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Wednesday, April 14, 2021
WASHINGTON, Jun 13 2013 (IPS) - The nine judges of the U.S. Supreme Court ruled unanimously Thursday that naturally occurring DNA, including component parts of that genetic material, cannot be patented.
The decision overturns three decades of practise to the contrary by the U.S. Patent and Trademark Office.
Health and civil liberties groups are celebrating the unusual unanimous ruling, as are consumer protection advocates.
Although the case dealt specifically with questions regarding the “isolating” of genes within the human genome, the judges did not limit their decision to human genetics, meaning the case will have an effect throughout the biotechnology industry.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote in the court’s final opinion.
He noted that U.S. patent legislation “permits patents to be issued to ‘[w]hoever invents or discovers any new and useful…composition of matter,’ but ‘laws of nature, natural phenomena, and abstract ideas’ ‘are basic tools of scientific and technological work’ that lie beyond the domain of patent protection”.
The court did, however, leave open the possibility of patenting synthetic or “complementary” DNA, artificial copies of DNA that are either separated or constructed in a lab and allowed to evolve on their own.
The biotech industry has long argued that stringent patent protection is needed for companies to feel comfortable spending the significant capital required to fund related research and development.
Others have suggested that allowing such patenting actually quashes innovation by limiting competition, while also pointing to the significant federal money that is often available for such research.
Still, the ruling will likely affect and potentially void thousands of patents on “isolated” genetic material taken out over the past decade or more, though experts say the legal process will now be required to move through each patent on a case-by-case basis. Isolated DNA is genetic material excised from chromosomes but not otherwise altered.
According to current estimates, about 40 percent of the human genome is currently covered in some way by patents.
Product of nature
“The court’s decision today represents a straightforward application of the ‘product of nature’ doctrine, which holds that a product of nature cannot be patented,” Sandra Park, a senior staff attorney with the American Civil Liberties Union (ACLU), a watchdog group, told reporters after the ruling.
“Maybe a product required great ingenuity to discover, but a product of nature needs to remain as part of the storehouse of knowledge.…This is a simple question but with profound consequences, and from our perspective this ruling is a victory.”
The ACLU has been involved in this case since 2009, when it helped bring a lawsuit on behalf of plaintiffs suffering from breast cancer who found themselves at the mercy of a U.S. company that had patented two genes linked to breast and ovarian cancer. Researchers working for that company, Myriad Genetics, isolated those genes and then developed tests for mutations based on the research.
“These patents here tied up all uses of those particular genes, so if you found a better way to do this testing, you couldn’t do it,” Jaydee Hanson, a policy analyst at the Centre for Food Safety, a Washington advocacy group, told IPS.
“In that way, this is a revolutionary change, and makes clear that the U.S. Patent Office has not understood what the Constitution says as relating to the patenting of naturally occurring things. This is very important, and we will be working hard to disallow Congress from trying to pass any new law suggesting that you can indeed patent DNA.”
In the initial lawsuits, plaintiffs argued that Myriad was able to charge exorbitant prices for the tests and that its patents disallowed competing labs from working with those genes in any way.
“Genes are not being held hostage by private corporations any longer,” Lisbeth Ceriani, a breast cancer survivor and original plaintiff in the case, told reporters Thursday.
“If you’ve been adopted or don’t know your medical history – say, if your parents are from other countries – up until today Myriad had been able to design the criteria for who should take their test, as opposed to doctor or patients. So I’m incredibly relieved, as something that’s been going wrong for more than a decade has finally been corrected.”
Medical experts are suggesting that the court’s decision will now have an immediate impact on public health, given that Myriad’s methods – and similar research based on isolated DNA – will be able to be put into broad clinical practice and subjected to further study.
Yet the implications of the ruling will almost certainly be felt beyond the confines of human health.
“Part of the significance of this ruling is that the judges did not specify that the decision applies only to human DNA, so this will now cover the whole range of DNA,” the Centre for Food Safety’s Hanson says.
“Many of the patents out there today are of other mammals, animals, plants and microorganisms. In fact, we’ve recently seen some decline in the number of human patents being issued, but large numbers of other patents are still being issued.”
He also notes that the decision has brought the United States somewhat more in line with legal precedent on this issue elsewhere, particularly in Europe.
“European patent law has set morality as a standard, so some countries have made restrictions on what is patentable gene sequence because it might be immoral to exclude people from being able to engage in certain testing or research,” he says. “In effect, the court has come down on the side of both the U.S. Constitution and moral obviousness.”
Still, those on the losing side of Thursday’s decision are suggesting that they are relieved the ruling did not go farther.
“I’m not fully happy with opinion, but it could have been much worse,” Greg Dolin, a co-director at the University of Baltimore School of Law’s Center for Medicine and Law who formally supported Myriad Genetics in the case, said in a press conference hosted by the Federalist Society, an association of right-wing attorneys.
“Luckily, the court did not undercut the biotechnology industry,” Dolin said. “It took a cautious step, but ultimately didn’t do too much damage – though that remains to be seen, in how the decision is applied to future cases.”
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