Traditional Knowledge And Patient Issues In India- Concerning Biopiracy

Introduction:
India is a mega diverse country with 6-7% of world’s biodiversity, with 100 million forest dwellers and tribal communities who have, accumulated over generations, the traditional knowledge of using around 10000 of such species. The economic value of this traditional knowledge in pharmaceutical sector is estimated to be around 5 trillion.
It is prudent to say that, the traditional knowledge about using local flora and fauna has helped the indigenous people live sustainably, in harmony with the environment for generations.
Contrary to traditional knowledge, which promotes community interest, patent laws encourage private ownership, profit and monopoly. In the current commercial world, the amalgamation of traditional knowledge and patent laws have gained importance.
Traditional Knowledge:
Even though TK is not expressly defined in WIPO, it considers TK as knowledge, skills, know-how and practices, developed from intellectual activity, sustained and passed on from one generation to other within a community, often forming a part of the community’s cultural or spiritual identity. WIPO’s program on TK also addresses traditional cultural expressions (TCEs) and genetic resources (GRs).[1]
It is a living body of knowledge, within people’s minds, closely intervened with their lives and involving the resources around them. The entire community is thus deemed as the collective owners of TK, rather than having any individual owners. It’s mostly kept oral and undocumented because the communities fear that, documentation or disclosure of the knowledge, will lead to loss of its purity or value and the resources may fall prey to exploitation.
Indigenous people’s TK covers various fields like agricultural, ecological, scientific, medicinal, technical, as well as about biodiversity.
Since Traditional Knowledge is mostly oral, undocumented and informal, it is difficult to protect it under the conventional system of intellectual property protection.
Basics of Patent:
Section 2(m)[2] of The Patents Act says “patent” means a patent for any invention granted under the act.
The term invention here, is defined in 2(j)[3] as, a new product or process involving an inventive step and capable of industrial application.
Sec 3 of the patents act, when stating what are all not considered inventions, says an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components is not considered invention under section 3(p).[4]
Patentability of TK:
From the above definitions it is clear that traditional knowledge cannot be patented because such knowledge lacks the three main components of an invention namely, a new product or process, inventive step and capability of industrial applications.
Even though TK has industrial applications, the other 2 conditions are not satisfied. It cannot be considered a new product under section 2(l) because it has been known for generations and attains the character of prior art and also available in public domain and inherently lacks novelty. The inventive step aspect of it cannot be proved. So there cannot be any limitation or prevention of commercial use of this knowledge.
Then how can TK be protected?
There are two modes of protection of TK namely, defensive protection and positive protection. The former prevents illegitimate use of TK by the third party, while the latter encourages the exploitation of the TK for the communities’ benefit.
So even though we can’t grant patent of traditional knowledge to the communities that possess them, we can still prevent others from learning the knowledge from them, patenting it in their own name and exploiting them.
One such common exploitation faced by Indian traditional knowledge is bio-piracy.
Bio-Piracy and its effects on India:
When IP systems are used to legitimize the exclusive ownership and control of a single or a group of persons or a company, over the biological resources, products and processes, that belongs to and have been used over centuries by developing/non-industrialized or indigenous culture can be defined as bio-piracy. In other words bio-piracy can be simply stated as the misappropriation of traditional knowledge with an intention of obtaining patent protection over that knowledge, without crediting the original owners.
They illegally make use of traditional knowledge and reap benefits out of such exploitation without obtaining prior consent or sharing the benefits with communities.
India is one of the few countries that are worst affected by bio-piracy, exploiting its rich flora and fauna and the ancient knowledge of its indigenous tribes. So it’s no surprise that India has always been a forerunner at combating the misappropriation of its traditional knowledge by foreign corporate entities and research organizations.
India’s steps to combat Bio-Piracy:
At international level:

