Gaining an insight into Traditional Knowledge Digital Library (TKDL) database will make one realize the magnitude and significance of Indian traditional medicinal system and heritage. Since primeval time, India has possessed an affluent traditional knowledge, which refers to knowledge inherent in aboriginal communities on diverse ways and means practiced to treat diseases, which have distressed people. This knowledge has generally been passed from generations to generations through oral means. Our prehistoric classical and other literature, encompass such information, which are often unapproachable by a common man and even when accessible remain to be exceptionally understood. Certification and documentation of existing traditional knowledge, available in public domain, on various traditional systems of medicine has gained importance to preserve the autonomy of Indian traditional knowledge and to protect it from being embezzled in the form of patents based on non-unique innovations.

The issue of biopiracy came into limelight in the late 1990s after Indian government successfully invalidated or restricted patents granted for turmeric and basmati rice by United States Patent and Trademark Office (USPTO) and for neem by European Patent Office (EPO). Due to the existence of India’s infinite traditional medicine knowledge in traditional languages like Sanskrit, Hindi, Arabic, Persian, Urdu, and Tamil, examiners at International Patent Offices (IPO) faced problems in terms of authenticating the invention claims due to inaccessibility to available traditional literature. Based on this happening and following India’s successful IPR battles on haldi (turmeric), neem and Basmati rice, department of AYUSH, government of India created a task force comprising of experts from the areas of traditional medicine systems of India (Ayurveda, Unani, Siddha and Yoga), patent examiners, IT experts, scientists and technical officers, for the creation of Traditional Knowledge Digital Library (TKDL). The first activity of TKDL was put on bench on June 1999 on “Recognition of need of creation of Traditional Knowledge (TK) data bases and need of support to developing countries by Standing Committee on Information Technology (SCIT) of World Intellectual Property Organization (WIPO)” during the Third Plenary Session of SCIT, WIPO under the Chairmanship of Dr. R. A. Mashelkar, the then Director General of CSIR, India. Finally and in a successful attempt, TKDL was initiated in 2001 as a joint collaboration between the Council of Scientific and Industrial Research (CSIR) and the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Dept. of AYUSH), Ministry of Health & Family Welfare, Government of India and is proudly considered as an Indian digital knowledge repository of the traditional knowledge, particularly about medicinal plants and formulations used in Indian systems of medicine. One of the major tasks included transcribing Sanskrit shlokas, which describe Ayurvedic formulations in text, using Traditional Knowledge Resource Classification (TKRC) devised for the purpose, so that any patent examiner, anywhere in the world can easily understand the provided information. In continuity, the information provided in TKRC is being structured under section, class, subclass, group and subgroup as per the International Patent Classification (IPC) for the convenience of its use by the international patent examiners. The entire 34 million pages of text related to traditional knowledge existing in local languages such as Sanskrit, Urdu, Arabic, Persian and Tamil has been consequently converted into five international languages such as, English, German, French, Spanish and Japanese. Accordingly, TKDL has shattered the language and format barriers and made the knowledge available to patent examiners in their own language and in a format which is easily understandable.

Progressively, TKDL is being crafted on the codified traditional knowledge on Indian Systems of medicine, Ayurveda, Unani, Siddha and Yoga. TKDL has also been able to set international specifications and standards for setting up of TK databases based on TKDL specifications. Regarding the system in which TKDL works, each sloka is read and converted into a structured language using Traditional Knowledge Resource Classification by subject (Ayurveda, Unani, Siddha or Yoga) experts. The codes are then filled into the data entry screen and the slokas are saved in the database. The translated version of all the TKRC codes is ported in the database and generalization is done by the subject experts. The codes, which get saved in meta data directory are converted into different languages based on Unicode Technology. Presently, the formulations are being converted into English, German, French, Japanese and Spanish languages. The converted format of the formulation is so easy and readable that it can be understood by a layman even though it is targeted for the better understanding of a patent examiner to make an appropriate and healthy decision. One of the major highlights of this system is that TKDL software along with its associated classification system i.e., TKRC does not transliterate; however it works on providing a knowledge-based conversion. The available options in the software also convert traditional terminologies into modern ones, for example, Jwar to fever, Turmeric to Curcuma longa, Mussorika to small pox, etc. TKDL includes a search interface and the search features include single or multiple word searches, complex Boolean expression search, Proximity search, Field search, Phrase search, etc in the form of simple and advance search options and also full text search and retrieval of traditional knowledge information on IPC and keywords in multiple languages. Searches can also be initiated using IPC and TKRC codes. TKDL serves as a bridge between formulations existing in local languages and a patent examiner at a global level, since the database provides information on modern as well as local names in a language and format understandable by the examiner.

