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1. Intellectual Property Rights is an acronym that hardly needs to be expanded nowadays. Everyone, who matters in scientific circles, is talking about intellectual property rights, and the importance of protecting scientific discoveries, with commercial potential, in a tight maze of patents. Legitimacy of the global intellectual property right system is in question for its inability to generate symmetrical opportunities for traditional knowledge-holders vis-à-vis the inventors and innovators in the formal sector. The status accorded to traditional knowledge and folklore poses particularly profound moral, legal, social and political problems. Such knowledge is not limited to definable or articulate sets of knowable elements. Yet, inter-generational equities could be irreversibly impacted internationally depending on the way solutions to appropriate benefits are structured by vesting ownership or use rights in such knowledge because resource availability and resource use would both be impacted.

2. Liberalisation and globalisation have dramatically altered perceptions about science and its practice in India. The unabashed drive to patent and protect every conceivable scientific advance, no matter how incremental, has now reached a ridiculous level in the West. American and multinational companies, never known for moderation and thoughtfulness, when commercial interests are involved, have set out to fence vast areas of science under the guise of protecting intellectual property. Exponential growth of scientific knowledge, increasing demand for new forms of intellectual property protection as well as access to IP related information, increasing dominance of the new knowledge economy over the old ‘brick and mortar’ economy, complexities linked to IP in traditional knowledge, community knowledge and animate objects, will pose a challenge in setting the new 21st century IP agenda. In the context of trade and business, Trade Related Aspects of the Intellectual Property Rights (TRIPS) and the Convention on Bio-diversity (CBD), respectably, required the creation of new economic rights and obligations to complement the IPR system under World Intellectual Property Organisation (WIPO). Matters concerning traditional knowledge, hitherto pursued only in the form of cultural rights or heritage issues at the UN, UNESCO and WIPO are regarded relevant also for development rights for which the United Nations Conference on Trade and Development (UNCTAD) was created and economic rights for which earlier UN-ECOSOC and more recently, WTO have been mandated. Also, there are certain categories of traditional knowledge like traditional medicine which still are subserving the public health objectives under WHO’s Traditional Medicine Strategy for 2002-2005. Moreover, traditional knowledge is valued not because of antiquity but because more of it is transmitted orally, as part of knowledge necessary to sustain lives and livelihoods and it has an economic value which is variable.

HUMAN RIGHTS PROTECTION OF TRADITIONAL KNOWLEDGE

3. Two protective paradigms have been employed to protect traditional knowledge using intellectual property tools. The first protective paradigm seeks to prevent others from using or securing intellectual property rights over traditional knowledge. For example, some communities have created traditional knowledge databases to evidence their traditional knowledge as prior art in order to prevent perceived abuses such as biopiracy. Although traditional knowledge database may pre-empt some from securing rights over traditional knowledge, databases do disclose such traditional knowledge to the public. This becomes a problem since many communities would rather keep such traditional knowledge within their community. Many communities have their own traditional or customary laws that regulate the use of traditional knowledge that may differ substantially from their national system or the international system of intellectual property rights. Disclosure may violate these customs.

4. The second protective paradigm (often called “positive protection”) seeks to secure protective legal rights over traditional knowledge. This is achieved by either using the existing laws or using legislative means to enact new sui generis laws. Some have argued that some countries like the United States may face constitutional problems with granting perpetual rights to these communities. They also raise utilitarian concerns with granting legal rights to traditional knowledge. For instance, some forms of traditional knowledge (such as cures for disease) may be used to help others; and of exclusive rights were granted, some may go upheld. Other concerns deal with the equitable sharing of benefits and resources.

5. Indigenous and local communities have argued that they generally don’t use such incentives to innovate. Their use of knowledge is spiritually and culturally guided. Misappropriation and misuse of this knowledge may violate customary laws that are at the core of their collective and cultural identity. These beliefs are currently protected by a number of constitutional provisions and statutory laws, and are increasingly being recognised as a distinct human right within the United Nations.

Similarly, indigenous and local communities have argued that public claims in their knowledge without their consent amounts to a misappropriation of their identity and heritage, a violation of their fundamental, inalienable and collective human rights.

