Maskus, Keith E. --- "A Review of the Economic Literature" [2009] ELECD 583; in Meléndez-Ortiz, Ricardo; Roffe, Pedro (eds), "Intellectual Property and Sustainable Development" (Edward Elgar Publishing, 2009)

Book Title: Intellectual Property and Sustainable Development

Editor(s): Meléndez-Ortiz, Ricardo; Roffe, Pedro

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781848446458

Section: Chapter 5

Section Title: A Review of the Economic Literature

Author(s): Maskus, Keith E.

Number of pages: 22

Extract:

5. A review of the economic literature
Keith E. Maskus

INTRODUCTION

As a consequence of the WTO TRIPS Agreement, many developing countries have
implemented or strengthened product patents in pharmaceuticals in recent years, though
the Doha Declaration of 2001 clarified that the least developed WTO Members may delay
such implementation or enforcement of drug patents until 2016. The TRIPS Agreement
requires the provision of patents across virtually all fields of technology, including phar-
maceuticals, for a minimum of 20 years. It also sets out restrictive conditions under which
compulsory licences may be issued. The agreement is silent on geographical exhaustion
of rights (thereby leaving it to each country whether to permit parallel trade) and whether
governments may allow a research exception from the patent-use exclusive rights. Lastly,
while requiring protection of confidential test data, the TRIPS Agreement does not
prescribe terms or a minimum period of protection. In short, TRIPS retains a number
of provisions under which governments in developing countries may reasonably use
regulatory authority to limit the scope of drug patents.
Discontented with this degree of protection, the European Union and, particularly,
the United States, have increasingly demanded intellectual property protection in phar-
maceuticals that go beyond TRIPS (so-called `TRIPS-Plus' standards) in bilateral trade
agreement negotiations with developing nations. These latter standards involve, inter
alia, virtually abandoning recourse to compulsory licensing, restricting parallel impor-
tation, the recognition of extension or continuation patents, and lengthy periods of
confidentiality for clinical trials test data.1
These provisions ...