Genomic Innovation, Intellectual Property, and Public Health: A Qualitative Study

Concern is mounting that recent changes to the law of patentable subject matter have weakened patent protection and that innovators are responding or soon may respond by increasingly choosing to protect their discoveries as trade secrets. With respect to biomedical discoveries, there is also concern that such a trend will negatively impact public health. This study sought to assess the validity of these concerns as applied to genomic innovations. ^ While it is impossible to quantify the extent to which innovators actually elect to protect their inventions as trade secrets rather than patents, interest in each strategy may be gauged through qualitative means. Utilizing expert interviews of 30 patent practitioners (attorneys and agents), legal academics, and scientists, this study probed the following predictions: (1) since 2012, the perceived advantages of patenting genomic innovations have decreased; and (2) since 2012, interest in protecting genomic innovations as trade secrets has increased. Interviews were conducted according to a semi-structured format using guides comprised of open-ended contextual and evaluative questions, and transcripts were analyzed according to conventional content analysis. ^ The data generally support the conclusion that, on the margins, trade secrecy is replacing patent protection where it is practical to do so and that this result is at least in part due to recent changes to the law of patentable subject matter. The data also support concerns that a shift in intellectual property strategies from patenting to trade secrecy may have important public health implications with respect to the translation of genomic discoveries to medical solutions.