With growing interest in medicinal plants, the need of the hour is a long term strategy to conserve and sustainably harvest these plant products. The use of medicinal plants in India and many other developing countries can be considered a living tradition. The World Health Organisation (WHO) estimates that the primary health care needs of approximately 80 per cent of the developing world’s population are met by traditional medicine.[i] Traditional Knowledge, per se, does not fall under any particular category but it ranges from the Ayurvedic, Unani, Siddha and Tibetan in India, the Kampo in Japan, the Jamu in Indonesia, and many more. The traditional systems of medicine largely depend on natural resources for their medicines, out of which plants form the bulk of the medicine.[ii] India, somehow, seems to be stranded between the international conventions and her nation’s need. A major concern for developing countries is the TRIPS Agreement which obligates all members to provide patent in all the field of technology and also provide IPRs (either by patents or a sui generis system) for plant varities. This essay shall put some light on the importance of protection of medicinal plants in India.
MEDICINAL PLANTS IN INDIA:
The All India ethnobiology Survey carried out by the Ministry of Environment and Forests estimates that over 7,500 species of plants are estimated to be used by 4,635 ethnic communities for human and veterinary health care across the country.[iii] These plants however face threat of habitat destruction. Under the Forest (Conservation) Act ,1980 and the Wildlife (Protection) Act, 1972, medicinal plants do get some amount of protection. But a lot of medicinal plants grow away from the protected areas domain and since there is no consolidated strategy for medicinal plants, a lot of them just disappear without any of its knowledge. Within protected areas also, the lack of a focused conservation strategy could cause a depletion of this valuable resource. Along with this, is an increased threat to the availability of medical plants. Over 95 per cent of the medicinal plants used by the Indian pharmaceutical industry are today collected from the wild.[iv] Over 70 per cent of the plant collections involve the use of roots, bark, wood, stem and in some areas the whole plant, leading to destructive harvesting. If not carefully monitored, this practice could lead to the depletion of genetic stocks and ultimately to the diversity of medicinal plants. It will also lead to the loss of biodiversity, deprivation of traditional knowledge and threatening of the survival of local communities.
TRADITIONAL KNOWLEDGE V. PATENT LAWS
One of the major problems that India is facing is exploitation of her traditional knowledge. Gene technology has given unlimited powers to developed countries to exploit the genetic resources of poor nations leading to a situation of ‘biopiracy’and ‘gene robbing’. Biopiracy can be defined as the stealing of biomedical knowledge from traditional and indigenous communities or individuals. The term can also be used to suggest a breach of a contractual agreement on the access and use of traditional knowledge to the detriment of the provider, and also applies to bioprospecting without the consent of the local communities. The issue of protection of traditional knowledge, bio-piracy and fair equitable sharing of benefits arising out of utilization of traditional knowelege is very important for India. The patent intervention is being quite visible, lately. A number of herbs, viz. neem, haldi and ashwagandha and plant drugs of India have been patented by outsiders on the basis of secondary researches. Perhaps rightly so, since Basmati, Neem and Haldi have never been too far from an Indian’s life, and the idea that someone else may acquire the right to own, trade and market it, is more than a bit jolting. The objective of the patents system is to develop new knowledge for prosperity of mankind which is getting diluted day by day. It is instead helping monopolisation of new knowledge for exploiting mankind.
Almost 80 per cent of the 4,896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices. In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries.[v] There were cases in the past which were the best epitome of exploitation, ignorance and negligence buoying up on the Patent laws of the developing countries like India.
CASES OF BIO-PIRACY:
In Turmeric case, the US patent and Trademark office granted a patent on the ‘use of wound healing’ which was successfully challenged by India on the grounds of ‘prior art’ and that this use of turmeric was well known and nothing new had been invented. The document relating to this traditional knowledge of India were unknown to the US patent and Trademark Office. When they came to know about this, patent was revoked.
Neem case- Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds can be used to cure cold and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, European Patent Office (EPO) granted a patent[vi] to the US Corporation W.R. Grace Company and US Department of
Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil .In 1995, a group of international NGOs and representatives of Indian farmers filed legal oppositionagainst the patent. They submitted evidence that the fungicidal effect of extracts of Neem seeds hadbeen known and used for centuries in Indian agriculture to protect crops, and therefore, wereunpatentable. In 1999, the EPO determined that according to the evidence all features of the presentclaim were disclosed to the public prior to the patent application and the patent was not considered toinvolve an inventive step. The patent granted on was Neem was revoked by the EPO in May 2000.
