Susanna Hall IST 618: Survey of Telecommunication and Information Policy Professor Raed Sharif Current Event Assignment

July 17, 2011

Innovative Patent Database Protects India's Traditional Medicine from Biopiracy

Gupta, V.A. "Protecting India's Traditional Knowledge." (June, 2011). WIPO Magazine. WIPO Publication No. 121(E). Retrieved from http://www.wipo.int/export/sites/www/ wipo_magazine/en/pdf/2011/wipo_pub_121_2011_03.pdf

What is WIPO? "The World Intellectual Property Organization (WIPO) is a specialized agency of the United Nations. It is dedicated to developing a balanced and accessible international intellectual property (IP) system, which rewards creativity, stimulates innovation and contributes to economic development while safeguarding the public interest." WIPO Magazine is published bimonthly by WIPO in Geneva, Switzerland. It is intended to help broaden public understanding of intellectual property and of WIPOs work.

The Issue: "Biopiracy" of traditional intellectual property India has centuries of Traditional Knowledge (TK) about medicinal formulations, and up until recently, this traditional medicinal knowledge has been held in ancient texts written in Sanskrit, Hindi, Arabic, Urdu and Tamil. For decades, when U.S. and European Patent offices have considered patent applications on, for example, tumeric's would-healing qualities and neem's antifungal qualities, they have erroneously granted these patents to Americans and Europeans because their "prior art" records have held no public information in languages they can read (if "prior art" information exists, then new patents cannot be granted because they are not new inventions). The result? Erroneous patents have long been considered "biopiracy" by the indigenous people of India, and a great deal of distress has been felt because a valuable asset has been taken away--this Traditional Knowledge "plays a critical role in their health care, food security, culture, religion, identity, environment, trade and development." Moreover, these patents have conferred exclusive rights to U.S. and European patent-holders to exploit the healing powers of a number of traditional medicinal plants--such as green tea, pomegranates, and pink lotus--and have thus constituted "a very real economic threat to Indian producers and their freedom to operate in foreign markets."

The Solution: A unique institutional repository In 2001, a year in which approximately 2,000 erroneous patents were granted based on Indian medicinal systems, a database called the Traditional Knowledge Digital Library (TKDL) was created by Dr. Gupta, the author of this article, in collaboration with Indias Council of Scientific and Industrial Research (CSIR), and the Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy). The TKDL contains "34 million pages of formatted information on some 2,260,000 medicinal formulations" that were originally held in 148 books, and the formulations have been translated into English, French, German, Japanese and Spanish. Furthermore, the TKDL has pioneered an innovative classification system1 that expands the sections relevant to medicinal plants from one subgroup into 207, thus making information retrieval much faster for patent examiners. This database costs about US$1,000 and has already been purchased by the European Patent Office (EPO) and patent offices of Australia, Canada, Germany, the United Kingdom, and the United States. These offices have signed nondisclosure Access Agreements promising to use the TKDL for search and examination purposes only and to reveal its contents only to third parties for the purposes of citation. The TKDL database is also the most cost-effective way to prevent misappropriation of Traditional Knowledge because it also records third party observations--any instance in which a member of the public questions the novelty and non-obviousness of a patent application before it is granted. This built-in monitoring capability has already resulted in the successful opposition of hundreds of patent applications filed around the world. Before this database existed, people had to attempt to revoke a patent after it was granted, which was costly and usually took five to seven years. Now, immediate corrective action can be taken at no cost.

Impact of the TKDL: A sharp decline (44 percent) in the number of patent applications filed concerning Indian medicinal systems, particularly in relation to medicinal plants. Since July 2009, 215 patent applications relating to Indian medicinal systems for which third party TKDL evidence has been filed have been identified. Two cases have been reversed and 33 applicants have withdrawn their applications after seeing TKDL evidence of prior art.

Stakeholders: Dr. V. K. Gupta, Senior Advisor & Director of TKDL: His professional reputation hinges on the success of TKDL.