At the WTO forum, India had initiated discussions on the issue of bio-piracy.[5]
India and other like-minded nations have been demanding, the disclosure in the patent applications, information like, source or origin of biological resources and evidence of prior informed consent and benefit sharing with communities, with the aim of reducing the chances of traditional knowledge exploitation and ensure protection to the local communities.
These countries have also proposed to amend TRIPS agreement to make such disclosure mandatory.
Within the nation:
Indian Parliament has passed many specialised legislations like National Biodiversity Act 2002, Protection of Plant Varieties and Farmers Rights Act 2001, Geographical Indication of Goods (Registration and Protection) Act 1999, and Scheduled Tribes and other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006 etc., that helps to protects traditional knowledge exploitation and emphasising on mandatory prior permission from the indigenous communities by any entity, before they seek IPR protection based on their traditional knowledge.
The patents act 1970, was amended in 2002, to introduce a new obligation in Section 10(4)[6], to disclose the source and geographical origin of the biological material mentioned in the patent application. This addition also does not violates the TRIPS agreement Article 27[7].
The patent applications based on TK, if not fulfilling the appropriate conditions, can be rejected under section 15[8] or section 25 (1) under clauses (d), (f) and (k) in pre-grant opposition and section 25 (2) under clauses (d), (f) and (k) in post-grant opposition.[9]
Section 64(1) allows for revocation of a patent on violation of the conditions given in section 10(4).[10]
It also requires all patent applications relating to Traditional Knowledge to be properly identified, screened and classified as “Traditional Knowledge” by RECS Section of Patent Office. This administrative process facilitates the examination process. The Examiner when considering an application based on TK, will carry out a search for anticipation[11] in TKDL or similar databases, and if the citation is made, then copy of the citation will be sent along with the final examination report (FER).
TKDL[12]:
Traditional Knowledge Digital Library is a product of collaborative effort of the Government of India through the Council of Scientific and Industrial Research (CSIR) and the Ministry of AYUSH. Its main function is to gather information on traditional knowledge existing in different parts of India, belonging to various indigenous communities, in various languages and compile it under a single repository, to be used as a reference of prior arts for patent examiners at International Patent Offices (IPOs).
It is a digitized portal available in public domain, containing ancient texts of traditional medicinal knowledge in the form of Ayurveda, Yoga, Unani, Siddha and Homeopathy 13, in five international languages, namely, English, Japanese, French, German and Spanish.
TKDL is a pioneer initiative of the Indian Government, created to backup India’s claims in their efforts to revoke patents on wound healing properties of turmeric and the antifungal properties of neem.
A TKDL task force report states that annually around 2000 patents are granted erroneously around the world, concerning the Indian traditional systems of medicine.
The two important features of TKDL are Accessibility and Availability.
It provides information in local language in the 5 internationally accessible languages, the accessible format of TKDL resembles a patent application, TKDL’s new classification, known as the Traditional Knowledge Resource Classification (TKRC), is similar to the structure of International Patent Classification (IPC)[14]. Every entry of TKDL mentions both TKRC and IPC codes. Thus making it accessible and easier for the patent examiners.
Considering availability, even though the complete form of TKDL is only available at certain national patent offices for use by patent examiners, a version of the same database is available at the TKDL website with about 1200 listings.
Another advantage of TK is that it can help save huge amounts of money on research and development, testing and results validation, and help develop best products, processes or practices.
TKRC:[15]
Traditional Knowledge Resource Classification (TKRC) is unique classification system of TKDL. TKRC has identified, structured and classified the traditional Indian Traditional Medicine System for AYUSH in around 25,000 subgroups.
It uses information technology tools and an innovative classification system to combat Bio-piracy and Misappropriation of TK.
All these steps by India to document the traditional knowledge has not only brought the importance of its protection at the centre stage of the International Intellectual Property System, but also provisions like Access (Non-Disclosure) Agreements with different international patent offices like USPTO, EPO, DPMA, CIPO, JPO, etc.[16]. By Indian Government has led to many patent applications concerning India’s traditional knowledge to be either been cancelled or withdrawn or amended.
The following are the most prominent cases with regards to misappropriation of TK from India.
• Turmeric- 2 US scientist were granted US patents in 1995 for use of turmeric in healing wounds and inflammation [17].
• Neem (Azadirachta indica) – a bio pesticide agent called Margosan-O was derived from neem oil and patented in US in 1985.
• George Williamson & Co had applied for patenting the age old method of manufacturing and packaging tea in UK.
• Cromak Research Inc. in US was awarded patent, for a composition made from mixture of brinjal, bitter gourd and black berry claiming to treat and cure diabetes.[18]
• A dozen patents were granted in US for different uses of Aswagandha (Withania somnifera) including treatment for insomnia, depression, gastric ulcers, and convulsions and as a supplement for healthy joints.[19]
• RiceTec Inc. was granted patent for a new plant variety that is a cross between American long-grain rice and Basmati rice[20], while Syngenta tried to patent around 23 thousand Indian rice varieties.
• Use of hessian cloth (jute) to cover waste and dumping grounds was patented in UK
• Eight formulations involving the use of Ginger (Zingiber officinale) for treating cough and cold was granted patents in US
• Patent for Indian Wheat variety, NapHal was claimed by Monsanto, the biggest seed corporation[21] and another patent was claimed for the, so called novel method of processing Atta by ConAgro[22].
• A claim for patent was made in Germany for a formulation using aloe Vera to treat obesity.
• Mint and green chiretta (Andrographis Paniculata/ kalmegh) used to treat ailments ranging from sour throat to H1N1 avian influenza, was patented by a Chinese company.[23]
• Pomegranate’s anti diarrhoea properties was patented in US[24]
• Pepper’s skin treatment properties granted US patent
• US granted patents for 13 claims for goose berry/amlas’s benefits.
India challenged all the claims, with the support of research papers, ancient texts and the likes of TKDL and has managed to revoke most of them.

In 2011, WIPO in collaboration with CSIR organised an International Conference was on ‘Utilization of Traditional Knowledge Digital Library as a Model for Protection of Traditional Knowledge’, at New Delhi, where facilitated an ‘International Study Visit to TKDL’ for 19 other countries who wanted to replicate of TKDL in their own country.
The legitimate rights of the TK holders of TK are acknowledged in the UN Convention on Biological Diversity (CBD),[25] which envisions three objectives including conservation of biological diversity, the sustainable use of its components, and equitable sharing of benefits arising from utilization of genetic resources.
Achieving a balance between patents and TK:
As stated by patent act and Biodiversity Act, 2002. Section 2(a)[26], read with Sec. 6 (2), [27]the concept of benefit sharing will help find a midway between patent issues and TK.
One such success story was the Jeevani case. Where the people of Kani tribe of Kerala shared their traditional knowledge that the fruits of Jeevani plant reduced fatigue, a formulation using the TK was patented by Tropical Botanical Garden Research Institute, and they shared 50% of their revenue with the Kani tribe.
Conclusion:
Traditional Knowledge, can be called the cultural backbone of India. After industrial revolution, though we have concentrated more on technological knowledge, in recent years, indigenous communities and governments, mainly from developing countries, have demanded equivalent protection for traditional knowledge systems. Many countries have developed special systems for protecting TK. India’s brain child was the TKDL, which has proved to be a strong tool in battling bio-piracy, by preventing unlawful claim of rights over existing knowledge of TK.
Since TK is a valuable resource with a lot of potential, it has to be explored to bring economic growth and development in the country. While doing so, there is a need to maintain a balance between the profit and commercial aspects relating to IPR and benefits and protection of the rights of the native communities, thus maintaining the socio-economic harmony of the nation.
Submitted by-
Deepikka R S

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