25 Mar, 2011
India Leads Battle Against Bio-Piracy Of Traditional Knowledge
NEW DELHI: While European and U.S. companies and governments seek to combat violations of their intellectual property rights in the developing world, their own companies are quietly attempting to patent thousands of years of traditional knowledge developed by the indigenous peoples of Asia, Africa and Latin America. At stake are billions of dollars worth of profits to be made in the rapidly-expanding health & wellness sector, including medical tourism.
Representatives from more than 35 countries wrapped up a three-day meeting in New Delhi that explored ways of emulating India’s Traditional Knowledge Digital Library (TKDL), a database documenting traditional medicinal treatment, to help protect potentially life-saving centuries-old traditional medicines from “bio-piracy”, a term that is defined as “misappropriation through international patents granted on non-original innovations.” India is the only country in the world to have set up such an institutional mechanism to protect its traditional knowledge and to prevent grant of wrong patents.
Co-organized by the UN World Intellectual Property Organization (WIPO) and India’s Council of Scientific and Industrial Research (CSIR), the March 22-24, 2011 conference was addressed by speakers from countries that are rich in traditional knowledge, such as Indonesia, Ecuador, Indonesia, Kenya, Peru, Republic of Korea and Thailand.
According to the India’s Ministry of Science and Technology, the genesis of TKDL dates back to the Indian effort on revocation of patent on wound healing properties of Turmeric at the US Patent & Trademark Office and anti-fungal properties of Neem at European Patent Office. In 2000, the TKDL expert group estimated that about 2,000 wrong patents concerning Indian systems of medicine were being granted every year at international level, mainly due to the fact that India’s traditional medical knowledge existing in languages, such as Sanskrit, Hindi, Arabic, Persian, Urdu, Tamil etc. was neither accessible nor comprehensible for the patent examiners at the international patent offices.
The TKDL technology integrates diverse disciplines (Ayurveda, Unani and Siddha), languages (Sanskrit, Hindi, Arabic, Urdu, Persian and Tamil), modern science and modern medicine. It has created a unique mechanism for overcoming the language and format barriers by scientifically converting and structuring the available information contents of 34 million A4 size pages of the ancient texts into English, Japanese, French, German and Spanish.
Through TKDL, a Sanskrit verse can now be read in international languages by an examiner at any International Patent Office on his computer screen enabled by two important features of TKDL: Relevant information technology tools and a novel classification system – Traditional Knowledge Resource Classification (TKRC). Today, through TKDL, India is capable of protecting about 226,000 medicinal formulations similar to those of Neem and Turmeric.
DRAMATIC SUCCESS
On an average, it takes five to seven years for opposing a granted patent at international level which may cost US$200,000 to US$600,000. Making this information available, via Access and Non-Disclosure Agreements, to six major international patent offices, the TKDL, coupled with India’s global bio-piracy watch system, has, according to the CSIR, achieved dramatic success in preventing the grant of erroneous patents, at minimal direct cost and in a matter of a few weeks.
TKDL has made waves around the world, particularly in rich countries by demonstrating the advantages of proactive action and the power of strong deterrence. The idea is not to restrict the use of traditional knowledge, but to ensure that wrong patents are not granted due to lack of access to the prior art for Patent examiners.
Mr Pawan Kumar Bansal, Union Minister of Science and Technology, Earth Sciences and Vice President, Council of Scientific and Industrial Research, said, “Today, India is well equipped to protect 226,000 formulations within a time range of ‘days and weeks’ and without any cost, whereas in the cases of ‘Neem’ and ‘Turmeric’ the country had to incur huge cost and it took more than 10 years to get the ‘Neem’ patent revoked at EPO. TKDL has been embraced by the World Intellectual Property Organization and by the EPO and US-PTO as well as other patent offices worldwide who have found in it a powerful weapon to fight biopiracy.”
The Minister explained that Traditional Knowledge is also the basis of the livelihood of a very large population in the world, in particular, in developing countries. He added, “ The issue of Traditional knowledge protection is quite a sensitive one, since traditional knowledge is the information that people in a given community, have developed over generations, on the basis of their experience and which is adapted to local culture and environment.
