The Supreme Court of the United States has now ruled on the patent eligibility of isolated DNA. On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics, Inc., the Court unanimously held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.”
The facts of this case relate to isolated human DNA molecules useful for measuring a patient’s predisposition to breast and ovarian cancer. Myriad had “discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer.” Based on that information, Myriad developed tests for “detecting mutations in a patient’s BRCA1 and BRCA2 genes” to identify “an increased risk of cancer.”
Myriad obtained numerous patents directed to this technology. At issue in Myriad are patent claims to the isolated forms of naturally occurring BRCA DNA, and to synthetic versions thereof, which are called complementary DNA or “cDNA.” Claim 1 of U.S. Patent 5,747,282 is representative, and is directed to “[a]n isolated DNA coding for a BRCA1 polypeptide” that has “the amino acid sequence set forth in SEQ ID NO:2.”
For an invention to be patentable, it must be patent eligible, as well as new, useful and non-obvious. Section 101 of the Patent Act governs patent eligibility. This section states that “[w]hoever invents or discovers any new and useful … composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
An important exception to this provision is that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.”
In Myriad, the question was whether the claimed DNA was patent eligible under Section 101. To address that question, the Court had to determine “whether the act of isolating DNA — separating a specific gene or sequence of nucleotides from the rest of the chromosome — is an inventive act that entitles the individual who first isolates it to a patent.” The Court held that it is not, and reversed the U.S. Court of Appeals for the Federal Circuit in that regard.
In applying the law of patent eligibility to Myriad’s patents, the Court identified its 1980 Diamond v. Chakrabarty decision as key to that task. Chakrabarty involved a genetically modified bacterium that was new and had “markedly different characteristics from any found in nature.” The Chakrabarty Court found the modified bacterium to be patent eligible, since it was “a product of human ingenuity” that had a “distinctive name, character [and] use.”
Although the Court did not find Myriad’s isolated DNA to be patent eligible, it did find that, like the genetically modified bacterium in Chakrabarty, Myriad’s cDNA is an entity “that is not naturally occurring” and is thus patent eligible.
Justice Thomas, who delivered the opinion, was careful to note that the case “does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”
The impact of this decision will no doubt become clearer over time. For now, it remains to be seen how and to what degree Myriad will affect the cost, quality and availability of BRCA gene-based tests. It is also unclear what economic effect this decision will have on the biotechnology and pharmaceutical industries, or whether the decision will facilitate research on human genes. Finally, it is too early to know how Myriad will affect the patent eligibility of other isolated, naturally occurring molecules such as plant-derived drugs.