Title Page

Name of the Authors:

Zennifer Zaman

Affiliation: Student of LL.M (I Year)

Address: Rajiv Gandhi National University of Law, Patiala (Punjab)

E-mail: jenniferzaman85@gmail.com

Telephone: 07508015889

Title of the Paper: BIO-PIRACY: AN USURPATION OF PRIOR ART

Sandip Bhosale

Affiliation: Student of LL.M (I Year)

Address: Rajiv Gandhi National University of Law, Patiala (Punjab)

E-mail: sandeepbhosalebsl@gmail.com

Telephone: 09814173436

Title of the Paper: BIO-PIRACY: AN USURPATION OF PRIOR ART

Key words: Bio-Piracy, Prior art, TRIPS, Traditional Knowledge.

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BIO-PIRACY: AN USURPATION OF PRIOR ART

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Meaning of Bio-Piracy:

The concept of “Bio-piracy” is commonly construed as the misappropriation of the knowledge and genetic resources of the farmers and indigenous people by individuals or institutions seeking exclusive monopoly control over these resources and knowledge. Hence, Bio-Piracy takes place in the form of applying and granting of ‘wrong patents’ or granting patents on ‘Inventions’ derived from a ‘Community Traditional Knowledge’ in other words known as “Prior Art”.

As defined by an online Dictionary, the term Bio-piracy is referred to the commercial development of naturally occurring biological materials, such as plant substances or genetic cell lines, by a technologically advanced country or organization without fair compensation to the peoples or nations in whose territory the materials were originally discovered[1].

Bio-piracy is the theft or usurpation of genetic materials especially plants and other biological materials by the patent process. Biological diversity or biodiversity encompasses all species of plants, animals and micro organisms and the variations between them, and the eco-systems of which they form a part. Traditional Knowledge (TK) associated with such biological resources is an intangible component of the resource itself. Such knowledge has the potential of being translated into commercial benefits by providing leads for development of useful products and processes. The commercial potential involved in biological resources and the associated TK has assumed enormous magnitude in the last couple of decades with the tremendous proliferation of the biotechnology industry. Given that most of the world's biodiversity rich countries are developing countries located in the tropics, these nations should have been in a strong position to benefit substantially by trading in such bio-resources and the associated TK. Unfortunately, this is far from the case. More often than not it is the giant MNCs of the developed world who are instrumental in appropriation of the precious bio-resources and the allied TK of the undeveloped nations, without the Prior Informed Consent (PIC) of the legitimate holders of such resources, thereby bypassing any benefit-sharing arrangement with them. The mounting profits emanating from the commercial exploitation of these prized resources accrue solely to the corporate giants of the developed world, courtesy the exclusive patent protection obtained by suppressing the true source of the relevant bio-resource or the TK. The country of origin of the concerned bio-resources or TK however remains deprived of its legitimate share of the profits generated out of them. Such unscrupulous business practices of the MNCs have come to be known as Bio-piracy.[2]

 Many of the indigenous communities are living on the basis of the knowledge they preserved for generations. The development of new technologies and the use of traditional knowledge are posing serious threat to the survival of these communities. The modern industries are now a day’s exploiting indigenous knowledge without permission or sharing of profit with these communities[3]. TK is capable of providing valuable leads which may result in products of high commercial value. The protection of TK would be necessary to bring equity to such unjust and unequal relations.

Another factor that calls for protection of TK is to maintain the practices and knowledge derived from traditional life styles. Preservation of TK is intended to provide self identification to these indigenous communities and thereby provide continuous existence of indigenous people. If TK is having a high economic potential, then its prospects should be used for the general wellbeing of the communities which preserved them for generations. Besides this maintenance of the distinct knowledge systems that give rise to TK is vital for the future well being, development, cultural and intellectual vitality of indigenous communities.

LANDMARK CASES

1.               The Case of Basmati Rice (Oryza sativa Linn)

Basmati rice, known for its aroma and long grains has its origins in the Indian subcontinent[4]. On 2^nd September 1997, Texas based Rice Tec Inc. was granted patent number 56663484, for the genetic lines of Basmati Rice, by the U.S patent and Trademark Office (USPTO). Immediately, Rice Tec began to develop hybrids using various blends of Basmati. Promoted as an,‘American type of Basmati rice’, Rice Tec developed a new plant variety cross between American long-grain and Basmati.

