Over a period of time the horizons of patent law are extended to many biological resources which is way beyond the old and conventional sphere of chemical or mechanical inventions. Biodiversity consists of an ecosystem of biological resources like plants, animals, humans, genes, bacteria, cells, microorganisms and even non-living matters interacting as a functional unit. Now according to the western developed countries especially, the United States (US) and European Union (EU) nations have enlarged the scope of patent eligible subject-matters to an unimaginable extent which includes such biological resources. The developed countries can now obtain patent right on biological resources conveniently by virtue of Agreement on Trade Related aspects of Intellectual Property Rights, 1995 (TRIPs) flexible standards. Due to this flexibility provided by TRIPs the developed countries can easily undermine and exploit the biological resources which mostly are available in the developing and underdeveloped countries which strive hard to conserve and use resources with sustainability. However, the Convention on Biological Diversity, 1994 (CBD) liberates such environment protectors which assures their rights and also marks the beginning of biodiversity conservation and sustainability at international platform. But when the developed countries obtain their patent right on the basis of small innovative manipulations by virtue of TRIPs leaving only a very thin line of difference between invention and discovery thereby taking away local community rights, the question arises as to how far can TRIPs and CBD be contemplated as progressive legal frameworks at international platform.
Convention on Biological Diversity, 1992:
Convention on Biological Diversity, 1992 appeared as one of the keystone agreement which came into force in 1994 and was adopted in the Earth Summit in Rio de Janeiro. The aims being conservation of biodiversity, sustainable utility of the resources and the most justified of all which is fair and equitable share in the benefits on using such resources. Many countries whether they possess rich biological resources or not have been party to this Convention including India. United States of America and some other nations chose not to be party to this Convention.
The CBD assures members sovereignty with the following objectives:
- Conservation and sustainability of use of biological resources and provide incentives to the deserving people.
- Regulation of accessibility to such biological resources and traditional knowledge, which includes obtaining of the prior consent of parties who provide these resources.
- To provide for a fair and equal share in all the benefits (which may arise from commercial utilization of such biological or genetic resource) with contracting parties(who could be the governments, communities possessing traditional knowledge, etc.) who provide these resources.
- Transfer arrangements of inventions based on biotechnology and access to the same which could be made to the governments, or local tribal communities providing the biological or genetic resources for creating inventions.
Article 15(1) of the CBD recognizes the sovereignty and rights on the natural resources within the States, the authority of determining access to the genetic resources is available with respective national authorities or governments and is also subject to their national legislation’. After appreciating the sovereignty and rights over biological and genetic resources, CBD necessitates parties to endeavour towards creating conditions for facilitating access to the resources. However, the developing countries which own rich biodiversity have always tried to restrict access to their resources. This is because of the unfair treatment by the developed countries’ system of granting patents to the isolated material or genes derived from biological material which could be taken from or originated in developing countries.
In view of the developing countries the developed countries like US who are never supportive of CBD are only thieves and such patenting is ‘colonial-style taking or theft’. In addition the developing countries’ environmental communities have also urged to adopt legislative actions restricting the accessibility to genetic and biological materials.
But the difficulty lies in the vague and lack of trustworthy enforcement mechanism which CBD provides. These vague provisions have possibility of working against the developing countries and their interests which are highlighted below:
- While it is provided under CBD for benefit sharing clause with indigenous and local people who possess traditional knowledge or biological material, it is left to the governments of national jurisdictions to provide legal rights to them (who are generally unaware of their rights or the significant knowledge or resources they own and this becomes difficult for national governments to detect the origins).
- The national legal systems working on biodiversity by virtue of CBD by themselves can never be enough to completely protect traditional knowledge like for example, the patent offices in national boundaries alongside their duty to prevent bio-piracy and establishing prior consent mechanism to assure incentive to traditional knowledge holders may not have ipso facto same action on applications of patent in different countries.
