[A2k] New York Times: U.S. Says Genes Should Not Be Eligible for Patents

Thiru Balasubramaniam thiru at keionline.org
Sun Oct 31 00:43:31 PDT 2010


October 29, 2010
U.S. Says Genes Should Not Be Eligible for Patents
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  

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.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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