13 June 2013

Law in Plain English: Association for Molecular Pathology v. Myriad Genetics, Inc.

This is one in a series of posts designed to describe court decisions in plain English. For more detail and background on the legal issues, see the link to the case below. For similar posts, click here.

Association for Molecular Pathology v. Myriad Genetics, Inc.

Myriad Genetics obtained several patents on “isolated” forms of several genes. A group of challengers (four national organizations of doctors, researchers, clinicians, and other health professionals, along with six leading geneticists, two genetic counselors, two women’s health and breast cancer organizations, and six patients who had been diagnosed as being at risk for one of the hereditary forms of cancer) opposed Myriad Genetics by claiming that Myriad hadn't created anything, since the genes remained unchanged, and “natural phenomena” or something that is merely the product of “the laws of nature” cannot be patented. The District Court ruled in favor of the challengers, but the Federal Circuit reversed, finding that all of the challengers (but one, a doctor from NYU who had been doing research on the genes in question but stopped because he feared Myriad might take action against him) lacked standing, and that Myriad's patents were valid. The question before the Court was whether human genes are patentable. In a 9-0 decision, the Supreme Court ruled that natural isolated DNA is not patentable, but synthetic DNA is patentable. A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. As a result, Myriad's patents (which were based on natural isolated DNA) are not valid.

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