The impact of Myriad on the future development and commercialization of DNA-Based therapies and diagnostics

Abstract

One of the reasons that the United States is a leader in biotechnology is its strong and reliable patent system. However, the Supreme Court’s decision in Myriad potentially limits an inventor’s ability to protect her DNA-based inventions. Fortunately, with creativity, there are numerous ways in which to “claim around” Myriad, enabling inventors to fully protect their diagnostic or therapeutic inventions. Thus, under a proper reading of the holding, the potential negative effect of Myriad on the progress of biotechnology would be negligible. Unfortunately, the U.S. Patent and Trademark Office has promulgated revised examination procedures in the wake of Myriad that have the potential to greatly limit the patentability of all inventions based on products found in nature and create uncertainty that will not be resolved in the near future.