The turmeric patent is just the first step in stopping biopiracy
Two recent decisions, one by the World Trade Organisation on a party's obligations under the TRIPs Agreement and the other, by the US Patent Office on the validity of a patent on turmeric have revived the whole debate on the patent regime imposed by the WTO.
by Vandana Shiva
TWO major decisions have revived the intensity of the patent debates that came to the centre stage of national politics during the finalisation of the Dunkel Draft Text of the GATT agreement and the subsequent coming into force of the World Trade Organisation (WTO).
The first is the WTO ruling against India in the US-India dispute on TRIPs. In July, the WTO ruled that India had not fulfilled its obligations under the TRIPs Agreement for interim measures to receive and protect new product patents applications in pharmaceuticals and agro-chemicals (so-called 'mailbox' applications), and to provide under stipulated conditions exclusive marketing rights (EMRs) for such products.
The second is the decision of the US Patent Office to revoke the turmeric patent on the basis of a challenge filed by the New Delhi-based Council for Agriculture Research (CSIR). The patent had been granted in March 1995 to two non-resident Indians associated with the University of Mississipi Medical Centre, Jackson, USA. As turmeric has been used for thousands of years for healing wounds and rashes, CSIR challenged the patent on the ground that it lacked novelty. The US Patent Office upheld the objection and cancelled the patent.
The WTO dispute ruling is an attempt to put pressure on India to adopt US-style patent laws. However, as the turmeric patent case makes it evident, the US patent system has its own weaknesses which allow biopi-racy to be practised as a rule. The withdrawal of the turmeric patent is only a first step in reversing biopiracy.
Patents on Neem, Amla, Jar Amla, Anar, Salai, Dudhi, Gulmendhi, Bagbherenda, Karela, Rangoon-ki-bel, Erand, Vilayetishisham, Chamkura all need to be revoked.
The US needs to revoke all the above patents based on Indian indigenous knowledge and 'prior art'. In addition, the US also needs to change its patent laws which sanction biopiracy by its non-recognition of foreign 'prior art'. Patents are supposed to satisfy three criteria of: Novelty, Non-obviousness, and Utility.
Novelty implies that the innovation must be new. It cannot be part of 'prior art' or existing knowledge. Non-obviousness implies that someone familiar in the art should not be able to achieve the same step. Most patents based on indigenous knowledge appropriation violate the criteria of novelty combined with non-obviousness because they range from direct piracy to minor tinkering involving steps obvious to anyone trained in the techniques and disciplines involved.
In the US, many distortions in law exist facilitating the patenting process for companies such as those in the pharmaceutical industry. One such distortion is the interpretation of 'prior art'. It permits patents to be filed on discoveries in the US, despite the fact that identical ones may already be existing and in use in other parts of the world.
Section 102 of the US Patent Act does not provide a general definition of 'prior art', but a very narrow rule-bound method to be used by low-level patent examiners for determining which materials will defeat a patent application by violation of the novelty and non-obviousness criteria. Prior foreign activity anticipates a US patent only when the foreign activity is in a tangible, accessible form such as a published document or a patent. However, prior foreign knowledge, use and invention are all excluded when the question of prior art is considered in relation to a US patent application.
Unless Section 102 of the US Patent Law is changed, new examples of biopiracy will continue to occur.
The phenomenon of biopiracy makes clear that it is not just Indian patent laws that need changing. The US laws also need to be changed to fit into a fair and honest global Intellectual Property Right (IPR) system. The WTO, which has been established to set up a multilateral rule-based system, has a role in ensuring that the inequity and injustice that biopiracy exhibits is removed from the IPR regimes of all member countries.
India needs to make a submission to the WTO to initiate proceedings to change US patent laws to give India adequate protection against biopiracy. This will serve India in two ways. If India gets a ruling in its favour, the world will have solved the problem of piracy of indigenous knowledge of the South. If India's submission is not accepted, and a panel is not set up to investigate the inherent weaknesses and inadequacies of the US patent system, the bias of the WTO towards the powerful countries will have been rendered transparent.
The haste with which the WTO has given a ruling on the US-India TRIPs dispute is an example of the built in bias of the WTO.
The first submission of the US to WTO against India's 'patent protection for pharmaceutical and agricultural chemical products' was made on 6 March 1997. The submission referred to Article 5 of the Indian Patent Act which excludes from the scope of patentable subject matter pharmaceutical and agricultural chemical products.
