The Genes You Can’t Patent

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Richard B. Levine
Newspapers showing front-page coverage of Angelina Jolie’s decision to have a preemptive double mastectomy to reduce her risk of breast cancer after genetic testing showed that she carried the abnormal BRCA1 gene, May 15, 2013

In a major decision issued on June 13, the US Supreme Court unanimously struck down the patents held by a biotechnology firm on the DNA comprising BRCA1 and BRCA2.1 These are the two genes that, in their abnormal forms, are known to dispose women to a dramatically heightened risk of breast and/or ovarian cancer. The case had originated in May 2009, when the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit in a federal district court to overturn the patents. The main defendant was the Myriad Genetics Corporation in Utah, which had located the two genes, extracted them from the chromosomes housing them, and, in 1997 and 1998, obtained the patents in question. The patents did not cover the DNA of the two genes while they are in the body but only in isolation from it.2

The patents controlled by Myriad entitled the company to exclude all others from using the isolated DNA in breast cancer research, diagnostics, and treatment. The plaintiffs—who originally included biomedical scientists and clinicians, advocates for women’s health, and several women with or at risk for breast cancer—held that Myriad’s enforcement of its patents interfered with the progress of science and the delivery of medical services. They contended that genes, even if isolated, were legally ineligible for patents and that well-established tenets of patent law precluded the grant to any person or institution of a monopoly over a substance so essential to life, health, and science as human DNA.

In March 2010, the district court struck down Myriad’s DNA patents, but in July 2011 the Court of Appeals for the Federal Circuit upheld them. After being told by the Supreme Court to vacate its finding, the appeals court upheld the patents again in August 2012. It had denied standing in the case to all the plaintiffs except one, Harry Ostrer, a biomedical scientist then at NYU. On November 30, 2012, the Supreme Court agreed to review the case, stipulating that both Ostrer and Myriad address only the salient issue of whether genes were eligible for patents.

A section of the US Code spells out the relevant criterion of eligibility for the patents in dispute. They can be granted to “whoever invents or discovers any new and useful…composition of matter.” Since the later nineteenth century, the courts have excluded from eligibility for patents laws of nature, natural phenomena, and natural products—for example, trees in the field and minerals in the earth. They were, the courts said, not new; they existed without anyone having made “an inventive step,” and universal access to them was essential to the progress of science and invention. They were, as the Supreme Court had said in a decision …

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  1. 1

    US Supreme Court, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., June 13, 2013. 

  2. 2

    For the background and development of the case, see Daniel J. Kevles, “ Can They Patent Your Genes?,” The New York Review, March 7, 2013. All case documents are available through WestlawNext at store.westlaw.com/westlawnext.