Arogyapacha raises IPR controversy

Seems like the famed Kerala’s "Arogyapacha" model of benefit sharing between industry, research institutions and tribal community for traditional knowledge is running into troubled waters. First the state forest department raised the first obstacle by not allowing Kanis, the tribal community of Thiruvananthapuram Agasthyar Forests to cultivate or take out the Arogyapacha (Trichopus zeylanicus) from the forests saying that it was not classified as a "micro-produce". Now a US-based firm has claimed that it owns the copyright and patent for "Jeevani", the herbal vitalizer developed out of Arogyapacha jointly by Kanis, Tropical Botanical Garden and Research Institute and Arya Vaidya Pharmacy of Coimbatore.

The executive vice president of the Kerala State Council for Science, Technology and Environment, Dr MS Valiathan opined that it is not yet clear whether Arogyapacha rights’, which are being contested by US-based companies, could be patented. He added that a patent could not be claimed for herbal formulations—only drugs made from herbs qualify. A clear legal opinion on the matter is yet to emerge. The case could be fought only on grounds of trademark violation, he said.

Meanwhile, attempts by CyberMedia News to elicit the opinion of Director of TBGRI Dr GM Nair did not yield any result. The queries related as to what legal remedy was TBGRI resorting to contest the claim made by the US based firms on copyright of Jeevani drug and how much amount was realized as result of the Tripartite agreement between Kanis, TBGRI and Arya Vaidya Pharmacy.

The controversy over the US firms claims surfaced when TBGRI went for a global tender for giving international marketing license for Jeevani as its seven-year contract with Coimbatore Arya Vaidya Pharmacy was over. The alleged violation of rights happened in a month after TBGRI director made a presentation of Jeevani on a biodiversity seminar in New Delhi. According to this deal, Kanis had been receiving royalty from the drug’s sales proceeds, claim TBGRI officials. It may be recalled that the herb also enabled a tribe to earn patent for the first time in the world.

The Arogyapacha issue raises several issues regarding the IPR for traditional knowledge, the rights of tribal to cultivate useful herbs and generate income and licensing of such knowledge to industry. It is maintained that in Korea cultivators of Ginseng, an energy enhancing herb have benefited out of commercialization of the herb under an arrangement with the industry.

If for some bureaucratic reasons or otherwise, if TBGRI or CSIR does not act in time and fight out the Arogyapacha issue, India’s further claims on rights of its vast traditional knowledge would be at stake. On the one hand Arogyapacha is a perfect model of benefit sharing evolved between tribal, research and industry. On the other hand it also serves as an important lesson for the scientific community in the country to follow proper procedures to protect its IPR.

R Sreekumar, CyberMedia News

India should take lead in biotechnology through regional cooperation

Dr Maharaj K Bhan

Regional cooperation should be taken as a priority, in dealing with biotechnology. This was an overwhelming sentiment during the second conference on biotechnology for Asian development, organized by the New Delhi-based NGO, Research and Information System (RIS) for the Non-Aligned and Other Developing Countries in collaboration with CII and IUCN Regional Biodiversity Programme and supported by UNESCO and Department of Biotechnology (DBT).

Addressing the inaugural session, KC Pant, deputy chairman, Planning Commission and chairman RIS Governing Council, pointed that for some time now it has been a discussion on the potential of biotechnology for development. "After various meetings, seminars etc, it is a well established fact that these technologies provide valuable tools for meeting a number of developmental challenges in different areas. Now, I hope the biotech industry in India further gears up to foster growth in Asia through regional cooperation and exploitation of synergies effectively."

Not just that, it is also important to address the concern over the "asymmetric" global Intellectual Property Rights (IPRs) regime that has failed to protect traditional knowledge from biopiracy. The gene-rich developing countries need to guard against any form of biopiracy, the conference acknowledged. RIS director-general Nagesh Kumar added, "There is an asymmetric treatment by the global regime for IPR protection of knowledge resulting from modern innovation systems vis-à-vis the products of traditional knowledge system and biodiversity that actually represents the work of the generation of farmers."

The regional cooperation would help promoting biotech, capacity building and addressing biosafety related issues on priority basis. There is no denying about the benefits of regional cooperation. Dr Sachin Chaturvedi of RIS rightly pointed out, "Asian countries collectively can do wonders in rapid growth of biotech in this part of the globe. But we still have some unanswered questions in front of us, such as, how to have the governments to come forward to lend support and facilitate alliances? What do we need from them? Each and every stakeholder of this community has to be clear on that. Further there are issues like funding biotech research."

According to Dr M K Bhan, secretary, DBT, "So far we were engaged in making strategies for prospective frontier areas in biotechnology sector. It has been observed that there has been a big difference in the outlook of public and private sectors. This can only be worked out after discussing biotech issues together, interacting with each other and sharing knowledge." He also emphasized the urgent need for educating the leadership in universities, institutes etc. for promoting private partnership. "We need to understand the practical way of securing success," remarked Dr Bhan. The feel good factor to be sustained India should hope to become the leader in South Asia, if not the entire globe.

Faiz Askari

FICCI proposes industry-friendly mechanism

The entire global scenario relating to the environmental protection laws is undergoing a change. And the Indian government has also decided to re-evaluate the constraints faced and raised by the biotech industry. Government authorities are also considering to draw up new rules replacing Rules 1989 of the Environmental Protection Act, 1986 that will comply with the Cartagena Protocol. On this issue, FICCI submitted its recommendations to the Ministry of Environment and Forests. Among the suggestions made are changes in the risk categories as defined in the annexures to the rules, changes to the title and clearer definition of the term gene-technology.

A letter of recommendations sent by FICCI to the environment secretary raised some extensive and serious suggestions. It is mentioned in the beginning, that the risk categories defined in the annexures of the rules need to be reworked. FICCI has suggested that microorganisms under category 1 should be exempted from regulations. The microorganisms in this category meet 95 percent of the requirements of the pharma industry. On the other hand, FICCI has asked for stringent regulations to govern categories 2 and 3. It has also suggested that a task force comprising scientists and scientists-turned-entrepreneurs be constituted. Explaining this point, Amit Mitra, secretary general, FICCI said, "There is an urgent need to streamline regulatory mechanism for biotech, apart from policy reforms like single window clearance to unleash the growth in the sector."

Moreover, coming back to the recommendations by this industry organization, it is emphasized that it would be responsible for redrafting the rules, keeping in view the requirements of protecting the environment, nature, plant, animal and human health, while promoting/facilitating the safe use of Living Modified Organisms (LMOs) and enhancing productivity. It has also been suggested that the redrafted rules be discussed with industry bodies FICCI, All India Biotech Association and other such organizations.

Among the other submissions made by FICCI is the inclusion of a biotechnology industry representative on the Genetic Engineering Approval Committee (GEAC). FICCI has suggested that it may be included as a non-voting member of the committee. It has also called for greater inter-ministerial co-ordination.

Faiz Askari