As on February 2009, 81,300 formulations from Ayurveda, 1,09,000 formulations from Unani and 12,200 formulations from Siddha have been completed and documented in TKDL database. Besides, 500 yoga postures have been transcribed and by the end of 2009, 1500 asanas have been added based on scanned 35 ancient texts including the Hindu epics, the Mahabharata and the Bhagwad Gita, and Patanjali’s Yoga Sutras in terms of registering each native pose. Hitherto, a total of 2,02,500 medicinal formulations have been transcribed and the database is present in the form of 34 million A4 sized pages. The selection of books was done based on the decisions of the Task Force Committees of eminent experts from the respective fields of medicine. The main aim of the library is also to protect the ancient and traditional knowledge of the country from exploitation through biopiracy and issue of unethical patents, by documenting it electronically and classifying it as per international patent classification systems. Furthermore, the non-patent database serves to cultivate modern research based on accessible traditional knowledge.

In the year 2006, Indian government allowed access to TKDL to international patent offices, including European Patent Office (EPO), Japan and the UK with respect to non-disclosure clause. European Patent Office (EPO), one of the International Search Authorities and a regional office with 34 member states such as UK, France, Germany, Italy, Poland, Norway, etc has signed the TKDL Access Agreement. TKDL Access Agreement is distinctive in character and possesses inherent protections on non-disclosure to protect India’s interest and traditional heritage in opposition to any potential exploitation. In February 2009, agreements were signed with EPO, with United Kingdom Trademark & Patent Office (UKPTO) in January 2010 and with the U.S. Patent and Trademark Office (USPTO) after the summit meeting between US President, Barack Obama and the then Prime Minister, Manmohan Singh. Furthermore, in 2010, Union Environment Minister, Jairam Ramesh stated that since the initiation of TKDL, 148 books on Ayurveda, Unani, Siddha and Yoga have been transcribed in public domain and more than 34 million pages of information have been collected at an estimated cost of Rs 7 crore, amongst which at least 36 cases had been identified by the EPO and 40 cases by USPTO. Consequently, several countries and organizations such as South Africa, Mongolia, Malaysia, Kenya, Thailand, SAARC countries, African regional Industrial Property Organization are enthusiastic to imitate the TKDL model for preventing misappropriation of their own traditional knowledge.

According to the information provided in the CSIR website, currently, based on the approval of Cabinet Committee on Economic Affairs, access of TKDL is available to nine International Patent Offices (European Patent Office, United State Patent & Trademark Office, Japan Patent Office, United Kingdom Patent Office, Canadian Intellectual Property Office, German Patent Office, Intellectual Property Australia, Indian Patent Office and Chile Patent Office), under TKDL Access (Non-disclosure) Agreement. Furthermore, negotiations are under way to conclude the Access Agreement with Intellectual Property Office of Russia and Malaysia. As per the terms and conditions of the Access agreement, examiners of patent office can utilize TKDL for search and examination purposes only and do not possess any rights in revealing the contents of TKDL to any third party unless and until it is obligatory for the function of citation. Based on the prior art evidences from TKDL, pre-grant oppositions are being filed at various International Patent Offices. So far about 200 patent applications from various pharmaceutical companies of United States, Great Britain, Spain, Italy, China etc. have either been set aside/ withdrawn/ amended, based on the Prior art evidences present in the TKDL database. Mr. V K Gupta, former director of the TKDL group in CSIR, and who retired in 2013 narrated to a leading newspaper (Deccan Herald) about identification of 1,500 cases of biopiracy, out of which about 200 have been checked by patent examiners and gained victory over 180 cases. Still there are 1,300 anomalous cases to be investigated. The first case against Colgate was instigated during his term. While talking about economical benefit, Mr. Gupta stated that in the year 2000, the Union Commerce Ministry spent Rs 7.61 crore as legal fee to invalidate a patent examiner’s decision on basmati rice. Hence, so far, the TKDL has saved Rs 500 crore by avoiding such situations. The fruitful effort put forward by Indian government has been of great aid in allowing patent examiners to appraise patent applications and impede attempts to patent traditional knowledge as “new and novel” inventions and has been recognized as an effective approach for preventing the grant of erroneous patents at the International Patent offices.

