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August 15, 2012

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Can Our Ancient Knowledge Of Ayurveda Be Protected?


- Debolina Partap, AVP & Head Legal [ Wockhardt Limited ]
- Hiral Vimadalal, Executive Legal & IP [ Wockhardt Limited ]

Debolina Partap & Hiral Vimadalal

Ayurveda is as old as life. It is almost synonymous with consciousness. Apsvantarmritmapsu Bheshajam, which is a part of Atharva Veda, describes that water is the elixir of life and has has medicinal value.

Water is the primary necessity of the human body. Water purifies the body and gives energy. Water also possesses medicinal value. It frees the body from the various doshas (ailments) and is known as Bheshagya. It gives us good health, happiness and contentment. Water is an inseparable part of Ayurveda.

Ayurveda has its genesis in Atharva Veda. , and essentially deals with Science and the 'magic' of doshas. Doshas are exclusively referred to in the Ayurveda, and does not find mention in any other stream of medicine.

It has been quite a challenging journey for Ayurveda since time immemorial as its values, niceties, USPs, and the precision in formulations have got lost in the scientific maize of Allopathy and its steady "step sister"- Homeopathy. It is much known today as the "Jack of Alternate Healthcare"; many a time going in conjunction with Yoga, which is a mode of alternate therapy to medicine. Ayurveda and intellectual property associated with it holistically includes inter alia, knowledge, processes and knowhow relating to plant, animal and account for 45 percent of the European market. Survey shows that 60 to 90 percent people in mineral based medicines, spiritual therapies, manual exercises applied singly or in conjunction or in combination. The mantra "Return to Nature" is getting prominence today and that too from US and European countries. Interestingly, today herbal medicines the UK rely on complimentary medicines. Therefore, it is imperative to see that Ayurveda from a clinical as well intellectual property protection perspective gets it due globally, and not just in India.

Ayurveda can be best described as the traditional k nowledge of mother nature, which is a matter of great interest in the existing legal regime. Traditional Knowledge refers to knowledge, innovation and practices of indigenous and local communities around the world. Traditional knowledge is, essentially, the knowledge which is stored in human memory and passed down through generations by word of mouth or by way of certain rituals. It can be described as a blend of knowledge and experience integrated with a value system. Till the year 1977, the term "folklore" was used to describe traditional knowledge. WIPO also recognized this concept in 1985.

Types of Ayurvedic Researches


The field of Ayurveda has a vast scope for research in variety of ways. Here are a few examples:

    1. Literary Research: This is the most important but the most neglected type of research. Finding out various kinds of manuscripts, studying them and then selecting a few and concentrating on them is the first step. Bringing out critical editing of available texts is itself a tedious and time consuming job. The work is most important because it is really the basis for any kind of research in Ayurveda. Exploration of textual information in variety of ways is another kind of literary research, which we have undertaken by the name Triskandha Kosha.
    2. Fundamental Research: Many Ayurvedic concepts are still unknown e.g. Rasa ( taste). In modern medicine, importance is given to food calories, but the taste of food is just neglected. On the contrary, the whole basis of study of a substance is the ‘Rasa’ according to Ayurveda. A fundamental research is a must to explore many such things.
    3. Clinical Research: This has been much tried until now, but the approach is of modern medicine. It is like finding out anti-diabetic activity of an Ayurvedic medicine. No doubt, first preference will go to those areas where modern medicine has very little success or no success at all, e.g. hepatitis, arthritis, I. T. P, multiple sclerosis, cancer, AIDS etc. But the method of clinical research should be such that it benefits Ayurveda e.g. we have undertaken cancer research project. It's a primary study and we want to understand cancer in Ayurvedic terms. Once this is achieved, we can think of Ayurvedic treatment. This way, clinical research can be taken up for any disease.
    4. Drug Research: There is a misunderstanding between the concept of drug and treatment. Many people believe both to be one and the same. Treatment is basically understanding the disease and intellectually fixing up the guidelines. So, drug research today has been confined to only clinical trials of a particular drug in a particular disease. This attitude needs to be changed. Identification of herbs, standardization of processes of manufacturing, analysis and toxological study of medicines containing gold, silver etc. are important drug researches yet unexplored to much extent.
    5. Inter Disciplinary Research: The philosophy of Ayurveda has been derived from various Indian philosophies. There are so many areas, where inter disciplinary research can be taken up e.g. Yoga and Ayurveda, Astrology and Ayurveda etc. This will definitely enlighten various unseen factors.