- Under Article 15.7 meaning of terms ‘fair and equitable’ in the benefits resulting from commercial profits from use of biological resources is not provided. No international arbitration is visualized as effective to establish this outcome.
- Incase of any disputes between the parties, CBD does not frame any stringent time limit to resolve them and also no punitive sanctions on trade are mentioned in the relevant Article. 27 and Annexure II of the Convention.
- There are many issues to be worked out before these general principles can be turned into effective laws, regulations and monitoring systems. For instance, how to define a ‘community’ that ‘owns’ a plant which may grow in several different areas and different countries, or, what is the criteria for ‘equitable sharing’ of the benefits of commercial exploitation. Many research and academic bodies, non-government organizations and inter-governmental expert institutions are yet working on these problems.
Review of CBD:
According to critics apart from above mentioned drawbacks on CBD, a review of the CBD on Article 16 could be considered for amendment for removal of the tensions in it, so as to give effect to principles of accessibility to and transfer of technology to developing countries. Measures by national authorities are insufficient to facilitate effective implementation of accessibility and fair and equitable benefit sharing arrangements. For example, the statute of a country of origin may mandate as part of its access contract that the collector cannot patent the product or traditional knowledge (or that such a patent can be applied for only under certain terms and conditions or benefit sharing arrangement); but that State would require the co-operation of patent authorities or biodiversity authorities of other States to be able to monitor its effective implementation in that contract. Therefore, review should be made regarding these concerns as they form basic principles of CBD and possibly an international protocol could be established with guidelines and standards for accessibility and fair and equitable sharing of benefits, as well as to establish international co-operation especially with TRIPs to enable implementation of the access and benefit-sharing arrangements along with prior informed consent.
Agreement on Trade Related Aspects of Intellectual Property Rights, 1995:
TRIPs Agreement was agreed upon in 1994 during the Uruguay round on trade negotiations and started functioning from 1st January 1995 in order to reduce distortions and impediments in international trade and taking into account the requirement to encourage effective and sufficient protection of the intellectual property rights. Maximum flexibility is provided in the national enforcement of laws in view of enabling them to form a reasonable and viable technological base. All members of TRIPs are members of the World Trade Organization (WTO).
Developing countries like India and many other underdeveloped countries became a member to TRIPs and ran in this race to cope with the new developments in the field of intellectual property law and fell in line with United States and other developed countries of European Union. Article 27.3(b) of TRIPs is dealing with the biological resources patenting and incorporates minimum standards for scope and criteria of this subject-matter. However, the members must provide for a suitable intellectual property title over plant varieties which could either be patent or an effective ‘sui generis’ method or by any combination thereof. The meaning of sui generis is any system a nation chooses on i.e., self-generating method for protection.
TRIPs Agreement necessitates to propose patents in all the fields of technology, to products and processes, a term which is 20 years is uniformly set for all patents irrespective of the total cost and profit ascertained from the patented invention. Article.27 of TRIPs Agreement deals with the standard which must be followed for the patent eligibility in all fields of technology, provided the invention ought to be falling under the patentability criteria of being new, involving an inventive step, and is capable of industrial application (under Article 27.1). Article 27.2 and Article 27.3 speak about the exceptions to this general standard of patent eligibility. Accordingly members may provide patent protection on the inventions.
According to Article 27.3 a “Member ‘may’ also exclude from patentability:
- Diagnostic and therapeutic and surgical methods for the treatment of humans or animals;
- Plants and animals other than micro-organisms, and essentially biological processes for the production of plants and animals other than non-biological processes 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 sub-paragraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”
Review of Article 27.3(b) of TRIPs:
Application of Article 27.3(b) while patenting vary a great deal among member countries. United States and other developed countries had recognised biological resources patenting much before the TRIPs Agreement came into existence and hence willingly supported the stance on biological resources patenting in TRIPs Agreement. To prevent bio-piracy most of the developing countries including India were skeptical about the ramifications of this Article and therefore aggressively supported the patenting of traditional knowledge (on which TRIPs Agreement has been silent). After having opened flood gates US seems to be committed to and even strongly defending its stance on biological resources patenting by granting patent not only on genetically modified living organisms but even on the products and processes derived from the traditional knowledge of biological resources. This was the reason and method used by US to obtain patent on basmati rice, neem (eucalyptus), etc. Article 27.3(b) has given the most flexible option to member countries which is very controversial. Different aspects relating to ecology, cultural, social, economic, ethical and health were bypassed as patent on inventions relating to biological resources were discussed in haste causing to be only a compromising situation for developing countries like India.