IPR AND TRADITIONAL MEDICINE

A. THE NEEM CASE

6. A controversy that can be tagged as a first for India and which rose doubts about strict patent system was the granting of patent to a company, namely, W.R. Grace. The company was granted a patent in the US and the European Union, for a formulation that held the active ingredient in the neem plant in the stable storage of azadirachtin, and the same was planned to be used for its pesticidal properties. It was admitted by the applicant regarding how the pesticidal uses of neem were known and he pointed out to the fact that storing azadirachtin for a longer duration is difficult without the use of neem. The US patent granted, covered a limited invention whereby the applicant was only given the exclusive right to use azadirachtin in the particular storage solution described in -the patent.

The grant of the said patent caused an uproar and it was challenged through re-examination and post-grant opposition proceedings before the United States Patent and Trade Mark Office (USPTO) and the European Patent Office (EPO), respectively. Though there was no success at the USPTO, the European Patent Office ruled in favour of the opposition stating the patent granted, lacked in novelty and inventive step.

B. THE ‘JEEVANI’ AND ‘KANI’ TRIBES

7. New experiments are beginning to emerge on benefit-sharing models for indigenous innovation. An example of India is worth sharing. It relates to a medicine which is developed from and based on active ingredients in a plant, Trichopus zeylanicus (Arogyapaacha), found in South-Western part of India. Scientists at the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala learnt of the plant, which is claimed to bolster the immune system and provide the additional energy. The medicine is traditional knowledge used by Kani Tribe. These scientists isolated and tested the ingredient and incorporated it into a compound, which they christened ‘JEEVANI’, the giver of life. The tonic is being manufactured by a major Ayurvedic drug company in Kerala.

C. TURMERIC PATENT

8. Two US based Indians, Suman K. Das and Hari Har P. Cohly were granted a US Patent 5,40,504 on 28.03.1995 on use of turmeric in wound healing. The patent was assigned to University of Mississippi Medical Centre, USA. This patent claimed the administration of an effective amount of turmeric through local and oral route to enhance the wound healing process, a novel finding. Any patent, before it is granted, has to fulfil the basic requirements of novelty, non-obviousness and utility. Thus, if the claims have been covered by the relevant published art, then the patent becomes invalid. CSIR could locate 32 references (some of them being more than 100-year-old and in Sankrit, Urdu and Hindi), which showed that this finding was well-known in India prior to filing of this patent. The formal request for re-examination of the patent was filed by CSIR at USPTO on 28.10.1996. On 20.11.1997, the examiner rejected all the claims once again as being anticipated and obvious. The re-examination certificate was issued on this case on 21.04.1998 bringing the re-examination proceedings to a close.

PROTECTION AND PROMOTION OF TRADITIONAL KNOWLEDGE

A. RE-EXAMINATION OF US PATENT ON BASMATI

9. Rice Tec Inc. had applied for registration of a mark ‘TEXMATI’ before the UK Trademark Registry. It was successfully opposed by Agricultural and Processed Food Exports Authority (APEDA). 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 (hereafter referred to as ‘484 patent’) granted by US Patent Office to Rice Tec on 02.09.1997 and this is how this patent became an issue for contest. The said patent covered 20 claims covering not only a novel rice plant but also various rice lines; resulting plants and grains, seed deposit claims, method for selecting a rice plant for breeding and propagation.

10. In the wake of this controversy, the Government of India set up a Task Force under the Chairmanship of Secretary, Ministry of Industrial Development, to examine the possibilities of filing a re-examination request against the above-mentioned US patent. The Task Force, in turn, set up a technical committee comprising primarily the ICAR and CSIR scientists to examine the patent specification in detail and to collect necessary documentary evidence that may be required to file the re-examination request against the US patent. Evidence from IARI Bulletin was used against Claims 1517. Eventually, a request for re-examination of this patent was filed on 28.04.2000. Soon after filing the re-examination request, Rice Tec chose to withdraw 15 claims and the threat of infringement by the export of Basmati grains to US has been averted. Now, with the surrender of all the other broad claims, even the alleged threat to the export of grains of insensitive rice lines from India has been averted.

