The anatomy of CUSMA’s patent: Does it still reflect an equipoise?

Abstract

The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics).

Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.