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
 

2.4 Non-patentable inventions: biotechnology inventions

As the general rule of the TRIPS Agreement is the patentability of any invention in any field of technology, the only exceptions authorized are those laid down by the Agreement. The Agreement authorizes certain exclusions from patentability*, based on “ordre public” or morality, especially in regard to protection of human, animal or plant life, or to prevent serious damage to the environment. Members may also exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals.

But the main concern is biotechnological* inventions. Article 27.3(b) provides that only plants, animals and essentially biological processes for the production of plants or animals may be excluded from patentability. However, the same provision states that micro-organisms, as well as micro-biological and non-biological processes are not covered and have to be patentable. But a doubt remains as to the nature of some of these biotechnological inventions, which find their origin in organisms existing in nature. Indeed, a patent can only be granted for an invention which is new, inventive and capable of industrial application, and not for a discovery. Micro-organisms only seem to be patentable on the condition that a real intellectual human contribution, which has to be new, is demonstrated.

Article 27.2 & 3
Exceptions

Comments

2. Members may exclude from patentability inventions

Two conditions for refusal to grant a patent:

the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment,

commercial exploitation (production, distribution, sale) of the product in question is prohibited throughout the territory in the interest of “ordre public”, morality, or the environment...by any entity whatsoever

provided that such exclusion is not made merely because the exploitation is prohibited by domestic law.

the only possible justifications for excluding an invention for patentability under this provision are “ordre public” or morality, including the health and life of humans, animals or plants and the environment. Hence a legal prohibition based on other grounds is not covered by this provision.

3. Members may also exclude from patentability:


a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;


b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

Specific exceptions allowed are essentially biological processes, plants and animals. But, patents for inventions of micro-organisms and for non-biological and micro-biological processes must be available. This means that inventions based on genetic engineering and gene transfers should be patentable whereas substances existing in nature should not.

Given the development perspectives of biotechnology, this question is extremely important. Indeed it is the only one for which a review (in 1999) has been specifically planned by the Agreement. Developing countries rich in natural resources, should, in their new regulations, define the ambiguous terms biotechnology and invention, in order to benefit from these new provisions.

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