Abstract
In June 2013, the Supreme Court unanimously decided Assn. for Molecular Pathology v. Myriad Genetics Inc., ruling that isolated naturally occurring sequences of genomic DNA (gDNA) cannot be patented. The Court left open the possibility of patenting complementary DNA (cDNA)—synthetic DNA containing the same protein-coding information as a segment of natural DNA but omitting non-coding portions called introns—and novel methods of manipulating genes or applying the information contained therein.1 Myriad is thus likely to trigger a series of follow-on suits to clarify the holding. Myriad's patents covered the precise location and sequence of two human genes, BRCA1 and BRCA2, mutations of which have been linked to breast2 and ovarian3 cancer.4 Myriad began as a suit filed by medical researchers, cancer patients, advocacy groups, doctors, and the American Civil Liberties Union, aiming to invalidate Myriad's patents on (1) BRCA1, BRCA2, and their associated cDNA, and (2) methods for testing drug efficacy and interpreting genetic test outputs by analyzing DNA sequences for BRCA mutations. Myriad held a patent-protected monopoly in U.S. screening tests targeting the genes.
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