Development Agendas in a Changing World
Elgar Intellectual Property and Global Development series
Edited by Ricardo Meléndez-Ortiz and Pedro Roffe
Chapter 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 pharmaceuticals, 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 pharmaceuticals 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 importation, the recognition of extension or continuation patents, and lengthy periods of confidentiality for clinical trials test data.1 These provisions are designed to slow down considerably the entry of generic competitors in patented pharmaceutical...
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