TRIPs through its rules, arbitrarily provides Biotech corporations to patent and exploit profits from pre-existing genetic material, which in turn leads to bio-piracy. The corporations have targeted all including traditional seed stocks, traditional plant-based medicines, and naturally developed immunities to certain diseases. Even though the particular seeds, plants and genomic immunities already exist in the nature and their benefits are well known to the local communities for ages, the corporations dubiously create monopolistic rights over any market-assisted distribution of such biological information by getting patents over their biological features and genetic codes. It leads to a situation wherein, the local farming communities which were sharing such special seed or plant freely for centuries, are suddenly being charged for its usage since some corporation gets patent rights over such seed or plant and the same is treated as its private property. The best example to understand this is that of the Indian Neem Tree case and that of the Mexican Enda Bean case. This situation has caused certain uneasiness and a strong sense of depravity in many developing countries. For example, a Japanese corporation obtained patent rights over a plant Plao Noi, which was traditionally used in Thailand for treatment of ulcers for many centuries and thus made the Thais lose all rights to market it. The communities that experience the sudden loss of rights by such process are victims of bio-piracy which is unethical and immoral. However, the corporations who register for patenting of such a seed or plant, etc., and collect rents over its usage, do not consider it as unethical or immoral at all, since it usually involves recoding of biological data in a scientific language.
India is a country which has centuries old indigenous knowledge systems based on its rich biodiversity which the Indian people have conserved through their traditional lifestyles and local economies. Two-thirds of our population even today is directly dependant on the biological resources and the indigenous knowledge. These resources and knowledge are used in an ethic of sharing so that the livelihoods and needs of the poorest are met. This is in direct contradiction with the ethics perpetrated by the WTO through TRIPs.
The WTO Director General responded back to such allegations of bio-piracy by TRIPs by contending that TRIPs Agreement protects only such claims over biological articles that involve some level of inventive step of innovation by the patent holder. He thus argued that, “TRIPs does not provide for the patent eligibility of biological material in its natural state or for indigenous knowledge in the public domain.” Many criticized this stand taken by the Director General. An American Consumer Rights group, ‘Public Citizen’ responded back by contending that the traditional users are still dispossessed by this monopolization process which compels them to undergo exceptionally lengthy and expensive ways to justify or prove by documents as to how their knowledge was in the public domain for years together. The ‘Public Citizen’ activists argue that the definition of ‘innovation’ as defined by the TRIPs is very weak and shallow which allows even the minor forms of recoding and recalibration to qualify. They argue that this ‘TRIPs notion of innovation’ permits a company to slightly alter an existing process or product and then obtain patent over the same claiming it as completely new. A firm can seize the knowledge of generations-old innovations that is being developed and practised by local farmers and forest dwellers that has not been patented, by slightly modifying the same and obtain a patent over it.
Even though ‘monopolization’ is the main issue raised by the critics, the real issue to be considered seriously is about the economic impacts with its far-ranging implications on local communities who are entitled to receive share in benefits of such patents. Some of the major ecological and health issues that developing countries and under-developed countries facing today are directly related to the basic bio-engineering that includes patenting of genetically engineered seeds and plants. This leads to soil erosion and loss of natural resources which is for ages conserved through traditional knowledge of local communities. The invention and patenting of ‘terminator’ seeds by big corporations such as Monsanto are aimed at monopolizing the food supply globally. Through this technology, seeds are genetically modified which lose the capacity of fertile second generation sowing seeds. Such plants grow up into plants with infertile seeds that wipe out the possibility of seed saving by the farmers for future sowing. Farmers globally used to save a portion of seeds from every harvest for future sowing, but firms like Monsanto have invoked the flexibility of TRIPs to prevent them from saving seeds year after year which has resulted into a larger portion of food supply being monopolized globally by multi-national corporate players who are being shielded by TRIPs-compliant national legislations in protecting their property rights over seeds. This is threatening to developing and underdeveloped countries which largely depend on saving seeds for future farming.
