India in the WTO

Indian scientists have completed an eight-year task of translating and compiling Indian traditional knowledge into a database (that lists over 200,000 treatments and extends to 30 million pages) to prevent patents being granted on this knowledge by overseas patent jurisdictions. The library which has an online home will be made accessible to patent examiners in the European Patent office to prevent attempts at patenting existing traditional knowledge. The EPO and the Government of India have entered into an access agreement that should be interesting to look at. Here is the news item from the website of the EPO:

India’s Traditional Knowledge Digital Library (TKDL): A powerful tool for patent examiners

On 2 February 2009 the Indian government granted access to its Traditional Knowledge Digital Library (TKDL), a unique database that houses the country’s traditional medical wisdom, to examiners at the European Patent Office (EPO).

EPO examiners will use the extensive database to prevent attempts at patenting existing traditional knowledge, a practice described as "bio-piracy".

The co-operation between India and the EPO comes at a time when many countries are struggling to protect traditional and respected knowledge against exploitation, primarily in the pharmaceutical sector.

"We take this seriously. Countries with rich traditional and holistic knowledge often have to spend lots of money on opposition procedures. The database could prevent that by helping the EPO to grant properly scoped patents", said Paul Schwander, Director of Information Acquisition at the EPO.

An improved patent granting process

Experts at the EPO say that 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 background information at an early stage of patent examination", Schwander said. "In the old scenario, a patent may have been granted and the countries had to present evidence against it after the fact".

Prominent cases of patent disputes include a US patent on the wound-healing properties of turmeric (revoked in 1997) as well as an anti-fungal product from the Indian Neem tree (revoked in 2008). Both herbal practices were evidence of traditional knowledge and the patents were rescinded.

In both instances, the Indian government needed to prove that the patented methods were not novel and were based on traditional knowledge. The process to challenge the granted patents proved lengthy and cumbersome as some traditional knowledge had only been documented in Sanskrit or other ancient writings and thus required extensive translation.

With the advent of the TKDL however, the once onerous process has been transformed into an organised and objective system. The texts, many of which are hundreds of years old, offer extensive details about ancient medical practices and can now be accessed digitally.

Moreover, the TKDL has translated these texts – first written in Hindi, Sanskrit, Arabic, Persian and Urdu – into English, French, German, Japanese and Spanish, granting easier accessibility to examiners.

A unique encyclopaedia

The TKDL is the result of a US$ 2 million joint project between five Indian government organisations, including the Council of Scientific and Industrial Research (CSIR) and the National Institute of Science Communication and Informative Resources (NISCAIR).

Under the direction of Vinod Kumar Gupta, the head of NISCAIR, more than 150 experts in traditional medicine, law and computer science spent the past ten years arranging and classifying the TKDL.

Highlights of the vast database include:

• 54 authoritative textbooks on ayurvedic medicine
• Nearly 150,000 ayurvedic, unani and siddha medicines
• Over 1,500 physical exercises and postures in yoga, more than 5,000 years old

Protecting prior art

The TKDL allows examiners to compare patent applications with existing traditional knowledge. New patent applications need to demonstrate significant improvements and inventiveness compared to prior art in their 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 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 said.

If a company seeks to patent the medicinal use of an herb listed in the TKDL, EPO examiners conduct a thorough investigation. "In some cases this will lead to a reduction of the scope of the patent or its refusal", Schwander said.

However, the company may still be granted a patent on a new method for industrial-scale production of the active ingredient of the herb, for example, if this process is new and inventive, Schwander explained.

"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".

Shedding light on gray areas

The TKDL is so precise that it lists the time, place and medium of publication for prior art. This new catalogue system, called the Traditional Knowledge Resource Classification (TKRC), ensures meticulous documentation.

The classification sheds light on what used to be considered gray area. Before the advent of the TKDL, any bio-prospector for a pharmaceutical company could dig up ancient medical wisdom and lay claim to the practice’s healing ability without consequence.

Now, thanks to the TKDL, patent examiners can prove exactly when and where a medical treatment became public knowledge, stymieing would-be bio-pirates.

A collection aimed at Patent Offices

Examiners at the EPO will use secure access methods to work with the TKDL. To measure efficiency, the EPO will count cases in which the database proved helpful.

Other countries have also opened their digital archives on traditional medical knowledge to EPO patent examiners. In 2008, the Chinese patent office (SIPO) granted the EPO access to its 32 000-entry database on traditional Chinese medicine.

