The World Trade Organisation (WTO) Ministerial Conference held in Doha in November 2001 is important in many respects. The conference adopted a declaration that inter alia dealt with a broad and balanced Work Programme.
The Work Programme included a number of issues such as agriculture, services, market access for non-agricultural products, etc, besides Trade-Related Aspects of Intellectual Property Rights (TRIPS). .
A separate Declaration was also adopted in a manner supportive of public health by promoting both access to existing medicines and research and development into new medicines. This Declaration is known as the TRIPS Agreement and Public Health. TRIPS issues incorporated in the Work Programme are as follows:
- Implementation of Article 23.4: The Declaration agreed to negotiate the establishment of a multilateral system of notification and registration of geographical indications for wines and spirits by the following ministerial conference. The Declaration also noted that issues relating to the extension of protection of geographical indications provided for in Article 23 to products other than wines and spirits be addressed in the Council for TRIPS as an outstanding implementation issue.
- Review of Article 27.3 (b) relating to patentability of micro-organisms and non-biological and micro-biological processes.
- Review of the implementation of the TRIPS Agreement under Article 71.1 and other relevant new developments foreseen by members.
- To examine inter alia the relationship between the TRIPS Agreement and the Convention on Biological Diversity, protection of traditional knowledge and folklore.
- Examination in a working group under the auspices of the General Council, the relationship between trade and transfer of technology and increased flows of technology to developing countries.
The Ministerial Declaration, in Paragraph 19, also stipulated that in undertaking the Work Programme mentioned above, the TRIPS Council shall be guided by the objectives set out in Articles 7 and 8 of the TRIPS Agreement, and shall take fully into account the development dimensions.
Paragraph 12 (b) of the Ministerial Declaration also provides that outstanding implementation issues shall be addressed as a matter of priority by the relevant WTO bodies, and shall be reported to the Trade Negotiations Committee by the end of 2002 for appropriate action.
A number of countries, including India, submitted their views on the above issues to the concerned negotiating groups. It is observed from the deliberations in the General Council during its meetings held on July 27 and 29, 2005, that progress in regard to the negotiations on TRIPS-related issues has been rather slow or incomplete. The relevant aspects of these issues are discussed below.
Protection of geographical indications
During the Uruguay Round of GATT negotiations, insofar as geographical indications is concerned, only wines and spirits were identified for protection. These products are relevant to France only. The other countries failed to identify their products for similar protection.
Article 23 (4) of TRIPS stipulates that “in order to facilitate the protection of geographical indications for wines, negotiations will be undertaken in the Council for TRIPS concerning the establishment of a multilateral system of notification and registration of geographical indications for wines eligible for protection in those members (meaning all WTO members) participating in the system”.
This stipulation indicates that the Council for TRIPS would be addressing issues relating to the establishment of a multilateral system of notification and registration of geographical indications only for wines and spirits.
Insofar as the issue of extending the system to other countries is concerned, India has enacted the Geographical Indications of Goods (Registration and Protection) Act, 1999. Under this Act, protection will extend to agriculture goods, natural goods or manufactured goods or any goods of handicraft or goods of industry including foodstuff.
This would prevent unauthorised persons from misusing geographical indications and would protect consumers. It would also add to the economic prosperity of the producers of such goods and would promote goods bearing Indian geographical indications in the export market. India has many products requiring international protection under this system.
At present, a geographical indication is protected in the country of its origin; there is no obligation under TRIPS for other countries to extend reciprocal protection. However, under the Indian Act, India would be required to extend protection to goods imported from other countries that provide for such protection. In view of this, it is important to have similar protection as is available to wines and spirits. Micro-organisms and non-biological and micro-biological processes
The TRIPS Agreement, in Article 27.3 (b), provides that “plants and animals other than micro-organisms and essential biological processes for the production of plants or animals other than non-biological and micro-biological processes are excluded from patentability”. This sub-article also provides that the provision be reviewed four years after the date of entry into the WTO Agreement. The mandated review process started in 1999 but there has as yet been no final decision on this matter.
Micro-organisms occur in nature, and whenever any new micro-organism is discovered it has to be considered as a discovery, not an invention. In view of this, since micro-organisms are not inventions, they should not be provided patent protection. The Concise Oxford Dictionary defines a ‘micro-organism' as an ‘organism not visible to the naked eye, for example, bacterium or virus'. Since micro-organisms are not visible to the naked eye as such, they should not be classified as ‘products'. On this score, product patents should not be provided to micro-organisms. The Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the purpose of patent procedure does not include any definition of the term ‘micro-organism', although it does define other, seemingly unambiguous, terms such as ‘patent procedure', ‘inter-governmental industrial property organisation', and ‘industrial property office'. The treaty's regulations also do not define ‘micro-organism'.
