Association for Molecular Pathology v. Myriad Genetics (2013)

United States, court ruling. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, was decided unanimously by the Supreme Court on 13 June 2013, with the opinion by Justice Thomas. The case was brought in 2009 by the American Civil Liberties Union and the Public Patent Foundation on behalf of pathologists, geneticists and patients against Myriad's patents on the BRCA1 and BRCA2 genes.

What the court decided: a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but complementary DNA (cDNA), which is synthesised and lacks introns, is eligible. The court did not rule on method patents or on new applications of knowledge about genes. Within hours competing laboratories announced BRCA tests, prices fell from more than 3,000 dollars, and multi-gene hereditary cancer panels became possible because no single company could block inclusion of a gene.

The arguments and aftermath: Myriad argued the patents rewarded its investment in discovering the genes and building a variant database; critics answered that patents had blocked second-opinion testing and research. The ruling, together with Mayo v. Prometheus (2012), also unsettled diagnostic method patents, and companies argue it has pushed investment away from diagnostics. Europe took a different course: Directive 98/44/EC allows patents on isolated gene sequences with a disclosed function, though the European Patent Office narrowed the BRCA patents on other grounds. Myriad's proprietary variant database remained its competitive asset, which is why data-sharing efforts such as ClinVar and the BRCA Exchange followed.