Criticism from Indian rice farmers logically ensued, as many were forced to pay royalties to the conglomerate. The production and cultivation of Basmati has with it a history dating back to centuries ago. In April of 2000 Indian officials publicly pleaded with the United States Patent and Trademark Office (PTO or USPTO) to review the RiceTec Basmati case, as Indian exports were beginning to be threatened[5].Government officials were armed with hundreds of pages of scientific data proving that the distinguishing characteristics of RiceTec’s rice were also found in Basmati[6]. Moreover, the use of the name ‘Basmati’ itself was misleading for customers considering that the product was a hybrid grain[7].The name ‘Basmati’ carries with it a reputation of culinary excellence, and RiceTec was benefiting from it. Under Article 23 of the TRIPs agreement, using words such as “kind”, “type”, and “style” is illegal, and RiceTec had used such words numerous times in advertising schemes[8].

Moreover, considering the geographical indicators clause of TRIPs, the entire process of approval and acquisition of RiceTec’s Basmati patent can be deemed to be illegal. Article 22 of the TRIPs agreement, (the geographical indicator clause) prohibits the use of both direct and indirect uses of a goods geographical origin. In this respect, Basmati is to the India what Champagne is to France, part of the regional identity.

On 14 August 2001 USPTO overturned a large amount of claims held under Patent No.5663484. Amidst great public scrutiny and criticism, RiceTec lost the right to use the ‘Basmati like’ advertising slogan. At the discretion of USPTO, out of 20 Basmati patent claims, 15 were withdrawn. RiceTec was able to keep their Indian-American hybrids Texmati, Jasmati and Kasmati .To the dismay and outrage of citizens and farmers, after the patent withdrawals, the Indian government publicly stated they were very satisfied and wished to drop all other charges.

The Case of Neem Tree (Azadirachta Indica)

DURING 1994, Indian farmers staged one mass demonstration after another against the proposed GATT Uruguay Round agreement. In March about 200,000 gathered in Delhi demanding, among other things, that the draft treaty known colloquailly as 'the Dunkel draft' after chief negotiator, Arthur Dunkel should be translated into all Indian languages. On 2 October, about half a million converged upon Bangalore to voice their fears about the impending legislation, aware of the threat that GATT poses to their livelihoods, by allowing multinational organizations to enter Third World markets at their expense[9].In particular, many of them began to question the Dunkel Draft's call for an international harmonisation of property rights legislation.

The Case of Turmeric (Curcuma longa Linn)

The patenting of neem, haldi or amla underscores the urgent need to evolve legal systems to protect our indigenous biodiversity in order to prevent such piracy through patents. The trouble is India still does not allow patents on plants[11]. Under the rules of World Trade Organisation, every nation is free to evolve its own method (sui generis) of plant protection. The US is the only country which grants patents on plants[12].

Prior to colonization, cotton was traded in the Indus Valley as mainly a Luxury good. It was only in the 19th century, after colonization that cotton cultivation followed a more mass production like structure.

Cotton production is a staple of the Indian agricultural economy. Some 7 million farmers depend on the crop for sustainable living, and overall 21% of all cotton produced globally comes from India. However, cotton is a very expensive crop to cultivate. Over half of India’s total pesticides (40,000 tonnes) are used in the upkeep of cotton cropland[13].

In 1998 Monsanto began a series of Bt cotton trial tests in India, albeit illegally. Monsanto did not apply for trial testing clearance, and was not given any sort of formal approval to conduct studies on rural land. After going public with the results of their trial tests, Monsanto promoted Bt cotton as the perfect cost-cutting crop for rural India. It was claimed that yield output would increase to 3,300 pounds per acre. Moreover, Bt cotton would need to be sprayed approximately 2.6 times less then both organic and hybrid cotton. Even though inputs were more expensive, the genetically engineered seed would be sprayed sparingly, ultimately reducing the cost of cultivation by 30% to 40% at least. With promises of higher yields and lower costs, the Indian government officially approved three Bt cotton hybrids (MECH 12, MECH 162, MECH 184) for clearance in 2002. This clearance was given to Monsanto in conjunction with the Maharashtra Hybrid Seed Company (Mahyco), which conveniently enough, Monsanto has a 26% stake in. Bt cotton was the first GM seed to be given clearance by the Indian government and is now viewed as the example of how agro-business conglomerates impact vulnerable rural communities[14].

Farmer suicides in Andhra Pradesh and Maharashtra have increased after Bt cotton was both approved and promoted by governing officials. The financial stress associated with Bt cotton, has indeed been grave. Moreover, with the adoption of such GM seeds and subsequent failure, many rural farmers have increasingly felt deep remorse. This sentiment of loss is a result of much regret associated with leaving cultural farming techniques, which carried with a sense of community and family. The loss of control over crop in both the indebted and sovereign sense is simply too much for many farmers.