The World Intellectual Property Organisation (WIPO) Committee of Experts on Biotechnological Inventions and Industrial Property, which met between 1984 and 1988, also did not define ‘micro-organism', although the term was frequently used in discussions, as is reflected in reports of the committee meetings.
The Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to Microbiological Inventions, prepared jointly by the European Patent Office, the Japanese Patent Office and the US Patent and Trademark Office, in 1988, also did not define micro-organism as such. In the absence of a clear-cut definition, therefore, it is difficult to decide the scope of patentability.
When naturally occurring micro-organisms are genetically modified, it involves human input and, as such, there would be an angle of invention. These genetically-modified micro-organisms are useful only to perform certain activities. Thus, the best course would be to provide process patents for genetically-modified micro-organisms.
Unfortunately, without considering the criticality of the issue involved, the Government of India has made a provision in the Amended Patents Act 1970 for the protection of micro-organisms. Now the only course left to resolve this issue would be that the application of provision relating to protection of micro-organisms be notified only after a review has been concluded by the WTO. We could then abide by the decision that may be taken by the WTO for multilateral application.
It must be pointed out here that renowned scientists are also against the patenting of micro-organisms and any other life form. A Technical Expert Group established by the government examined this issue in a report that was made public in December 2006 (click here to read more about the report).
There has been no progress at the WTO forum too, in spite of the fact that a number of countries have submitted their views.
Review of TRIPS Article 71 of TRIPS stipulates that, “the Council for TRIPS shall review the implementation of this (TRIPS) Agreement after the expiration of the transitional period referred to in Paragraph 2 of Article 65 (of TRIPS)”.
According to Article 65, the transitional period for developing countries ended on December 31, 1999. Further, according to Article 71, “the (TRIPS) Council shall, having regard to the experience gained (by the members) in (TRIPS) implementation, review it two years after that date, and at identical intervals thereafter”. Accordingly, the TRIPS Council is also required to undertake reviews in light of any relevant new developments that may warrant modification or amendment of the TRIPS Agreement.
The mandated reviews have not even been initiated by the TRIPS Council. There are several problematic issues that require consideration by the TRIPS Council:
- Article 27, Paragraph (1) provides that the patent-holder will enjoy patent rights without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. This means that the patent-holder has been absolved of the obligation of producing the product in the country that grants the patent. This provision may be relevant for small countries, but not for a big country like India. It is always possible to produce any new product in India with economic viability, as assured demand can be generated within a short period. This issue needs to be reviewed by the TRIPS Council.
In connection with this issue, it may be pointed out that Section 83 of the Amended Indian Patents Act 1970 provides “that patents are granted to encourage inventions and to secure that the inventions are worked on in India on a commercial scale to the fullest extent that is reasonably practicable without undue delay”.
This section also provides “that (patents) are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article”. The implication of this provision is that patent-holders, when they are granted patents under the Patents Act 1970, have an obligation to produce the patented product in our country and not resort to the import of their patented product to exploit domestic markets at monopoly prices.
- Article 31, sub-clause (f) of TRIPS provides that “any such use (compulsory licence) shall be authorised predominantly for the supply of the domestic market of the member authorising such use”. The use of the word ‘predominantly’ has become the subject of much discussion. When such a word is used to grant a compulsory licence, it means that there is scope for meeting demands other than those arising in the domestic market, that is, it should be possible to export the patented product by the compulsory licence-holder. This aspect needs to be debated and clarified so that the compulsory licence-holder can play an effective role in outside markets.
In connection with this issue it may be pointed out that Section 84 (7) (a) (iii) of the Indian Patents Act 1970 provides that “the reasonable requirement of the public shall be deemed not to have been satisfied -- if, by reason of the refusal of patentee to grant a licence or licences on reasonable terms for a market for export of the patented article manufactured in India is not being supplied or developed”.
This stipulation in our law needs to be strengthened further using Article 31 (f) of TRIPS. There should not be any dispute raised on this count in the country or at the WTO forum.
- Sub-clause (h) of Article 31 of TRIPS provides that “the right-holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorisation”. This provision is not explicit in the sense that neither is there a fixed royalty, nor is there a ceiling on royalty. Absence of this aspect would raise disputes between patent-holder and the licensee. It would be appropriate if specific provision is made with regard to royalty payment. It is also important to incorporate guidelines for arriving at a reasonable royalty.