Basmati Rice Case: Rice Tec. Inc. had applied for registration of a mark “Texmati” before the UK Trade Mark Registry. Agricultural and Processed Food Exports Development Authority (APEDA) successfully opposed it. One of the documents relied upon by Rice Tec as evidence in support of the registration of the said mark was the US Patent 5,663,484 granted by US Patent Office to Rice Tec on September 2, 1997. This US utility patent was unique in a way to claim a rice plant having characteristics similar to the traditional Indian Basmati Rice. It was challenged and later revoked by USPTO. (Subbiah).
On one hand, Patent on traditional knowledge is not easily accessible whereas on the other hand, if modified so as to be distinguishable, can be patented. The need of the hour is to grant patents in a way that serves public interest. Our traditional knowledge is the result of hard work of our ancestors. It should be used for the benefit of humanity. But in this competitive world of patents, it needs to be protected. The grant of patents on non-patentable knowledge which is either a part of the traditional knowledge of the developing world or a minor variation thereof has been causing great concern to the developing world” India was the first to raise the fundamental issue at the World Intellectual Property Rights Organization (WIPO) as to why the traditional knowledge-based system should not be treated at par with the industry-based system.
The problem is deep and systemic. And it calls for a systemic change, not a case by case challenge. If a patent system which is supposed to reward inventiveness and creativity systematically rewards piracy, if a patent system fails to honestly apply criteria of novelty and non-obviousness in the granting of patents related to indigenous knowledge then the system is flawed, and it needs to be changed.
ESSENTIALS OF PATENT:
Patent is ground in favour of the inventor which confers the patent holder the right to use his invention to the exclusive of all others.[vii] Patent grants the inventor a privilege of making, manufacturing, selling or using the invention and also a right to authorise other to do so.
Patent is only granted to those inventions which are new and useful.This is to say that it must have novelty and utility.[viii]Producing advantageous results will be a sufficient element of novelty to support the patent. It is essential for the validity of the patent that it must be inventor’s own discovery.[ix] This is the basic principle which has to be followed while granting the patent to the inventor. The claim to patent can be challenged on different grounds which are given the Indian Patent Act, 1970. For the purpose of the act there are some the inventions which are not patentable. The controller will not grant patent if invention is, an invention which is frivolous, an invention intended to be used contrary to law or morality or injurious to public health, a mere discovery of scientific principle, a substance obtained from mere admixture, etc. All these invention are not liable to be granted as patent.[x]
Apart from the above list of non-patentable invention the patent can be challenged on other grounds too. These grounds are also given in the Indian Patent Act, 1970. These grounds for opposition are[xi]: 1) That the person claiming the patent has wrongly obtained the invention or the right to make the application for patent; 2) That the invention for which patent claimed is already published; 3) That there is already a prior claim in the complete specification earlier filed; 4) That there was prior knowledge of the claim made in the complete specification from the date anterior to the date of its priority; 5) That the invention suffers from obviousness and lacks inventive step; etc. All these grounds are listed in the section 25 of the Indian Patent Act, 1970.
These are the important essential of the patent which has to be looked into before the patent is granted to inventor. The principle of novelty and utility is the most important essential on which the patent the claim for the patent is tested. Further opposition to the claim is based on this principle only. As we can see that, the prior knowledge is a ground for challenge and claim to patent can be rejected if it is proved that the invention is made based on prior knowledge. The traditional knowledge is part of this prior knowledge and any claim to the invention of new medicine should be challenged on the ground that it from the part of traditional and hence is not novel. The use of medicinal plants in India is also a part of our traditional knowledge.
International Laws on IP and its effect on Patent Law regime in India
Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) is at the centre of international regime concerning the protection of Intellectual Property Rights (IPRs). For the developing countries this is of great significance as its ratification implies important changes in the IPR laws. The entry in to the force of the TRIPS agreement for developing counters makes the issue. The TRIPS agreement has introduce the protection of plant varieties, product patenting and Exclusive Market Rights (EMRs). This has compelled the developing countries like India to make changes in there IPR laws.
The Patent Act of 1970, has exclude the patenting of life forms and specifically precludes the patenting of methods of agriculture and horticulture.[xii] Further, while allowing for the process patent on the substance intended for use as food, medicine or drugs, the Act rejects the possibility to grant patents in respect of substance themselves.
The TRIPS has the effect of extending the application of IP standards already in use un most OECD countries to all General Agreement on Tariffs and Trade(GATT) signatories. In the specific case of patents, the TRIPS agreement have wide-ranging implications. It provides for instance that patent must be available for invention, whether processes or products. Plant varieties are given protection by patent or by an effective alternative system. Article 27.3.b of the TRIPS agreement provides that, the member states can choose to provide plant variety protection through sui generis system.[xiii]The other important characteristic of the agreement is that, the EMR for five years or until a product patent is granted or rejected should be given to the applicant.
