Justices, 9-0, Bar Patenting Human Genes
By ADAM LIPTAK
WASHINGTON — Human genes may not be patented, the Supreme Court ruled unanimously on Thursday. The decision is likely to reduce the cost of genetic testing for some health risks, and it may discourage investment in some forms of genetic research.
The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with an increased risk of hereditary breast and ovarian cancer. The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated. After the ruling, at least four companies announced that they would begin offering genetic testing in the field of breast cancer. “Myriad did not create anything,” Justice Clarence Thomas wrote for the court. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” The course of scientific research and medical testing in other fields will also be shaped by the court’s ruling, which drew a sharp distinction between DNA that appears in nature and synthetic DNA created in the laboratory. That distinction may alter the sort of research and development conducted by the businesses that invest in the expensive work of understanding genetic material. The decision tracked the position of the Obama administration, which had urged the justices to rule that isolated DNA could not be patented, but that synthetic DNA created in the laboratory — complementary DNA, or cDNA — should be protected under the patent laws. In accepting that second argument, the ruling on Thursday provided a partial victory to Myriad and other companies that invest in genetic research. The particular genes at issue received public attention after the actress Angelina Jolie revealed in May that she had had a preventive double mastectomy after learning that she had inherited a faulty copy of a gene that put her at high risk for breast cancer. The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women. That price “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case, as competitors start to offer their own tests. The ruling, he said, “will have an immediate impact on people’s health.” Myriad’s stock price was up about 10 percent in early trading, a sign that investors believed that parts of the decision were helpful to the company. But the stock later dropped, closing the day down by more than 5 percent. In a statement, Myriad’s president, Peter D. Meldrum, said the company still had “strong intellectual property protection” for its gene testing. The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection. Myriad’s discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Thomas wrote. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” he said. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” “Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria” for patent eligibility, he said. Mutations in the two genes significantly increase the risk of cancer. Knowing the location of the genes enabled Myriad to develop tests to detect the mutations. The company blocked others from conducting tests based on its discovery, filing patent infringement suits against some of them. “Myriad thus solidified its position as the only entity providing BRCA testing,” Justice Thomas wrote.
Even as the court ruled that merely isolating a gene is not enough, it said that manipulating a gene to create something not found in nature is an invention eligible for patent protection. “The lab technician unquestionably creates something new when cDNA is made,” Justice Thomas wrote. He also left the door open for other ways for companies to profit from their research. They may patent the methods of isolating genes, he said. “But the processes used by Myriad to isolate DNA were well understood by geneticists,” Justice Thomas wrote. He added that companies may also obtain patents on new applications of knowledge gained from genetic research. Last year, a divided three-judge panel of a federal appeals court in Washington ruled for the company on both aspects of the case. All of the judges agreed that synthesized DNA could be patented, but they split over whether isolated but unaltered genes were sufficiently different from ones in the body to allow them to be protected. The majority, in a part of its decision reversed by the Supreme Court, said that merely removing DNA from the human body is an invention worthy of protection. “The isolated DNA molecules before us are not found in nature,” Judge Alan D. Lourie wrote. “They are obtained in the laboratory and are man-made, the product of human ingenuity.” Long passages of Justice Thomas’s opinion read like a science textbook, prompting Justice Antonin Scalia to issue a brief concurrence. He said the court had reached the right result but had gone astray in “going into fine details of molecular biology.” “I am unable to affirm those details on my own knowledge or even my own belief,” Justice Scalia wrote. The ruling on Thursday followed a unanimous Supreme Court decision last year that said medical tests relying on correlations between drug dosages and treatment were not eligible for patent protection. Natural laws, Justice Stephen G. Breyer wrote for the court, may not be patented standing alone or in connection with processes that involve “well-understood, routine, conventional activity.” ■ PUBLISHED JUNE 13, 2013 http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html |
By ANDREW POLLACK
Almost immediately after the Supreme Court ruled that human genes could not be patented, several laboratories announced they, too, would begin offering genetic testing for breast cancer risk, making it likely that that test and others could become more affordable and more widely available.
The ruling in effect ends a nearly two-decade monopoly by Myriad Genetics, the company at the center of the case.
“It levels the playing field; we can all go out and compete,” said Sherri Bale, managing director of GeneDx, a testing company, which plans to offer a test for breast cancer risk. “This is going to make a lot more genetic tests available, especially for rare diseases.”
Just how many other tests are affected is a bit unclear. Experts say there are not that many tests offered exclusively by one company because of patents.
But some other patents, like those on bacterial genes that might be useful in producing enzymes or biofuel, might also now be in jeopardy.
Still, biotechnology industry officials and patent lawyers said on Thursday that the decision should have little effect on the pharmaceutical industry and on developers of genetically engineered crops. That is partly because while the court held that isolated DNA could not be patented because it is a natural product, it did allow patenting of a more synthetic form of DNA that is more commercially valuable.
