Gene Sequences held Unpatentable as the ACLU Defeats Myriad Genetics

Gene Sequences held Unpatentable as the ACLU Defeats Myriad Genetics

Alex Gloor is a JD Candidate at Osgoode Hall Law School

Doctors, cancer patients and virtually the entire biotech industry are joined in celebration after a District Court ruling in New York invalidated two important patents on gene sequences held by Myriad Genetics. The basis of the invalidity holding is that naturally occurring gene sequences, popularly coined as "isolated DNA" as a means to confer patentability, is essentially "the physical embodiment of biological information" and thus does not constitute patentable subject matter under 35 U.S.C. 101.

The celebratory mood brought on by this decision to those outside of the legal community is the result of two factors. First, the gene sequences in question, BRCA1 and BRCA2 are vitally important in many cases of breast or ovarian cancer. As was noted by many of the plaintiffs to the case (there were twenty in total), Myriad's patent and their refusal to grant licences on BCRA1/2 testing meant that people with a high risk of cancer, or cancer patients themselves, were often unable to afford the necessary genetic testing to discover the actual cause of the cancer.

The second reason why some are lauding this decision is based on the impact that this ruling could have on the broader issue of gene patenting as a whole. Those in the scientific community widely deride gene patenting. It is seen as an obstacle to the comprehensive genomic analysis, something that appears to be on the horizon. As noted in this article, while Myriad charges $3,000 for screening of the two genes at issue, within a couple of years we will have the technology to screen all 25,000 genes in the human body for the same price. Thus, it is easy to see how the patenting of gene sequences could act as a great hindrance to scientific progress (not to mention human health), acting in direct contradiction to the purpose of the patent system in the first place.

Still, nobody should be planning the parade as of yet, as this is certainly not the end of the story regarding gene patenting. Myriad has already noted its intention to appeal. Dennis Crouch, author of the patently-O blog, expects the appeal to succeed. Judge Sweet relies amazingly little on settled case law and precedent for a 152 page decision, leaving lots of room for wrangling. Some commentators think that the ACLU would have been smarter to argue non-obviousness rather than section 101. Regardless, there is a strong feeling that this case has the US Supreme Court written all over it.