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US Supreme Court hears arguments in gene-patent case

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SCOTUS/Franz Jantzen

The United States’ highest court heard arguments today in a long-running debate over the validity of patents on human genes.

US Supreme Court justices will not issue a decision until later this year — probably near the end of June — but today’s questioning suggested that they will find isolated human DNA ineligible for patents. The justices did seem inclined, however, to protect patents on cDNA, which is DNA synthesized using RNA as a template. (cDNA is often shorter and easier to manipulate in the lab than genomic DNA, and many patents on DNA sequences claim cDNAs.)

The case has been working its way through the courts since 2009, when the American Civil Liberties Union and the Public Patent Foundation filed a complaint against Myriad Genetics, a medical diagnostics company based in Salt Lake City, Utah, that holds patents on two genes related to breast and other cancers. The groups filed the complaint on behalf of patients, physicians and researchers who argued that the patents, which claimed isolated BRCA1 and BRCA2 genes, cover a product of nature and are therefore invalid.

In this morning’s arguments, the justices did not spend much time challenging the lawyer for the plaintiffs on that assertion, noted SCOTUS blog publisher Tom Goldstein, who hosted a panel discussion after the session. Instead, many of their questions focused on whether invalidating the patents would squelch the biotechnology industry, or if companies would have other avenues — such as patents on methods or cDNAs — available to protect their investment in research. That, said Goldstein, suggested the justices were testing the scope of their ruling, rather than whether the plaintiff’s argument was right or wrong: “I would be very surprised if the Supreme Court says isolated gene sequences would be patent-eligible subject matter after today’s argument.”

The justices seemed to have been heavily influenced by a friend-of-the-court brief filed by Eric Lander, genomics whiz and founding director of the Broad Institute in Cambridge, Massachusetts. The brief argued against a lower court’s ruling that a snippet of DNA isolated from its chromosome does not occur in nature and is therefore patentable. To the contrary, wrote Lander, isolated DNA fragments do exist and are found circulating free in the blood. Indeed, a search of two public databases of DNA sequence data obtained from fetal DNA circulating in maternal blood revealed fragments that contained the BRCA1 and BRCA2 genes. “I think that raised a whole new ‘oops’,” said Robert Cook-Deegan, a policy researcher who has studied the case at Duke University in Durham, North Carolina.

The justices never heard a proper response to Lander’s argument from Myriad’s attorney, who seemed to have either misunderstood the Lander brief or confused it with another when questioned.

Comments

  1. Report this comment

    Michael Wosnick said:

    I applaud the “skepticism” that seems to be coming form the Court. Not sure I see the difference between isolated DNA and cDNA, mind you, but we need to wait for the rest.

    My own contribution to this debate was posted on my blog last night if any readers are interested:

    http://www.michaelwosnick.com/patent-my-jeans-not-my-genes/

  2. Report this comment

    Allison Stelling said:

    You know, I took a class in business law at the local community college for fun when I was in high school.

    I also took genetics in high school, and did quite a bit of molecular biology work for my PhD.

    It would be nice if USA lawyers would take a genetics class before they made laws about genes. And if they would learn the difference between “discovery” and “innovation”. One mustn’t patent a discovery. Nature made that, not an inventor.

    If you make an entire function protein from scratch amino acids, sure: that DNA sequence you can patent. If you made a test for a naturally occurring gene or protein: that you can patent.

    I thought trying to make money off of things you did not make was illegal in my country…..

    1. Report this comment

      Tianren Wang said:

      Myriad Genetics was one of the many organizations that were trying to clone BRCA when it was first implicated to exist, and they only managed to win the right for patent because they were the ones who won the “race”. I’d say it is pretty arbitrary to give the patent right to one company just because that company did things slightly faster than all other companies. Its not like BRCA couldn’t have being cloned if Myriad Genetics didn’t exist…..

      1. Report this comment

        Michael Wosnick said:

        Actually it is even “worse” than that. The 1994 Science paper was co-authored by a multitude of scientists, some at Myriad, some at the University of Utah and a number of them around the world including colleagues of mine here in Canada. The work was supported in part by a “myriad” (pun intended) group of PUBLIC funders. So how did Myriad Genetics get assigned this patent when so many other “non-Myriad” scientists (and dollars) contributed?

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      Timothy Roberts said:

      ‘Discoveries’ are the only things that are patentable in USA – that’s what the Constitution says. But the law defines ‘discoveries’ as including ‘inventions’. In Europe, only ‘inventions’ can be patented – ‘discoveries’ are unpatentable. Actually, for the most part, what you can patent is much the same in US as in Europe – though that may change if the US Supreme Court decides genes (or human genes) are unpatentable. Lawyers use words to mean what they choose – as Humpty Dumpty said “The question is, which is to be master – that’s all”

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