The growth of international trade relations among the nations has become a subject of concern for the indigenous people. This is because the nations, particularly the developed ones are in search of those countries which are rich in natural resources. There geographical location is such that it is endowed with rich and diverse natural resources. In the last few decades there has been an increase in the biotechnology. Biotechnology is “any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals or to develop micro-organisms for specific uses”. It has played a vital role in the agricultural, pharmaceutical and medical industries. Biotechnology is presently a billion dollar industry that gains its commercial potential from scouring the globe for rich source material and active compounds that can be turned into a commercial product. With this boom in the biotechnology many of the inventions can be turned into multi-million dollar industries. These corporations use the traditional knowledge possessed by the indigenous people to locate the biological species which has medicinal significance, they bring it to their laboratory for research and later on after some changes the y patent it as their own invention. This misappropriation on biological resources and traditional and cultural knowledge is known as biopiracy.
SIGNIFICANCE OF BIOLOGICAL RESOURCE AND TRADITIONAL KNOWLEDGE
Biological resources including plants animals and micro-organisms and the traditional knowledge related to them are fundamental to indigenous community life in the developing countries. They provide reasonable alternative means of health care and nutrition along with employment and income generation. For example, in the South and South East Asia; produces 90% of global rice, a significant staple for majority of the Asian families that account for almost 80% of daily intake of calorie as well as important levels of employment and income.
Traditional knowledge of different medical plants and their healing properties are also vital to the work of scientific community that provides important lead for the development of new drugs by pharmaceutical companies. Collectively traditional medicines command a global market worth of approximately USD 60 Billion. Biological resources and traditional knowledge also provide useful means for cultural expression and the assertion of local authorities.
Biopiracy can be defined as misappropriation and commercialization of genetic resource and traditional knowledge of the indigenous people. This involves commercialization of freely available natural resources such as plants, trees, seeds etc. by imitating the techniques which have been used by the local people from generations in their everyday activities to take care of themselves, may it be cosmetic or medicinal. The cosmetic, pharmaceutical and the agro food firms are the ones who mainly resort to biopiracy. They draw on biodiversity hotspots in order to create supposedly innovative products and guarantee their monopoly on them through patent system. These corporations identify biological matter which has medicinal significance with the help of the indigenous people who possess the knowledge about the location and the benefits of the matter, bring it back to their labs and later patent it as their own invention. These indigenous people have been cultivating and constantly improving these locally available species for years.
Natural resources such as plants, minerals, etc are not meant to be subjects of patent system, but these million dollar corporations have devised a method to bring the natural world into the domain of patents. With the immense growth in the biotechnology industry the potential carried by these biological resources fused with the traditional knowledge has assumed enormous magnitude within the past few decades.
EVOLUTION OF BIOPIRACY WITH PATENT LAWS
The origin of patent laws can trace back to the 14th century Venice where patents and the intellectual property were a mode of rewarding innovation and knowledge. Initially the Intellectual property rights had been associated with the field of industrial inventions, arts and literature. It was not possible to foresee the development that has taken place in the biotechnological field, because activity in those inventions at the time was to a considerable extent subject to casual relationship. However the classical view that patent laws does not, to a great extent concern itself with living material no longer accords with reality ,in the last century there have been significant developments in the field of agriculture and biology, ergo there was a demand for an IPR system which addresses to agricultural and biological inventions.
The first patent in life forms was issued in Finland in 1843 and in the United States in 1873 a patent was granted for isolated yeist.Under the U.S. law Plant Patent Act, limited to the protection of asexually propagated varieties, was passed in 1930 followed by Plant Variety Protection Act, also encompassed sexually propagated plants. Due to the belief that living organisms and cells were non-patentable products of nature, patent protection for biological material was for many years restricted.
The 1970’s witnessed several events where Intellectual Property Rights were linked with the agricultural and biological inventions. Before that neither the U.S. Patent Law nor any of the European patent laws had any provision regarding the patents of living organisms.
In 1975, French Company failed-though purely on technicality-to patent a “dwarf, egg laying chicken hen produced by a (breeding process)” that exploited a “sex-linked recessive dwarfism gene”.
