From biopiracy to bioprosperity

From biopiracy to bioprosperity

Age-old remedies are part of boardroom presentations today, as pharmaceutical companies tap tradition, searching for the next blockbuster molecule. Is this biopiracy or bioprospecting? Sachin Jagdale analyses

The more things change, the more they remain the same. Ancient civilisations like India and China have served as the source of indigenous knowledge and bio-resources for centuries. In India’s case, the East India Company, as part of its empire building agenda, employed botanists to compile local knowledge and transfer samples of bio-resources to Britain. These were then transplanted in Kew Gardens, which were established in 1772 by joining two royal estates in London. This venture was financed by banks who facilitated its growth as a centre for biological knowledge sharing.

Today, in the era of Intellectual Property Rights (IPR), and patents, this ‘transfer’ has many ramifications. It has contributed to an inequality between biodiversity-rich developing countries and developed countries with pharmaceutical companies that have the capability to exploit these indigenous resources. However, over the last few years, an infrastructure has been put in place so that nations like India can safeguard their interests.

Laws in place

“There is nothing wrong in taking steps towards protecting a country’s bio-resources and traditional knowledge.”

– Gopakumar Nair Gopakumar Nair Associates

Patent and Trademark Agents

Giving more details on the laws in place, Aditi Kare Panandikar, Director, Business Development and HRD, Indoco Remedies, says, “Two conventions related to the subject are the Convention on Biological Diversity (CBD) and the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). For example, commercialisation of various products from Hoodia (from Africa, the source of weight loss drugs), turmeric (Curcuma longa), neem (Azadirachta indica), bitter gourd (Momordica charantia), Aloe vera and Basmati rice (from India). So biopiracy is ‘pain for one and the gain for others.’

Chirag Mehta, Head, Strategic Planning and Research, Intas Biopharmaceuticals reveals other aspects of the debate. He says, “The CBD, by asserting the sovereignty of nations over their respective biodiversity, explicitly recognises the right of countries to establish legislation regulating access to genetic resources and, if they wish, require payment for that access. Moreover, it requires that any company or country collecting biodiversity obtain the prior informed consent of the source country.” Elaborating on the issue, he says, “Because of this convention, there is a standard practice in place for collectors to pay fees for access to biodiversity and to enter into contractual agreements with source countries (or companies/institutions within those countries) that allocate a share of royalties (or the patent itself) to the source country. It also takes care of the ethical and moral issues, which earlier prevailed when it was considered that genetic resources are ‘common heritage of humankind’, meaning that there was no law or moral obligation requiring a company that collected genetic material from another country to pay for access to that material.”

Infamous cases

“Because of the Convention on Biological Diversity (CBD) there is a standard practice in place for collectors to pay fees for access to biodiversity and to enter into contractual agreements with source countries (or companies / institutions within those countries) that allocate a share of royalties (or the patent itself) to the source country.”

– Chirag Mehta, Head, Strategic Planning and Research

Intas Biopharmaceuticals

The history of biopiracy has some prominent cases that have been the part of thousands of articles on biopiracy, written all across the globe. A classic case is Vinca rosea, better known as Rosy Periwinkle or Madagascar Periwinkle. The plant’s traditional medicinal role prompted research and led to the discovery of large number of biologically active chemicals. Vincristine, an agent necessary for leukaemia chemotherapy, was also one of those chemicals. Eli Lilly discovered the method for purifying vincristine. Though it was initially patented and marketed by Eli Lilly, the buzz is that the country of origin was left empty-handed.

The case that provoked India involved the neem tree, which has been part of the traditional heritage of the country. In 1995 the US Department of Agriculture and a pharmaceutical research firm, W R Grace and Company, was granted a patent on a technique to extract an antifungal agent from the neem tree. In fact, neem’s antifungal properties were long known to Indian villagers. Post this patent, the Indian press raised a huge hue and cry, which was echoed by many developing countries. Government of India took legal action and the patent was overturned in 2005. Similar battles followed over turmeric, karela and the much criticised attempt by RiceTec Inc, a US company to patent Basmati rice.

Biopiracy of marine organisms is also common. When the US based pharma company Neurex isolated and patented the toxin SNX-111 produced by the Philippine sea snail Conus magnus, both the company and government had to face the wrath of civic organisations. The company intended to use the toxin for the production of a pain killer. Besides this, University of California researchers have also been shunned for patenting pseudopterosin, an anti-inflammatory agent found in sea whips in the Caribbean that was later used in a skin cream. Similarly, in India two Czech scientists, Petr Svacha and Emil Kuchera, were caught and arrested for collecting insects from the Singalia National Park in West Bengal. The level of biopiracy can be gauged by the fact that in 1997, an enquiry estimated that about 20,000 individual plant samples were illegally removed from the Amazon region of Brazil every year.

Those involved in such trade defend their actions saying that developing countries are ‘finding problems in solutions’. How fair is this criticism?

Gopakumar Nair, Gopakumar Nair Associates, Patent and Trademark Agents, says, “There is nothing wrong in taking steps to protect a country’s bio-resources and traditional knowledge. However, the provisions enacted should serve and fulfil the objectives in a practical and pragmatic manner. What is wrong with India’s efforts to protect traditional knowledge and bio-resources through the Bio-diversity Act is that the way the Act and its provisions are drafted and more importantly, so rigidly and improperly implemented without regards to ground level realities, needs serious attention, review and remediation or rectification.”

