On June 13, 2013, the US Supreme Court issued a long-awaited opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court unanimously held that, in line with the Court's reasoning in the Mayo, Chakrabarty and Funk Brothers decisions, Myriad's composition patent claims drawn to:

The Court emphasized that Myriad's discovery of the location and DNA sequencing of the BRCA1 and BRCA2 genes, and the association of mutations of these genes with breast and ovarian cancers, was simply not enough to transform these naturally-occurring biological entities into patent eligible compositions of matter. The Court reasoned that Myriad's asserted composition of matter claims were not drawn to any specific molecular composition, but rather, were directed primarily to the information contained in the BRCA genetic sequence. Because these claims covered neither the BRCA genes' chemical composition nor any chemical changes to the isolated BRCA genes or their DNA segments, the Court concluded that the claims recited products and laws of nature and not patent eligible subject matter.

In contrast, the Court ruled that Myriad's claims directed to cDNA were patent eligible. It reasoned that these composition claims did not present the same obstacles to patentability as Myriad's claims to naturally occurring, isolated BRCA DNA segments. Specifically, the Court noted that, save for certain short DNA sequences that do not code for proteins (introns), cDNA differs from natural DNA in that the DNA's introns are removed in synthesizing the cDNA molecule. The Court concluded, therefore, that although cDNA also contains the same protein-coding information found in natural DNA (exons), the inventor's extraction of introns from isolated cDNA renders cDNA patent eligible because it does not occur naturally except in possible "rare and unusual" cases.

The Court, therefore, reversed the part of the Federal Circuit's decision upholding the patent eligibility of Myriad's composition patent claims directed to its location and isolation of the BRCA1 and BRCA2 genes and genetic material and affirmed that portion of the decision upholding Myriad's cDNA composition patent claims.

The Supreme Court's decision in Myriad breaks new ground in holding that the mere isolation of naturally-occurring genes and genetic material is not enough to sustain a patent-eligible composition of matter patent claim, even if incidental changes to these biological materials occur in the isolation process. The Court expressly recognized that this ruling is contrary to the USPTO's existing practice and, as such, has the potential to invalidate a significant number of existing patents. However, the Court deemed this a matter better left to Congress.

The decision does not present a total defeat to the patentee, Myriad, which retains both its method patents relating to BRCA (which, the Court noted, were not at issue) and its patented composition of matter in BRCA cDNA.

For more information on Myriad, including background facts, lower court opinions and legal analyses, see In Dispute: Ass'n for Molecular Pathology v. Myriad Genetics.