India was not up for the TRIPS agreement from the beginning; it has opposed the agreement for very long time. Strong international pressure was being put on India to accept the TRIPS agreement and to modify the patent law. In the event India signed the GATT 1994 Agreement and become member of WTO. The ratification of TRIPS was made compulsory to India and hence the changes that came to the Indian patent law were[xiv]:
- The system for filling and handling product patent application for pharmaceutical and agriculture chemical product and grating the EMR.
- The elimination of any restriction on granting of product patents.
- The elimination of restriction on patentable subject matter such as method of agriculture and horticulture.
- The lengthening of patent duration to 20 years, from the current 14 years and 7 years for food and pharmaceuticals.
- Restriction and modification concerning compulsory licensing, license of right and the rights of revocation.
- The adoption of legal regime for the protection of plant varieties.
These changes were made in the Indian Patent Act and therefore have resulted in many controversies as discussed above.
The result of these changes are that, the protection to the traditional knowledge is limited. The traditional knowledge of medicinal plants are now not protected to the extend they were before. The provision for product patent has made it difficult for indigenous people to protect their traditional knowledge. It is in the nature of chemical products that their composition can be easily known and they can then be made through alternative processes. Any company that makes a drug developed and patented by somebody else but uses another process avoids the bulk of the development costs and thus able to produce and sell it at a low cost. This is how the Indian pharmaceutical Industries were working. Now that the product patent is introduced the Indian industries has to bear high development cost for the production of drugs. One of the major provisions introduced was regarding grant of compulsory licence, which means that Indian manufacturers will be able to manufacture and export patented medicines to countries, which have insufficient or no manufacturing capacity. The introduction of a provision to enable grant of compulsory licence for export of medicines to the countries that have insufficient or no manufacturing capacity to meet emergent public health situations, is in accordance with the Doha Declarations on Trade Related Intellectual Property rights (TRIPs) and public health.
UPOV is one other international law which had its effect on the patent law in India.. The mission of UPOV is to provide and promote an effective system of plant variety protection, with the aim of encouraging the development of new varieties of plants, for the benefit of society. Most countries and intergovernmental organizations which have introduced a plant variety protection (PVP) system have chosen to base their system on the UPOV Convention in order to provide an effective, internationally recognized system. TRIPS has taken this into account for introducing the provision for protection of plant varieties.
TRIPS agreement has not affected the Patent Law alone. It also have change the Biodiversity law in India. The Convention of Biodiversity on one hand provide for appropriate access to utilization of resources. The signatories are required to “respect, preserve and maintain knowledge” of indigenous communities. Article 1 of the convention provides for this protection of traditional knowledge along with article 8. This provide for protection of traditional knowledge in one hand and TRIPS provides for exclusion of plant and animal material from patenting, yet there is spurt in the arena of IPR, which can be seen in the our above discussion on different controversies.
Therefore, if we can take a final look in to the controversy and effect of TRIPS majorly we can see that, the patent protection in TRIPS has not provided any protection to the traditional knowledge of medicinal plants in India. We can rather say that, Intellectual property is important, but the appropriate intellectual property regime for a developing country is different from that for an advanced industrial country. The TRIPs scheme failed to recognize this. In fact, intellectual property should never have been included in a trade agreement in the first place, at least partly because its regulation is demonstrably beyond the competency of trade negotiators. Hopefully, in WIPO’s reconsideration of intellectual property regimes, the voices of the developing world will be heard more clearly than it was in the WTO negotiations.
Now, the time has come to compile and document available knowledge on our valuable plant resources and to prove their utility scientifically through detailed phytochemical, biological and pharmacological investigations at selected centres in different regions of the country. Following are the few suggestions that can help in improving the present scenario regarding the patent of medicinal plants:
- Proper documentation of Traditional Knowledge.
- Registration and innovation of Patent System.
- Removal of Article 27.3 from TRIPS, like, retracting the demand for patents on life form.
- Let it be the choice of countries to draft their own Sui generis legislation(s) for plant varieties that are in compliance with UPOV.
- Apply Article 29 of TRIPS which requires disclosure in the case of patent applications, to genetic resources and traditional knowledge used in invention for which IPRs are claimed.
- Increase the scope of Art. 23 of TRIPS to strengthen protection of geographical indications.
- Heavy penalty for those parties who exploit traditional knowledge in disguise of modification.
