India: Traditional Knowledge And Patent Issues: An Overview Of Turmeric, Basmati, Neem Cases.

Introduction

Traditional Knowledge (TK) is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity1. Traditional Knowledge per se that is the knowledge that has ancient roots and is often informal and oral, is not protected by conventional intellectual property protection systems. This scenario has prompted many developing countries to develop their own specific and special systems for protecting traditional knowledge. India has played a very significant role in the documentation of traditional knowledge thereby bringing the protection of traditional knowledge at the centre stage of the International Intellectual Property System. Provision of Traditional Knowledge Digital Library (TKDL) Access (Non-Disclosure) Agreements with several international patent office's including USPTO, EPO, JPO etc. by Indian Government has led to many patent applications concerning India's traditional knowledge have either been cancelled or withdrawn or claims have been amended in several international patent offices2.

Traditional Knowledge Digital Library

TKDL is a pioneer initiative of the Indian Government, and came to the fore due to the

India's efforts on revocation of patent on wound healing properties of turmeric at the USPTO and the patent granted by the European Patent Office(EPO) on the antifungal properties of neem. India's traditional medicinal knowledge 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. It was identified by the TKDL expert group in 2005 that annually around 2000 patents were granted around the world erroneously concerning Indian system of medicine by patent offices around the world. TKDL provides contents of the ancient texts on Indian Systems of Medicines i.e. Ayurveda, Siddha, Unani and Yoga, into five international languages, namely, English, Japanese, French, German and Spanish, with the help of information technology tools and an innovative classification system - Traditional Knowledge Resource Classification (TKRC) Bio-piracy and Misappropriation of TK.

The use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products and processes that have been used over centuries in non-industrialized culture can be defined as "bio-piracy". In other words bio-piracy means misappropriation of traditional knowledge with an intention to gain patent protection over that knowledge. Devolution, encroachment, the bio prospecting rush, lack of appropriate legal systems and a clash of systems all make traditional knowledge highly vulnerable to bio-piracy. Traditional knowledge is associated with biological resources which in turn is a component of biodiversity. The clues/ leads provided by TK can be utilized to develop best practices/processes/ system for mankind without the investment of huge amount of money for research and results validation through clinical trials in labs, above all such knowledge saves time. In the recent past, several cases of bio-piracy of TK from India have been reported. The following are the most prominent cases with regards to misappropriation of TK from India.

Turmeric Patent

Turmeric is a tropical herb grown in east India. Turmeric powder is widely used in India as a medicine, a food ingredient and a dye to name a few of its uses3. For instance, it is used as a blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also used as an essential ingredient in cooking many Indian dishes. In 1995, the United States awarded patent on turmeric to University of Mississippi medical center for wound healing property. The claimed subject matter was the use of "turmeric powder and its administration", both oral as well as topical, for wound healing. An exclusive right has been granted to sell and distribute. The Indian Council for Scientific and Industrial Research (CSIR) had objected to the patent granted and provided documented evidences of the prior art to USPTO. Though it was a well known fact that the use of turmeric was known in every household since ages in India, it was a herculean task to find published information on the use of turmeric powder through oral as well as topical route for wound healing. Due to extensive researches, 32 references were located in different languages namely Sanskrit, Urdu and Hindi. Therefore, the

USPTO revoked the patent, stating that the claims made in the patent were obvious and anticipated, and agreeing that the use of turmeric was an old art of healing wounds. Therefore, the TK that belonged to India was safeguarded in Turmeric case.

Neem Patent

The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA in European Patent Office. The said patent is a method of controlling fungi on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition has been filed by India against the grant of the patent. The legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP)4. A tree legendary to India, from its roots to its spreading crown, the Neem tree contains a number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree are used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and ulcers. Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents' submitted evidence of ancient Indian ayurvedic texts that have described the hydrophobic extracts of neem seeds were known and used for centuries in India, both in curing dermatological diseases in humans and in

protecting agricultural plants form fungal infections. The EPO identified the lack of novelty, inventive step and possibly form a relevant prior art and revoked the patent. Apart from this, several US patents were recently taken out Neem-based emulsions and solutions.

Basmati patent

The US patent office granted a patent to 'RiceTec' for a strain of Basmati rice, an aromatic rice grown in India and Pakistan for centuries .Rice is the staple food of people in most parts of Asia, especially India and Pakistan. For centuries, the farmers in this region developed, nurtured and conserved over a hundred thousand distinct varieties of rice to suit different tastes and needs. In 1997, in its patent application Ricetec also acknowledged that "good quality Basmati rice traditionally come from northern India and Pakistan...Indeed in some countries the term can be applied to only the Basmati rice grown in India and Pakistan." However, the company then went on to claim that it had invented certain "novel" Basmati lines and grains "which make possible the production of high quality, higher yielding Basmati rice worldwide." The Indian Government had pursued to appeal only 3 claims out of 20 claims made in the original patent application of RiceTec Inc. What were being challenged were only claims regarding certain characteristics of basmati (specifically starch index, aroma, and grain dimensions)5. It is to be noted that WTO Agreement does not require countries to provide Patent protection to plant varieties. It only requires countries to legislate so that plant varieties are protected

in some manner (not necessarily through patents). However, US being a strong proponent of Patent protection of plant varieties allowed the patent application. Three strains development by RiceTec are allowed patent protection and they are eligible to label its strain as "Superior Basmati Rice". Therefore, in Basmati case, RiceTec altered the strain through crossing with the Western strain of grain and successfully claimed it as their invention and the case is an example of problems illustrated in TRIPS with regards to patenting biotechnological processes.

TKDL as Global IP watch systems

"Global IP watch monitoring systems have an important role to play in enabling the identification of published TK-related applications on which third parties – in accordance with the patent law of the country concerned – may file observations."6

Advantages-

  1. TKDL has enabled the submission of third party observations (TPOs) which has proven the only cost-effective way of misappropriation of TK at the pre-grant stage.
  2. TKDL has enabled successful opposition of hundreds of patent applications filed around the world.
  3. Enables immediate corrective action to be taken with zero cost so as to prevent bio-piracy.

Conclusion

It is to be noted that the IP world has acknowledged the importance of successful

documentation of indigenous TK like India's TKDL- play a role in defensive protection within the existing IP system. As suggested by World Intellectual Property Organization (WIPO) as a global measure to curb bio-piracy and misappropriation of TK the following strategies are discussed. Inventions based on or developed using genetic resources (associated with traditional knowledge or not) may be patentable or protected by plant breeders' rights. The other couple of measures considered, discussed and developed by WIPO7 are firstly, defensive protection of genetic resources which aims at preventing patents being granted over genetic resources (and associated traditional knowledge) which do not fulfill the existing requirements of novelty and inventiveness. The said measure further entails the possible disqualification of patent applications that do not comply with Convention on Biological Diversity (CBD) obligations on prior informed consent, mutually agreed terms, fair and equitable benefit-sharing, and disclosure of origin. Secondly, WIPO members want to make it mandatory for patent applications to show the source or origin of genetic resources, as well as evidence of prior informed consent and a benefit sharing agreement.

Footnotes

1 http://www.wipo.int/pressroom/en/briefs/tk_ip.html

2 http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_39_1_5-tk-guidelines.pdf

3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038276/

4 http://www.countercurrents.org/bhargava140709.htm

5 http://www.delhiscienceforum.net/intellectual-property-rights/87-victory-on-basmati-by-amit-sen-gupta-.html

6 http://www.wipo

7 http://www.wipo.int/pressroom/en/briefs/tk_ip.html

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