The review of the TRIPs with regard to amendments should be made in Article 27.3(b) to bring the scope of exclusion of biological materials and processes in line with environmental and ethical considerations as well as the need for preventing bio-piracy; and an interpretation can be made that the sui generis option for plant varieties can include the protection of traditional knowledge and local community rights, in line with the CBD. A number of developing countries, including Brazil, China and India, have made proposals that the TRIPs agreement be changed to make it mandatory to include ‘disclosure of the origin’ of genetic or biological resources in patent applications. Article 27.3(b) is the sole provision in the TRIPs Agreement subject to an early review (1999) due to controversial nature of special protection given to some specific inventions like biological resources. The framers of the said Article expected a negotiated revision of the terms of Article 27.3(b) as the primary way of resolving this controversy for which the member countries seek modification and clarification of controversial terms through the WTO’s administrative committees and dispute settlement procedures.
TRIPs could be amended to strengthen the situation prevailing in developing countries in context of review (by virtue of Article 71.1). This proposal was made by developing countries in the Fourth Ministerial Conference of the WTO in Doha, where, the Doha Ministerial Declaration directed the TRIPs Council to scrutinize, inter alia, ‘the relationship between the TRIPs Agreement and the CBD, the protection of traditional knowledge and folklore, and other relevant new developments raised by members pursuant to Art. 71.1 of TRIPs (which authorizes the TRIPs Council to undertake reviews in the light of any new developments which might warrant modification or amendment of this agreement).’ Thus an amendment can ensure relaxation on standards of patents relating to environmentally harmful technologies and technologies which use biodiversity. This will enable TRIPs to come in line with principles of CBD, and with Article 16 of CBD, including the provisions dealing in transfer of technology on concessional and preferential terms and conditions. This will even help to ensure other aspects of CBD to be incorporated in TRIPs like to check if patent rights are supportive of and do not conflict to the overall objectives of CBD. However, even after having consensus over want of review between developed and developing countries the reason and proposals for the same differ to a great extent and still pending.
Despite of the fact that the African group(five countries in Central and Latin America, and India) had proposed changes to the Article 27.3(b) of TRIPs on the basis of their right under TRIPs agreement in respect to the need for review, developed countries are firm on their stance of preventing any reforms on this Article. At the ‘Green Room’ consultation most industrialized countries made their point clear to the Director General by objecting and rejecting all the proposals regarding the reformation of the said Article by stating that WTO cannot be subordinated to other international agreements. This Green Room meeting was an undemocratic approach to developing and underdeveloped countries. Hence there prevails a fear that our environment is sacrificed for trade reasons. The biotechnology rich west is using the WTO to protect its corporate status and rights.
Critical review of relation between TRIPs and CBD:
The current text of TRIPs which is available is nothing but a compromise between US and other developed countries which do not give due consideration to the concerns of developing countries like India. CBD also being an important convention relating to patenting, its principles need to be incorporated in TRIPs effectively to be adopted by all member countries stringently. However this has not been done during the drafting of TRIPs and even today it is due for the fact that there is delay in review of TRIPs Article 27.3(b). There are many reasons discussed above to believe that this Article has serious and dangerous ramifications on developing countries which calls for an urgent review by considering the draft proposals made by India and other countries jointly for preservation of biodiversity, promote its sustainable use, in public interest make it mandatory to include disclosure of the origin of genetic resources in patent applications, most importantly giving fair and equal share to the deserving local communities and indigenous people (possessing traditional knowledge or owning biological resources).