The Traditional Knowledge Resource Classification System (TKRC). 2

 Indias Council of Scientific and Industrial Research (CSIR): Led by Indias Prime Minister, Dr. Manmohan Singh, this research and development council includes the Department of Biotechnology, which will clearly benefit from the TKDL. The Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy): An Indian government department that aims to strengthen research institutions and colleges of Medicine and Homeopathy as well as promote and cultivate medicinal plants. Their interest is to strengthen and keep TK within India. WIPOs International Patent Classification (IPC) system has benefitted from the inclusion of TKDL data. WIPO itself ratified the TKDL, and since 2004, the IPC has been reformed to include the 207 subgroups pertaining to medicinal plants. IGC Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. A WIPO committee formed in 2000 that is working to create in international legal instrument to protect IP, genetic resources, TK, and folklore. The Traditional Knowledge Classification Task Force (China, the EU, India, Japan and the U.S.). This task force will likely work to create TKDLs in other developing countries. The European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) have purchased the TKDL and signed Access Agreements, but this does not mean that complex ethical and policy issues have been satisfactorily resolved around the issue of patent access to traditional knowledge. Patent applicants: Depending on their country of origin and their intent to patent a medicinal plant originating in India, applicants may either find the TKDL beneficial or harmful to their application. I dont know to what extent patent applicants are educated about the TKDL before they develop their applications. Third-party objectors: benefit greatly from the existence of the TKDL because they can more easily oppose a patent application before it is granted based on evidence within the database. Global Intellectual Property think tanks and watchdog organizations, such as IP Watch, a non-profit independent news service. My guess is that they would side with indigenous cultures patent rights to traditional knowledge.

Analysis: International policy implications: WIPO and many other countries have been inspired by the early success of the TKDL and are working to build consensus to develop a global framework and an internationally legally binding instrument that will protect the Traditional Knowledge of the worlds indigenous cultures from misappropriation. Dr. V. P. Guptas biography notes that several countries have sought Indias support in establishing similar systems for themselves, including the Republic of South Korea, Thailand, Nigeria, South Africa, Mongolia, and Cambodia. Over the coming years, databases like the TKDL could be developed in these and other countries, leading to numerous protections for indigenous peoples. This could strengthen systems of medical and homeopathic training, research, and practice in many developing countries--thus empowering these countries to have more economic power within and beyond their borders.
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Implications for innovation and access to / promotion of medicinal plant patents: Though the World Health Organization2 recommends the widespread use of databases like the TKDL, it also notes one of the key ethical dilemmas with respect to intellectual property rights-their ability to either open up or restrict access to medical knowledge. Human diseases are present in every country of the world, and every human has the right to access medicines, remedies, and medical systems (modern and/or traditional/homeopathic) that may alleviate or heal their pain. Western bioprospecting, biotechnology, and pharmaceutical companies fear that databases like the TKDL will prevent them from being able to develop modern medicines based on natural products if the countries that hold the patents on these products will not grant permissions to foreigners out of fear of misappropriation. Natural products have active ingredients that can be isolated, synthesized, and reproduced in order to create innovative medicines that can be commercially distributed. How should patent holders best provide access to traditional knowledge so that these innovations can benefit the the greatest number of people? How will the commercial benefits of such innovations be shared with traditional knowledge holders so that biopiracy will not result? If intellectual property is hoarded or restricted, will innovation be inhibited and global public health be harmed? Who will decide the most equitable way to share the results of research and development, and upon which terms will patent holders and researchers be able to mutually agree? These complex ethical conversations are ongoing between institutions such as the Convention on Biological Diversity, the World Trade Organization (WTO), and WIPO. Reflections (1) While Dr. Gupta was creating the TKDL, did he gain informed consent from traditional knowledge holders before including their information in the database? If he was mainly uploading medicinal knowledge from 148 texts, some of them ancient, who exactly did he ask for informed consent? If it is common knowledge in India that, say, tumeric can help to heal wounds, who really owns that knowledge? When traditional knowledge is not written in a text, who owns it? (2) In reviewing the list of TKDL Outcomes against bio-piracy, I cant help but wonder about biodiversity in general. When a natural resource/product grows in multiple geographical areas, who can claim ownership of its medicinal powers? In one example from the list, arjuna, an Indian herb used in Ayurvedic systems, was listed in the TKDL, so a patent application from Germany (hoping to develop an arjuna-based anti-aging skin treatment) was withdrawn. If arjuna only grows in India, this is understandable. Yet in another example, a patent applicant from the Netherlands who hoped to use grape juice and/or apple juice as a cardio-tonic was also presented with TKDL evidence and the application was withdrawn. Since apples and grapes grow in many countries, is this not an instance in which the TKDL may be unfairly restricting access?

World Health Organization (2006). Fostering Innovation in Developing Countries. In Public Health Innovation and Intellectual Property Rights. Report of the Commission on Intellectual Property Rights, Innovation, and Public Health. (Chapter 5, pp. 141-164). Retrieved from http://www.who.int/intellectualproperty/report/en/ 4