0911-A3
Meeta Biswal and Debidutta Biswal 1
Across the cultures, knowledge about use of medicinal plants exists in the form of local folklore available with families, tribes and cultures, handed down from generation to generation. Some of this knowledge also exists in written form as well, but is difficult to interpret due to the local script used.
Due to this improper and unstandardized documentation of traditional knowledge, patents are often granted to parties who are traditionally not the owners of this knowledge, thereby, leading to conflict in trade interests of the parties involved. Moreover, a part of the profits made by the patent holders also does not flow back to the holders of traditional knowledge, thus leading to discontent amongst the latter.
In addition to this, responsibility for conservation of these medicinal plants also remains undefined between patent holders and holders of traditional knowledge. As a result, sustainable management of the resources suffers, large-scale exploitation of these resources occurs due to profit maximization by patentee, thereby leading to the extinction of many species with medicinal value and many more becoming endangered.
This paper tries to trace the history of traditional knowledge about the use of biodiversity over the centuries, examines existing arrangements for international trade in medicinal plants and, thereafter, proposes strategies to be followed by developing countries in negotiations on intellectual property rights (IPRs).
Since ancient times, medicinal herbs were considered as a gift from gods. In early cultures of the world, herbal healing usually involved purification rites and prayers by the priest or priestess who built the foundations of herbal history and passed on their knowledge through song, chant and story to the next generation. There is no record of the earliest herbal healings except a Sumerian tablet from around 2500 BC, which lists popular herbs of the era. Chinese emperor, Shen Nung, discovered medicinal herbs and composed Pen-ts'ao Ching or The Classic Herbal in 2700 BC (Keville, 1991). Rigveda very briefly records between 3500-1800 BC, medicinal herbs in Suktas. More detailed account is in Atharva Veda. Later about 1500 drugs of plant origin were recorded in native medicine list due to the extensive works of Charak and Susruta (1).
With onset of many incurable diseases, medicinal plants provide us with a new hope. Traditional knowledge about wide application of medicinal herbs in various communities has even led to discovery and development of drugs that are now used as therapeutic agents. Some prominent ones are digitalis, morphine, cochicine, artemisinin, podopyllotoxin, salicin, etc.
It has been estimated that the biodiversity of India amounts to approximately 12.53% of the global biodiversity. The immense biotic wealth of India has approximately 7000 species reportedly used for the medicinal purposes mostly for the extraction of rare drugs. Utilization extent shows that there are about over 0.36 millions ayurveda practioners, 29.7 thousand Unani and 11.6 thousand Siddha specialists in India. Village based health traditions are still carried on by housewives, birth attendants and vaid-hakeems (herbal healers), making it 70% of the health care needs of India which is dependent on the medicinal plants. Such biodiversity rich regions or `hotspots' are found in various continents across the globe and harbor flora of immense medicinal importance(2).
The international drug market demand has affected these species of paramount importance in a drastic manner. The global market of herbal medicines was estimated at $16.5 billion in 1997, which rose to $22 billion in 2000. Europe dominates international market, with $ 7.2 billion sales in 1997, followed by Asia with $5.5 billion including markets of Japan of $2.5 billion (Gruenwald, 1998, 1999). The fastest growing markets for botanical medicines is found in USA, with 1997 retail sales of $3.6 billion and of $3.87 billion in 1998 (NBJ, 1998). Annual mass- market growth in USA is more that 100% (Brevoort, 1998) (3).
The medicinal plants are ruthlessly exploited in an unsystematic manner leading to most of the species making an entry into the Red Data Book list published by IUCN. This list also includes species, which had been a part of the indigenous traditions and sustainable use since the time immemorial. Most people in these regions even today live utilizing the benefits from the herbal plants. Local communities consider the biodiversity of these areas as a part of their culture and understand need to conserve this for all times to come (4).
There are about 7000 spp. of medicinal plants and over 15,000 medicines based on herbal formulations in different systems (5). Further, the traditional knowledge is drawing global attention as well as patronization due to awareness regarding the side effects of allopathy. This has not only made the traditional knowledge systems popular but has also made the indigenous system prone to `biopiracy' and `patenting' both within the country of origin as well as outside. One estimate shows that the current value of global market for the medicinal plants due to traditional knowledge to be alarmingly at $43 billion! Further this has led to 400% increased efficiency in screening of medicinal plants (Shiva, 2001) (6). This can be exemplified by grant of patents on use of products of Neem and Phyllanthus niruri, which had been a part of the traditional health systems since time immemorial. Although derived from the indigenous knowledge, the use of products of Neem and Phyllanthus niruri, WR Grace Company who bagged the patents justifies it to be novel, as it claims that modernized extraction `processes' constitutes genuine innovation. So the `product' even though is same as had been used in Indian traditional systems since time immemorial, the `new process' makes the same thing novel enough for patenting. This not only implies `wrongful ownership' of someone else's property but also exploits the rightful owner without recognizing or protecting the indigenous knowledge. This can be further confirmed since the patents though can be obtained on slight modification of the indigenous way of processing for the product, it cannot be given for indigenous knowledge directly since these are age old practices and do not meet the three basic criteria for patentability i.e., novelty, non-obviousness and industrial applications.
