The Need for the Tort Law Necessity Defense in Intellectual Property Law

Abstract

The COVID-19 pandemic has laid bare inherent tensions between the protection of intellectual property (IP) and the health of individuals touched by life-threatening medical conditions. Examples from around the world have made front page news: hospitals desperate for ventilator parts while 3D-printing instructions for such parts remain unshared for fear of liability; potentially lifesaving medicines whose manufacture and distribution on sufficient scale is limited by the threat of patent infringement; proprietary clinical data essential for making life-or-death decisions withheld from doctors and patients; the list continues. The threat of liability for IP infringement also dampens the ability to innovate under conditions of emergency, further contrasting the protection of IP with the protection of human lives. A number of policy responses for the current pandemic have been advanced, including the application of government rights under the Defense Production Act to IP contexts, compulsory licensing, legislation that would allow for emergency overrides to IP protections, and efforts to encourage companies to make their IP freely available voluntarily through the Open COVID Pledge. But fears of disrupting IP protections have curtailed the use of these measures, leaving the tensions between protection and life-saving access largely unaddressed.

In this Article we argue that the time is ripe for doctors, hospitals, independent compounders, medical products manufacturers, engineers and, ultimately, litigants and the courts to consider the necessity doctrine as an old-new tool for resolving IP disputes. Doing so would not only be ethically sound but would also help to resolve many of the public health critiques that have been plaguing IP law by attenuating ingrained misalignments between IP frameworks and the furtherance of public health goals. The Article demonstrates the need for the necessity doctrine in IP law; explains how claims under the doctrine may allow defendants to avoid liability in circumstances in which infringement is necessary to prevent adverse public health outcomes; and shows why the adoption of this doctrine is needed to increase preparedness ahead of future—indeed expected—outbreaks of infectious diseases.

Keywords: COVID-19, coronavirus, necessity, lesser-evil, lesser harm, defense, privilege, intellectual property, IP, Lake Erie, Vincent v. Lake Erie, respirators, 3d printing, pharmaceuticals, public health, public necessity, private necessity, imminent harm, torts, common law, emergency