Patent Term Restoration – Why It Matters For Drug Development And For Drug Accessibility

20 February 2019
Calgary, Alberta

Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, many national jurisdictions allow for patent term extensions within certain limits. Canada only recently made the controversial decision to launch its own patent term extension program. In this session, we will discuss two recently published studies about the U.S. experience with patent term restoration extensions, where these laws have been in place since the 1980s. The main features of the new Canadian laws surrounding “Certificates of Supplementary Protection” (i.e., patent term extensions) will also be outlined and some implications discussed, including why these laws matter for drug developers and those concerned about affordable drug pricing and access.

Patent term restoration – why it matters for drug development and for drug accessibility


Reed Beall Profile PictureReed F. Beall is a population health researcher who works largely with medicine patent, regulatory, and utilization data to investigate the long-term impacts of national and international policy decisions which aim to balance incentives between equitable drug innovation and equitable drug access. He is an Assistant Professor in Healthcare Policy in the Department of Community Health Sciences within the Cumming School of Medicine and at the O’Brien Institute for Public Health at the University of Calgary. He also serves as affiliated faculty for the Program on Regulation, Therapeutics, and the Law (PORTAL) based within the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital and Harvard Medical School. He has been invited to provide testimony on his research to the trilateral technical symposium of the World Health Organization, the World Intellectual Property Organization, and the World Trade Organization, as well as to the United Nations Secretary-General's High-Level Panel on Access to Medicines. Dr. Beall’s work has been published in Value in Health, Nature Biotechnology, Health Affairs, PLoS Medicine, and Social Science and Medicine, among others.

The Network of Alberta Health Economists and the NOAHE Health Economics and Technology Assessment Rounds are supported financially and in-kind by Alberta Health, through the Health Funding and Economics Capacity (HFEC) Grant. Please note that the views expressed in this series and other deliverables associated with NOAHE are not necessarily representative of any particular organization involved.