Planned bioprospecting

“The Indian government should explore the possibility of converting biopiracy into bioprosperity and helping the country to develop”

– Aditi Kare Panandikar Director, Business Development and HRD

Indoco Remedies

Is ‘bioprospecting’ just another dignified name for biopiracy? Is it possible to distinguish between these two terms? Nair says, “Bioprospecting is sometimes confused with ‘biopiracy’. Encouraging sustainable development of bio- resources is not a crime. But insensitive, irrational over-exploitations or ‘killer-exploitation’ (exploitation leading to extinction of the resources) is a criminal offence under the Wildlife Conservation Act and this must be treated and enforced as such.” He adds, “Government, however, must encourage bioprospecting in a planned, systematic manner, to ensure that value addition and value creation is done indigenously, with a commitment to nurture, care, develop and enrich the very same bio-resource that is being prospected. Indians should be free to obtain protection for Indian resources in fair and reasonable terms.”

Panandikar feels that bioprospecting contracts lay down the rules, between researchers and countries, of benefit sharing and can bring royalties to lesser-developed countries. Dr Rajani Jaiswal, Patent Consultant, Intellectual Property Rights, Lakshmikumaran and Shridharan too defends bioprospecting because she reasons, “Bio-prospecting is not illegal because it identifies the biological resources or knowledge having commercial value.” However, Jaiswal is quick to identify possible misuse of bioprospecting as well. According to her, bioprospecting facilitates biopiracy, whereby the biological resources or knowledge associated is obtained without prior permission of the concerned authority.

Biodiversity for all?

“Bio-prospecting is not illegal because it identifies the biological resources or knowledge having the commercial value”

– Dr Rajani Jaiswal Patent Consultant Intellectual Property Rights

Lakshmikumaran and Shridharan

Health is a basic right of any countrymen. Are the developing countries denying the world a chance of developing effective new medicines by not allowing the use of their biodiversity? It has become necessary to streamline the process where countries that are rich in biodiversity would get enough credit for making available their raw material. Nair analyses the situation. He says, “The scenario can only be improved by ‘self-introspection’, ‘soul-searching’ and positive contribution from all developed, developing and least-developed countries. There should be no dispute at all that bio-resource and traditional knowledge owners and possessors should be reasonable or adequately rewarded through benefit sharing. However, it is not fair to “rob Paul and not even pay Peter”.

According to Nair, what the Biodiversity Act (of India) prevents (virtually blocks) is to rigidly apply the provision of the Act, to prevent grant of patents (based on national products of Indian origin) to all inventors and applicants who apply for patent in India. Bio-diversity Authorities demand flat royalties of five percent, (Sec 6(2) and Sec 19(3) of the Biodiversity Act, 2002) irrespective of whether the bio-resource is home-grown or not. India can impose this only in India and has no control or right to sue overseas for not adhering to an Indian Act.

As the pharma industry is one of the main pillars of the debate, Indian pharma companies have to play a crucial role in the current situation. “Developing countries, rich in indigenous resources, need to tighten biodiversity laws to stop the usurpation of the resources and knowledge of their people. Indian pharma companies should keep the example of the INBio-Merck agreement in front of their eyes to generate mutual interests. The Indian government should explore the possibility of converting biopiracy into bioprosperity and helping the country to develop,” opines Panandikar.

The agreement refers to National Biodiversity Institute (INBio) of Costa Rica, a non-governmental, non-profit, public interest organisation of civil society, granting Merck the right to evaluate the commercial prospects of a limited number of plant, insect, and microbial samples collected in Costa Rica’s 11 conservation areas. In return, the pharma giant paid INBio $1 million over two years, and provided equipment for processing samples and scientific training. Merck also agreed to pay a royalty – to be shared equally by INBio and the Costa Rican Ministry of Environment and Energy (MINAE) – on the profits of any future pharma product or agricultural compound that is isolated or developed from an INBio sample.

The question of denial or unpleasant repercussions will not arise if the guidelines pertaining to biodiversity given in the CBD are followed by any country, company or institution. Mehta paints a positive picture where he says that countries gifted with a variety of medicinal diversity now have an advantage, as they are extended monetary compensation and royalties from companies utilising their resources to come out with a product with more health benefits.

Legal loopholes

Previous brushes with biopiracy have forced India to take some preventive steps. India has prepared digital archives of ancient manuscripts containing old remedies. The texts were recorded from Persian, Sanskrit, Urdu and Arabic and made available to patent offices in German, Japanese, French, and Spanish languages. Besides this, hundreds of yoga poses are also recorded in the collection. However, this is not enough.

“Developing countries should review their provisions in their domestic acts and must make them pragmatic and practicable. Since extreme and excessively aggressive postures are detrimental to progress, both developed and developing countries should discuss, deliberate and negotiate with an open mind to resolve existing hassles and build bridges,” suggests Nair.

Highlighting some of the lacunas in the current act, Nair adds, “The Biodiversity Act, 2002 of India needs to be reviewed, revised/amended with exceptions. Without identifying the IP owners for benefit sharing, it is ill-advised to collect royalties. The entire objective of bio-diversity protection is being abused under the present Act. This is indeed very sad and is a retrograde step which discourages herbal and bioresearch.”

Nair also points out that the legal provisions in Biodiversity Act, 2002 are more favourable to overseas applicants. Indian inventors cannot patent Indian innovative research and results on herbals and micro-organisms in India. Overseas applicants (inventors) can file overseas patent applications without bio-diversity permission from Indian authorities as they do not have jurisdiction outside India.

Policies are easy to implement but difficult to monitor. Though we have legal provisions to protect our biodiversity we still need to evolve up to that level where we will be aggressive enough and ‘poachers of biodiversity’ will never dare to exploit our traditional knowledge.