India’s struggle to protect traditional medicines against ‘biopiracy’
5/03/2009

Under normal patenting procedures, a patent application should be rejected in cases in which information regarding the invention has been disclosed publicly.

Therefore, in an effort to protect and avert groundless patenting leading to commercial exploitation of traditional medicines inherent to India, the Indian government recently permitted access to its Traditional Knowledge Digital Library (TDKL), a unique database that houses ancient texts and methods, to examiners at the European Patent Office (EPO).

This initiative came into play after the startling discovery by scientists in Delhi of the extent of “bio-prospecting” of natural remedies by foreign countries.

The UK’s Guardian newspaper reveals that an investigation of government records had shown that 5000 patents had been issued, at a cost of at least US$150 million, for “medical plants and traditional systems”. “More than 2000 of these belong to the Indian systems of medicine,” claims Vinod Kumar Gupta, head of the National Institute of Scientific and Informative Resources (NISCAIR). The discovery raised the question of why multinational companies are spending millions of dollars to patent treatments that they claimed were ineffective, Gupta said.

In order to discontinue multinational companies from patenting traditional remedies from local plants and animals sources, the Indian government has effectively licensed 200 000 local treatments as “public property”, making the local remedies free for everyone but not to be branded for sale.

The database, which took more than 150 researchers almost a decade to compile, and involved meticulously translating ancient Indian text and information that details the 200 000 treatments. This database will now be used by EPO examiners to prevent attempts at patenting existing traditional knowledge, a practise described as “bio-piracy”. Also, access to the 30-million-page database will help to correctly examine patent applications relating to traditional knowledge.

“With the TKDL, examiners have improved access to the background information at an early stage of patent examination. In an old scenario, a patent may have been granted and the countries had to present evidence against it after the fact,” said Paul Schwander, Director of Information Acquistion at the EPO. (See a similar article on the Indian bio-piracy issue published on the EPO's website.)

In an aim to protect prior art, the TKDL permits examiners to compare patent applications with existing traditional knowledge. New patent applications will be required to demonstrate significant improvements and inventiveness compared to prior art in the relevant field. If the medical use of an herb is a traditional practice, and thereby public knowledge, it is considered prior art under EPO regulations. “Even if a treatment is only available in Sanskrit (an ancient Indian text) in an Indian library, it belongs to the prior art because it had been disclosed openly in the public domain at an earlier point in time,” Schwander explained.

In cases in which a company wants to patent the medical use of an herb listed in the TKDL, EPO examiners carry out a thorough search. “In some cases this will lead to the reduction of the scope of the patent or its refusal,” Schwander said. However, a patent may still be granted to a company on a new method for industrial-scale production of the active ingredient of the herb, if the process is new and inventive, Schwander explained.

He further stated, “The public may perceive this as bio-piracy, but there is a difference. The patent applicants would not claim ownership of the active ingredient itself. The scope would then be limited to a method of producing or isolating the ingredient.”

The course of legal action to challenge granted patents had proved lengthy, costly and burdensome in the past, said Schwander. This drawn-out procedure was largely attributed to the extensive translation of traditional knowledge which had only been documented in Sanskrit or other ancient writings.

Prominent legal battles of patent disputes that dragged on for more than a decade included a US patent on the wound-healing properties of tumeric which was revoked in 1997 and an anti-fungal product from the Indian Neem tree which was revoked in 2008.

In these cases, India succeeded because it was possible to prove that the patented methods were not innovative and were derived from traditional Indian knowledge. Schwander explained that the TKDL database system could prevent countries with rich traditional and holistic knowledge that often have to spend a lot of money on opposition procedures by helping the EPO to grant patents of proper scope.

Efforts to protect traditional medicines in India has strengthened the demands that India, supported by countries such as Brazil, Cuba, Kenya, the European Union (EU), Pakistan and Switzerland, has made at the World Trade Organisation (WTO) that the protection of biodiversity and associated traditional knowledge be incorporated into the WTO’s Agreement on Trade-Related Aspect of Intellectual Property Rights, or TRIPS Agreement.

Support for such a move has been patchy. More than 100 WTO Members, including the EU, Brazil, China and several African countries, have indicated their support for amending the TRIPS Agreement by incorporating provisions to ensure the protection of traditional knowledge. Furthermore, these countries have demanded that a TRIPS amendment to examine bio-piracy should be viewed as a prime priority, instead of being relegated as a secondary concern.

However, the TRIPS amendments have also been strongly opposed by countries such as the United States, Japan, Singapore, Korea, New Zealand, Canada, Australia and Argentina, among others, which argued that more technical talks and practical evidence should be brought forth, before commencing with negotiations on such an amendment. Up to date no progress in attending to this issue has been made in view of the failure to reach an agreement in world trade discussions at the end of July last year.

Estimates have shown that a quarter of new drugs produced in the US are derived from plants and that 42% of the population in the US and 70% of the population in Canada have used traditional medicine at least once for treatment. These results have indicated that there are growing interests in the use of traditional medicines. Gupta said that it cost the West US$15 billion and 15 years to produce a “blockbuster drug”. This is owing to the fact that most drugs have to undergo extensive clinical trials to evaluate their potency.

The lifespan of a patent is 20 years, which implies that a pharmaceutical company has only five years to recover its development costs, which therefore makes conventional treatments very expensive. Gupta further argued that an active ingredient can be isolated from a natural remedy, which is only followed by drug trials and marketing procedures. He is positive that traditional medicine could herald a new age of cheap drugs.

This initiative by the Indian government to take stern action to overcome bio-piracy stems from the belief that the developing world’s rich biodiversity could be a source which offers a wide variety of essential precursors for the synthesis of novel drugs and crops, important for drug discovery.

REFERENCES

• “India’s Traditional Knowledge Digital Library (TKDL): A powerful tool for patent examiners” – European Patent Office, http://www.epo.org/topics/issues/traditional.html.
• “India Moves to Protect Traditional Medicines” – ICTSD, http://ictsd.net/i/news/bridgesweekly/41660/.
• “India hits back in ‘bio-piracy’ battle” – BBC News, http://news.bbc.co.uk/1/hi/world/south_asia/4506382.stm.
• “India tries to protect traditional medicines” – Digital Journal, http://www.digitaljournal.com/article/267811.
• “India moves to protect traditional medicines from foreign patents” – FOCUS Information Agency, http://www.focus-fen.net/?id=n171850.
• “India moves to protect traditional medicines from foreign patents” – The Guardian, http://www.guardian.co.uk/world/2009/feb/22/india-protect-traditional-medicines.

Dr Natasha October
Medicinal Chemistry Expert
natasha-o@adamsadams.co.za

Adams & Adams