Autumn Is Coming: A Novel Liability Theory That May Kill Pharmaceutical Evergreening

Pharmaceutical evergreening-attempts by brand-name manufacturers to leverage patent rights to artificially extend legal protection for drugs-is among the most pressing and unresolved public policy challenges of our time. On July 14, 2021, in Sanofi et al vs. Unipharm Ltd., the Israeli Supreme Court adopted a novel and internationally unprecedented legal policy to combat the evergreening pandemic. By using its equitable powers, the Israeli court empowered a generic manufacturer. Unipharm, to claim on behalf of the public interest the wrongly obtained monopoly profits that a brand-name manufacturer, Sanofi, obtained by improperly leveraging its improvement patent to impair generic market entry. This article introduces and critically evaluates the provocative Israeli decision. It explains that the logic of the new remedial mechanism that the Israeli court adopted-while sensible from a domestic perspective-is also more powerful and more convincing when adjusted and applied to U.S. health policy. Finally, this article provides such an adjustment. Generalizing.from the Sanoti case, the article structures a desirable and.feasible policy mechanism to combat the evergreening pandemic. Many of the suggested policy prescriptions are equitable in nature and can be adopted by the Federal Courts without the need. R,r legislative refbrm. 1.f adopted, the suggested remedial solutions would contribute greatly to aligning pharmaceutical innovation incentives with the welfare of drug-seeking patients. [ABSTRACT FROM AUTHOR]