Patented genes like bonded labour?

by Chakravarthi Raghavan

Geneva, 4 Oct 2000 - In a paper (Doc IP/C/W/209) submitted to the recent meeting of the Council for TRIPS, the United States has suggested that patenting of life forms does not amount to ownership but only preventing others from taking certain actions.

A trade observer said this would be then a case of ‘bonded labour’ of the patented gene for 20 years (the normal life of a patent). “You don’t own a bonded labour, just prevent him from doing things for himself or others.”

The US paper also argues that there is no need to define ‘micro-organism’, and that the ordinary dictionary meaning could be used for interpretation!

[Art. 27.3 of TRIPS says: Members may exclude from patentability:

(a)  ....

(b)  plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and micro-biological 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. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.]

The US paper says on micro-organisms:

“Some Members have asked about the meaning of the term ‘micro-organisms’, expressing uncertainty regarding what Art. 27.3(b) requires be patentable and what can be excluded from patentability.

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on 28 April 1977, does not include a definition of the term micro-organism although it does define other, seemingly unambiguous terms such as ‘patent procedure’, ‘intergovernmental industrial property organization’ and ‘industrial property office’. The Treaty regulations also do not define ‘micro-organisms’.

[The simple explanation would appear to be that the entire scheme of WIPO treaties, while laying down rights of holders and duties of states to provide national treatment etc, in effect leaves acceding countries to make their own laws and define the patents. The problems have arisen because the WTO/TRIPS has gone beyond and has sought to lay down uniform minimum standards of protection]

The US paper continues:

“The WIPO Committee of Experts on Biotechnological Inventions and Industrial Property, which met between 1984 and 1988, also did not define the term ‘micro-organism’, although the term was used frequently in the discussions, as is reflected in the reports of the meetings of that Committee. The reason for the lack of definition is reflected in the Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to Micro-biological Inventions, dated 20 January 1988, prepared jointly by the European Patent Office, the Japanese Patent Office, and the US Patent and Trademark Office. Page 3 of that document contains the following under the heading ‘Definition of Microorganisms, If Any’.

None of the laws administered by any of the offices contains a formal definition of the term ‘micro-organism.’ Where definitions are used in either classification definitions or administrative guidelines, the term is defined as a non-exclusive list of organisms which are included within the scope of that term. As noted by the EPO, it does not seem expedient to introduce such a definition as the rapid evolution in the field of microbiology would necessitate its frequent updating.”

“The principles of international law regarding the interpretation of treaties and international agreements should be used to determining what is meant by the term micro-organism in Article 27.3(b) of the TRIPS Agreement. Articles 31 and 32 of the Vienna Convention on the Law of Treaties require, inter alia, that treaties be interpreted ‘in good faith in accordance with the ordinary meaning to be given to the terms of treaty in their context and the light of its object and purpose.’ The Concise Oxford Dictionary of Current English defines ‘micro-organism’ as ‘an organism not visible to the naked eye, e.g.bacteriums or virus.’ That definition should be sufficient to distinguish plants and animals generally from micro-organisms for purposes of the discussion in the TRIPS Council.

“To be patentable a micro-organism cannot be as it exists in nature. The patent granted by the US Patent and Trade Mark Office, to which India refers in its paper (IP/C/W/161, page 3, paragraph 8), claims a biologically pure culture of streptomyces violaceus which is capable of producing the antibiotic BU-3839T in a recoverable quantity upon cultivation in a culture medium containing assimilable sources of carbon and nitrogen under submerged aerobic conditions.  The claim and specification, when compared to available prior art, makes it clear that the invention is new, involves an inventive step, and is capable of industrial application, as required under TRIPS Art.27.1. What is claimed does not exist naturally. The patent, therefore, is granted for an invention, and not merely a discovery. The key to what should be patentable as a micro-organism is not what name is given the biological material which the invention is based, but the subject claimed; is that subject matter new, does it involve an inventible step,and is it capable of industrial application. If the subject matters meets these criteria, Art.27.3(b) requires that it be patentable.” .....

On issues about ethical considerations against life patents, says the US paper:

“Several Members have referred to ethical concerns regarding the extent to which private ownership should apply to life forms. Many of these concerns result from a misunderstanding regarding the nature of the rights provided by a patent. As we have noted previously and Article 28 makes clear, a patent claiming a plant or animal does not represent private ownership of life forms. A patent gives its owner, for a limited period of time, the right to prevent others from taking certain actions in relation to a protected invention. The patent does not give its owner the right to take those actions itself.

“In light of some of the interventions made during previous meetings of the TRIPS Council, a point we stressed in our previous paper bears repeating.  Holding a patent on an isolated, identified and modified gene does not amount to ownership of the gene itself. A patent claiming an isolated, identified and modified gene taken from a human being certainly would not provide any property rights with regard to the source from which the original gene was obtained.

“Excluding particular subject matter from patentability will not prevent research in particular fields. Research will go forward in any area in which individual scientists and institutions have an interest. The patent system plays a significant, often critical role in determining whether the broad results of research that promise benefits to mankind are developed into products and processes that will realise those benefits. It is no accident that countries with strong patent systems, where exclusions from patentability are few, are also countries with strong private industries covering the broad range of technology, providing jobs and contributing to the creation of capital that can be invested further. Similar kinds of encouragement can be observed in relation to the development of industries related to other forms of intellectual property as well.”

(The US paper also deals with sui generis systems, indigenous knowledge, and the compatibility of the CBD and the TRIPS. These will be reproduced in subsequent issues)-SUNS4754

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