Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007: PART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT: 2. Reading the TRIPS Agreement from the perspective of access to drugs: 2.7 During the transitional period: Possibility of exclusive marketing rights

Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007
(1998; 97 pages) [French] [Spanish]

Table des matières

Acknowledgements
Abbreviations and acronyms
PART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT
	Executive summary
	Introduction
	1. Brief historical background to the international trading system
		1.1 The simultaneous creation of the GATT, the IMF and the World Bank
		1.2 The objectives, nature and functioning of the GATT
			Objectives
			Nature
			Obligations of the contracting parties
			The “Rounds”
		1.3 The Uruguay Round and the creation of the WTO
			The new global economic environment
			Long and difficult negotiations
			The results of the Uruguay Round: strengthening and enlargement of the multilateral trade system
			How does the WTO differ from the GATT?
		1.4 The protection of intellectual property rights before the WTO
	2. Reading the TRIPS Agreement from the perspective of access to drugs
		2.1 General presentation of the Agreement
		2.2 Fundamental principles and objectives of the Agreement: the necessary balance between intellectual property and accessibility
		2.3 Patents for pharmaceutical products and processes available all over the world
		2.4 Non-patentable inventions: biotechnology inventions
		2.5 Effects of protection: a monopoly of working for 20 years
			Attenuation of the monopoly through exhaustion of rights
			Strengthening the monopoly through the patenting of processes
			Extension of the duration of the monopoly
		2.6 Application of the TRIPS Agreement
			For industrialized countries: 1996
			For developing countries: 2000 or 2005
			For least-developed countries: 2006
		2.7 During the transitional period
			Establishment of a “mail-box” in 1995
			Possibility of exclusive marketing rights
			What happens to existing patents?
		2.8 How can the monopoly be limited?
			Exceptions
			Compulsory licences
	3. Conclusions: issues at stake and constraints on access to drugs
		3.1 The drug patents debate
		3.2 Some recommendations
	Definitions and terminology⁴
	Selected bibliography⁵
		GATT/WTO and the TRIPS Agreement
		The TRIPS Agreement and pharmaceutical products
		Country studies
PART II: PRESENTATIONS AT THE AD HOC WORKING GROUP ON THE REVISED DRUG STRATEGY HELD IN GENEVA ON 13 OCTOBER 1998
	1. Speech of the WHO Director-General, Dr Gro Harlem Brundtland
	2. World Intellectual Property Organization (WIPO)
	3. World Trade Organization (WTO)
		3.1 Pharmaceutical Patents and the TRIPS Agreement
		3.2 Overview of the WTO Agreement on Technical Barriers to Trade
	4. South Centre
	5. Health Action International (HAI)
	6. International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
	7. International Generic Pharmaceutical Alliance (IGPA)
Other documents in the DAP - Health Economics and Drugs Series
Back cover

Possibility of exclusive marketing rights

Furthermore, if a patent application for a pharmaceutical product filed in a developing country after 1^st January 1995 (or within the priority period of the Paris Convention) under the “mail-box” clause, should obtain a marketing authorization in this country before the expiry of the transitional period, (which is before 2005), the Agreement provides for the applicant to be accorded upon request exclusive marketing rights, for a maximum duration of five years, until the patent is either granted or refused.

Two conditions are necessary for the implementation of this provision: a patent must have been granted for the same product in another Member country in response to a patent application filed only after 1^st January 1995 (or within the priority period of the said Convention), and a marketing authorization for this product must have been obtained in this other Member country.

These conditions have been devised to ensure that the product for which an application has been filed is indeed a genuine invention. In the pharmaceutical sector, it may then be of importance to provide the possibility of exclusive marketing rights only for new chemical entities and to ensure that the other country in which a patent has been granted has effectively examined whether the application meets the patentability requirements.

Article 70.9 Protection of existing subject matter	Comments
Where a product is the subject of a patent application in a Member in accordance with paragraph 8(a)	For inventions covered by “mail-box” protection,
exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter,	Pending the granting of a patent, exclusive marketing rights shall be granted during the transitional period, as from the time the invention receives marketing approval. These rights will be accorded for a maximum of five years until such time as the patent is granted or rejected
provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member.	To be accorded these exclusive marketing rights, four conditions must be met: • a patent application must have been filed in Member State A after 1 January 1995; • an identical application must have been filed in another Member State B after the entry into force of the WTO Agreement and a patent actually granted; • a marketing authorization for the patented product must have been obtained in State B; • a marketing authorization is also obtained in State A.