On June 13, 2013 a unanimous United States Supreme Court held that the natural sequence of isolated human genes is a non-patentable product of nature. The Court also held that cDNA sequences—non-natural sequences—are patentable. Association for Molecular Pathology v. Myriad Genetics, No. 12-398 (June 13, 2013).
Background
Myriad's composition claims generally relate to DNA isolated from the genes BRCA1 and BRCA2. Mutations in these genes create a hereditary predisposition to developing breast and ovarian cancers. Myriad uses some of the claimed DNA sequences as part of its diagnostic testing services to determine a patient's risk for developing these hereditary breast and ovarian cancers.
A panel of the Federal Circuit twice held, 2-1, that the composition claims to isolated natural DNA molecules are patent-eligible subject matter, and twice held unanimously that the composition claims to cDNA molecules are patent-eligible.
The Supreme Court limited the issue before it to the patent-eligibility of "human genes." Specifically, the Court considered only the patent-eligibility of the isolated natural DNA sequences and cDNA sequences claimed by Myriad. By way of background, the isolated natural DNA sequence contains the natural sequence of the DNA of a gene as it exists in humans, isolated from the chromosome. cDNA, however, is not the same as the natural sequence. While isolated natural DNA contains sequences that code for proteins (exons) intermixed with non-coding domains (introns), cDNA contains the coding exons without the introns. Myriad's claims encompass both isolated natural DNA sequences and cDNA sequences of BRCA1 and BRCA2.
The Court's Opinion
The Supreme Court held, in a narrowly written decision, that isolated DNA sequences are not patentable subject matter, but that cDNA may be patentable subject matter. Thus the Court invalidated Myriad's claims to isolated BRCA1 and BRCA2 but upheld its claims to cDNA for those genes.
First, the Court held "that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material." Isolated DNA sequences are unpatentable products of nature because the natural and isolated sequences are the same. The sequence did not become patentable merely because "extensive effort" was required to isolate them or because isolation "severs chemical bonds and thereby creates a nonnaturally occurring molecule" with the same sequence.
The Court also rejected policy-based arguments for upholding the patentability of naturally-occurring sequences, such as long-standing USPTO practice and patentees' reliance on that practice. The Court explained that any policy-based arguments are more appropriately addressed to Congress.
Second, the Court held that cDNA sequences may be patentable because "they are not a 'product of nature.'" cDNA sequences do not exist in nature and human action is required to create them. The Court noted the possibility of an exception for "very short series of DNA may have no intervening introns to remove when creating cDNA."
Finally, the Court explicitly stated that it did not consider the patentability of other kinds of inventions, such as methods of manipulating genes, "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered," or "new applications of knowledge about the BRCA1 and BRCA2 genes."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.