Justices Appear Skeptical About Patenting Of Human Genes.

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The Supreme Court on Monday heard arguments in a key case about whether or not human DNA could be patented by biomedical firms. Media coverage portrayed the justices as skeptical about the assertions of Utah-based Myriad Genetics Inc., which holds patents on two genes.

        The AP (4/15, Holland) reports that the Supreme Court "seemed worried" during Monday arguments "about the idea of companies patenting human genes." Noting that the US Patent and Trademark Office "has been awarding patents on human genes for almost 30 years," the AP adds that "opponents of Myriad Genetics Inc.'s patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body." Myriad argues that "the company's genes can be patented because the DNA that Myriad isolated from the body has a 'markedly different chemical structure' from DNA within the body."

        The Wall Street Journal (4/16, Bravin, Subscription Publication) reports that challengers to the Myriad patents, including a medical researchers' group represented by the American Civil Liberties Union, argue the genes themselves, like all natural products, cannot be patented, but methods for isolating them or using them might be.

        The New York Times (4/16, Liptak, Subscription Publication) reports that in "lively" exchanges, the justices "struggled to find a narrow way to rule on the momentous question of whether human genes may be patented." Noting that the court's ruling "will shape the course of scientific research and medical testing," and "may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material," the Times adds that the Obama Administration, through Solicitor General Donald Verrilli Jr., "largely supported" the challengers, and argued that the court's ruling last year in Mayo Collaborative Services v. Prometheus Laboratories "suggested that the correct answer in the case argued Monday was that merely isolating a gene was not sufficient for patent protection."

        USA Today (4/16, Wolf) reports, "Using analogies ranging from baseball bats to chocolate chip cookies, a majority of justices said Myriad Genetics' isolation of the breast cancer genes was largely a force of nature, not invention. At the same time, the justices indicated a compromise could be in the works, siding with the company on its patent for a type of DNA that goes beyond merely extracting the BRCA1 and BRCA2 genes from the body."

        The Washington Post (4/16, Barnes) reports, "Even the normally confident justices expressed some trepidation as they considered the complexities of patent law and the mysteries of biochemistry." The Post notes that the justices' "caution is warranted," as the ruling "could shape the future of medical and genetic research and have profound effects on pharmaceuticals and genetically modified crops."

        The Los Angeles Times (4/16, Savage) reports, "During the argument Monday, most of the justices questioned the decision of the U.S. Patent and Trademark Office to grant Myriad Genetics a patent on two isolated gene sequences that signal a high risk of breast or ovarian cancer."

        Bloomberg News (4/16, Stohr, Decker) reports that "the case has ramifications for the growing field of personalized medicine as well as efforts to map the human brain and discover new uses for embryonic stem cells." Challengers to Myriad's patents include the American Medical Association, Association for Molecular Pathology, and the American College of Obstetricians and Gynecologists.

        Politico (4/16, Norman) notes that "much of the research community has bristled against patenting genes for decades, even as the policy at the patent office has consistently favored it. The American Medical Association weighed in against the practice, but some biotech interests argue that outlawing the patenting of genes could discourage companies from investing in genetic research."

        In a second article, the Los Angeles Times (4/15, Brown) reports that, according to Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, "Myriad's patents on the genes 'have really held back the field,' as the company has issued cease-and-desist letters to some academic centers attempting to study the BRCA1 and BRCA2 genes." Topol claimed that "Myriad's patents also have a chilling effect on genomics research because the company's tight control over BRCA1 and BRCA2 test results has prevented scientists from accessing useful data about genes and associated traits."

        Although supporters claim that the "patent only covers isolated molecules that are outside the body," ABC News (4/16, De Vogue) quotes Sandra Park, a senior attorney with the ACLU, as stating: "The patents are framed as covering and claiming the isolated genes. What that means is that the moment the gene is removed from the cell, Myriad owns it. The scope of the patent is incredibly broad." The ACLU argues "that although Myriad has not exercised its authority to stop all research, it has a monopoly on clinical testing in the U.S., and the ability to discourage research because laboratories are dissuaded from pursuing scientific work that requires using patented genes." In an amicus brief on behalf of the American Medical Association and others, Lori B. Andrews, a professor from Chicago-Kent College of Law, claimed that "patents on human genes impede the provision of health care, thwart public health objectives, shackle innovation and violate ethical tenets."

        On its website, NBC News (4/15, Williams) reports that the ACLU claims that Myriad's exclusive patent "creates a monopoly that denies women the ability to seek a second opinion, based on another test of the genetic material, and dissuades other laboratories from pursuing research on the patented genes." The ACLU contends that, because Myriad's breast cancer "test costs roughly $3,000, many women cannot afford it or lack the necessary insurance coverage." Regarding availability of the test, Myriad "says the cost of the test is covered by private insurance, Medicare, and Medicaid."

        The Salt Lake (UT) Tribune (4/16) reports that "one area where ACLU attorney Christopher Hansen seemed to stumble was when justices pressed him on whether invalidating gene-related patents would mean companies and investors would be much less likely to pour money into research and development. Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Kennedy said wasn't sufficient." The Tribune notes that "the court is expected to rule before the end of the summer."

        BBC News (4/16) reports that "the ramifications of any decision by the Supreme Court are uncertain," but "one thing is certain: A deeper understanding of how genes affect health is already starting to transform medicine. It is helping to deliver targeted drugs to the right patients as well as tests for cancer risk genes."

        Also reporting on the story are Reuters (4/16, Hurley), McClatchy (4/16, Doyle), CNN (4/15, Mears), NPR (4/15, Totenberg), Daily Mail (UK) (4/16, Lawson), HealthDay (4/16, Steele), and MedPage Today (4/16, Pittman).

        More Commentary. In a column for USA Today (4/15, Turley), George Washington University law professor Jonathan Turley writes, "The Myriad case raises fundamental questions on the meaning of property, including the treatment of the human genome as akin to a Hoover vacuum. As the Supreme Court deliberates over the very ownership of our genes, there has never been a national debate over the commoditization of American life. If we do not want to live by the leave of a new property class, we have fight for our rights."

        In his Los Angeles Times (4/15, Healey) column, Jon Healey writes that "the justices were clearly concerned about preserving innovation in medicine and biotechnology," but "the issue presented by Myriad Genetics' patents on the BRCA genes cuts both ways, leading to a potential split among the justices." Healey notes that, "during Monday's oral argument, several justices seemed worried about the implications of allowing patents over something extracted from nature."

        However, in a "Blowback" opinion piece in the Los Angeles Times (4/14, Meldrum), Peter D. Meldrum, president and chief executive of Myriad Genetics, writes in support of Myriad's patents on BRCA1 and BRCA2, which he claims "do not cover human genes from anyone's body." Claiming that the patents were a "product of creative, human ingenuity," Meldrum adds, "Without our patents, our tests could not have been developed." He concludes that "the issue before the Supreme Court is not about Myriad," but rather it "is about the consequences to the life sciences - and for innovation."

        In his column for the Washington Post (4/16) , Dana Milbank writes that "Based on the justices' questioning, there was little doubt that corporations such as Myriad have a legitimate claim to the DNA in our bodies. The argument was mostly about whether corporations own the material itself or merely have the exclusive rights to use our genes for research and commerce."

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