The Supreme Court today released a unanimous decision in the Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. patent case regarding the human BRCA1 and BRCA2 genes associated with breast cancer, holding that while a naturally occurring DNA segment is a product of nature and therefore not patent eligible, synthetic molecules called “cDNA” are patent eligible because they are not naturally occurring.
A group of physicians, patients and researchers challenged the Myriad patents in the Southern District of New York, seeking a declaration that certain claims of the patents are invalid under 35 U. S. C. §101. The Court granted summary judgment to the petitioners on the claims at issue, holding that the claims were directed to products of nature and where therefore invalid.
In 2012, the Federal Circuit – on remand from the Supreme Court in light of in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc. – reversed the district court and held that both isolated DNA and cDNA are indeed patent eligible under §101. The Supreme Court granted certiorari and oral argument was held on April 15, 2013.
Isolated DNA Sequences Are Not Patent-Eligible Subject Matter
In holding that the mere isolation of naturally occurring DNA sequences does not result in patent eligible subject matter under §101, the Court noted that “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” and that “[t]he location and order of the nucleotides existed in nature before Myriad found them.” Although Myriad’s discoveries may have been “[g]roundbreaking, innovative, or even brilliant,” this was not sufficient to satisfy the §101 inquiry. According to the Court, merely identifying the BRCA1 and BRCA2 genes and isolating them from the “surrounding genetic material” was not an act of invention.
Indeed, the issue of whether isolating DNA from a chromosome renders the isolated sequence patent eligible was largely dismissed despite comprising a substantial portion of the Federal Circuit’s decision. These claims are not expressed in terms of chemical composition, the Court reasoned, and do not rely on any chemical changes that may result from the isolation of a particular section of DNA. Instead, the claims focus on the genetic information encoded in the DNA.
Synthetic cDNA Sequences Are Patent-Eligible
In contrast to isolated DNA sequences, the Court held that cDNA sequences are patent eligible because the “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.” Although the petitioners argued that the sequence of cDNA is dictated by nature rather than by a scientist, the Court rejected that argument and reasoned that “the lab technician unquestionably creates something new when cDNA is made.”
The Court did highlight at least one situation where cDNA may in fact be naturally occurring and therefore not patent eligible: when a very short DNA sequence may have no intervening introns to remove when creating cDNA, in which case “a short strand of cDNA may be indistinguishable from natural DNA.”
Myriad Does Not Implicate Method or Application Claims, or Modified DNA Sequences
The Court carefully noted that this decision does not implicate method claims, although the Court did echo its recent decision in Mayo. While Myriad might have sought a method patent directed to some “innovative method of manipulating genes” if it had created such a method, the Court noted that the processes used by Myriad to isolate the BRCA1 and BRCA2 genes were “well understood, widely used, and fairly uniform” and were not at issue in this case.
Similarly, the decision does not implicate claims directed to applications of knowledge about the BRCA1 and BRCA2 genes. Indeed, many of the unchallenged claims in the Myriad patents are directed to such applications.
Further, the decision does not consider the patentability of modified DNA sequences, since “[s]cientific alteration of the genetic code presents a different inquiry.”
Although the Court’s decision may seem far-reaching, the ultimate impact may be limited. Indeed, one recent study found that there are relatively few patents directed to naturally occurring human gene sequences. As a result, it may only be Myriad and a limited number of similar patentees that feel the impact of the Court’s holding.
In light of Myriad, patent portfolio strategies should focus on applications of knowledge about identified DNA sequences rather than on the DNA sequences themselves. This strategy will steer clear of Myriad while providing valuable patent protection for uses of the discovery.