Express Pharma

Battle Against Bio-Piracy

9

20151015ep14

An overview of Indian IPR laws and their effectiveness in preventing bio-piracy of traditional knowledge. By Sachin Jagdale

During the recent meeting with CEOs of Fortune 500 companies in New York, Indian Prime Minister, Narendra Modi, assured them the protection of their Intellectual Property Right (IPR), if they invest in India. The PM’s assurance holds significance since India is always considered as a country where IPRs are not properly protected. However, India also has a story to tell where the country itself is a victim of IPR breach. In India, knowledge about medicinal plants have existed for hundreds of years in the form of local folklore and passed on from one generation to another. According to Natural Medicinal Plants Board (NMPB), about 960 species of medicinal plants are estimated to be in trade of which 178 species have annual consumption levels in excess of 100 metric tonnes. However, due to improper documentation of this traditional knowledge (TK), parties who came into the possession of this knowledge much later, are trying to patent it.

India’s stand against bio-piracy

Modern medicines still enjoy supremacy in the global market. However, over the years, disease patterns have changed enormously. Though allopathy offers quick relief, it also comes with several side effects. In the quest to find effective medicines which are free from side-effects, the global population started turning towards the ancient forms of Indian medicine. However, such global interest also led to a rise in bio-piracy. Efforts were made to patent indigenous plants like Kumari, Amaltas, Kala Jeera, Harad, Aswagandha, Neem, Turmeric etc.

20151015ep15
Dr Gopakumar Nair

“Bio-piracy was more prevalent in the 80s and 90s. India enacted the Biodiversity Act, 2002 and Biodiversity Rules 2004 much ahead of all other countries of the world. India has also come out with the ‘Traditional Knowledge Digital Library’ (TKDL), incorporating millions of formulae, claims for treatment and cures of diseases found in the ancient texts of ayurveda, siddha etc. In early international cases involving neem for use as pesticide, India had to deal with the lack of adequate documentation of prior knowledge (India succeeded eventually). This was the trigger for initiating work on TKDL,” informs Dr Gopakumar Nair, Chief Executive Officer, Gopakumar Nair Associates.

He adds, “India does not allow patenting of plants or medicinal plants or indigenous medicinal plants. Only the US grants plant patents. India allows grant of protection of new plant varieties under Plant Varieties and Farmers Protection Act.”

20151015ep16
Shashank Sandu

Though India is a big victim of bio-piracy, it is not the only country to have faced these issues. “Approximately 90 per cent of the world’s biodiversity is concentrated in the tropical and sub-tropical regions within developing countries, specifically in India, Sri Lanka, Mexico, Brazil, Indonesia, Australia, and Democratic Republic of Congo,” informs Shashank Sandu, Director, Sandu Pharmaceuticals. According to Sandu, countries like Mexico, Peru, Ecuador, El Salvador, Brazil, Argentina, Chile etc too have been affected by bio-piracy.

Lack of ammunition?

Over the last few decades, repeated attempts were made to patent Indian TK. India had to fight many cases in the international courts to get back what originally belongs to the country. However, the question that arises is how did somebody from outside the country manage to invade the Indian property, in the first place? Don’t we have a capable or strong enough IPR system to safeguard our medicinal plants?

Nair highlights, “India’s Intellectual Property Law has Section 3(p) reads as follows:

Sec. 3 Inventions not patentable : (p) an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.”

He says, “India is far ahead of all countries of the world having introduced the Biodiversity Act and Traditional Knowledge Digital Library (TKDL) to protect India’s natural resources, in addition to 3(p). While the Nagoya Protocol for Biodiversity was signed by member countries of WTO only in 2014, India has enacted a much stricter Biodiversity Act, purportedly for encouraging ‘benefit sharing’, but in practice, virtually preventing benefit generation, through impractical royalties and premature financial claims.”

In contrast to general belief that India is not doing enough to protect its TK, Nair makes a striking statement and says, “India is overprotecting, not lagging behind.” Nair is an authority in the field of IPR. Hence, his observation is not just going to raise eyebrows in the industry but is also likely to generate a meaningful debate.