"It’s a win-win situation for all involved. These databases help the EPO improve the relevance and content of prior art searches, while the countries holding traditional knowledge can protect their assets against misappropriation", Schwander said.

A Mint story gives more background:

The Indian government is also in talks with the US Patents and Trademark Office, or USPTO, to extend the initiative to that country.

The Council for Scientific and Industrial Research, or CSIR, India’s largest state-managed research agency, will begin sharing the home-grown catalogue with EPO later this month. CSIR and EPO recently signed an access agreement to this effect. This will likely result in at least 40 patent filings in Europe getting rejected, which could have otherwise passed muster.

“The EPO doesn’t give a patent for an invention which has already been known in public anywhere else,” Rainer Osterwalder, director, media relations, EPO, told Mint by email.

The Traditional Knowledge Digital Library, or TKDL, has been created by the National Institute of Science Communication and Information Resources, or Niscair, a CSIR body, and contains a 24-million-page searchable database that translates text from Sanskrit into English, German, French, Spanish and Japanese.

“TKDL provides a new major source…in technical fields that are sometimes concerned with questions of traditional knowledge,” Osterwalder said.

CSIR has collaborated with the health ministry’s department of Ayush (Ayurveda, yoga and naturopathy, unani, siddhi and homeopathy) to make this happen.

A CSIR official said that though 2,000 existing patents can now be challenged, there were no plans to initiate litigation. “This is meant as a deterrent…though technically we can initiate litigation saying that these patents are based on well-known formulations, it would be too expensive and long-drawn,” the official said on condition of anonymity.

“This is a very positive step for us in protecting traditional knowledge. It’s a big achievement,” Samir Brahmachari, director general of CSIR, said over the phone. The next step is to take this initiative to the US. S. Jalaja, secretary, department of Ayush, said: “This is a big breakthrough for us and we are also in talks with the United States Patent and Trademark Office for a similar agreement.”

This will likely result in at least 40 patent filings in Europe getting rejected

Patenting of products that are based on of India’s traditional knowledge has long been an issue the government has been struggling to resolve. In a widely reported case, EPO in 1995 granted a patent on the anti-fungal properties of neem. India opposed the patent, which was finally revoked and invalidated after 10 years of litigation. Again in 1995, USPTO had granted a patent on the wound healing properties of turmeric that was revoked in 1997.

“India did fight successfully the revocation of patent on wound healing property of turmeric at United States Patent and Trademark Office and (a) patent on anti-fungal properties of neem at European Patent Office,” Niscair director V.K. Gupta, who is also lead coordinator for the project, said in a 2006 report. “However…(a) legal battle on revocation is extremely expensive and time consuming.”

For anything to be granted a patent, the applicant must prove that it is novel and not previously known. “Indian traditional knowledge is prior art, which means it is already known publicly. Hence, once TKDL opens out to EPO, anyone applying for a patent on which we hold traditional knowledge will not be successful,” said Elizabeth Varkey, an advocate at the Kerala high court.

“Any patents that have been granted already and fall under TKDL can also be revoked, though that would be a long, expensive process,” she said.

EPO, however, is unsure of the extent to which TKDL will be applicable. “Many cases affected by aspects of traditional knowledge are occurring in the field of medicinal preparations. We estimate that at the EPO, about 100 patent applications per year are related to such aspects, but not all of them relate to subjects covered by TKDL,” Osterwalder said.

There is an argument that the database be used other ways too. “The government should also think about negotiating access rights (to TKDL) to private parties and other non-governmental entities. Given that the new chemical entities pipeline is drying up, innovators need to focus more on traditional knowledge that offer potentially unique insights for new drugs,” said Shamnad Basheer, professor of intellectual property law at the National University of Juridical Sciences, Kolkata.

“Also private parties could then challenge patent applications that misappropriate Indian traditional knowledge.”

The comment by Shamnad Basheer quoted above on granting access rights to private parties and NGOs is interesting but likely to raise issues of compensation for use of this knowledge by private parties. The codification of this knowledge in a repository owned by the government will have ramifications for who will now benefit from this.

The Independent has a report today about an Indian govt project to compile a multi-lingual digital database of traditional knowledge.