 The Case of Ayahuasca (Banisteriopsis Caapi)

Shamans the indigenous tribals of Amazon basin were using the bark of B.Caapi to produce a ceremonial drink known as “ayahuasca” for generations. “Ayahuasca” means wine of soul and is used in religious and healing ceremonies to diagnose and treat illness. An American national Loren Miller obtained a US plant patent, Patent no 5751, issued in 1986, granting him rights over an alleged variety of B.Caapi which he had collected from a domestic garden in Amazon and was named as “Dä Vine”, which was peculiar for its medicinal properties. But in this case “Da Vine” represented a new and distinct variety of B.caapi because of its flower colour. 

The coordinating Body of Indigenous Organizations of Amazon basin which represents more than 400 indigenous tribes in the Amazon region, along with others protested against granting of wrong patent for B.Caapi. They made argument that ayahuasca that had been known to the natives of Amazon basin for its medicinal uses. This argument was accepted and on re examination USPTO revoked this patent on 17^th April 2001

The Case of Hoodia Cactus 

Hoodia (and the similar Trichocaulon) are two succulent plants indigenous to southern Africa. For long, they have been used by San and Khoi shepherds of the harsh arid environments of southern Africa to reduce hunger and thirst. The South African Army also uses it to suppress appetite.

CSIR, one of Africa’s largest scientific and technological research institutions and the UK Company Phytopharm have entered into an agreement to develop an appetite suppressant, which has been named P57derived from Hoodia[16]. As we all know, obesity is one of the main public health problems in developed countries, so the market potential is huge.

The international patent application WO 9846243 claims monopoly use of the P57 appetite suppressant agent of the extracts of Hoodia or Trichocaulon and its use in pharmaceutical appetite suppressants.

The Jamun Case

It is a plant; known for its anti-diabetic properties. It is common knowledge and everyday practice in India. Their use in the treatment of diabetes is documented in authoritative treatises such as the “Wealth of India”, and the “Treatise on Indian Medicinal Plants”. A US patent was granted in 1999 to Cromak Research Inc., based in New Jersey, USA. The assignees are three non-resident Indians[17].

The indigenous knowledge and use of the Jamun consist of prior art, that is, no patent should be given where prior art exists, since patents are supposed to be granted only for new inventions on the basis of novelty and non-obviousness. As Article 102 of the US Patent Law, which defines prior art does not recognise technologies and methods in use in other countries as prior art. Because of this, the Jamun could be patented in the USA.

 LEGAL ASPECTS

The Convention on Biological Diversity

A big step was made in 1994 when the Convention on Biological Diversity (the CBD) came into force. This convention gave sovereign national rights over biological resources[18]. One of the advantages of it is that it enables developing countries to better benefit from their result of traditional knowledge.

The objectives of the CBD are:

• to protect biodiversity
• to promote its sustainable use

·         to share the benefits of such use equitably between providers and users.

The convention on biological diversity (CBD) was the result of discussion concluded at Rio de Janerio on United nations conference on earth and development (Earth Summit), 1992.The convention provides for protection of environment without compromising with the ongoing economic development¹⁷.The convention provides for recognition of knowledge of local and indigenous communities in genetic materials and sharing of benefit derived from it.

CBD can be regarded as the first international initiative to recognize the contribution of indigenous and local communities in conservation of biodiversity. In its preamble CBD recognizes the dependence of many indigenous communities on biological resources and stress on the desirability of benefit sharing.

 Trade Related Aspects of Intellectual Property Rights (TRIPS agreement)

TRIPS agreement also has some provision which can be applied in a limited way for protection of traditional knowledge. Article 1 of TRIPS Agreement provides that members may but shall not be obliged to implement in their domestic laws more extensive protection than that is required by the agreement, provided that such protection does not contravene the provisions of this agreement. Many Jurists have opined that this provision can be invoked for protection of TK. They argue that absence of term TK in the agreement does not prevent any member from enacting any provision for protection of TK[19]^.

But under TRIPS it is not possible to protect TK under patent law. TRIPS requires member state to grant patent only to that inventions which are new, involving an inventive step and are capable of industrial application. But these attributes cannot be applied in the field of TK, as it is not new and is incapable of industrial application as such. But it is to be noted here that the same provision can be invoked to prevent bio-piracy. Besides this there are authors who argue that obligation to protect geographical indications provided by TRIPS agreement can be used to protect TK. TRIPS agreement by itself does create any measures for protection of traditional knowledge and innovations of indigenous people instead it creates measures for establishing alternative measures for its protection.