“Many countries are struggling to protect their traditional knowledge, against wrongful exploitation, primarily in the pharmaceutical sector. This knowledge is used to sustain the community and its culture, as well as biological resources necessary for the continued survival of the community. As per World Health Organization reports, it is estimated that more than 70% of the population is dependent on traditional medicines for their primary health care needs,” the minister said.
Closing the conference which he called “path-breaking… extremely successful,” WIPO Executive Director Naresh Prasad said TKDL could be a model for the protection of traditional knowledge. Such knowledge is a source of innovation and could inspire life-saving medicines, he said, adding that it should also be shared and communities should participate and benefit. “It is up to Member States to tell us if and how to proceed and where to take things from here,” Mr. Prasad said, calling on them to provide feedback on whether they wish it to enter into an institutional arrangement with the CSIR to facilitate the sharing of the TKDL model.
FULL COOPERATION EXTENDED
Minister Bansal also assured participants “all cooperation will be extended to all of you, in particular, to WIPO, so that countries rich in traditional knowledge and biodiversity, desirous of adopting TKDL as a model of traditional knowledge protection, are able to do so.”
WIPO is a specialized UN agency that 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 Director General Francis Gurry praised India’s leadership in taking domestic and international action to combat misappropriation of the wealth of traditional knowledge. He said India’s TKDL could be a good model for others and WIPO is ready to facilitate international collaboration for countries which were interested in establishing their own systems.
Mr Gurry described the TKDL approach as complementary to the work currently underway in WIPO’s Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, where WIPO’s 184 member states are negotiating an international legal instrument to ensure the effective protection of TK and traditional cultural expressions, and to regulate the interface between IP and genetic resources.
“The IGC’s negotiations are about developing the international legal architecture. In parallel, however, there is an important supplementary role for practical initiatives, which can change the international landscape often faster than legislative or normative approaches,” said Mr. Gurry, noting “The TKDL is an excellent example of a technical platform which can work alongside legislative frameworks and support them.”
Mr. Gurry cautioned that there is no one-size-fits-all solution and that the Indian model might need to be adapted to the specific situation of individual countries. In countries where indigenous peoples and local communities are recognized as holders of TK, wide consultations and adherence to the principle of free, prior and informed consent might be essential. In countries where TK is mainly oral, additional steps might have to be added to collect and record TK.
There are also, in some quarters, political concerns associated with TK documentation projects, which are perceived by some as “facilitating biopiracy”, since documentation projects may facilitate access to TK that was not publicly available before or TK that had been disclosed without the free, prior and informed consent of affected indigenous and local communities.
More About the Traditional Knowledge Digital Library
(Source: Ministry of Science & Technology, India)
The TKDL is a collaborative project between the Council of Scientific and Industrial Research (CSIR), Ministry of Science and Technology, and the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH), Ministry of Health and Family Welfare, of India, and is being implemented at CSIR. An inter-disciplinary team of Traditional Medicine (Ayurveda, Unani, Siddha and Yoga) experts, patent examiners, IT experts, scientists and technical officers were involved in the creation of the TKDL for Indian Systems of Medicine.
After fighting successfully for the revocation of turmeric and basmati patents granted by United States Patent and Trademark Office (USPTO) and neem patent granted by European Patent Office (EPO), India initiated its project for the creation of a Traditional Knowledge Digital Library (TKDL) in 2001. The TKDL seeks to prevent the granting of patents over products developed utilizing TK where there has been little, if any, inventive step. The TKDL is intended to act as a bridge between information recorded in ancient Sanskrit and a patent examiner, since the database provides information in a language and format understandable to patent examiners. By facilitating access to information not easily available to patent examiners, the TKDL minimizes the possibility of patenting “inventions” for minor/insignificant modifications.
TKDL contains information for patent examiners on prior art which would otherwise be available only in Sanskrit and other local languages in Indian libraries and it will precisely list the time, place and medium of publication for prior art search of patent examiners.
