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

Christopher      M. Holman

Abstract

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

Keywords: Chakrabarty, LabCorp, Metabolite, Prometheus, Classen, Ariad, thiopurine, fundamental principle, machine or transformation test, Patents, Bilski, patent eligibility, patentable subject matter, personalized medicine, diagnostics, Pharmaceutical Industry, patent-eligibility doctrine, combover” hairstyling techniques, mc2, hydrocarbons, Federal Circuit Court of Appeals, misnomer, synthetic polynucleotides, adrenaline, cellular milieu, NF-B, homo-cysteine, human chorionic go-nadotropin, Down syndrome, prostaglandin H syn-thase-2, COX-2 spe-cific inhibitor, human KCNE1 gene, gas chromatography, mass spectrometry, Abbott test, NF-B-mediated intra-cellular signaling, NF-B pathway, raloxifine, Rader's dire prognosis, BRCA1 gene, human KCNE1