SCOTUS Watch: Synthesized DNA is A-OK
The Supreme Court today decided that isolating naturally occurring DNA is not eligible for a patent, but synthesized (lab-created) DNA is. The case involved the well-known BRCA1 and BRCA2 genes, which can involve mutations that increase the likelihood of breast cancer. Myriad Genetics argued that it pioneered the process of isolating the genes that increase women’s risk of breast and ovarian cancers, and that it therefore deserved a patent on that isolated gene (and therefore on the testing for breast cancer). On the other side, the ACLU and the Public Patent Foundation, argued that a gene isolated by Myriad’s process was still naturally-occurring human DNA, so it was not eligible for a patent.
The Myriad case centered around the first of five requirements that patent applications must meet in order for a machine, process, or invention to be patentable. These are: (1) patentable subject matter, (2) usefulness, (3) novelty, (4) nonobviousness, and (5) “enablement,” meaning that other people must be capable of replicating the patented process, or making the invention, or building the machine. In fact, a patent application must disclose the best mode of practicing the invention. See 35 USC Section 101-103. Every patent application, therefore, has to include information that satisfies these five elements. If someone has made a thing before, it isn’t new and factor 3 isn’t satisfied. If a process is unique to the person who first did it and cannot be replicated, then factor 5 isn’t satisfied. And, importantly, SCOTUS has found that patentable subject matter includes “anything under the sun that is made by man,” which means the laws of nature, physical phenomena, and abstract ideas are not patentable. See Diamond v. Chakrabarty, 447 U.S. 303 (1980). As such, the relevant distinction between patentable and unpatentable subject matter is between products of nature, living or not, and human-made inventions.
This ruling paves the way for increased access for women, men, and transfolk to testing for breast-cancer-causing genes. Myriad’s monopoly on the gene isolation meant it could charge whatever price it wanted for testing. As Angelina Jolie noted in her New York Times article describing her choice to undergo preventative surgery after testing revealed that she carried the BRCA gene, testing can cost more than $3,000 dollars. This decision should alleviate some of that burden and make the tests easier for people without $3,000 of disposable income to access.