On June 16 1980, the US Supreme Court ruled in Diamond v. Chakarvarty case that a genetically engineered bacterium from the genus pseudomonas that possesses the special quality of breaking down oil was a patentable subject. A patent was granted for the bacterium on the grounds that the microorganism was not a product of nature but was an invention and therefore it was patentable. Patent and Trademark Office as a result of which during the 1980’s the number of patent application for biological materials increased many fold in the United States as well as other industrialized and developed countries. In the year 1973, The European Patent Convention was adopted and the first attempts were made to have important molecular biology achievements patented in June 1978, when the European Patent Office started to accept patent applications Sweden also acceded to the European Patent Convention in 1978. Further Denmark and Finland became parties to the convention in the year 1991 and 1996 respectively.
IMPLICATIONS OF BIOPIRACY
Biopiracy may be morally questionable but in the absence of specific legal provisions cannot be regarded as a crime. But we cannot turn a blind eye to this phenomenon. The patenting of biological resources denies the fundamental norm of common heritage which have been instrumental in the management of natural resource for centuries. The notion of “common heritage” has been traced to a certain ambassador Pardo, who in 1967 used the term to describe places like Antarctica, outer space, the ocean bed and the resources they contain. And for a while, the notion was also espoused by the Food and Agriculture Organization (FAO), with regard to genetic resources relevant to food and agriculture, as can be seen in Article 1(1) of its International Undertaking on Plant Genetic Resource for Food and Agriculture (1983), which stated that the undertaking was based on the “the universally accepted principle that plant genetic resources are common heritage of mankind and consequently should be available without restriction”. This means that nobody can claim sovereignty over these resources. But this notion , in combination with the lopsided nature if the Intellectual Property System, the advances in modern biotechnology and the accompanying spate of biopiracy, grossly disadvantaged indigenous communities, since the implication was to place their resources squarely at the disposal of technologically developed user countries. This has led to commercialization and commoditization of free goods which belong to the people into individual properties.
The system of Intellectual property is suitable for the industrialized societies which have already undergone the process of industrialization and have a profound research and development facility. The developing countries fall short in their research and development, ergo lack the ability to innovate and invent. Therefore the introduction of an Intellectual Property System will act counter to them. The industrialised countries were the ones who were instrumental in drafting the norms of Intellectual property rights such as the TRIP’s agreement and therefore these are more favourable to them. In a way the global standard of patenting of biological resources is inequitable.
Biopiracy along with the threat of hampering the traditional knowledge and national heritage of developing countries also pose a potential threat to the economic interests of these countries whose major employment generation depends on the agricultural sector. Biopiracy also leads to an intrusion to the sovereignty of a country when the individuals, corporations or governments of the other countries take the advantage from securing patents of generic resources which is derived from the native species and the knowledge possessed by the indigenous people of that country. This means not only the violation of the concept of common heritage of mankind, but also the violation of a state’s sovereign rights to its own resource.
ILLEGAL PATENTS: FADING TRADITIONAL KNOWLEDGE
The recent technological advancements in the field of biotechnology has posed a question on the effectiveness of the present patent system. As this technological field has developed to a stage where the three basic patentability criteria of novelty, inventive-stepand industrial applicability are not problematic, patents may be granted for inventions in biotechnological inventions.Moreover by Article 52(2) of the European Patent Convention, certain specified types of subject matter, one of which is by Article 52(2) (a) ‘discoveries…as such’, (or ‘mere discoveries’) are not to be regarded as inventions within the meaning of Article 52(1).If a patent fails to comply with one of the four criteria for access then it must regarded as illegal and same must be cancelled.
Therefore patents which are based on traditional knowledge is illegal, on the grounds that it does not acknowledge the principles of novelty or inventiveness it is a mere discovery rather than invention. The corporations who file patent claims on plants and other natural beings and techniques only discover the subject rather than inventing them as the plants and natural beings have always been there in the nature and the techniques and methods were prevalent among the traditional and indigenous societies.
