Posted by: Paul A. Forsyth | April 17, 2013

Supreme Court Oral Arguments in Myriad Genetics

On Monday, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc., a case concerned with whether patent applicants should be allowed to obtain patents on human genes.

Patently-O has a summary of the history in this case (bolded emphasis added):

Myriad Genetics and the University of Utah own several patents covering particular isolated human genes, seemingly man-made complementary DNA that mimics the natural DNA sequence, methods for obtaining the DNA, and methods for using the DNA to test for disease. The major breakthrough made by the Myriad Scientists was to discover the naturally occurring sequence of DNA that codes for early-onset breast cancer. These are the so-called BRCA1 and BRCA2 genes. This was a huge breakthrough and has been applied to save many lives. However, historic patent law is clear that the mere information discovered is not patentable. That information could be classified as both a natural phenomenon and an abstract idea—both of which lack patent eligibility. So, instead of patenting the information, the researchers applied molecular biology tools (conventional at the time) to isolate the DNA, and create cDNA. It was those structures and methods that Myriad patented, although the innovative heart of each patent claim remained the particular unpatentable genetic sequence. A group of public-minded researchers and groups challenged the patents.

At oral argument on Monday, the Justices seemed troubled by Myriad’s legal arguments. It looks like Myriad may have overreached. Tom Goldstein at SCOTUSblog writes: “It seems clear that the Court has grave doubts about holding that isolated DNA segments are themselves patentable. At the same time, it does not want to inhibit patents that truly add something new or identify a valuable use. So I expect a narrow ruling by a substantial majority that isolated DNA itself is patent ineligible. But the Court will hold or suggest that cDNA, as well as use or process patents involving isolated DNA, are patent eligible. The question in individual cases will be whether those further patents are invalid because they are obvious.”

Also at SCOTUSblog, Amy Howe has a lucid and accessible post on the oral arguments, “Justices debate gene patenting issues: In Plain English” (emphasis added):

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… . 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. … 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.”

Lyle Denniston also has a recap of the oral arguments. Denniston’s recap includes this: “if there was one inclination that emerged most strongly on the legal side of the argument, it is that the Court is not going to accept the recommendation of Myriad’s attorney that it dilute the long-standing doctrine that a product of nature is simply not eligible for a patent.”

Finally, Jacob Sherkow at Stanford has a recap post that takes a swing at vote counting: “I count at least five votes decidedly on board to invalidate Myriad’s claims: Chief Justice Roberts, and Justices Kennedy, Ginsburg, Sotomayor, and Kagan. All bets are off when it comes to Justice Scalia and anything scientific, and Justice Thomas has, much to many’s surprise, shown to be an apt and even-handed student of the history of patent law. And lastly, Justice Alito seemed ready to defend Myriad’s claims to their logical absurdities.”

Personally, I hope that Myriad fails, and the course of Monday’s oral argument gives me hope in that regard. This case bears careful watching.

* * *

These days, our thoughts and prayers are with Boston.

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