One June 13, 2013, the Supreme Court of the United States (SCOTUS) ruled in favour of the American Civil Liberties Union and the Public Patent Foundation as well as invalidated Myriad Genetics’ patent claims to the genes BRCA-1 and BRCA-2. Carriers of malformed versions of these genes have a 90% chance to develop breast cancer in their lifetimes.
Originally, lower courts had ruled that Myriad’s patent was valid since isolated DNA segments did not exist in nature and had to be processed before they could be useful for scientific use, therefore fulfilling the requirement that the patent be “non-obvious.” In the past, similar logic had been applied to other human-derived products such as adrenaline and insulin.
The immediate effects of this ruling would allow patients at high risk for breast cancer to get genetic testing done at a lower cost since Myriad would no longer have a monopoly on testing for BRCA-1 and BRCA-2. Patients would also be able to get second opinions done.
Beyond BRCA-1 and BRCA-2, the ruling against Myriad is a landmark case in motivations and innovations. Were Myriad’s case upheld, companies would continue to have their discoveries and technologies protected by patents, encouraging scientific innovation. Myriad itself benefitted greatly from its patent, growing from a startup in 1994 to a publicly traded company in 2012 with an annual revenue of $500 million. A great many discoveries today would not have been had their owners not been guaranteed intellectual protection through the patent system; genetic innovations are no different. Furthermore, disallowing patents on just gene material will encourage researchers to keep their discoveries secret for as long as possible rather than patenting the genes and licensing them for the use of other researchers.
However, opponents of gene patents maintain that the patents stifle innovation by requiring scientists to jump through hoops to license genes and techniques for research and restrict patient options with regards to genetic diagnostic services.
It is important to note that the Supreme Court issued a number of caveats in their ruling. The court agreed that naturally occurring DNA segments were ineligible for patents as they were products of nature and simply separating from the surrounding genetic material using common scientific techniques was not innovative enough. Furthermore, they determined that Myriad had not developed a particularly innovative method of manipulating genes while searching for BRCA-1 and BRCA-2 gene mutations and, instead, used well-understood methods that would have been employed by any scientist searching for the gene. They note that Myriad was still in a position to patent new applications on the knowledge about the BRCA-1 and BRCA-2 genes or an innovative method to find such genes.
I had previously written that I believed that Myriad held a valid patent on the genes BRCA-1 and BRCA-2 on the basis that thousands of other segments of the human genome have been patented and that disallowing the patent might prove disastrous to Myriad’s business practices. What I didn’t take into account was the commonality of the techniques required to isolate genes and identify flaws therein or the possibility that Myriad could still have patented special applications and novel diagnostic techniques to BRCA-1 and BRCA-2, if such existed. Thus, if Myriad’s business practice relies on their soon-to-expire patent on a few specific genes, they might have succeeded by monopolizing something besides the genes themselves.
All in all, this is a great step forwards in easing the legalities of the process of scientific discovery and providing patients with a choice as to their testing facilities.
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