THREAT TO ECOSYSTEMS
Commercialization and commoditisation of nature can have adverse consequences. Local people tend to follow their age old practices of crop diversity and crop rotation whereas the corporations emphasise on monoculture, cultivating a single crop as it tends to be more profit yielding. These corporations emphasise on the use of chemicals and artificial fertilizers to augment the process of production. In the long run these lead to decline in the overall fertility of the soil and leave it uncultivable. Due to excessive use of chemicals the soil is not able to replenish itself with the requisite minerals leading to unchangeable ecological disturbances which along with the nature can have serious effects on the lives of the indigenous people. Indigenous people are totally dependent on the nature, have their fixed crop cycles and land use pattern. Their whole lifestyle and daily living has to counter serious disadvantages due to this exploitation of land.
SOCIO-ECONOMIC RISKS INVOLVED
Biopiracy is not only the piracy of the natural resources of a country but also is the theft of economic development opportunities. In many instances the firms reciprocally promises to give jobs and working opportunities in return for the access to the biological resource to the people. But even if a firm established hires the indigenous people, they are minimised to menial jobs and are not given the opportunity to learn about their own product and develop them subsequently. They are not provided with any information related to the research and development which is being carried.
Often profit sharing negotiations can also lead to clash between the communities. Sometimes these biological resources are evenly distributed in the entire region or country, within the access and utility of several communities. If a particular plant is being used commonly by several communities, it poses a problem in accessing the share of benefits as each community claims their command over the traditional knowledge associated with the biological commodity. This often leads to clashes and layers of litigation between the communities of the same region as the corporations provide employment as well as monetary benefits.
A CASE HISTORY OF SIGNIFICANT BIOPIRACY CASES
Neem: Common Heritage
In 1994, a US Department of Agriculture granted a patent to a US based company WR Grace, for a fungicide made from Neem oil. The decision was later opposed by many of the NGOs and environmental organizations considering it as ‘biopiracy’. Subsequently, the European Patent Office agreed to withdraw the patent in May, 2000 confirming that “nothing has been invented, and that knowledge and use of Neem have been widespread in India and elsewhere for many decades”.
Basmati rice: Geographical Indication Act
In September, 1997, a Texas company named, ‘RiceTec Inc.’, was granted a patent by the US Patent Office to call the aromatic rice grown outside India as ‘Basmati’. As a result of which the company was entitled to not only call its rice as ‘Basmati’ within US, but also label it Basmati for its export purposes. This gave rise to a great repercussion for India and Pakistan as the patent would result into India not only loosing US import market but also its position in significant markets like Asia, Europe and UK. This brief diplomatic crisis between US and India with the later threatening the former to take the matter to WTO for a clear violation of TRIPs, as the Geographical Indication products cannot be patented under the provisions of TRIPS, ultimately came to an end with the US Patent Office deciding against RiceTec.
Maca: The Revitaliser
Considered to be a plant that ‘revitalises’, Maca acts as a tonic, helps in consolidating fractures, rebalances the menstrual cycle and is especially renowned as an ‘aphrodisiac’ for both men and women. Since the Aphrodisiac market is highly lucrative, it has attracted the attention of many Western health food companies. Subsequently, in 2010, the European Patent Office, following an action taken by the Peruvian National Anti-Biopiracy Commission, cancelled several patents on Maca.
The Sacha Inchi, because of its highly concentrated nutritional nature and very high fatty acid content, is considered of great interest in the cosmetic and food industries of developing countries. The Peruvian National anti- Biopiracy Commission and the Collective for an Alternative to Biopiracy in France marshaled and worked together to fight the illegitimate patents being sought on this plant. The outcome was the total definitive cancellation of the Greentech patent in October, 2009.
Novartis v. UOI
Supreme Court in a Landmark Judgment in Novartis AG v. UOI delivered on April 1, 2013, dismissed the appeal of the Swiss drug maker Novartis for grant of a patent over its anti cancer drug Glivec in India. The judgment was a massive blow to the pharma major, and came down strongly on ‘evergreening’ of drugs. Supreme Court accepted the existence of imatinib mesylate as prior art by looking into Zimmerman patent and thus declared it not to be a ‘invention’ under section 2(1)(j) and section2(1)(ja) of the Patents Act, 1970.
