Reversing a longstanding policy, the US government said on Friday that human and other genes should not be eligible for patents. 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 US Department of Justice late on 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 the genes of various organisms, including on an estimated 20 percent of human genes.
However, in its brief, the government said it now believed that the mere isolation of a gene, without further alteration or -manipulation, did 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.
James 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 US$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 Sweet of the US District Court in Manhattan ruled the patents invalid. He said 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 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.
Reines, 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.
OPTIMISTIC: A Philippine Air Force spokeswoman said the military believed the crew were safe and were hopeful that they and the jet would be recovered A Philippine Air Force FA-50 jet and its two-person crew are missing after flying in support of ground forces fighting communist rebels in the southern Mindanao region, a military official said yesterday. Philippine Air Force spokeswoman Colonel Consuelo Castillo said the jet was flying “over land” on the way to its target area when it went missing during a “tactical night operation in support of our ground troops.” While she declined to provide mission specifics, Philippine Army spokesman Colonel Louie Dema-ala confirmed that the missing FA-50 was part of a squadron sent “to provide air support” to troops fighting communist rebels in
PROBE: Last week, Romanian prosecutors launched a criminal investigation against presidential candidate Calin Georgescu accusing him of supporting fascist groups Tens of thousands of protesters gathered in Romania’s capital on Saturday in the latest anti-government demonstration by far-right groups after a top court canceled a presidential election in the EU country last year. Protesters converged in front of the government building in Bucharest, waving Romania’s tricolor flags and chanting slogans such as “down with the government” and “thieves.” Many expressed support for Calin Georgescu, who emerged as the frontrunner in December’s canceled election, and demanded they be resumed from the second round. George Simion, the leader of the far-right Alliance for the Unity of Romanians (AUR), which organized the protest,
ECONOMIC DISTORTION? The US commerce secretary’s remarks echoed Elon Musk’s arguments that spending by the government does not create value for the economy US Secretary of Commerce Howard Lutnick on Sunday said that government spending could be separated from GDP reports, in response to questions about whether the spending cuts pushed by Elon Musk’s Department of Government Efficiency could possibly cause an economic downturn. “You know that governments historically have messed with GDP,” Lutnick said on Fox News Channel’s Sunday Morning Futures. “They count government spending as part of GDP. So I’m going to separate those two and make it transparent.” Doing so could potentially complicate or distort a fundamental measure of the US economy’s health. Government spending is traditionally included in the GDP because
Hundreds of people in rainbow colors gathered on Saturday in South Africa’s tourist magnet Cape Town to honor the world’s first openly gay imam, who was killed last month. Muhsin Hendricks, who ran a mosque for marginalized Muslims, was shot dead last month near the southern city of Gqeberha. “I was heartbroken. I think it’s sad especially how far we’ve come, considering how progressive South Africa has been,” attendee Keisha Jensen said. Led by motorcycle riders, the mostly young crowd walked through the streets of the coastal city, some waving placards emblazoned with Hendricks’s image and reading: “#JUSTICEFORMUHSIN.” No arrest
RSS