Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement - Health Economics and Drugs Series, No. 007 (Revised)
(1998; 97 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
Close this folderPART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT
View the documentExecutive summary
View the documentIntroduction
Open this folder and view contents1. Brief historical background to the international trading system
Close this folder2. Reading the TRIPS Agreement from the perspective of access to drugs
View the document2.1 General presentation of the Agreement
View the document2.2 Fundamental principles and objectives of the Agreement: the necessary balance between intellectual property and accessibility
View the document2.3 Patents for pharmaceutical products and processes available all over the world
View the document2.4 Non-patentable inventions: biotechnology inventions
Open this folder and view contents2.5 Effects of protection: a monopoly of working for 20 years
Open this folder and view contents2.6 Application of the TRIPS Agreement
Close this folder2.7 During the transitional period
View the documentEstablishment of a “mail-box” in 1995
View the documentPossibility of exclusive marketing rights
View the documentWhat happens to existing patents?
Open this folder and view contents2.8 How can the monopoly be limited?
Open this folder and view contents3. Conclusions: issues at stake and constraints on access to drugs
View the documentDefinitions and terminology4
Open this folder and view contentsSelected bibliography5
Open this folder and view contentsPART II: PRESENTATIONS AT THE AD HOC WORKING GROUP ON THE REVISED DRUG STRATEGY HELD IN GENEVA ON 13 OCTOBER 1998
View the documentOther documents in the DAP - Health Economics and Drugs Series
View the documentBack cover
 
Possibility of exclusive marketing rights

Furthermore, if a patent application for a pharmaceutical product filed in a developing country after 1st 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 1st 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.

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