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Supreme Court hears gene patentability arguments

The court will decide whether two genetic sequences linked to breast and ovarian cancer constitute unpatentable “natural law”

The Supreme Court on Monday will hear oral arguments from a group of doctors and patients who contend that patents on human genes are hindering medical research.

Plaintiffs in the suit, who are represented by the American Civil Liberties Union and the Public Patent Foundation, say that Myriad Genetics Inc. should not be allowed to hold patents on two genetic sequences that are linked to a higher hereditary risk of ovarian and breast cancer.

The company says that its seven patents are valid because it used a new technique to isolate the BRCA1 and BRCA2 genes, one with involved “an enormous amount of human judgment, including how to define the beginning and end of these genes.” Although a federal judge rejected this argument and invalidated the patents, the Federal Circuit overturned that decision on appeal.

The appeals court stuck to its ruling even after the Supreme Court asked it to reconsider the decision in light of Mayo Collaborative Services v. Prometheus Laboratories. In that case, the high court ruled that Prometheus could not patent a system for administering a drug and analyzing a patient’s blood sample, because it constituted “natural law.”

The doctors, patients and researchers who asked the Supreme Court to review the Myriad case argue that patents on human genes prevent medical research, diagnostic testing and treatment. In 2004, for instance, Myriad stopped sharing its database of BRCA sequences—which helps to determine if a given genetic mutation is dangerous—with the National Institutes of Health’s breast cancer database, Thomson Reuters reports.

Myriad, meanwhile, contends that gene patents actually help medical innovation by incentivizing research. It also notes that 18,000 scientists have been able to publish 10,000 papers on BRCA.

For more InsideCounsel coverage of the gene patentability issue, see:

Gene case a big win for biotech industry

Supreme Court will rule on gene patentability

ACLU asks Supreme Court to hear gene patentability

Mayo v. Prometheus cuts back on patentable inventions

Technology: The ethical and legal challenges of large-scale human genome sequencing


Alanna Byrne

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