Sandu explains the issue further, “India was the first to raise the fundamental issue at the World Intellectual Property Rights Organisation (WIPO) as to why the TK based system should not be treated at par with the industry-based system. Until and unless our TK is protected, the country would have to fight for patents claimed by other countries as in the case of Haldi, Neem and Basmati. Unfortunately, public awareness about protecting our TK is very low. Indigenous people are all too often unaware of the value of their knowledge.”

He adds, “In order to protect India’s sovereign rights of the indigenous communities and the indigenous bio-wealth and Indian TK, Indian government, under the Ministry of AYUSH, has taken the initiative of digitalising the available TK through TKDL. Due to this, many patent claims world over have been rejected.” He also predicts that many other patent claims would also be rejected as the Indian government has given access to TKDL to all patent offices of other countries. This will also ensure that no frivolous patent claims are made.


Some examples of bio-piracy of traditional knowledge

Turmeric (Curcuma longa Linn.)

20151015ep17The rhizomes of turmeric are used as a spice for flavouring Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics and dyes. As a medicine, it has been traditionally used for centuries to heal wounds and rashes.

In 1995, two expatriate Indians at the University of Mississippi Medical Centre (Suman K Das and Hari Har P Cohly) were granted a US patent (no.5, 401,504) on use of turmeric in wound healing. The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a re-examination case with the US PTO challenging the patent on the grounds of existing of prior art. CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not a novel invention. Their claim was supported by documentary evidence of traditional knowledge, including ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. Despite an appeal by the patent holders, the US PTO upheld the CSIR objections and cancelled the patent. The turmeric case was a landmark judgment case as it was for the first time that a patent based on the traditional knowledge of a developing country was successfully challenged. The US Patent Office revoked this patent in 1997, after ascertaining that there was no novelty; the findings by innovators having been known in India for centuries.

Neem (Azadirachta indica A. Juss.)

20151015ep18Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds can be used to cure cold and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, European Patent Office (EPO) granted a patent (EPO patent No.436257) to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition against the patent. They submitted evidence that the fungicidal effect of extracts of Neem seeds had been known and used for centuries in Indian agriculture to protect crops, and therefore, was unpatentable. In 1999, the EPO determined that according to the evidence all features of the present claim were disclosed to the public prior to the patent application and the patent was not considered to involve an inventive step. The patent granted on Neem was revoked by the EPO in May 2000. EPO, in March 2006, rejected the challenge made in 2001 by the USDA and the chemicals multinational, W. R. Grace to the EPO’s previous decision to cancel their patent on the fungicidal properties of the seeds extracted from the neem tree.

Basmati Rice (Oryza sativa Linn.)

20151015ep19Rice Tec. had applied for registration of a mark “Texmati” before the UK Trade Mark Registry. Agricultural and Processed Food Exports Development Authority (APEDA) successfully opposed it. One of the documents relied upon by Rice Tec as evidence in support of the registration of the said mark was the US Patent 5,663,484 granted by US Patent Office to Rice Tec on September 2, 1997 and that is how this patent became an issue for contest.

This US utility patent was unique in a way to claim a rice plant having characteristics similar to the traditional Indian Basmati Rice lines and with the geographical delimitation covering North, Central or South America or Caribbean Islands. The US PTO granted the patent to Rice Tec on September 2, 1997. The said patent covered 20 claims covering not only novel rice plant but also various rice lines; resulting plants and grains, seed deposit claims, method for selecting a rice plant for breeding and propagation. Its claims 15-17 were for a rice grain having characteristics similar to those from Indian Basmati rice lines. The said claims 15-17 would have come in the way of Indian exports to US, if legally enforced.

Evidence from the Indian Agricultural Research Institute (IARI) Bulletin was used against claims 15-17. The evidence was backed up by the germplasm collection of Directorate of Rice Research, Hyderabad since 1978. Central Food Technological Research Institute (CFTRI) scientists evaluated the various grain characteristics and accordingly the claims 15-17 were attacked on the basis of the declarations submitted by CFTRI scientists on grain characteristics.

Eventually, a request for re-examination of this patent was filed on April 28, 2000. Soon after filling the re-examination request, Rice Tec chose to withdraw claims15-17 along with claim 4.

