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.
LANDMARK CASE: ‘Every night we were dragged to US soldiers and sexually abused. Every week we were forced to undergo venereal disease tests,’ a victim said More than 100 South Korean women who were forced to work as prostitutes for US soldiers stationed in the country have filed a landmark lawsuit accusing Washington of abuse, their lawyers said yesterday. Historians and activists say tens of thousands of South Korean women worked for state-sanctioned brothels from the 1950s to 1980s, serving US troops stationed in country to protect the South from North Korea. In 2022, South Korea’s top court ruled that the government had illegally “established, managed and operated” such brothels for the US military, ordering it to pay about 120 plaintiffs compensation. Last week, 117 victims
China on Monday announced its first ever sanctions against an individual Japanese lawmaker, targeting China-born Hei Seki for “spreading fallacies” on issues such as Taiwan, Hong Kong and disputed islands, prompting a protest from Tokyo. Beijing has an ongoing spat with Tokyo over islands in the East China Sea claimed by both countries, and considers foreign criticism on sensitive political topics to be acts of interference. Seki, a naturalised Japanese citizen, “spread false information, colluded with Japanese anti-China forces, and wantonly attacked and smeared China”, foreign ministry spokesman Lin Jian told reporters on Monday. “For his own selfish interests, (Seki)
Argentine President Javier Milei on Sunday vowed to “accelerate” his libertarian reforms after a crushing defeat in Buenos Aires provincial elections. The 54-year-old economist has slashed public spending, dismissed tens of thousands of public employees and led a major deregulation drive since taking office in December 2023. He acknowledged his party’s “clear defeat” by the center-left Peronist movement in the elections to the legislature of Buenos Aires province, the country’s economic powerhouse. A deflated-sounding Milei admitted to unspecified “mistakes” which he vowed to “correct,” but said he would not be swayed “one millimeter” from his reform agenda. “We will deepen and accelerate it,” he
Japan yesterday heralded the coming-of-age of Japanese Prince Hisahito with an elaborate ceremony at the Imperial Palace, where a succession crisis is brewing. The nephew of Japanese Emperor Naruhito, Hisahito received a black silk-and-lacquer crown at the ceremony, which marks the beginning of his royal adult life. “Thank you very much for bestowing the crown today at the coming-of-age ceremony,” Hisahito said. “I will fulfill my duties, being aware of my responsibilities as an adult member of the imperial family.” Although the emperor has a daughter — Princess Aiko — the 23-year-old has been sidelined by the royal family’s male-only
RSS