This false claim on novelty and use of indigenous knowledge for commercial benefits needs to be checked. It is essential to preserve not only the traditional and indigenous knowledge but also to preserve the biodiversity of a locality and culture of the indigenous people from `small time advantages' in the area of patents, IPRs etc.
Table - I shows some indigenous plants forming a part of the Indian traditional knowledge over centuries, which have been claimed as novel and patented.
Table - I: List of indigenous plants of India which were patented in other countries (7)
Common name |
Botanical name |
US Patent no. |
Patentee |
Purpose |
Kumari |
Aloe barbadensis |
5652265 |
Michael Collins |
Medicine |
Amaltas |
Cassia fistula |
5411733 |
Toyoharu, Japan |
Antiviral |
Kala Jeera |
Cuminum cyminum |
5653981 |
Hilton, USA |
Activates immune system |
Pomegranate |
Punica granatum |
5411733 |
Toyoharu, Japan |
Antiviral agent |
Harad |
Terminalia chebula |
5529778 |
Surendra Rastogi, India |
Ayurvedic importance |
Aswagandha |
Withania somnifera |
5466452 |
Whittle, USA |
Skin disorder |
Though these show clear acts of biopiracy and lack of careful scrutiny on part of patent issuing authority, these patents are less likely to be useful as much of the knowledge derived from the traditions is already in public domain. Hence, even the patent enforcement becomes difficult. Hence, in the absence of legal protection system for biodiversity and traditional knowledge in the respective countries across the world, regulating biopiracy will be a tough nut to crack.
Both the diversity of traditional knowledge system on use of medicinal plants as well as the resource itself is facing a major challenge in the area of patents and IPRs. The major International Regulations effecting IPRs and traditional knowledge are "Convention on Biological Diversity" (CBD) and "Trade Related Intellectual Property Rights" (TRIPs).
In the fast developing world of today, when multilateral trade between different countries is the order of the day, the agreement on TRIPs, which was signed by 138 Countries (as on July, 2000), was by far the most important legislation to have been drawn up in order to provide protection to the IPR holders against the differences in legal provisions on IPRs in various countries.
TRIPS is an important international agreement, which:-
All WTO members were given one year i.e. up to January, 1996 to phase in these changes into their IPR or other laws and regulations. Developing and other countries were given an additional four years time i.e. up to January, 2000 and the least developed countries ten years i.e. up to January, 2006. A further period of five years i.e. up to January, 2005 was given to developing countries for introducing the product patents in the field of technology excluded thus far from their patent laws. Therefore, developing countries effectively have time up to January, 2005 to promulgate regulations on product patents on food, medicines and drugs (9).
The prime objective in Article 1 of CBD is to conserve biological diversity on one hand and to provide appropriate access to this resource for utilization. Moreover, the signatories of CBD are required to "respect, preserve and maintain knowledge" of indigenous communities. The use of the term "traditional" along with the term "knowledge, innovation and practices" implies all notions of time bound and historical. As a result the traditional knowledge systems of indigenous communities fall within the purview of this article. This usage of terms also bestows ownership of knowledge, innovation and practices upon indigenous local communities. Moreover, this article also encourages equitable sharing of benefits, thereby making the indigenous communities as stakeholders in benefits arising out of the utilization of knowledge, innovation and practices.
The article 8j also emphasizes upon in situ conservation of knowledge, innovation and practices of indigenous and local communities. Conservation of indigenous knowledge would therefore, include conservation of bio-resources being used.
Article 15 emphasizes the access to genetic resources and reaffirms the sovereignty rights of States over their natural resources as an established principle of international law. Therefore, it indirectly implies that natural resources are under the ownership of States and cannot be patented by individuals. Only the use of these bio-resources can be patented and in, that too, the traditional knowledge holders will have a stake.
Article 16 makes a direct reference to IPRs by emphasizing on the access to and transfer of technology. It outlines that the access to and transfer of technology to the developing world shall be facilitated under fair and favorable terms. In case of technology subject to patents and other IPRs, such access and transfer of technology shall be provided on terms, which recognize and are consistent with effective protection of IPRs on mutually agreed terms.
Article 17 and 18, stress upon the exchange of the information, which is to be facilitated by contracting parties by all publicly available sources including indigenous and traditional knowledge. Most indigenous and traditional knowledge is based on the utilization of bio-resources becomes important.
At the time of the TRIPs negotiations in the Uruguay Round, the US and the EU differed in their approaches to the patenting of biotechnological inventions. While the US believed that `anything under the sun made by man', except human beings, was patentable, the EU was grappling with strong internal resistance to patents on living organisms. Since the debate had not yet been settled in committing to revisit this provision within four years from the entry into force of TRIPs i.e. by 1999. Article 27.3(b) of TRIPs incorporates this minimal agreement.