B. RULINGS RELAVENT TO YOGA

11. In this regard, the applicant registered his copyright interest in the book regarding sequence of asanas with the Copyright Office, and then, in 2002 he filed a supplemental registration i.e. a correction filed when the original registration is incorrect or incomplete. According to the said supplemental registration, the applicant was not only claiming rights in the book itself but also on the sequence of 26 asanas taught in the book. An organisation called Open Source Yoga Unity, which, according to its website, is a non-profit collective to ensure the continued natural unfettered development of Yoga, challenged this supplemental registration and asked the US District Court for the Northern District of California to issue a declaratory judgment saying that the applicant could not have exclusive rights over the sequence of asanas as mentioned in the book. However, the said argument was rejected by the Court in 2005, stating that the sequence might be protectable as a compilation. Later, when a question was put to the Copyright Office for its opinion on the said matter, the agency in June 2012 issued its Policy Statement, which concluded that sequences of yoga asanas or any sequence of exercises or movements, excluding choreography, could not be protected as compilations, as they were not compilations of literary works, musical works, or any of the other kinds of works protected by the copyright law.

Within six months, the Policy Statement formed the basis of another court’s decision, when in December 2012, the US District Court for the Central District of California was faced with another dispute over Bikram Yoga. The dispute started when two yoga instructors in Buffalo, New York completed the certification course from the applicant and were authorised by his organisation to teach the basic Yoga system. They formed their own educational enterprise, Evolation Yoga LLC, and opened a series of yoga schools. The applicant sued Evolation Yoga LLCa lleging copyright infringement, however the court granted summary judgment for Evolation, stating that as a matter of law a sequence of yoga asanas cannot be copyrighted.

C. TRADITIONAL KNOWLEDGE DIGITAL LIBRARY

12. These cases were an eye opener and they triggered the Government of India to create Traditional Knowledge Digital Library (TKDL) and also to include traditional knowledge in the International Patent Clarification System. TKDL is an initiative by India to digitise and document knowledge available in the public domain to facilitate systematic arrangements, dissemination and retrieval of information. While granting patents, authorities check invention to prior art in public domain. Documentation of knowledge will help them trace invention in public domain and help them to know whether it is eligible for patents, thus preventing misappropriation of traditional knowledge.


* Advocate and qualified Chartered Accountant. Author is currently Senior Associate in the Dispute Resolution Practice at L&L Partners Law Offices, New Delhi. Author’s views are personal.

GNLU
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 Vidya Dadati Vinayam, Vinaya Dadati Paatrataam I

Paatratva Dhanamaapnoti, Dhanaat Dharmam Tatah Sukham II

This shloka in Sanskrit means true/complete knowledge gives discipline, from discipline comes worthiness, from worthiness one gets wealth, from wealth one does good deeds, from that comes joy.

This ancient Sanskrit proverb resonates of the power and value of knowledge. It also echoes the need for protection of traditional knowledge, a branch under intellectual property rights (IPR) that spurt on the global platform with the finalisation of Convention on Biological Diversity (CBD), 1992.

A broad worded explanation of traditional knowledge is provided under Article 8(j) of the Convention, which reads as:

Traditional knowledge refers to the knowledge, innovations and practices of indigenous and local communities around the world. Developed from experience gained over the centuries and adapted to the local culture and environment, traditional knowledge is transmitted orally from generation to generation. It tends to be collectively owned and takes the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices, including the development of plant species and animal breeds. Sometimes it is referred to as an oral traditional for it is practiced, sung, danced, painted, carved, chanted and performed down through millennia. Traditional knowledge is mainly of a practical nature, particularly in such fields as agriculture, fisheries, health, horticulture, forestry and environmental management in general.[1]

Traditional knowledge, as opposed to common belief, is not so called because of its antiquity. It is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, and often forms part of its cultural or spiritual identity. As such, it is not easily protected by the current intellectual property system, which typically grants protection for a limited period to inventions and original works by named individuals or companies. Its living nature also means that “traditional” knowledge is not easy to define.[2]

Protecting and promoting traditional knowledge is an amalgamation of various ideas like human rights, conservation of resources, sustainable development, intellectual property rights and benefit sharing mechanism. This work looks at traditional knowledge through the lens of intellectual property ecosystem.

In term of Intellectual Property (IP) protection for traditional knowledge, two types are being sought:

(i) Defensive protection which aims to stop people outside the community from acquiring intellectual property rights over traditional knowledge. India, for example, has compiled a searchable database of traditional medicine that can be used as evidence of prior art by patent examiners when assessing patent applications. Defensive strategies might also be used to protect sacred cultural manifestations, such as sacred symbols or words from being registered as trade marks.[3]

(ii) Positive protection under which there is granting of rights that empower communities to promote their traditional knowledge, control its uses and benefit from its commercial exploitation. Some uses of traditional knowledge can be protected through the existing intellectual property system, and a number of countries have also developed specific legislation.[4]

However, the international legal system has not surfaced with an instrument for specific protection of such traditional or indigenous knowledge and even though some national laws do accord protection, this may not hold sufficient for other countries.