The relation between TRIPs and CBD is complicated yet both instruments are quintessentially significant in their own ways. The CBD lays down standards for accessibility to biological materials, while emphasizing the obligation of acknowledging the same on its exploitation and also providing equitable share in benefits to concerned people on obtaining patent. And the TRIPs Agreement is a multilateral framework for an efficient and adequate protection of intellectual property rights to reduce distortions and impediments which may arise in international trade and provides procedures to enforce such intellectual property rights.
The developed countries like US are of the opinion that the CBD should be maintained as a separate framework and its principles need not be incorporated in the TRIPs. They strongly condemn the amalgamation of TRIPs and CBD. They suggest that principles of CBD can be implemented between its member countries’ laws by a mutual bilateral treaty in a supportive manner or by voluntary contracts (by virtue of TRIPs) between them for the purpose of equitable share in patent benefits to obligate principles of CBD. They contend that benefit sharing can be possible even through governmental funding activities and monetary mechanisms provided under Articles 20 and 21 of CBD.
Developing countries view on this is to give proper effect to ethical issues internationally and the incorporation of both TRIPs and CBD is necessary and inevitable. There is no valid reason for developed countries to be reluctant of such incorporation between the two especially to share benefits with the communities with the help of whom the benefit has been derived. To prevent such unfair treatment to the developing countries a mandatory provision is required to be inserted in TRIPs relating to the mechanism to implement disclosure of origin of biological material obtained and consent for the same and fair and equitable share in the benefits on use of such biological material, which in most cases are derived from developing countries.
India, to stop such exploitation has taken certain steps, for example, to facilitate access and benefit sharing and in order to prevent any unauthorized use of the biological resources of India, suitable amendments were made in 2005 to Section. 10 of the Patents Act, 1970, wherein disclosure of the source and geographical origin of the biological material was made mandatory in an application for patent when the said material is used in an invention. In addition, a declaration by the applicant regarding the required permission from the competent authority was inserted in Form 1 of the Patents Rules, 2003.
India’s Council for Science and Industrial Research could get a patent based on widely known traditional knowledge of turmeric which was cancelled in US only after producing written documentation of such a use in India.India has the distinction of being a country of actively protecting traditional knowledge and experimenting a benefit sharing model that implemented Article 8(j) of CBD into Biological Diversity Act, 2002 in letter and spirit for example, a medicine development which is based on the active ingredient of Trichopus Zeylanicus plant. Scientists at Tropical Botanic Garden and Research Institute (TBGRI), Thiruvananthapuram, Kerala, India isolated the active ingredients of the plant and incorporated these ingredients into a product, which they christened ‘jeevani’ on the basis of traditional knowledge of Kani Tribals. TBGRI, which is the sole patent holder struck an agreement with the tribal community to share a license fee and 2% of net profits. This marks perhaps for the first time that compensation in the form of cash benefits has gone directly to the Kani Tribals, traditional knowledge holders.
India and few developing countries are now reacting very sharply against the patent systems by enforcing their access restricting regime. Example, Indian law prohibits any person from applying for any intellectual property right anywhere to inventions based on research or information on a biological resource obtained from India without the prior approval of the National Biodiversity Authority. The authority has the discretion to impose a benefit-sharing fee and/or royalty as a condition of approval. In Brazil, applicants for patents and other forms of intellectual property protection must ‘specify the origin of the genetic material and the associated traditional knowledge’, presumably in their applications for such protections. In order to recognize their access-restricting regimes at the international level, developing countries are persistently demanding that developed countries require patent applicants to disclose the country of origin of any genetic material used to develop the item sought to be protected. Furthermore, they are also demanding that developed countries either refuse to enforce or refrain from granting patents to innovations, such as synthesized genes and bioengineered goods that utilize material that come from developing countries, unless it has been obtained in compliance with the country of origin’s access-restricting laws. So there is a great need to provide compensation or property interests for those, whose samples are studied, and allow them at least a say in how a patented invention should be used in order to mitigate purely commercial motives that could hinder access. The ‘sources’ to genetic material must be seen more than just exploitable founts of ‘raw’ material, with legitimate interests in share in the benefits of research in which they have made a contribution, intellectually or materially.