World Intellectual Property Organization

In 2000 the WIPO General assembly established the IGC as a forum for discussion of intellectual property issues in relation to access to genetic resources, benefit sharing and protection of traditional knowledge and expressions of folklore. It acts as an international forum for international policy debate, development of legal mechanisms and for creating practical tools for protection of traditional knowledge and traditional cultural expressions against misappropriation and misuse. IGC work has produced large number of discussion papers on the subject of protection of TK.IGC has produced a number of practical outcomes which include, a toolkit for the management of IP in the context of documenting TK and genetic resources, a practical guide for protection of traditional cultural expressions, proposal for revision of international patent classification to contain categories of TK.

The committee has made substantial progress in addressing the practical linkages between the current intellectual property system and the custodians of TK. Committee is trying to bring about an international understanding regarding the principles that should guide the protection of traditional knowledge.

Besides all these international initiatives, last decade has witnessed many regional initiatives for laying down measures for protection of TK. African countries under Organisation of African Union prepared a model law on community rights and access to biological resources. The African Model Legislation for the Protection of Rights of Local Communities, Farmers, Breeders, and for Regulation of Access to Biological Resources aims at establishing a framework of national laws to regulate access to genetic resources and associated TK. Its provisions on access to biological resources make it clear that the recipients of biological resources or related knowledge cannot apply for any IP rights of exclusive nature. Besides this they provide for community rights over their biological resources and their right to collectively benefit from their use, rights to their innovations, practices, knowledge and technology and the right to collectively benefit from their utilization[21].Thus, in practice this model legislation intends to create a system which allow the community, right to prohibit access to their valuable resources and knowledge.

The World Trade Organizations (WTO)

The Ministerial Declaration of the WTO’s fourth Ministerial Conference (Doha- 9-14 November 2001) emphasized the importance of TK. It instructed the Council for Trade-Related Aspects of Intellectual Property Rights to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by Members pursuant to Article 71(1)   In addition, it instructed the Committee on Trade and Environment in pursuing its work on all items on its agenda give particular attention to three issues, including the relevant provisions of the TRIPS Agreement. Moreover, it “recognized the importance of technical assistance and capacity building in the field of trade and environment to developing countries, in particular the least- developed among them.”

 INDIA- COMBATING BIO-PIRACY

The Patent (Amendment) Act, 2005

India has amended the Patents Act in 1999 and 2002 to comply with the obligations of Trade-related Aspects of Intellectual Property Rights (TRIPS). The TRIPS agreement signed along with WTO agreement in 1995 provides for making certain changes in domestic patent laws, for reaching a uniform system of legislations relating to patent throughout the world. In order to fulfill this obligation under TRIPS patent act was duly amended in 2005. This amendment introduced into Indian IP system certain new measures for protection of TK.

Another provision is inclusion of new provision for opposition of patent, on specific grounds under section 25(1) of the Act. It provides after publication of patent application any person can in writing make an opposition to the controller of patents on the ground of lack of novelty or inventive step, or non disclosure or wrongful disclosure of source or geographical origin used in  the invention and anticipation of invention by the knowledge, oral or otherwise available within any local or indigenous groups in the complete specification.  Also now we can oppose a complete patent specification which was publicly known or publicly used in India before the date of claim⁴⁰.

 All the above provisions are defensive in nature which can help to oppose any patent granted to an invention which is based on the knowledge available within the indigenous groups of this nation. But these provisions are also not capable of covering the entire area covered by TK, which necessitates the need for a sui generis system for protection of TK.

CONCLUSION

Around the world, various local communities possess knowledge and practices gained by them through experience of centuries and transferred from generation to generation. TK is the result of intellectual activities in diverse traditional contexts. One of the challenges posed by the modern age is to find ways for strengthening and nurturing the roots of traditional knowledge so that its fruits can be enjoyed by future generation and so that the traditional communities can develop and sustain in ways consistent with their own values and interests[22].

There has been a growing interest in the International communities in the present times regarding  these old and obsolete sources of knowledge which are highly adaptive and creative when transformed into commercially valued products. Knowledge, both modern and traditional, is under peril in the age of Globalisation. The most unfortunate part of the unfair acts of bio-piracy is that the actual holders of the TK are, most often, not aware of the unfair exploitations of their knowledge being taking place. Hence, the chances that these victims of illegal patenting would ever complaint about the infringement of their rights are meager. The International community has long ago realised that national initiatives alone are incapable for TK protection and hence the World nations are currently engaged in extensive discussion on preservation of traditional knowledge under various International Institutions.