Impact of the US Patent System on the Promise of Personalized Medicine.

Abstract: The biotechnology revolution promises unfathomable future scientific discovery. One of the potential benefits is the accelerated introduction of new diagnostics and treatments to the general public. The right medication for the right patient is the goal of personalized medicine, which directly benefits from many of biotechnology''s biggest and most recent advances. The US patent system rewards innovation in medicine and other arts and sciences by granting innovators, for a period of time, the right to exclude others from using what was invented. One of the purposes of the patent system is to trade that right to exclude, and in its stead obtain the patent holder''s obligation to fully and publicly disclose the essence of the innovations so that they can be improved, thus advancing the common welfare. A tension exists between personalized medicine''s need for access to and use of scientific advances and the patent system''s reward of exclusive use or nonuse to innovators. This tension may result in fewer diagnostic and therapeutic tools brought to the market and generally adopted. The risk seems particularly acute with respect to the diagnostic and therapeutic tools arising from genetic testing that hold specific value for a subset of the population. The judicial system has introduced ethical exceptions that overcome a patent holder''s right to exclude; these judicial overrides relate to the provision of certain types of medical procedures and the development of certain types of new drugs, and not, apparently, to the use of diagnostic and therapeutic tools essential to the success of personalized medicine. A serious question exists as to whether legislative action is necessary to increase public access to genetic testing. [Copyright &y& Elsevier]