Access to the TKDL database was granted to EPO in February 2009, the India Patent Office (CGPDTM) in July 2009, to the German Patent Office (DPMA) in October 2009, to USPTO in November 2009, to the United Kingdom Patent and Trademark Office in February 2010, to the Canadian Intellectual Property Office in September 2010 and to IP Australia in January 2011. These patent offices are allowed to utilize the TKDL for prior art searches and patent examinations. However, patent offices cannot reveal the contents of the TKDL to any third party, to protect India’s interest against any possible misuse.
Since the grant of access in February 2009, the EPO has identified 36 patents making use of Indian TK. In some cases, the EPO set aside its intention to grant the patent, while in others applicants withdrew their application and similar results are expected by the CSIR for the rest of theses cases. This could prevent engagement in legally complex and extremely expensive opposition processes, according to the CSIR.
Misappropriation of traditional knowledge and bio-piracy of genetic resources are the issues of great concern for all the developing countries. These issues are being pursued at several multilateral forums, such as Convention on Biological Diversity, TRIPs Council, World Trade Organisation and World Intellectual Property Organisation. However, so far a ‘global framework’ for traditional knowledge protection system has not been established. It is mainly for this reason that Mexico had to fight a legal battle for 10 years to get the patent on Enola bean at the United States Patent & Trademark Office (USPTO) cancelled in July 2009. Similarly, the cancellation of Monsanto Soybean patent in July 2007 at the European Patent Office (EPO) took 13 years of legal battle.
In 2000, the TKDL expert group estimated that about 2,000 wrong patents concerning Indian systems of medicine were being granted every year at international level, mainly due to the fact that India’s traditional medical knowledge existing in languages, such as Sanskrit, Hindi, Persian, Arabic, Urdu, Tamil etc. was neither accessible nor comprehensible for the patent examiners at the international patent offices.
The TKDL technology integrates diverse disciplines (Ayurveda, Unani and Siddha), languages, modern science and modern medicine. It has created a unique mechanism for overcoming the language and format barriers by scientifically converting and structuring the available information contents of 34 million A4 size pages of the ancient texts into five international languages, namely, English, Japanese, French, German and Spanish.
Through TKDL, a Sanskrit verse can now be read in these languages by an examiner at any International Patent Office on his computer screen enabled by two important features of TKDL: Relevant information technology tools and a novel classification system – Traditional Knowledge Resource Classification (TKRC). Today, through TKDL, India is capable of protecting about 226,000 medicinal formulations similar to those of Neem and Turmeric. On an average, it takes five to seven years for opposing a single granted patent at international level which may cost US$ 200,000 – 600,000.
India has already signed TKDL Access Agreement with (i) European Patent Office (Feb 2009), (ii) United State Patent & Trademark Office (Nov 2009), (iii) Canadian Intellectual Property Office (Sep 2010), (iv) German Patent Office (Oct 2009), (v) United Kingdom Patent & Trademark Office (Feb 2010) and (vi) Intellectual Property, Australia (Jan 2011). In-principle Agreement has been reached with the Japan Patent Office while negotiations are under way to conclude the Access Agreement with the Intellectual Property Office of New Zealand.
These unique international Access Agreements are expected to have long-term implications on the protection of both traditional knowledge and global intellectual property systems in view of the fact that in the past, patents have been granted at various patent offices on the use of over 200 medicinal plants due to the lack of access to the documented knowledge in public domain. Also, 40-50 patent applications based on Indian traditional knowledge are awaiting grant of patent at any point of time.
Significant impact has already been realized at EPO after the signing of the Access Agreement. Beginning July 2009, TKDL team has so far identified about 230 patent applications at EPO which concern Indian systems of medicine and filed third party TKDL evidences at EPO. In two such cases, EPO has already set aside its earlier intention to grant patents after it received TKDL evidence. In one case, the applicant modified its earlier claims. In other thirty three cases, the applicants themselves decided to withdraw their four-to-five year old applications on being confronted with TKDL evidence which is a tacit admission of bio-piracy by applicants themselves.
It is expected that in the balance 200 plus cases, either EPO would reject these applications or applicants themselves would withdraw their wrong claims/patent applications in coming months. In addition, TKDL evidences against misappropriation in 400 more cases have been submitted at other International Patent offices. Similar outcomes are also expected at the other International Patent Offices.
Loading ...
Liked this article? Share it!