A competition law approach to accessing insulin: A working paper

December 2022

United Nations Development Programme (2022)

in A New Global Economic Order, pgs. 197-226, Chia-Jui Cheng ed. (Brill/Nijhoff) (2022)

Frederick M. Abbott

F. Abbott, R. Abbott, J. Fortunak, P. Gehl Sampath & D. Walwyn

Research Paper 116, South Centre, Geneva (August 2020)

Download here 

69 GRUR International 260 (2020)(Oxford), doi: 10.1093/grurint/ikz023

Public-Private Partnerships as Models for New Drug Development: The Future as Now

by Frederick M. Abbott

by Frederick M. Abbott

published in IIC - International Review of Intellectual Property and Competition Law

Volume 49, Number 7 (2018)

IIC (2018) 49:845-853

DOI 10.1007/s40319-018-0734-y

ISSN 0018-9855

US Section 301, China, and technology transfer: Law and its limitations revisited (again)

IIC - International Review of Intellectual Property and Competition Law, March 2018, Volume 49, Issue 3, pp 259–266, https://doi.org/10.1007/s40319-018-0683-5

Bilateral, regional and plurilateral trade and investment agreements negotiated by the United States since the conclusion of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) limit public health regulatory autonomy. In negotiating plurilateral trade and investment agreements (PT&IAs), the immediate post-Uruguay Round negotiating objectives of the United States involved filling in perceived gaps left in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This included expanding the minimum scope of patent subject matter coverage, adding specificity regarding the criteria of patentability, requiring patent term extension, expanding the scope of obligations regarding protection of regulatory data through marketing exclusivity requirements, and bringing intellectual property (IP) disputes within the sphere of investor to state dispute settlement (ISDS).

More recently, the PT&IA template advanced by the United States initiates a deeper intrusion into the public health regulatory arena.

Published by: Geneva: World Health Organization; 2017

Download Amicus Brief here

Summary of Arument

UC Irvine Law Review, Volume 6, Issue 3, pp. 281-320, Dec. 2016

This article is divided into two parts. The first addresses competition policy and why it is appropriate to develop the doctrine of excessive pricing to address distortions in the pharmaceutical sector. The second addresses the technical aspect of how courts or administrative authorities may determine when prices are excessive, and potential remedies.

The policy prescription of this article is twofold: first, the United States should incorporate excessive pricing doctrine in its antitrust arsenal, and; second, other countries should maintain the status quo with respect to multilateral competition rules that allow them flexibility to develop and refine doctrine, including excessive pricing doctrine, that is best suited to their circumstances and interests.

Submitted to Senate Finance Committee on March 3, 2016 in response to request feedback regarding the report on “The Price of Sovaldi and its impact on the U.S. Health Care System” of December 1, 2015 (Senate Print 114-20). Transmittal letter accompanies abstract and download.

in Trade and Health: Towards building a National Strategy 117-40 (eds. R. Smith et al.), World Health Organization (2015)

This is a chapter of a book published by the World Health Organization to assist governments in developing trade strategies to promote public health.

Chapter in The ACTA and the Plurilateral Enforcement Agenda 31-45, eds. P. Roffe and X. Seuba, Cambridge Univ. Press (Dec. 2014)

Bridges Africa, Vol. 3, No. 8, pgs. 15-17 (International Centre for Trade and Sustainable Development, Geneva, Switzerland 2014)

The WTO previously authorised least developed country (LDC) members not to implement or enforce patent and regulatory data rules until January 1, 2016. Should LDCs seek renewal of the pharmaceutical-related extension at the TRIPS Council before it expires, or does the recent “general” extension for LDC implementation of the TRIPS Agreement until July 1, 2021 already cover the necessary ground?

by Frederick M. Abbott

in Emerging Markets and the World Patent Order, eds. Frederick M. Abbott, Carlos M. Correa and Peter Drahos, Edward Elgar Publishing (Cheltenham UK and Northampton USA), 2013, pgs. 391-406