The worlds of genetics, law, and health care all stand to be affected by a recent federal court ruling that a patent on human genes is invalid because the genes are natural substances and thus not subject to patent by a company called Myriad Genetics. The so-called BRCA genes are used to determine susceptibility to two types of cancer, and Myriad had sought to be the exclusive licensee of the patent.
The plaintiffs, including the ACLU, called on the expertise of Shobita Parthasarathy, a University of Michigan professor who wrote extensively about BRCA discovery and testing in her book Building Genetic Medicine. So we asked Shobita about the case, her participation, and the wider implications of the case. She sent along the following:
The plaintiffs asked me to write a declaration in support of their case, based on the findings from my book. This declaration--and my book--discusses the process of BRCA gene discovery, the development of BRCA testing, and Myriad's effort to patent the BRCA genes in the US and elsewhere, and its aggressive position towards its intellectual property. The evidence presented disputes the company's claim that the BRCA genes would not have been discovered without Myriad's involvement, and also describes the implications of Myriad's BRCA gene patents for scientists, health care providers, and patients. In his ruling, Judge Sweet cited my declaration--and by extension, my book--quite extensively.
As this case goes through the appeals process over the coming months, the public should pay attention to its enormous potential implications. First, if gene patents are ultimately invalidated, this could transform the field of biotechnology. Although it might negatively affect the fortunes of the biotechnology industry, the traditionally collaborative culture of biomedicine may reemerge, which will benefit research and health care. Scientists will no longer be able to patent "upstream" research tools like genes and biochemical pathways, stimulating innovation by allowing other scientists to get involved in early stages of research. Second, the invalidation of gene patents may improve health care delivery by creating a more competitive market for genetic testing and therefore likely improve quality and reduce costs. Finally, the benefits and risks of patents may become a more central topic in public debate. For the first time, Judge Sweet ruled that citizens without direct financial interests in a particular patent nevertheless had legal standing in the case and could therefore file suit. With this ruling, we are likely to start a national conversation about how the public interest should be defined in the context of patent law. Should it be focused primarily on economic competitiveness? Or should it also consider the morality of commodifying life, the implications of patents for the future of scientific research, and the costs of health care delivery? This discussion has now begun.
Also: Take a look at a video of Shobita discussing the case here.