Bilski: Assessing the Impact of a Newly Invigorated Patent-Eligibility Doctrine on the Pharmaceutical Industry and the Future of Personalized Medicine

摘要

The patent-eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, nprinciples of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon na pronounced expansion in its definition of patent-eligible subject matter, particularly with respect to software and busi-nness method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics nfrom the public and private sectors arguing that the threshold for patent-eligibility needs to be raised in order to ensure nthat patents fulfill their constitutional objective of encouraging innovation rather than impeding it. The courts and PTO nappear to have heard these critics, and have begun to actively rein in the scope of patent-eligible subject matter. This shift nin the swing of the patent-eligibility pendulum will likely have a profound impact on the patentability of innovations aris-ning out of the pharmaceutical and biotechnology industries, particularly those relating to diagnostics and personalized nmedicine. In this article, I discuss the current status of the patent-eligibility doctrine, how it is that we got here, and what nthe future might hold, particularly for the life science industries.