India leads the way in protecting traditional knowledge

Intellectual property laws have fallen well short of providing appropriate legal protection and guaranteeing returns on indigenous knowledge, such as varieties of crop plants or herbal remedies, or newly-exploitable resources such as genetic diversity. Now India is setting up a database to establish prior art on traditional knowledge.

To date, international systems of intellectual property law have failed to protect traditional knowledge. After long and often heated discussions on the subject on 8 December 2006, member governments of the World Intellectual Property Organisation (WIPO) agreed the need to bring genetic resources within the framework of international law.

The WIPO Inter-governmental Committee (IGC) will meet again in July to assess how concrete progress can be made.

But by then India expects to be one step ahead, after opening its newly built Traditional Knowledge Digital Library (TKDL), for international patent searching. The country is currently negotiating agreements with the patent offices in the United States, the European Union, and Japan, a move that was triggered by a 2005 inquiry from the EU patent office to be granted access to the Library.

The roots of TKDL go back to 2001, when the Council of Scientific and Industrial Research (CSIR) in New Delhi decided to translate and digitise all available information on traditional medicine.

Undocumented and unpublished (traditional) knowledge is not considered ‘prior art’ by patent offices. The CSIR argued that capturing all formulations from ancient texts in a digital database would make it so.

“To date we have documented more than 120,000 formulations from over 100 texts belonging to the three principal systems of traditional medicine,” says Vinod Kumar Gupta, architect of the project, and head of Information Technology at CSIR in New Delhi.

Since India has built TKDL on a system of classifying resources (used in traditional knowledge) which is in line with the International Patent Classification (IPC), the latter has consented to include the Indian classification system.  

The 30-million page encyclopedia will be available in five languages – English, Spanish, German, French and Japanese. It contains information on traditional medicines and carries exhaustive references, scans of original ancient texts and photographs of the plants.

The crushing need

The original idea was put forward in 1997 when India fought an expensive patent battle to revoke a US patent on turmeric, a yellow spice used in Indian curries, granted for its wound healing properties.

“It’s an age-old grandma’s remedy in India, but the US patent was granted because the US patent office had no clue what the medicinal properties of turmeric are. Now that TKDL has been prepared, grant of such silly patents can be prevented,” says Muhammad Majeed, chairman and managing director of Sami Labs, a bioscience company in Bangalore. Sami Labshas accused a US raw materials company, DNP International, of infringing its patent on bioprine (a pepper extract), which is used widely in health supplements.

Sami Labs is also preparing to defend another US patent on curcumin, which it says is being violated by many US manufacturers. The industry, believes Majeed, can firmly build on the TKDL foundation. “You tell the world, these resources exist; and if anyone develops anything novel out of this, one can seek a patent,” he argues.

Officials say India has been losing hold on its genetic resources by the year. According to the National Institute of Science Communication and Information Resources in New Delhi, which built TKDL, in 2000 almost 80 percent of about 5,000 references to the plant-based medicinal patents in the US Patent and Trademark Office related to seven medicinal plants of Indian origin.

“In 2005, references to plant-based patents worldwide went up to 35,487. We estimate that about 2,000 patents misappropriating Indian resources are being granted every year,” says Gupta. One of the reasons Gupta cites for overlooking India’s interests is that of over 130 academic journals used by the international patent offices for searching prior art, hardly any are published in developing countries.

“We managed to get two CSIR journals – Medicinal and Aromatic Plant Abstracts and Indian Journal of Traditional Knowledge – included in the patent examiners’ search list,” says Gupta. He is confident that the mere presence of TKDL has deterred global life sciences industry from misappropriating traditional medicine resources. “I am told since June 2006, when the Indian government gave its approval to make TKDL accessible to patent searches, the number of patent applications with references to Indian medicinal plants has reduced,” says Gupta.

India seeks to demonstrate that international harmonisation on these issues is welcome. Many other countries including Japan, South Korea, South Africa, Pakistan, Maldives, Indonesia, Thailand, Cambodia, the African Regional Industrial Property Organization (representing 18 countries on the continent) and the International Property Office in Singapore have shown an interest in developing similar databases.

International debates and expected delays

The European Union and countries including Brazil, India, Pakistan, Thailand and Peru are proposing an amendment the World Trade Organisation’s TRIPS (Trade-related aspects of intellectual property rights) seeking disclosure of the source of origin of genetic resources in a patent application.

But some developed nations including the US, Australia, and Japan are opposing the proposal on grounds that it does not fulfill the criteria of ‘patentability’ (novelty, inventiveness, and industrial application) and hence is not necessary.

At the same time Switzerland has proposed an amendment to WIPO’s Patent Cooperation Treaty that will allow countries to seek such disclosure in patent applications. Since the Swiss proposal involves voluntary disclosure of source, and does not raise complex issues like prior informed consent or benefit sharing, it is believed that getting international consensus would be faster.

In the interim, WIPO IGC has developed draft provisions for the protection of Traditional Knowledge (TK). “Until last month, there was a stalemate because some countries opposed text-based discussions on the ‘provisions’, recognising that the mandate of IGC includes ‘development of a legal instrument or instruments,” says Shakeel Bhatti, Head, Genetic Resources, Biotechnology and Associated Traditional Knowledge Section at WIPO.

The IGC has agreed to work on the basis of a ‘list of issues’ that will guide further discussions and development of the outcomes.

“Future sessions of the IGC will decide whether they are able to translate this mode of proceeding into concrete progress towards outcomes or not,” says Bhatti.

But that’s easier said than done, especially when one needs to establish the lineage of the TK and also decide what’s the most appropriate way of protecting. “So long as TRIPS clarifies all this and doesn’t create confusions as it did in the case of software (software patent versus software copyright), to please multiparty consensus, I am happy,” says Mary Mathew, a faculty at the IP cell of Indian Institute of Science in Bangalore.

Global negotiations are not easy, agrees Mary, as there is “multiparty pull in polarized directions to opposing actions” but the international community can learn from ‘consensus’ laws that create more confusion than ever intended.

Database, laws are fine; scientific tools are needed too

Having a database of traditional knowledge and folklore is no doubt important, but it’s a “double-edged sword” says Gupta, who thinks “if not properly safeguarded it would add to misappropriation.”

Moreover, a database by itself will not yield commercial benefits, which is the anticipated goal of most such efforts. Bio prospecting is often based on the assumption that genetic resources are invaluable for pharmaceutical and industrial products. “These resources are of limited value unless they are accompanied by significant investments in fields such genome sequencing, combinatorial chemistry and bioinformatics,” cautions Calestous Juma, professor of the Practice of International Development, Belfer Center for Science and International Affairs, Harvard University in Cambridge.

Those who have such capabilities, says Juma, will derive products from genetic resources. “In the long-run, advances in science will make biological resources less useful and firms will turn to bio-informatics and other tools for leads in drug development,” he cautions.