Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007
(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
 
What happens to existing patents?

Under the heading of “Protection of Existing Subject Matter”, the Agreement sets out the steps that must be taken or not by Member States at the end of the transitional periods in respect of subject matter that already exists on those dates such as patents current at the end of the relevant transitional period.

Article 70
Protection of existing subject matter

Comments

1. This Agreement does not give rise to obligations in respect of acts which occurred before the date of application of the Agreement for the Member in question.

The Agreement will be binding only once it applies in a country (i.e. the end of the transition periods at the latest) and therefore is not retroactive.

2. Except as otherwise provided for in this Agreement, this Agreement gives rise to obligations in respect of all subject matter existing at the date of application of this Agreement for the Member in question, and which is protected in that Member on the said date, or which meets or comes subsequently to meet the criteria for protection under the terms of this Agreement....

DCs in 2000, and the LDCs in 2006, must give protection, in accordance with the rules of the Agreement, to the products or processes already patented on their territory, or grant a patent for inventions already made and still fulfilling the conditions for protection stipulated by the Agreement.

3. There shall be no obligation to restore protection to subject matter which on the date of application of this Agreement for the Member in question has fallen into the public domain....

Inventions falling into the public domain before 2000 and 2006 do not incur any obligation for Member States.

6. Members shall not be required to apply Article 31, or the requirement in paragraph 1 of Article 27 that patent rights shall be enjoyable without discrimination as to the field of technology, to use without the authorization of the right holder where authorization for such use was granted by the government before that date this Agreement became known.

Compulsory licences granted before the date the Agreement became known are not subject to the provisions of Article 31.2

7. In the case of intellectual property rights for which protection is conditional upon registration, applications for protection which are pending on the date of application of this Agreement for the Member in question shall be permitted to be amended to claim any enhanced protection provided under the provisions of this Agreement. Such amendments shall not include new matter.

Applications for patents pending examination on 1 January 2000 or 2006 may be reformulated to obtain better protection under the Agreement, provided the content of the application is identical in regard to the criterion of novelty.

2 It should be noted however that the wording of Article 70.6 about the “date [this] Agreement became known” is quite unusual in an international instrument and that there are no right answers until a WTO panel takes a decision.

For countries already granting patents for pharmaceutical products, as a result of these provisions, the patents granted before 1995 continue to be governed by the old regulations up until 2000 for developing countries and 2006 for least-developed countries (subject to TRIPS national treatment and MFN which became applicable on 1 January 1996). When the transition period expires, however, the obligations of the Agreement will also apply to patents still in force. In other words, a patent still valid on that date in the country in question should enjoy a minimum of 20 years’ protection from the filing date, even if the patent was originally granted for a shorter period.

Thus, at the expiry of the transitional periods, that is, in 2000 or 2005 for developing countries, and 2006 for the least-developed countries, patents existing at that time should be protected by the provisions of the Agreement. In other words, a Member State is obliged, as from that date, not only to make available the substantive provisions required by the Agreement but also to ensure that procedures and remedies are available so as to permit the right holder to take action against any infringing act under the terms of the Agreement (cf. Article 28 - “making, using, offering for sale, selling or importing” the protected product or process).

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