US needs to change patent laws which sanction biopiracy

Dr. Vandana Shiva

Two major decisions have revived the intensity of the patent debates that came to the centre stage of national politics during the finalization of the Dunkel Draft Text of the GATT agreement and the subsequent coming into force of the World Trade Organization (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 Mississippi Medical Centre, Jackson, USA.

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 biopiracy to be practiced 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.
Many distortions

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 exist and be 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 Rights (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 favor, 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.
(To be continued)

Vandana Shiva