Section 101 of the Patent Laws sets out four broad categories of subject matter considered eligible for patenting - any "process, machine, manufacture, or composition of matter." For decades, Section 101 was viewed as a low bar designed to "include anything under the sun that is made by man," as the U.S. Supreme Court famously stated in its 1980 Chakrabarty decision. However, through a handful of decisions issued roughly a decade ago, the Supreme Court raised the threshold for patent eligibility, recasting the test as an exacting inquiry into the "inventive concept" embodied in patent claims that implicate a law of nature or abstract idea. These decisions rendered ineligible for protection broad swaths of subject matter long deemed patentable. The life sciences industry was hit especially hard. As the Federal Circuit noted in Illumina v. Ariosa (2020), courts in the last decade have “consistently held diagnostic claims unpatentable as directed to ineligible subject matter." Patents in affected areas were significantly weakend, with related innovation concomitantly disincentivized. Worse still, market participants struggled to navigate the shifting goalposts, as exemplified in the 2019 Cleveland Clinic case, where the Federal Circuit invalidated a patent claim conceptually identical to another listed in the USPTO's guidance as a patentable example. Industry was not well served by the chaos. But there is hope. From a decade of case law, we can now construct a roadmap to patent eligibility. The starting point is the Supreme Court’s 2012 decision in Mayo, in which claims directed to the correlation of metabolite concentrations to therapeutic outcomes were deemed unpatentable. Subsequent decisions applying Mayo stake out three general rules - (1) methods of treatment are patent eligible unless directed only to a finding that some therapy is ineffective for patients with certain conditions [Vanda (2018); INO Therapeutics (2019); Boehringer Ingelheim v. Mylan (2020)]; (2) diagnostic method claims that include new specific sample prep steps may be patentable [Illumina v. Ariosa (2020) vs. Ariosa v. Sequenom (2015)]; and (3) new laboratory techniques, e.g., methods of making samples or operating equipment, are generally patentable [Cellzdirect (2016); XY v. Trans Ova (2020)]. This presentation will derive general rules from these and other cases, identify where the lines are blurry, and explain how best to protect/assert/invalidate life sciences method patents.

At long last, a roadmap to patent eligibility in the life sciences

Fall 2022 abstracts, posters, and presentations will launch in mid-September.

ACS Fall 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.