Justices debate gene patenting issues: In Plain English
on Apr 15, 2013 at 1:15 pm
Since the Supreme Court began this Term in October 2012, the Justices have heard oral arguments in several potentially historic cases, involving front-page issues such as affirmative action, same-sex marriage, and voting rights. But today the Justices heard a little over an hour of arguments on a very different but still consequential question: whether human genes can be patented. One former Solicitor General – no stranger himself to high-profile cases – has called Association for Molecular Pathology v. Myriad Genetics the most interesting case in which he has ever been involved. And it quickly became clear that the Justices – although obviously not scientists – also found the case fascinating. We won’t know more than that until the Court issues its decision, probably in late June, but it seems likely that at least five Justices are poised to agree with the challengers that at least some of the human genes at issue in the case cannot be patented.
Christopher Hansen of the American Civil Liberties Union argued today on behalf of the medical researchers, breast cancer groups, and cancer patients challenging the patents on two genes held by Myriad Genetics, a Utah-based company that for nearly twenty years has either owned or held the licenses for those patents. Women who have mutations in those two genes, known as the BRCA1 and BRCA2 genes, have a significantly higher chance of developing breast or ovarian cancer, and they may be at risk of developing other kinds of cancers. (Lyle Denniston of this blog reviewed the issues in the case in a “Made simple” post for this blog last year.) He began his argument by asking the Justices to focus on one question: what had Myriad actually invented? He was willing to agree that Myriad had “unlocked the secrets” of the BRCA genes, but he emphasized that the “genes themselves are decisions made by nature, not Myriad.” Thus, although Myriad should get the “credit” for isolating the BRCA genes, he concluded, it did not deserve a patent for that.
That argument seemed to find traction with several Justices, at least with regard to the “isolated DNA” that Myriad contends is covered by its patents. (Myriad argues that the process of isolating the genes outside of the body requires human ingenuity, for which it is entitled to a patent; the challengers counter that the form and characteristics of the isolated DNA do not change just by removing them from the body.) Thus, the Chief Justice repeatedly (and skeptically) pressed attorney Gregory Castanias, representing Myriad Genetics, to explain how the process of isolating the BRCA genes was any different from merely “snipping” them out of a chromosome, while Justice Sotomayor emphasized that Myriad could only obtain a patent if it had added to nature – which, her remarks suggested, she did not believe it had. Other Justices echoed this line of thinking. Justice Kagan, for example, asked Castanias whether the first person to isolate a human chromosome would be entitled to a patent and then extended that hypothetical to ask whether the first person who discovered the liver could get a patent on that. And Justice Kennedy observed that Myriad’s reasoning could apply equally to a patent for atomic energy.
Although the Justices seemed to be moving in the direction of a holding that isolated DNA cannot be patented, it was also apparent that they had qualms about the broader implications of their decision and how they might limit it. Justice Kagan was one of the first to raise these concerns, asking Hansen to explain what incentives a company like Myriad would have to make the very substantial investment (in this case, approximately $500 million before breaking even) to isolate the gene in the first place. The Justices seemed unsatisfied with Hansen’s first answers, in which he tried to reassure the Court by noting that other laboratories would not have even tried to get a patent for the genes and that scientists would be willing to do the research because of the recognition that they would receive for important discoveries. Justice Kagan suggested another, compromise possibility with which Hansen would agree – that “there are still things that [a company] could patent” (for example, the use of the isolated DNA, even if not the isolated DNA itself) “to make it worth [the company’s] while.” Justices Kennedy and Sotomayor also expressed support for the position of the United States, which appeared as a “friend of the court” today, as another way in which the Court could strike a balance between, on the one hand, encouraging companies to incur the expenses required to make the initial advances and, on the other hand, making the genes available for researching and testing by other scientists: the Court could hold that, although “isolated DNA” is not eligible for a patent, “complementary DNA (cDNA)” – synthetic DNA molecules, which can only be created in a laboratory with more human intervention – would be.
Even if the Court were to hold that “isolated DNA” cannot be patented, it isn’t clear what the impact of that decision might be. Greg Stohr and Susan Decker of Bloomberg News reported last week that the impact on human gene research could be limited, but it could also affect other industries like agriculture and biotechnology. Whatever the result, if (as they are for me) these concepts are difficult for you to understand, you can take some comfort that the Justices – although extraordinarily smart lawyers – seemed to have trouble understanding them too. And the good news for us is that they – not we – now have to write an opinion to resolve those issues. When they do, we’ll be back to cover it in Plain English.