Article 5 of the Patent Act provides
'In the case of inventions-
(a) claiming substances intended for use, or capable of being used, as food or as medicine or drug, or
(b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semiconductors and intermetallic compounds), no patent shall be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture shall be patentable.'
In particular, the US submission averred that:
'India has not yet made available product patent protection for pharmaceuticals and agricultural chemicals, and thus has chosen to take advantage of at least part of the exclusive marketing rights. Thus, India has violated its obligations under Article 70, paragraphs 8 and 9, of the TRIPs Agreement to (1) establish a mailbox system in its law, and ensure that no applicants are denied eligibility for patent protection because of the delay in establishing the mailbox system, and (2) establish a system for the grant of exclusive marketing rights.'
India has until 1 January 2005 to make available product patent protection for pharmaceuticals and agricultural chemicals. We need to utilise this transition period to the fullest to ensure that our patent laws do not violate the ordre public or have a negative impact on animal and human health or the environment.
Article 27.2 of TRIPs allows exclusions on grounds of public morality.
'Members may exclude from patentability inventions, the prevention within their territory of commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their domestic law.'
Quite clearly, EMRs cannot be granted for products which would violate our public morality, our environment, our public health and nutrition, and our socio-economic and technological development. Clauses 70.8 and 70.9 of TRIPs which required an instant creation of a mail box arrangement and granting of EMRs when the WTO agreement came into force thus in effect negated the transition period available to countries to evolve legislation appropriate to their contexts. This is further complicated by the fact that without changes in US patent laws many patents will be based on biopiracy.
Should India give an EMR to a corporation which has a pharmaceutical patent or an agrichemical patent based on indigenous knowledge systems of India or should the system to prevent biopiracy be put in place first?
Suppose a corporation like W R Grace applies for an EMR for neem- based pesticides in India, will India grant it? Suppose a corporation asked for EMRs for hepatitis drugs derived from Phyllanthus Niruri, is it in our interests to give such EMRs?
Unless we have a system in place which prevents the granting of EMRs on the basis of patents obtained through biopiracy, EMRs will basically become an instrument of destruction of our economy.
We have a legitimate method under our international legal obligations to stop biopiracy and protect our indigenous innovations. We need to evolve legislation to first protect our own innovations. Foreign claims to innovation should be protected after our own systems have been put in place.
The Convention on Biological Diversity does allow us mechanisms to frame laws to prevent biopiracy. In particular Article 8 (j) recognises that each contracting party shall
'... subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of benefits arising from the utilisation of such knowledge, innovations and practices'.
It is in India's interest to implement our national biodiversity legislation before granting EMRs or changing the Indian Patent Act. The determination and will to defend our national interest and our public interest and protect our innovation should be stronger than the determination and will to defend US interest and protect US biopiracy. This is a real test of our freedom and sovereignty. We need to do a rapid stock-taking of the scale and extent of our biodiversity-based economy which, in my assessment accounts for two-thirds of our productive economy but is invisible because it is the economy of people our centralised planning has rendered invisible. We need to show how much the potential loss to India is in the form of both global markets and domestic markets due to biopiracy by countries like the US. We need to go through this exercise to protect our sovereignty and make our rightful claims with trading partners. The exercise of the potential loss due to biopiracy also needs to be done to avoid unnecessary and illegitimate trade action by the US due to the TRIPs dispute ruling.
When the US introduced IPRs in the Uruguay Round as a new issue, it accused the Third World of 'piracy'. The estimates provided for royalties lost in agricultural chemicals are US$202 million and US$2,545 million for pharmaceuticals. However, as the Rural Advancement Foundation International (RAFI), in Canada has shown, if the contribution of Third World peasants and tribals is taken into account, the roles are dramatically reversed: the US owes US$302 million in royalties for agriculture and $5,097 million for pharmaceuticals to Third World countries, according to these latter estimates. In other words, in these two biological industry sectors alone, the US owes $2.7 billion to the Third World. This debt will not be paid by the US unless we have our biodiversity legislation in place.
India needs to take stock of her biodiversity-based economy for both ecological survival and economic and political survival in the 50th year of her independence.
It is not the US submission, or the ruling of the WTO Dispute Panel, which will determine whether we will act as a sovereign country. It is the parliament and people in whose hands the exercise of our sovereignty lies. (TWR No. 86, October 1997)
Vandana Shiva is a scientist and activist. She is also a contributing editor for Third World Resurgence.