Source: Traditional Knowledge Digital Library


An interesting fact that came to light while researching this issue is that there are many Indian-origin applicants among those who seek patents for medicinal plants. So, it indirectly suggests that though India is pulling up its socks to protect its TK, ironically, there are Indian hands which are playing a significant role in handing over Indian wealth to some other country.

However, coming back to protection of TK, there are international IPR laws as well. Nair explains, “Developed countries like the US and Europe are not keen to enact laws for protecting bioresources. The US, Europe and other developed countries are very liberal in granting patents for patentable inventions (novel and inventive) based on natural products and bioresources. Globally, India has the strictest Intellectual Property Laws (Patent Act, Biodiversity Act, TKDL etc.), for restricting or even blocking almost all patenting of natural product or bioresource-based patenting. Nagoya Protocol based biodiversity protection is yet to be enacted by countries other than India.”

However, Vikram Naharwar, Director, Amsar, has a different opinion to offer. He feels that the Indian legal system is weak and there are several loopholes which allow offenders to get away scott-free. He says, “The Indian courts are a mess, no international company has any fear of Indian courts as it takes forever to have a case heard and settled. There needs to be a special court to handle such medicinal plant patent related issues.” Goa-based Amsar is an Indian herbal extraction company with a wide range of products in botanicals, nutraceuticals, ayurvedic medicines and herbal personal care.

Are we too demanding?

As mentioned before, few decades back bio-piracy was at its peak. India fought the legal cases and managed to reverse many patents. However, this aggression by foreign parties made India work on a strategy to safeguard its TK, which is often misappropriated, because it is conveniently assumed that since it is in public domain, communities have given up all claims over it. After years of hard work, TKDL constituting thousands of pages was developed. TKDL compiles Indian systems of medicine, namely, Ayurveda, Unani, Siddha and Yoga available in public domain. Attempts to patent TK never stopped, though such incidents reduced considerably due to initiatives like TKDL.

However, according to industry experts, sometimes genuine patent seekers get unnecessarily punished due to the stringent laws.

Nair explains, “Most attempts to patent Indian TK overseas (even in India) are being opposed by India through the Council of Scientific and Industrial Research (CSIR). However, even genuinely patentable inventions are also being opposed by CSIR, based on TKDL. Biodiversity Authority based in Chennai is claiming five per cent royalty upfront for giving no-objection or permission to patent office to grant patent based on natural products or bioresources. This is highly counter-productive. It prevents Indians from protecting Indian research on Indian bioresources, but leaves open developed countries to conduct research on them.”

Though TKDL is now in place, Sandu points out that TK is still at threat. He feels that modern intellectual property law is capable of protecting innovations produced by industries based mainly in the developed world, however, it is unable to adequately protect innovations produced in the developing countries. Hence, unequal distribution and concentration of patent ownership and the unequal share of benefits obtained from industrial use of biogenetic resources are closely related. “It has been observed that Indian TK is at threat on account of loopholes in the patent laws existent in the developed countries, like, the patent claims TK in the form in which it was acquired. The patent covers a refinement of the TK, patent covers an invention based on TK and other modern/ traditional knowledge,” says Sandu.

According to Nair, India is fully aware of Indian TK and is keen to protect the same. While the entire ongoing discussion on TK protection is within the ambit of IPRs, the large majority of think tanks and policy makers want to keep TK protection outside intellectual property.

While explaining the solutions to secure TK, Nair adds, “To protect India’s TK, India should take proactive action. I am strongly and vehemently proposing that Indian Government (Central or States or their designated agencies) should systematically protect all the TK and biodiversity and create a protected data bank. The agency handling the protected data bank may grant or issue permissions to use or utilise this protected knowledge or even assign or licence to those applicants who wish to avail or use these knowledge and/or the bioresource therein. Kerala Government is reportedly moving in this direction, which is welcome and appreciated.”

Through measures like TKDL, India has taken a strong step towards protecting its TK. However, fight against bio-piracy is not just the prerogative of the Indian government. Unless the people of India, who are the true owners of TK, are educated about its importance, the fight against bio-piracy will remain half won.

[email protected]

Comments are closed.