Today the Supreme Court unanimously ruled that the BRCA gene patents held by Myriad Genetics are invalid. This seems to negate a great deal of intellectual property on gene technology going back to the Diamond v. Chakrabarty, 447 U.S. 303 (1980) decision. The key element of the new ruling seems to lie in the phrase “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. “ As a biologist I find this perplexing since the cDNA still derives from a natural (RNA) sequence.
However, the major issue now is how today’s ruling will impact the future evolution of the commercialization of genetic technology. In simplest form the decision should prevent companies like Myriad from monopolizing genetic tests thus lowering cost and accessibility. Clearly this would be a very good thing. However, the ruling is likely to have many ramifications that may not be easily anticipated and that may have a chilling effect on some forms of translational research. Not being a lawyer I may be naïve about the legal intricacies. However, a few cautionary examples readily come to mind. For example, there is a lot of interest in using short sequences of RNA (siRNAs, miRNAs) to regulate disease genes. Since these are based on naturally occurring base sequences, does the new ruling undermine the patentability of this approach? I would imaging that there will be a lot of work for patent lawyers in processing the full ramifications of today’s decision!