For almost 30 years, the United States Patent and Trademark Office has been granting patents directed to “isolated DNA.” On June 13, 2013, in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (Slip Op. No. 12-398), the Supreme Court of the United States unanimously held that DNA isolated from nature is no longer patentable subject matter because such DNA falls under the “law of nature” exception to 35 USC § 101 as a “product of nature.” However, Justice Clarence Thomas, the author of the opinion, carefully distinguished naturally occurring DNA from other types of DNA, such as cDNA, which has been manipulated by man and which, therefore, remains patentable subject matter.
Myriad Genetics discovered the precise location and sequence of two human genes (the BRCA genes), which when mutated, are associated with a substantial increase in breast and ovarian cancer. In addition, Myriad develops and sells the BRACAnalysis test, which detects mutations in the genes it discovered and permits a risk assessment of developing breast or ovarian cancer. While Myriad has a variety of patents covering different aspects of its discovery, the patents at issue were directed to the segments of the naturally occurring DNA where the BRCA mutations might occur. Based on decades of legal precedence, Myriad argued that the act of “isolating” (i.e., separating the BRCA genes from the rest of the genes) rendered its invention patentable subject matter.
In rejecting this argument, the Court had to distinguish its own earlier cases, particularly, Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980). In that case, the patent in question was directed to a modified bacterium having “markedly different characteristics from any found in nature.” Slip op., page 11. The claim to the bacterium was therefore found to be directed “not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter — a product of human ingenuity ‘having a distinctive name, character [and] use.’” Chakrabarty, 447 U.S. at 309–310. By contrast, the Court found that “Myriad did not create anything. To be sure, it found an important and useful gene but separating that gene from its surrounding genetic material is not an act of invention.” Slip op., page 12. It does not render the genes “new…compositions of matter” that are patent eligible. Id., page 13. Further, it found that “intensive effort alone is insufficient to satisfy the demands of §101.” Id., page 14.
This decision invalidates many previously-issued patent claims directed to isolated molecules of DNA. Accordingly, owners of patents directed to isolated DNA or other isolated naturally-occurring substances, such as amino acid sequences, should conduct a review of the claims of each potentially-affected patent. As questions arise regarding the impact of the Myriad decision on particular patent claims, and options for pursuing reissue applications, continuation applications, or other strategies for patents that are directed to isolated DNA molecules, please contact the patent group at Arent Fox. Researchers considering the impact of this decision on their ability to use patented DNA molecules may also wish to consult with us to determine how patent claims in question are affected by the Myriad decision before proceeding.
Finally, it is important to repeat that the Court did not broadly put an end to all patenting of human genes. The Court recognized that “patent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘imped[ing] the flow of information that permit, indeed spur, invention.” Slip op., page 11. For example, as noted above, the Court held that “cDNA is patent eligible because it is not naturally occurring,” while recognizing that “[t]he nucleotide sequence of the cDNA is dictated by nature.” Slip op., pages 16–17. Further, uses of human genes are not affected, as no position was taken regarding “new applications of knowledge” derived from isolated DNA molecules. Id., at page 17. “Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of 101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” Id., at page 18.