- There is no control on the exploitation of medicinal plants from outside protected areas. Most species banned for export are thus because of their endangered status and not their medicinal value. A national level policy is required if any consolidated effort towards the conservation of medicinal plants is foreseen.
It is in India’s interest to implement our national biodiversity legislation before granting EMRs or changing the Indian Patent Act. The determination and will to defend our national interest and our public interest and protect our innovation should be stronger than the determination and will to defend US interest and protect US biopiracy. This is a real test of our freedom and sovereignty. We need to do a rapid stock-taking of the scale and extent of our
Bio-diversity-based economy which accounts for two-thirds of our productive economy is invisible because it is the economy of people our centralised planning has rendered invisible. We need to show how much the potential loss to India is in the form of both global markets and domestic markets due to biopiracy by countries like the US. We need to go through this exercise to protect our sovereignty and make our rightful claims with trading partners. The exercise of the potential loss due to biopiracy also needs to be done to avoid unnecessary and illegitimate trade action by the US due to the TRIPs dispute ruling
India has successfully built edifice of its relationship with Patent laws through the prism of TRIPs and other international conventions. The plight however is the growing influence of the developed nations over the developing ones. In such case, protection of medicinal plants has become extremely important. TRIPS stance on its standards required for the protection of Intellectual Property Rights and contentious Article 27.3, is not so clear. Notwithstanding this, for the protection of Intellectual Property Rights India realizes the need of protecting her traditional knowledge from patent bio-piracy. There have been steps taken to ameliorate the present stance of India on protection of medicinal plants, which are still in process. India, inter alia, has been successful in preparing a proper exercise which is easy navigable. It is a computerized database regarding documentation of Traditional Knowledge created by the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy-(AYUSH), erstwhile Department of Indian System of Medicine and Homoeopathy (ISM&H) constituting an inter-disciplinary Task Force, for creating an approach paper on establishing a Traditional Knowledge Digital Library (TKDL). This is one major assurance to secure medicinal plants from known patents. Furthermore, provisions in patents ( second amendment) Bill that makes disclosures in the patent application mandatory, for the source of biological resource has got the entire picture subject to transparency. Work is going on in various intergovernmental bodies like CBD,WIPO,FAO, WTO and UNCTAD in this regard. While all these improvements keep on working at their own pace, it is important for India to have a stronger legislative stance on this issue. Apart from these developments, there are many medicinal plants that stand on the verge of extinction. First the patent concern was on wound healing property of Haldi and now hypo glyceimic property of karela, brinjal etc. They are widely used in India and their bio piracy agitates the entire country. There is an urgent need to have few amendments in international conventions that govern patent laws on medicinal plants and implement them as soon as possible. Protecting these resources and integrating them into modern medicinal practice would bring enormous benefits.
- Carlos M. Correa, Protection and Promotion of Traditional Medicine in Developing Countries
- Dr. V. Manickavasagam, Intellectual Property Rights and the Impact of TRIPS agreement with Reference to Indian Patent Law, Report Submitted to Planning Commission( SER Division) New Delhi; Philippe Curllet, Revision of the TRIPS Agreement Concerning protection of Plant Vareities: Lessons from India concerning the development of a SUI generis system, 2 Journal of World intellectual Property 617 ( 1999).
- Foundation for the Revitalisation of Local Health Traditions or FRLHT, 1997
- Maitreyi Das, Impact of TRIPS Agreement on Competition in Pharmaceutical sector in India, Report submitted to Competition Commission of India New Delhi (2013)
- N.K.Dubey and Pramila Tripathi ,Global Promotion of Herbal Medicine: India’s Opposition
[i]N.K.Dubey and Pramila Tripathi ,Global Promotion of Herbal Medicine: India’s Opposition
[ii]Carlos M. Correa, Protection and Promotion of Traditional Medicine in Developing Countries
[iii] Foundation for the Revitalisation of Local Health Traditions or FRLHT, 1997
[iv] FRLHT, 1997
[v] 2000, CSIR(Council of Scientific and Industrial Research)
[vi](EPO patent No.436257)
[vii]Dr. V. Manickavasagam, Intellectual Property Rights and the Impact of TRIPS agreement with Reference to Indian Patent Law, Report Submitted to Planning Commission( SER Division) New Delhi; Philippe Curllet, Revision of the TRIPS Agreement Concerning protection of Plant Vareities: Lessons from India concerning the development of a SUI generis system, 2 Journal of World intellectual Property 617 ( 1999).
[x]Maitreyi Das, Impact of TRIPS Agreement on Competition in Pharmaceutical sector in India, Report submitted to Competition Commission of India New Delhi (2013)
[xi]Indian Patent Act § 25 (1970).
[xii] Supra at i