Inspite of such demands developed countries like US do not show any interest and hardly are giving any share in benefits arising from the use of biological material derived from developing countries. Moreover even today developing countries are ignorant about the rich traditional knowledge and heritage and avid resources they possess so the developed countries feel free to take advantage of the situation. Despite this, TRIPs Agreement neither recognizes the contribution of traditional knowledge nor the need for benefit sharing. This is a point at which TRIPs Agreement and CBD are controversial and become challenging for developing countries. This situation necessitates the reinforcement of relationship between TRIPs and CBD.
The controversies discussed need utmost attention at domestic and international level at the earliest as there could be serious ramifications if not addressed. Apparently the present situation does not seem amicable for any such discussions as the international bodies and instruments are biased towards the most developed countries. But this would only make the rich countries richer and advanced compared to the other developing and underdeveloped countries. Though few developing countries like India have been role models by bringing amendments to existing patent law and even introducing national progressive legislations to promote rights of local community people who practice traditional knowledge and conserve natural biological resources, that does not suffice to meet objectives of CBD because unless necessary amendments are internationally introduced the developed countries will not adhere to progressive system which CBD aims and rights of indigenous people will never be re-stored. To give fair and full effect to objectives of CBD and TRIPs, the drawbacks need to be seriously considered by a review and amendments must be brought about as per the interests of both patent rights as well as local community rights which will aid to balance the legal frameworks of both the instruments to build trust and effectiveness. US and other developed nations which are not open to be party to CBD for they do not want to give due recognition to indigenous rights or the origin of biological resources or to the people conserving such resources will automatically adhere to both TRIPs and CBD when the suggested amendment to TRIPs is brought into force. All developed nations will fall in line resulting in lesser cases of bio-piracy. This also will bring balance between TRIPs and CBD.
 Convention on Biological Diversity, 1992, art.15(1).
 Convention on Biological Diversity, 1992, art.15(2).
 Sabrina Safrin, “ Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control the Building Blocks of Life”, The American Journal of International Law, p.123 (2004).
 TRIPs Agreement, Preamble.
 Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, (New Delhi: Oxford University Press, 2009), pp.128-131.
 Frederick M. Abbott, Amy Kapczynski and T. N. Srinivasan “The draft patent law”, The Hindu, March 12th, 2005, available at: http://www.hinduonnet.com/2005/03/12/stories/2005031201151000.htm (last visited November 9th, 2018).
 TRIPs Agreement, art.27.3
 Doha WTO Ministerial 2001, Ministerial Declaration, Nov. 14, 2001, para. 17 and 19, available at : https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm (last visited on September 8th, 2016).
 Krishna. Dronamraju, Emerging Consequences Biotechnology Biodiversity Loss and IPR Issues, pp. 240-242 (World Scientific Publishing Co. Pte. Ltd, Singapore, 2008).
 World Trade Organisation, The Relationship between the TRIPs Agreement and The Convention on Biological Diversity, (WTO, 2006), available at: https://www.wto.org/english/ tratop_e/trips_ e/ipcw368 _e.pdf (last visited September 6th, 2019)
 Office of the Controller General of Patents, Designs and Trademarks, Guidelines for examination of biotechnology applications for patent, (CGPDTM, India, 2013) available at: https://www.ipindia.nic.in/ writereaddata /Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf, (last visited December 12th, 2019).
 Supra note 7.
 Biological Diversity Act, 2002, s. 6(1).
 Biological Diversity Act, 2002, s . 6(2).
 TRIPs Agreement, art. 27.3(b) review, available at: https://www.wto.org/ english/tratop_e /trips _e/art27 _3b_background_e.htm (last visted March 20th, 2017)