Indian medicines made safer from patent piracy

Traditional Indian medicines, comprising some 200,000 formulations, should from n ow on be safe from 'pirate' patenting in the West. Armed with a recently-created data base of traditional medicines, the government has finally managed to reach an agreement with the European Patent Office (EPO) to prevent the wrongful grant of patents relating to Indian systems of medicine.

Close to 2000 wrong patents of medicines prescribed under the ayurvedic, unani and sidha yoga systems are still being granted annually at the global level, causing financial loss to India. The most blatant examples are the grant of a patent on the wound healing properties of turmeric in 1995 by the US Patent and Trademark Office, and on the anti-fungal properties of neem granted by the EPO.

These cases led to an initiative in 2001 to create a 'traditional knowledge digital library' (TKDL) database. Now, after over eight years of toil by a team of over 200 scientists and experts from the Centre for Scientific and Industrial Research (CSIR) and the union health ministry's Ayush department, the TKDL has been made available to the patent examiners from the EPO and its 34 member nations.

So far, foreign companies have got away with wrong patents because India's traditional medicinal knowledge existed only in Sanskrit, Hindi, Arabic, Urdu and Tamil - languages which international patent examiners did not understand. But TKDL has scientifically converted the information into open domain textbooks in five international languages - English, Japanese, French, German, and Spanish.

All this information has been made available in 30 million pages to EPO. So far 81,000 formulations in Ayurveda, 104,000 in Unani, and 12, 000 in Sidha yoga have been digitalised under TKDL. However, TKDL's information will be restricted only for patent search and examination purposes. EPO will not be able to disclose the information to a third party.

Under a three-year agreement with the EPO that came into effect on 3 February, TKDL's database would be available to the patent examiners at EPO (34 member states) "for establishing prior art", in case of patent applications based on Indian systems of medicine (ISM). While India will help EPO with search assistance, EPO will inform India every three months about what data was used as citation from the TKDA.

"Now patent examiners at EPO will be in a position to establish prior art in case they receive patent applications based on Indian systems of medicine. They can thus refuse the grant of new patent," said V K Gupta, IT head, CSIR, who played a key role in creating the TKDL.

"For example, if someone wants to patent the sexual healing properties of white mulberry, examiners would know that such qualities already exist in Indian traditional formulations. If TKDL existed earlier, then international disputes regarding patenting of neem, turmeric and basmati would not have occurred," Gupta added.

The Indian government is also in talks with the US Patents and Trademark Office (USPTO) to extend the initiative to that country. Gupta said that a study conducted in 2000 showed that 80 per cent of the 4,896 medicinal plants that were patented under the USPTO were on plants of Indian origin.

"In a study of 760 such patents, we found 350 patents should have never been granted. Over 200-500 such patents are granted every year, mainly due to the lack of access to documented knowledge in India," Gupta said.

Till this development, all India could do was oppose a wrong patent in case it had the relevant information. It takes about five to seven years to oppose a granted patent at the international level and the process costs about Rs3 crore per case. Thus, the country has lost over 15,000 patents of medicinal plants to the West.

Patents have been granted by the European Patent Office (EPO) on the use of over 285 traditional Indian medicinal plants such as papaya, Indian long pepper, kali tulsi, pudina, ginger, aloe, isabgol, aaonla, jira, soybean, tomato, almond, walnut and methi. Ayush secretary S Jalaja said, "People will now think twice before even applying for such dubious patents."

The TKDL has become a model for other countries wanting to defend their traditional knowledge from misappropriation. South Africa, Mongolia, Nigeria, Malaysia and Thailand have asked India to help them replicate TKDL.