India—An overview of wealth

India is a mega diverse country with only 2.4% of the world’s land area, harbours 7-8% of all recorded species, including over 45,000 species of plants and 91,000 species of animals. Of the 34 global biodiversity hotspots, four are present in India, represented by the Himalaya, the Western Ghats, the North-East, and the Nicobar Islands.[5] Further, India is the largest producer of medicinal plants and the traditional medicinal systems found under Ayurveda, Siddha and Unani, are concepts that were developed between 2500 and 500 BC in India.[6]

That India is a biologically diverse and the traditional knowledge possessed regarding various resources, especially the medicinal system, makes it a richer nation is understood, however such the possession of such knowledge must be both protected and promoted. India has undergone many struggles in trying to safeguard her traditional knowledge. These resulted from patents granted to corporations, for knowledge that is India’s legacy. I will enunciate three popular cases that brought to the fore the supposed “stealing” of Indian traditional knowledge and access of biological resources, in contravention of the Biological Diversity Act, 2002.

The Neem case

A controversy that can be tagged the “first” for India, and which rose doubts about a supposedly “strict” patent system, was the granting of patent to a company W.R. Grace. The company was granted a patent in the United States and the European Union, for a formulation that held in the stable storage of azadirachtin, the active ingredient in the neem plant; it planned to use azadirachtin for its pesticidal properties. Traditional systems of medicine like Ayurveda and Unani, identify antiviral and antibacterial properties of the neem tree also known as the “curer of all ailments” in Sanskrit, and prescribe the same for treating  skin diseases and as a natural pesticide. The applicant admitted in the patent application of how the pesticidal uses of neem were known and pointed out to the fact that storing azadirachtin for a longer duration is difficult. The US patent granted, covered a limited invention whereby the applicant was only given the exclusive right to use azadirachtin in the particular storage solution described in the patent.

The grant of the patent was followed by an uproar and it was challenged through re-examination and post-grant opposition proceedings before the United States Patent and Trade Mark Office (USPTO) and the European Patent Office (EPO), respectively. Though there was no success at the Uspto, the European Patent Office ruled in favour of the opposition stating the patent granted, lacked in novelty and inventive step.

The Turmeric case

As the USPTO and EPO were dealing with the Neem case, a similar matter was boiling; a patent was granted for “use of turmeric in wound healing” and claimed a method to heal wounds in a patient by administration of an “effective amount” of turmeric. Suman K. Das and Hari Har P. Cohly were the inventors of this patent and had later assigned the patent to the University of Mississippi.

A re-examination application was filed against the granted patent, along with nearly two dozen references, which resulted into early success. The inventors’ defence was proven weak in front of the modern commentaries on classic ayurvedic texts, extracts from Compendium of Indian Medicinal Plants and nineteenth century historical texts from the library of Hamdard University, resultantly in August 1997, the USPTO ordered revocation of the patent, which lacked novelty.

The Basmati case

Another case that created much havoc was a patent granted by the USPTO to an American company called RiceTec for “Basmati rice lines and grains”. Basmati rice is a traditionally grown aromatic variety of rice, in India and Pakistan. The grant of this patent created multitude IP issues besides that under the patent law i.e. under trade marks and geographical indications.

RiceTec had been granted patent for the invention of hybrid rice lines that combined desirable grain traits of Basmati rice with desirable plant traits; this was due to the inferior quality of Basmati rice that grew in US in comparison to the good quality Basmati rice being cultivated in northern India and Pakistan and would help in growing a better crop of Basmati rice in the western hemisphere, especially US. A re-examination request was filed, with declarations from two scientists, along with several publications on Basmati rice and the research conducted on the rice in India—one of which made the USPTO realise that core claims of RiceTec were non-obvious. This resulted into RiceTec not challenging the USPTO’s decision and reducing its twenty claims to three.

Traditional Knowledge Digital Library (TKDL)

In June 1999, the then Planning Commission under the Central Government constituted a “Task Force on Conservation and Sustainable Use of Medicinal Plants”.[7] One of its objectives included identification of measures to facilitate the protection of “patent rights and IPR of medicinal plants”. One among several recommendations of the Task Force, was creation of a library to ensure collation of traditional knowledge on one platform, which is available digitally and is helpful in proving to the world that traditional medicinal knowledge with India is prior art due to which, patent applications based on such knowledge will not fulfil the criteria of novelty.[8] Thus, a database of India’s traditional knowledge, took birth.

