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
Open this folder and view contents2.7 During the transitional period
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
 

2.3 Patents for pharmaceutical products and processes available all over the world

The TRIPS Agreement requires patent protection to be available for any invention in any field of technology in all WTO Member States. This provision is essentially aimed at pharmaceutical products, for which certain developing countries, as well as developed countries, had refused to grant patents. Because of the high prices of patented drugs and the large amount of expenditure required for research and development (R&D*) in the pharmaceutical field, some countries had chosen to imitate products patented in industrialized countries through reverse engineering*, in order to meet their national requirements for drugs at a lower cost and to develop their technology. Other countries with no pharmaceutical industry bought these copies of patented drugs at competitive prices.

This is similar to the practice adopted by many developed countries some years ago when their own pharmaceutical industry was not yet very highly developed.

Despite the positive contribution that the patent system may bring to public health by generating incentives for innovation, it should be pointed out that the emergence of a generic* drug sector in a number of developing countries represents a set of successful social policies that may be harder to duplicate under TRIPS.

The table below gives a detailed explanation of Article 27.

Article 27.1
Patentable subject matter

Comments

... patents shall be available for any inventions, whether products or processes,

Some countries only made available process patents for pharmaceutical inventions. Under TRIPS, product patents must also be available; the protection of rights on a product is much broader in scope.

in all fields of technology,

Some countries, unable to invest in R&D, have been excluding pharmaceuticals from patentability so as to allow the possibility for copies of patented drugs to be produced locally or imported - from other countries which also do not respect pharmaceutical patents - without the authorization of the company that invented the drug.

provided that they are new, involve an inventive step and are capable of industrial application.

Usual definition of the conditions of patentability of an invention.

... patents shall be available and patent rights enjoyable without discrimination as to the place of invention

No discrimination between national and foreign inventions, or between foreign inventions.

the field of technology

No discrimination between types of products - pharmaceutical or other.

and whether products are imported or locally produced.

Some countries have been issuing compulsory licences for lack of exploitation of patents. This type of obligation was intended to require foreign companies to set up on the national territory in order to exploit their patents, with resultant transfers of technology. The Agreement would here appear to allow these companies to import their patented product without having to transfer the related technology.

Henceforth, from the end of the transition periods, patent holders must be given the right and legal means to prevent imitation of a patented drug. If national regulations on patents do not provide it, or if it is not respected, the Member State in question may, pursuant to the disputes settlement process, be the subject of a complaint before the WTO Dispute Settlement Body*.

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