Protection of Ayurveda


India is known in the world for its rich heritage and its vast and deep rooted traditional knowledge in music, dance, language, Mathematics and most importantly, its traditional and ancient knowledge in medicinal regimes such as Ayurveda, Unani, Siddha, Naturopathy and Homeopathy. Out of all these, Ayurveda is widely exploited the world over.

Sadly, it was only after the patenting of Neem and Turmeric (Haldi) in the US that India realized the treats that that traditional knowledge faces. This brought to the fore the defensive and positive rights that were required to protect traditional knowledge in the domain of Ayurveda. It was in the case of “Jeevani” that we realized how “protection” and “conservation” could sometimes be in conflict when it becomes “unsustainable”.

Ayurveda, as traditional knowledge, can be protected in the regimes discussed below:

The Patents Act, 1970


Under the Patents Act, 1970, an invention must be new, involve and inventive step and be capable of industrial exploitation. The concerns of the holders of traditional knowledge in protecting it under the Patents Act, is two-fold. First, for those seeking protection, certain aspects of traditional knowledge may be known and are therefore not novel and do not involve an inventive step. Second, for those seeking to prevent others from obtaining patent protection, the concern is of publicizing certain aspects of traditional knowledge so as to prevent others form patenting it, because upon its publicity, that aspect of traditional medicine is not new and hence loses novelty. Two new sub-sections have been inserted in Section 25 by the Patents (Second Amendment) Act, 2002, providing that a patent can be revoked for ‘non-disclosure of the source or geographical origin of biological material used for the invention’ and ‘knowledge, oral or otherwise, available within any local or indigenous community in any country’

Trade secret and traditional knowledge are inter-related in some ways. Over the years, traditional knowledge may have become known not necessarily being kept as a secret. However, there are secret regimes which control knowledge in a secret manner, albeit not rigid. Medicinal knowledge is protected by groups in such secret regimes for a number of reasons; the personalized nature of the healing process induces a private knowledge of botanical resources and for the healer, these plants are an extension of his knowledge. While a lot of our medicinal knowledge has been documented in Sanskrit literature, various aspects of it have been transmitted through secret instructions within families of healers.

The Biological Diversity Act does not prohibit grant of intellectual property rights over biological resources, it only states that any person intending to apply for a patent or any other form of protection must apply to the National Biodiversity Authority (NBA), which may grant approval for the same subject to any conditions, as it deems fit. However, it recognizes only two rights; sovereign rights of the government and the private rights of the company and/or individual. Holders of traditional knowledge are not expressly included in this. However, such holders can claim protection under “benefit claimers”, which means conservers of biological resources, their byproducts, creators and holders of knowledge and information relating to the use of such biological resources.

The Protection of Plant Varieties and Farmers’ Rights Act confers plant breeders’ rights and hence introduces intellectual property rights to our agriculture. Traditional knowledge might be appropriated as plant breeders’ rights, but without compensating any in situ conservation effects.

The Act talks about traditional knowledge in two levels; farmers’ rights and rights of local communities.

Certain plants and ingredients used in Ayurveda preparations are native to the Indian soil and climate. Hence, such plants and ingredients can be protected under the Geographical Indications Act and be exploited by communities so protecting it.

Case Studies: Defensive and Positive Rights in Traditional Knowledge


In March 1995, a US patent on “use of turmeric in wound healing” was awarded to the University of Mississippi Medical Centre. The claim covered “a method of promoting healing of a wound by administering turmeric to a patient afflicted with such wound”, including surgical wounds and body ulcers.

In India, every person is aware of the the properties of turmeric, which is applied on cuts and bruises and is an essential ingredient in daily food to prevent infection in the body. In the mid 1996, the Centre for Scientific and Industrial Research (CSIR) requested USPTO to revoke the said patent on the basis that turmeric powder is widely known in India and is used for its healing properties, and that a great deal of scientific research has already been undertaken by Indian scientists that confirms the existence of these properties. The patent was revoked after CSIR’s challenge on the basis of absence of novelty. Hence, this brings to light the defensive right (right to stop others from using traditional knowledge) held in respect of traditional ancient knowledge.