- Article 33 of TRIPS provides that “the term of protection available shall not end before the expiration of a period of 20 years counted from the filing date”. This term appears to be on the high side. The argument used for the enhanced term of 20 years was that it used to take seven to eight years to grant a patent. The reality now, however, is different. In many cases, a patent is granted within one or two years. Further, a new generation of products is being introduced at a much faster pace, affecting the utility of earlier products. In view of this consideration there is strong justification for reducing the long period of protection of 20 years. However, to meet the arguments advanced, the best possible solution would be that Article 33 be revised as follows: “The term of protection available shall not end before the expiration of a period of 20 years counted from the filing date, or 12 years from the date of grant of the patent, whichever is earlier.”
The above will clearly provide for effective use of the patent for 12 years.
- Article 27 of TRIPS stipulates that a patent shall be available for any invention, whether product or process, in all fields of technology, provided it is new, involves an inventive step and is capable of industrial application. The terminologies used in this Article, viz ‘invention’, ‘new’, ‘involve an inventive step’ and ‘capable of industrial application’ need to be defined explicitly so that frivolous claims are not filed. As regards the definition of invention, it would be appropriate to define the same as ‘patentable basic invention’. The idea is that the research aspect is applicable only to basic research and not on subsequent incremental modifications or additions to basic inventions. Similarly, for the pharma and chemical sectors, only basic molecules should be patentable.
Patent rights provide exclusivity whereby others are legally prohibited from exploiting the patent. Such an exclusive right ought to be extremely selective and provided for products of real basic research. Similarly, other patent terminologies should also be defined appropriately. This would facilitate the filing of patent claims and their examination by the concerned patent control authority.
Relationship between TRIPS Agreement and the Convention on Biological Diversity
The Convention on Biological Diversity was negotiated in Rio de Janeiro in 1992. The Convention reaffirms that States have sovereign rights over their own biological resources. Article 15 of the Convention provides that “access to such resources, where granted, shall be on mutually agreed terms and prior informed consent of the Contracting Party providing such resources”.
It is also provided in this Article that “each Contracting Party shall take legislative, administrative or policy measures, as appropriate, with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilisation of genetic resources with the Contracting Party providing such resources and thus sharing shall be upon mutually agreed terms”.
The Indian Parliament, in order to legalise application of the provisions of the Convention on Biological Diversity, enacted the Biological Diversity Act 2002. One of the major challenges before India in enacting this legislation lay in adopting an instrument that could help realise the objectives of equitable sharing of benefits as enshrined in the Convention.
Consequently, Section 21 of the Biological Diversity Act stipulates that “the National Biodiversity Authority shall, while granting approvals under the Act, ensure that the terms and conditions to which approval is granted secures equitable sharing of benefits arising out of the use of accessed biological resources, the by-products, innovations and practices associated with their use and applications and knowledge relating thereto in accordance with mutually agreed terms and conditions”.
In order to legalise the benefit-sharing, suggestions have been made by several countries that, as a means of benefit-sharing, the patent applicant be required to identify or indicate in the application the source of any genetic material or traditional knowledge used in developing the claimed invention.
This suggestion has to be examined and a decision taken on the relationship between the TRIPS Agreement and the Convention on Biological Diversity as part of the Doha Work Programme.
In this regard too there has been hardly any progress in the relevant Working Group. Unfortunately, the United States is against benefit-sharing. It does not agree with commercial benefit accruing from a patented product. The US is suggesting that the benefit angle be settled at the time of approving access to biodiversity material.
Trade and transfer of technology
Paragraph 37 of the Doha Ministerial Declaration deals with trade and transfer of technology. The Declaration stipulates that the Working Group, under the auspices of the General Council, examine the issues relating to the relationship between trade and transfer of technology, and steps that might be taken within the framework of the WTO to increase the flow of technology to developing countries. The General Council was supposed to submit its report to the Cancun Ministerial Conference on progress in these negotiations.
In connection with trade and transfer of technology it may be stated that Article 7 of the TRIPS Agreement on objectives provides that “the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations”.
The situation in Article 7 is quite clear. What was needed was to provide specific provision for the transfer and dissemination of technology as and when compulsory licences are granted on patented products or patented processes as the case may be. Our amended Patents Act 1970 does not provide for this for reasons best known to the government. Because of Article 7 there was no question of any negotiation in the Working Group.
It is pertinent to point out that such issues are within the domain of national governments to implement, rather that to raise at the WTO forum. At the WTO forum there is no easy finality on such issues. Again, this is an issue of serious concern for developing countries, not for developed countries. Developed countries are indifferent to these issues, as transfer of technology goes against their interests.
Conclusion
To sum up, it is evident that almost all the TRIPS-related issues of the Doha Work Programme are in a state of limbo, and for that the blame lies with developing countries that are not fully alive to their interests in the negotiations. There is the need for a proactive approach to settling these issues
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