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
 
Establishment of a “mail-box” in 1995

Article 70.8
Protection of existing subject matter

Comments

8. Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:

For countries that do not grant pharmaceutical patent protection as of 1 January 1995,

(a) notwithstanding the provisions of Part VI,

independently of the transitional periods accorded to them,

provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed;

these countries must implement as from 1 January 1995 an adequate infrastructure to receive patent applications for such inventions of pharmaceutical products.

(b) apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and

These applications shall be examined at the latest in 2005 for developing countries and 2006 for the least-developed countries, in terms of the criteria for patentability set out in the Agreement, which shall be applied as if they were being applied on the filing (or priority) date of the application. This is a juridical artifice to preserve the novelty of the inventions made from 1995 onwards that will not receive patent protection for a maximum of some ten years.

(c) provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in subparagraph (b).

Such inventions will receive the protection due to them (if they meet the criteria of the Agreement for patentability) as from the date of the grant of the patent after the end of the transition period and for the remainder of the 20 years counted from the filing date.

In summary, as from the entry into force of the WTO, on 1 January 1995, countries must have an adequate infrastructure to receive and store patent applications for new drugs. Since it takes about ten years to test a new molecule and authorize its marketing, the invention should remain pending until 2005 at least. This is also the date at which the TRIPS Agreement becomes applicable to some developing countries in regard to pharmaceuticals. Those developing countries therefore will not have to examine before 2005 pharmaceutical patent applications filed since 1995. If the application properly fulfils the necessary conditions for patentability (novelty, inventiveness, and capable of industrial application), which are to be applied on the filing date, the patent will be issued for a period of 20 years. This is done on the understanding that the period will commence on the filing date (1995 for example) and run for the remainder of the due term* (until 2015 in the example).

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