In 1987, scientists from the Tropical and Botanical Garden Research Institute (TBGRI) discovered anti-fatigue properties of arogyapaccha, a plant growing in the forests and used by the Kani Tribals. TBGRI, through various tests and analysis, was successful in preparing a herbal drug, which was named “Jeevani” and was released for commercial exploitation in 1995 by Arya Vaidya Pharmacy. TBGRI agreed to share the license fee and royalty with the tribal community on a fifty-fifty basis. Hence, this case brings to light the positive right (right to exploit) held in respect of traditional knowledge.

Traditional Knowledge Digital Library (TKDL)


The TKDL is the creation of CSIR, being an effort to record every known traditional treatment and thus pre-empt its patenting as a novel idea. It is a traditional knowledge resource and records 45,000 medicinal plants that went into a web site containing 35,000 ayurvedic shlokas. Efforts to link it to the International Patent Classification are underway.

Need for a sui generis regime


Due to the intricate nature of traditional knowledge and the lack of definitive protection for this rich and vast intellectual property, there is a need for a sui generis regime to protect traditional knowledge.

A system which identifies traditional ecological and biological knowledge is being suggested to protect against bio-piracy. The broad policy objectives are; determination of protectable subject matter; ownership of rights and procedure for acquiring such rights.

Future Initiatives to Safeguard this Science Globally, there is an increasing interest in alternative routes to health such as Ayurveda. There is a need to conduct globally acceptable clinical research in ayurvedic therapeutics (AT). Some of the issues in investigating AT in randomized clinical trials (CT) are: selection of appropriate AT, non-drug and/or drug AT, identification of objective outcomes, devising adequate placebo/positive controls, difficulties of blinding, guarding against bias, duration of trials, number of patients, dose optimization, etc. There is also a need to establish reasonable safety of this therapy in CT. If AT has to compete with new chemical entities and biotechnology products, clinical research and development of AT should focus on unmet medical needs utilizing principles and practices of modern CT approaches.

In India, according to CII, there is a potential to attract 1 million tourists per annum through medical tourism. Ayurvedic Systems are can help attract more medical tourists. According to CII, Yoga, meditation, Ayurveda, Allopathy help India offer a unique basket of services to an individual that is difficult for other countries and too in a price effective package.

Following steps can help promote and protect Ayurveda and our traditional knowledge:

    1. More streamlined clinical research studies in Ayurveda could prove the effectiveness in immunological diseases like diabetes, thyroid, cancer, HIV, etc. These studies should be recognized under special laws and become liable for drug protection, innovative research registrations besides patent, and other regulatory protections.
    2. Adequate government and private sponsorships and funding should be made available for such clinical research and studies.
    3. Special protection should be conferred by the Government through drug protection in the case of life saving drugs pertaining to heart, brain, lungs, liver, etc in the field of Ayurveda.
    4. The proper protection of proprietary intellectual data requiring investment in time, resources and creativity is the key to an effective IPR Policy and even for this area. Without adequate safeguards in place, the owners and creators of such ayurvedic data and formulations are seriously prejudiced and there is a disincentive to generate it in the first place. As an example, the existence of 10 years of data protection has already encouraged some European pharmaceutical companies to invest in the development of non-patent protected drugs. The GOI should take appropriate steps to provide effective protection of trade secrets.
    5. The Government should ensure through continuous monitoring that this balance which the IP laws seek to achieve is maintained with changing times in the medical world.
    6. The Government should organize IP awareness programmes with respect to Ayurveda aimed at raising awareness about the importance of Ayurveda. It should also support awareness programmes organized by private bodies.

Ram Rajya:


In Ramayan, when Lakshman was severely wounded during the battle against Ravana, Hanuman is sent to fetch the Sanjivani, a powerful life-restoring herb, from Dronagiri mountain in the Himalayas. The herb revives Lakshman. If inspiration is to be drawn from this fable or legend or history, then Ayurveda is the only science which can perhaps unravel the mystery of death and find a final solution to it. The laws and the law makers should make efforts to protect this invaluable stream of knowledge and sceince.

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