid. He saidthat genes were important for the information they convey, and in thatsense, an isolated gene was not really different from a gene in thebody. The government said that that ruling prompted it to re-evaluateits policy.
Myriad and the University of Utah have appealed.
Saying that the questions in the case were “of great importance to thenational economy, to medical science and to the public health,” theJustice Department filed an amicus brief that sided with neither party.While the government took the plaintiffs’ side on the issue of isolatedDNA, it sided with Myriad on patentability of manipulated DNA.
Myriad and the plaintiffs did not comment on the government’s brief bydeadline for this article.
Mr. Reines, the attorney, who is with the firm of Weil Gotshal & Mangesand is not involved in the main part of the Myriad case, said he thoughtthe Patent Office opposed the new position but was overruled by otheragencies. A hint is that no lawyer from the Patent Office was listed onthe brief.
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