“The Supreme Court got it exactly right,” said Eric Lander, the president of the Broad Institute, a genetic research center affiliated with Harvard and M.I.T. “It’s a great decision for patients, it’s a great decision for science, and I think it’s a great decision for the biotechnology industry.”
It is not necessarily a great decision for Myriad Genetics, which held the patents on the two genes, called BRCA1 and BRCA2, at issue in the case.
Women with certain mutations in either of these genes have an extraordinarily high risk of developing breast or ovarian cancer. The actress Angelina Jolie, who has one of those mutations, recently had both breasts removed to sharply reduce the risk of getting cancer.
Myriad, which charges about $4,000 for a complete analysis of the two genes, had used its patents to keep others from offering such tests.
The company, based in Salt Lake City, said it did not anticipate any impact on its business from the decision, which it said affected only a small number of its patent claims.
“We have 24 patents, more than 500 patent claims, the vast majority of which are still valid and enforceable,” Richard Marsh, Myriad’s general counsel, said in an interview.
But the groups that sued Myriad and some testing laboratories said the patents that were invalidated were the main barriers to competition.
Besides GeneDx, which is a subsidiary of Bio-Reference Laboratories, others that said that they would offer testing of the BRCA genes include Ambry Genetics; the University of Washington; Montefiore Medical Center and Quest Diagnostics, the nation’s largest clinical laboratory company.
Mr. Marsh declined to say whether Myriad would try to enforce its remaining patents against any of these companies.
Robert Cook-Deegan, a research professor at Duke University’s Institute for Genome Sciences and Policy who has closely studied gene patenting, said he doubted that would happen.
“I think there might be some blustering or saber rattling, but I would be really surprised if they sue anybody for patent infringement for a diagnostic test,” he said.
Myriad’s stock initially shot up 10 percent after the court’s opinion was issued, but it then retreated as investors realized that competition would indeed be coming for BRCA testing, which accounted for about $132 million of Myriad’s $156 million in revenue in the most recent quarter. Myriad shares ended the day at $32.01, down 5.63 percent.
The company, however, had also faced other challenges from the rapid improvement and declining costs of gene sequencing.
“Many academic labs, including our own, will soon be offering panel tests for dozens, or even hundreds of genes, for the same price Myriad historically charged for just two genes,” said Dr. Kenneth Offit, chief of the clinical genetics service at Memorial Sloan-Kettering Cancer Center.
Myriad itself has announced plans to phase out its BRCA gene tests by the middle of 2015 and replace them with a test that will analyze 25 genes that contribute to the risk of breast cancer and several other types of cancer. The price is expected to be similar to what the BRCA analysis costs now.
Also becoming more practical is whole genome sequencing. Some experts had feared that having numerous patents on individual genes would impede the ability to sequence and analyze a person’s entire genome, though others doubted that. In any case, that threat is now removed.
Some experts say that other genetic tests that are exclusively controlled by a patent holder include the test for spinal muscular atrophy and the test for an inherited form of deafness.
Dr. Bale of GeneDx said the deafness gene also caused a skin disease. Her company is allowed to test for mutations that cause the skin disease, but if it discovers a mutation for hearing loss, it cannot tell the doctor. Instead, a new blood sample has to be drawn and sent to Athena Diagnostics, which controls the testing for the deafness gene. Dr. Bale said the court’s decision should eliminate the need for that arrangement.
It is often said that patents cover 4,000 human genes, or about 20 percent of all human genes, meaning the decision could have a large impact.
But many of these patents were obtained in the genomics gold rush of the late 1990s and are either close to expiring or have been allowed to lapse for not being useful.
Moreover, said Christopher M. Holman, a biotechnology patent expert at the University of Missouri-Kansas City School of Law, many of the gene patents are actually patents on complementary DNA, or cDNA, which is essentially a gene with extraneous parts removed. The Supreme Court said cDNA was eligible for patenting because it was not naturally occurring.
Complementary DNA is commercially valuable because it is generally used to genetically engineer a cell, a plant or an animal.
Still, the Supreme Court ruling could have some broader effects — on bacterial genes, for example. An analysis in Nature Biotechnology in May concluded that more than 8,000 genes might be at risk in the Myriad decision, less than half of which were human genes.
It is also possible that the decision could make it hard to patent things other than genes that are isolated from natural products, like drugs derived from microorganisms or plants.
Patents on human genes are “almost yesterday’s I.P.” said Hans Sauer, deputy general counsel for the Biotechnology Industry Organization, a trade group, using the abbreviation for intellectual property. But inability to patent bacterial genes could slow innovation, he said.
“Paradoxically enough,” he said, “the case bites harder in areas that have the least to do with human genes.”
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PUBLISHED JUNE 13, 2013
http://www.nytimes.com/2013/06/14/business/after-dna-patent-ruling-availability-of-genetic-tests-could-broaden.html