- In 1997, the US patent office revoked the patent of Turmeric (Curcuma Longa Linn.) given to the University of Mississippi Medical Center, after ascertaining that there was no novelty; the findings by innovators having been in India for centuries.
- Disputes related to Kava patent rights- a cash crop grown in the pacific; Ayahuasca patent rights- a ceremonial drink throughout the Amazon basin; Quinoa case- a staple food crop grown in the Andes; Hoodia cactus case in Africa and many more other instances when the developed countries have tried to infringe the rights of developing countries over their own resources guaranteed under different international conventions and treaties.
BIOPIRAY: LEGAL PROSPECTIVE
Biopiracy being a very complex issue relates to various branches of law. There are numerous provisions, texts and declarations under international law, intellectual Property Rights, environmental laws, regulating biopiracy. However because of difference in subject matter and object, from time to time these provisions seem to contradict each other. On one hand laws related to International Trade, IPR or any other commercial matters aims at maximization of benefit on the other hand laws dealing with environment protection and indigenous people’s rights look for more of a sustainable and ethical approach. These different aims time and again result in contradictory outcomes occasionally leading to conflict of interest.
In order to provide an international frame work for the protection of IPRs, WTO in 1995 introduced Trade Related Aspects of IPRs Agreement (TRIPs). Implementation of the TRIPs agreement, which allows patenting the live forms, has actually encouraged biopiracy.
Doctrine of Sui Generis
Article 27(3)(b) of the TRIPs Agreement requires member state to grant protection to plant varieties, either by patent or under a sui generis system, or a combination of both. It however, does not indicate the nature of the sui generis system referred to. Consequently, a controversy has emerged between the developed and developing countries.
TRIPs do recognize geographical indication to identify the origin of a good in a particular territory of a member, or a region or locality in that territory. According to the provisions of the agreement the registration of a trademark which uses a geographical indication in a misleading manner must be refused or invalidated ex officio, as was applied in Basmati case.
The doctrine of common heritage of mankind
Article 1(1) of FAO’s International undertaking on Plant Genetic Resources for Food and Agriculture, 1983, states that the undertaking was based on “the universally accepted principle that plant genetic resources are a common heritage of mankind and consequently should be available without restriction”. Meaning thereby that nobody an claim sovereignity over those resources.
On one hand, the challenges posed by those who bred successive plant varieties from existing ones led to calls by plant breeders’ right holders for the enhanced protection of their rights through alteration in the prevailing plant variety regimes, on the other hand the indigenous communities and their supporters begin to shout for the protection of their own resources and traditional knowledge from misappropriation by the holders of plant breeders’ rights and patents. As a result, the common heritage notion was reviewed and eventually discarded with the adoption of the CBD.
Convention on Biological Diversity
The Convention on Biological Diversity not only recognizes the dependency of indigenous people on biodiversity but also their unique role in conserving life in earth. It is for this reason that the convention provides that the parties have undertaken to respect, preserve and maintain the knowledge, innovations and practices of indigenous and local communities relevant for the conservation of Biodiversity. Also emphasizes to promote their wider application with the approval of knowledge holders and to encourage equitable sharing of benefits arising out of the use of biodiversity. It also recognizes states sovereignty over its own resources, thus getting benefited from these resources without the prior permission of such state is not permissible.
The Nagoya Protocol
Ratified in 2010, the Nagoya Protocol specifies the means by which the CBD can be applied. The protocol mainly deals with Access and Benefit Sharing (ABS). It aims at better regulation of access to genetic resources and encourages states to set up an agency to which firms and researchers must request operating licenses. States should also ensure the setting up and running of an equitable mechanism of sharing any benefits arising from the use of resources.
INDIA AND BIOPIRACY LAWS: THE ROAD AHEAD
The Protection of Plant Varieties and Farmers Rights Act, 2001
The act recognizes the role of farmers as cultivators and conservers and the contribution of traditional, rural and tribal communities to the country agro-biodiversity by rewarding those for their contribution through benefit sharing and protecting the traditional rights of the farmers. The act establishes a National Gene Fund to promote the conservation and sustainable use of genetic resources of agro-biodiversity and a Plant Varieties and Farmers’ Right Authority to perform all functions relating to the protection of plant varieties.
