This is interesting:
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.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.
Via the New York Times
Read the brief here: Department of Justice Brief on Genes
Disclosure: I am not a good lawyer. Full Disclosure: I am not a lawyer at all. Are you? Chime in!