TKDL is establishing itself as an effective restraint against bio-piracy and is being recognized as a global leader in the area of traditional knowledge protection. In 2011, an International Conference was organized by World Intellectual Property Organization (WIPO) in collaboration with CSIR on ‘Utilization of Traditional Knowledge Digital Library as a Model for Protection of Traditional Knowledge’, at New Delhi. Subsequently, WIPO in collaboration with CSIR and DIPP (Ministry of Commerce and Industry) organized an ‘International Study Visit to TKDL’ for 19 countries, who demonstrated interest in replication of TKDL. The most recent milestone of TKDL includes refusal of CGPDTM on the application no. 212/DEL/2006 entitled “A herbal preparation for the prevention and management of various types of Carcinoma” filed by Prof. S. S. Trivedi, India, based on the TKDL evidences.

As per the emerging news with respect to Indian traditional medicine, India has effectively blocked two patent claims of US consumer goods key company, Colgate-Palmolive, which wanted intellectual property right (IPR) cover on two oral compositions prepared from commonly consumed Indian spices and other herbs.

According to the previous reports, the decision for one of the patents was on hold for almost seven years, after the New York-based company filed a claim at the European Patent Register on September 29, 2008, for a composition including botanical extracts from three herbs, including cinnamon, which is commonly known as “dalchini” and is a common Indian kitchen spice, full of all the beneficial and medicinal values. Majorly all the Indian dishes include this precious spice, irrespective of the culture and religion. India opposed the claim using the on the basis of TKDL. Subsequently, two years after filing the first patent claim, Colgate-Palmolive stimulated another application in 2010 before the European Patent Office (EPO), seeking fortification for another oral composition again containing certain commonly known Indian spices like, nutmeg, ginger, “Bakul” tree, camphor, cinnamon, turmeric, Indian banyan, black pepper, long pepper, neem and clove. Colgate-Palmolive proposed in their application that the invention is for treating oral cavity diseases. Nevertheless, this invention was challenged in June 2014 by TKDL, which proved to the patent examiner the dearth of novelty in the Colgate claims based on the available data in ancient Indian texts, which have mentioned exploitation of extracts from these plants for similar disorders of known and unknown cause. Apparently, the claim was rejected in March 2015.

Moreover apart from Colgate, the other big competitors who are presently the targets of TKDL bullets are Nestle, L’Oreal, Avasthagen, Ranbaxy and Unilever.

TKDL has created a revolution around the world, predominantly in traditionally knowledge rich countries with an idea of appropriate utilization of traditional knowledge. The system ensures that erroneous patents are not granted due to lack of access to the prior art on traditional knowledge for patent examiners. As a prospective project, a people’s Register of Biodiversity, is being set up by the Indian government, to document and protect, traditional knowledge passed down through the oral tradition, under India’s National Biodiversity Act of 2002 and as per the suggestion of Mr. Gupta that manuscript based knowledge should also form a part of TKDL database apart from addition of more ancient text books, related efforts are on their way.

Based on the information provided by CSIR website, for entering into TKDL Access Agreement by a Patent Office, Dr. (Ms) Archana Sharma, Project Leader, CSIR Traditional Knowledge Digital Library Unit (Email: asharma@csir.res.in) could be contacted.