The Patent Act, 1970
The act provides for what all the things that are not considered as invention for the purposes of this act. Section 3 declares any plants and animals in whole or any part thereof, or any traditional knowledge not to be considered as an invention under the act. Since they are not an invention, no person can claim for the patent rights of these things.
Furthermore, after amendment in 2002 and subsequently in 2005, the Act requires “mandatory disclosure of source and geographical origin of the biological material in the specification when used in an invention. In case of a failure to disclose this information, or participation in wrongful disclose this information, or participate in wrongful disclosure, then the amendments permit opposition to, or revocation of, the patent.
The Biological Diversity Act, 2002
As per the Article 15 of the CBD, the act regulates the access to biological resources and associated traditional knowledge to ensure equitable sharing of benefits arising out of their use. In December 2012, the First National Biodiversity Congress, 2012 (Congress) held in Kerala, organized by Ministry of Environment and Forest, the NBA, and SBBs to address numerous biodiversity issues, together with the management of traditional Knowledge and access and benefit sharing of genetic resources.
The Traditional Knowledge Digital Library (TKDL)
In 2001, Indian Government launched a very ambitious project to preserve the traditional knowledge from biopiracy. A digital library with an object to identify all traditional use of India’s indigenous biological resources, sourcing from different books in local languages was opened. Characteristics, usages and bibliographical sources of various plants are identified and translated in five different international languages. The aim is to set up a competent mechanism to establish anteriority of traditional Knowledge in cases of biopiracy. To fight biopiracy and unethical patents, the library is set up as repository of 1200 formulations of various systems of Indian medicine, such as ayurveda, unani and siddha. The library also has 50 traditional ayurveda books digitized and available online. One can say this is a very novel and innovative initiative that can be a very good example for other developing nations.
Geographical Indications of Goods (Registration and Protection) Act, 2003
GIG Act, 2003 is a sui generis legislation enacted by union government of India, with an aim to protect the geographical indications of the country. Under this act a product is defined by a geographical area where it is traditionally found. It also advance product standards, provide cataloguing and categorization and enforces regulation. Darjeeling tea became the first GI tagged product in India, in 2004–05, since then 193 goods had been added to the list as of March 2013.
Within such a short span of time, the way Indian government reacted to the exaggerating problem of biopiracy is exemplary for other developing countries. But like Robert Frost said “miles to go before I sleep”, there is lot to be done to eradicate this crisis from the indigenous community.
COCLUSION AND SUGGETIONS
In these times of Patent wars, each time someone alleges even a small piece of India i.e. Bharat as their own, the nation goes into a tailspin. Annoyance, disorder, anxiety and will power to struggle it out one more time do insist the Government, environmental groups and NGOs around the nation. Indian government and other institutions are fighting the war for the claim of over 40 products throughout the globe. The fear that someone else may get hold of the right over the ownership, trade and marketing of Indian commodities around the world, is more than a bit jolting and possibly rightly so, as happened not far back with the neem, basmati, haldi and so many other Indian traditional goods.
In darkest of situations, there exists a hope. Though, India is now trying to protect its indigenous community’s rights and traditional knowledge through legislations under its municipal laws, but as we all know it isn’t sufficient enough. There exists a need of an ‘umbrella’ legislation governing the entire landscape of Indigenous Community and their Traditional knowledge.
As the time demands the indigenous people do have a right of self determination of their future, so the patent laws should reflect their right as the true inventors rather than following the out dated western definition of “invention” by manipulating genes. Indigenous people should have the access to information related to protection of their traditional knowledge using various international and municipal laws of the land.
Both morality and justice demand that the developed countries treat Indigenous people of developing countries with respect; they do require the support of national and international laws, instrumentalities and equivalent foothold at the negotiable desk.
Authors: Sidhant Tigga and Sachin Mishra
 Student, Hidayatullah National Law University, Raipur, Chhattisgarh
 Student, Hidayatullah National Law University, Raipur, Chhattisgarh
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 In the US the criteria for patentability are anticipation, non-obviousness and utility.
 Supra note 5
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