See http://news.independent.co.uk/world/asia/article3187089.ece

“The battle for ayurveda: India is racing to record the details of its traditional medicine

By Andrew Buncombe

Published: 23 November 2007

They range from the everyday to the decidedly obscure, from items with a specific, specialised use to those with a host of applications. Their common heritage is one of the world’s oldest cultures, and their details are being gathered together to guard against theft by the West.

For several years the Indian authorities have been collating information about hundreds of thousands of plants, cures, foods and even yoga poses to create a vast digital database of traditional knowledge dating back to up to 5,000 years ago, available in five international languages. Now, the first part of that database – relating to ayurveda or traditional Indian medicine – has been completed and it is set to launch the fight back against what some have termed “bio-colonialism”.

“The ayurveda part has been completed,” said Dr Vinod Gupta, the chairman of India’s National Institute for Science Communication and Information Resources (Niscair), which is overseeing the project. “Now we are negotiating an agreement with international patent offices [for access to this database].”

The database, totalling more than 30 million pages and known as the Traditional Knowledge Data Library, has come about for one very simple reason: to prevent Western pharmaceutical giants and others using this traditional Indian information to create a product for which they then obtain a patent.

The danger of such “misappropriation” is all too real. In 1994 an American company was granted a patent for a product based on the seeds of the need tree, an item that had for centuries been used in India as an insecticide. It took the Indian authorities more than 10 years to have the patent overturned. Similar battles were fought over a product based on the spice turmeric – traditionally used to heal wounds – as well as a Texan company’s attempt to trademark its strain of rice as “Texmati”.

“In 2000 we did a study of the US patent database. We found there were 4,986 patents for products based on medicinal plants,” said Dr Gupta. “Of those around 80 per cent were based on plants from India … 50 percent of those patents should never have been given – there was no change to the traditional knowledge.”

Under international guidelines, patents should not be given if it is shown there is “prior knowledge” or existing information about the product or item. In the United States – where many of the patent applications have been made – this prior existing knowledge is only recognised if the information has been written down. It does not consider information passed down for centuries by means of oral tradition to be valid.

Unlike many cultures from which traditional information has been misappropriated, India has an extensive written tradition. But most of the writing was in languages not widely read in the West. For example ayurvedic texts were written in Sanskrit or Hindi, writings about unani medicine – based on Ancient Greek practices now only practiced in the sub-continent – were in Arabic and Persian, while writings about another form of traditional medicine known as siddha was in the Tamil language.

To get around this challenge, Dr Gupta called in more than 100 practitioners of Ayurveda, siddha and unani to help compile the information using computer software. The database is being made available in Japanese, English, German, French and Spanish and the contents will be made available to patent officials once agreements on protecting the information and preventing it from being passed to corporations, are reached.

Also included within the database are more than 1,500 positions or asanas of yoga. This is because in recent years several yoga teachers in the West have tried to copyright methods of teaching yoga that they are argue are unique but which have existed for centuries in India.

One high-profile case involved Los Angeles-based Bikram Choudhury, the self-styled “yoga teacher to the stars”. Mr Choudhury, who moved to America in the 1970s, first obtained a copyright for a book he wrote. But when other teachers began copying the way he taught yoga – with 26 specific poses performed in a room heated to 41C (105F) – he sought legal advice and was told to obtain a copyright for the moves themselves. It has been recognised by the US courts despite India’s objections.

Dr Dinesh Katoch, an adviser on ayurveda within India’s Ministry of Health and Family Welfare, said more than 50,000 different ayurvedic formulations for treating everything from heart disease to memory loss had been entered into the database. Some of the information is mentioned in the Vedas, the ancient Hindu texts that date back several thousand years.

“We want to use this information for the global benefit but it should be done in a judicious way, not by stealing,” he said, sitting in his office in central Delhi. “We want to prevent misappropriation. Prevention is the most important thing because it is not easy to repeal a patent.”

In addition to the considerable cost incurred by the Indian authorities fighting patents they do not believe are genuine or fair, there is a widespread feeling that Western corporations should not be making vast profits from traditional knowledge while the people who discovered the information receive no benefit.

But campaigners say the misappropriation also has cultural and political implications. “I have termed it bio-colonialism,” said Vandana Shiva, an Indian environmental activist and author.

“The international intellectual property laws as promoted by the World Trade Organisation [WTO] promote bio-colonialism because while they say there should be a global system to patent everything, the reality is that patent inspection is done at a national level. If you want to have a global system you have to have global inspection,” she said. “This would involve setting up a global database. This will take a decade and cost billions of dollars.”"