Traditional Knowledge Digital Library (TKDL), is a database of over 2,50,000 formulations used in traditional medicine systems in India, namely, Ayuveda, Siddha, Unani and Yoga. TKDL is a pioneer initiative of India to prevent misappropriation of country’s traditional medicinal knowledge at international patent offices on which healthcare needs of more than 70% population and livelihood of millions of people in India is dependent.[9]

The world has noted India’s move towards a defensive protection in preparing the digital library, so as to curb biopiracy and misappropriation of traditional knowledge. However, mere acknowledgement is not sufficient, rather the implementation of an equitable benefit sharing mechanism which is imperative.

In 2005, the TKDL expert group estimated that about 2000 wrong patents concerning Indian systems of medicine were being granted every year at international level, mainly due to the fact that India’s traditional medicinal knowledge which exists in local languages such as Sanskrit, Hindi, Arabic, Urdu, Tamil, etc. is neither accessible nor comprehensible for patent examiners at the international patent offices.[10]

Conclusion

Knowledge is wealth and traditional knowledge has immense potential to resolve man’s budding problems. Exploitation of this knowledge is extremely important but it must be coupled with protection, promotion and benefit sharing.

Traditional knowledge may be termed as the IP family’s newest member. However, the decisions on tackling this child have to be taken considering several factors, besides the (un)willingness of nations. Correctly put, the knowledge system of informal sector i.e. traditional knowledge, is often oral and not properly documented, thus non-defendable.[11] India has taken a step ahead and created a repository of its ages old knowledge, which grows periodically but at an international level the need of a legal instrument becomes increasingly urgent. The linking of traditional systems of knowledge with a modern IPR system is the question of relevance.

A sui generis law is often pitched in as a probable solution for proper protection of traditional knowledge, however till the time a legislation is formulated, policies and ideas like the National IP Policy, Digital India and Startup India can rescue the fast fading system of traditional knowledge. It will not be wrong to suggest, that in order to secure the future of species and mankind, the current generation will have to help protect a fading generation’s valuable knowledge.

 

*Hetvi Trivedi is Research Associate, GNLU-GUJCOST Research Centre of Excellence in IP Laws, Policies & Practices.

[1]  Convention on Biological Diversity, available at <https://www.cbd.int/traditional/intro.shtml>, last visited on 4-4-2018.

[2]  WIPO, Traditional Knowledge and Intellectual Property, available at <http://www.wipo.int/pressroom/en/briefs/tk_ip.html>, last visited on 4-4-2018 .

[3]  WIPO, Traditional Knowledge and Intellectual Property, available at <http://www.wipo.int/pressroom/en/briefs/tk_ip.html>, last visited on 4-4-2018.

[4]  Ibid.

[5] National Biodiversity Authority, India’s Fifth National Report to the Convention on Biological Diversity, 2014, available at <http://nbaindia.org/uploaded/Biodiversityindia/5th_NationalReporttoCBD.pdf>, last visited on 4-4-2018.

[6] M.M. Pandey, Subha Rastogi and A.K.S. Rawat, Indian Traditional Ayurvedic System of Medicine and Nutritional Supplementation, Evidence-Based Complementary and Alternative Medicine (2013), available at <https://www.hindawi.com/journals/ecam/2013/376327/cta/>, last visited on 5-4-2018.

[7]  V.K. Gupta, An Approach for Establishing a Traditional Knowledge Digital Library, 5 JIPR 307 (2000), available at <http://nopr.niscair.res.in/bitstream/123456789/26010/1/JIPR%205%286%29%20307-319.pdf>, last visited on 4-4-2018.

[8]  Prashant Reddy T., Sumathi Chandrashekaran, Create, Copy, Disrupt: India’s Intellectual Property Dilemmas, 271 (Oxford University Press 2017).

[9]  Traditional Knowledge Digital Library, available at <http://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng>, last visited on 4-4-2018.

[10]  Ibid.

[11]  V.K. Gupta, An Approach for Establishing a Traditional Knowledge Digital Library, 5 JIPR 307 (2000), available at <http://nopr.niscair.res.in/bitstream/123456789/26010/1/JIPR%205%286%29%20307-319.pdf>, last visited on 4-4-2018.