Article 27 of TRIPs requires that patents be made available, for both processes and products, in all fields of technology. Under Article 27.3(b), plants and animals, and essentially biological processes for their production may be excluded from patentability. However, microorganisms and microbiological or non-biological processes must be protected. While there is uncertainty as what is "biological', clearly, microorganisms and microbiological processes are not excluded from patent protection despite resistance from some developing countries during the TRIPs negotiations.
Although, CBD provides for access and sharing of biological resources on one hand and TRIPS provides for exclusion of plant and animal material from patenting, yet, there has been a spurt in the arena of IPRs, which periodically give rise to controversies. Some such controversies are as given below:-
The TRIPs agreement in an attempt to homogenize the IPR regimes between countries, restricts a country's or a community's freedom to choose the way in which it wants to deal with the use and protection of IPRs, which are permitted by CBD through Sovereignty Rights. It also does not contain a provision for the protection of indigenous knowledge, which is available in plenty in developing countries. Moreover, it also does not recognize the need for equitable sharing of benefits accruing from use of knowledge related to Biodiversity. This has, thereby, resulted in conflicts between commercial use of biodiversity related knowledge and the community use of this knowledge. Besides, TRIPs also ignores the responsibility of protection and conservation of this biodiversity, which is being used commercially and traditionally. These differences between two major international regulations need to be ironed out in order to prevent vested interests from exploiting the lawful owners of IPRs.
4.5.1 Loopholes within TRIPs
Although, TRIPs essentially favours the expansion of current IPR regimes, there are some provisions in TRIPs that can be exploited by parties having greater money power.
Article 8 provides for legal measures to protect public health and nutrition in public interest. Environmental protection has not been explicitly built into this provision. Although, "Public Interest" would be interpreted to include environmental protection, however, this provision gives a wide scope to interpretation of the term "Public Interest".
Article 27 (2) provides for exclusion from patentability of inventions, whose commercial use needs to be prevented to safeguard against "serious prejudice to environment". This phrase is rather vague. A country would be required to first define "what is serious prejudice ?", justify the prevention of commercial use and only then justify non-granting of patents.
Article 27 (3) provides the countries to exclude plants and animals from patentability by providing an effective means or sui generis system of protection of IPRs related to these, which will be interpreted differently by various countries.
4.5.2 Loopholes within CBD
Although conservation of biological resources has been considered as important in CBD, exploitation of biological resources can run counter to conservation and sustainable use as clear cut standards for sustainable use have not been defined. Moreover, CBD is subject to national and international legislations, which raises the issue that between TRIPs and CBD which holds legal priority. Legal opinion, would perhaps be that between the two, TRIPs being the later treaty would supersede CBD in case of conflicts. However, given that CBD deals much more with the protection of public interest and morality, which TRIPs acknowledges as valid grounds for any measures that a country would take, it could be argued that CBD's provision should supersede those of TRIPs. This interface between TRIPs and CBD is yet to be tested in international legal arena. The CBD unfortunately is at a serious disadvantage, as it does not have a dispute resolution mechanism of its own, unlike WTO as in TRIPs. Besides, CBD in Article 8j requires the countries to respect and protect indigenous and local community knowledge and ensure its equitable sharing of benefits arising out of use of such resources. Various parties involved in the sharing mechanism can interpret this provision differently.
The issues raised in this paper would lead to the following suggestions to be followed by the signatory countries in negotiations on IPRs and Traditional Knowledge:-
The provisions of TRIPs and CBD have tried to develop a system of protection of traditional knowledge globally, which needs to be further strengthened in terms of providing incentives for disclosure and dissemination of valuable traditional knowledge. The disclosure and dissemination of traditional knowledge is to be achieved by linking the grassroots knowledge systems with the global opportunities for financing the commercial use of biological diversity (11). Moreover, the regulation of the extent of such dissemination of traditional knowledge is also essential. For instance this kind of regulation has been aimed at in India by designating a regulatory Board under the recently promulgated Biodiversity Act, 2000 (12).
Documentation of indigenous and local knowledge systems is, therefore, of prime importance, especially for the developing countries, which have a rich abundance of this knowledge. This documentation in electronic format would not only serve as a databank for searching for information before grant of patent but also would register the traditional use patterns (11).
The terms "public interest" and "sui generis" need to be clearly defined.
The relevant provisions of CBD read with the articles of TRIPs need to be pushed in international forum, so as to enable the protection, conservation and sustainable use of biological resources with the simultaneous dissemination of traditional knowledge on the use of this bioresource.
The countries should push forward for an effective dispute resolution mechanism for CBD and for WTO to also consider CBD as a relevant international regulation important in international trade.
All technologies emanating from the access and use of biological diversity must be environment friendly.
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1 Associate Professor, Indira Gandhi National Forest Academy, P.O. New Forest, Dehradun - 248006, Uttaranchal, India. [email protected]