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Dear Saxena ji,
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With the adoption of the Patents (Second Amendment) Bill by Parliament on May 14, a trips (Agreement on Trade Related Aspects of Intellectual Property Rights) compliant patents law is now only a matter of the President of India's formal assent.
The amended legislation provides for changes in the scope of patentable inventions, grant of new rights, extension of the term of protection, provision for reversal of burden of proof and conditions on compulsory licencing (cl). In making these changes, it appears the government has been pushed in a big way by multinational corporations (mncs) to accept provisions that fail to capitalise on the flexibility available to India within the trips framework.
As per Article 65(4) of trips, India could have up to 2005 to introduce product patents for microorganisms. However, the amended legislation provides for immediate product patent protection for microorganisms. Further, the amended legislation fails to address the issue of patentability for pharmaceuticals in a clear and firm manner. The Indian Drug Manufacturers' Assoc-iation (idma) has been seeking a foolproof definition of the term 'patentable inventions' to prevent holders from extending the term of patents beyond the proposed 20-year period.
Patents on formulation and dosage also work towards extending the monopoly. The legislation needed to give firm and clear directions strictly restricting patentability to new chemical entities. A clear provision on the issue of patentability for pharmaceuticals would go far to check the greed of mncs. It seems that at least until 2005, this issue will continue to hang over the head of the domestic pharmaceutical industry like Damocles' sword.
The amended legislation also does not provide for cl. This, in spite of the fact that Article 31(b) of the trips Agreement allows use without authorisation from the right holder, if the user had offered 'reasonable commercial terms and conditions' and has not succeeded in obtaining permit 'within reasonable period'. cl provisions in the bill give patentees wide scope for delaying and obstructing third parties from using cls effectively.
The points noted above are merely illustrative of the many gaps in the bill, especially in terms of failure to utilise the space legitimately available to India within trips. The bill fails to incorporate provisions on conditions that are consistent with the country's development aims, such as cl, right to manufacture for exports, adequate protection for indigenous research and development, control of the term of patents, and revocation of patents to protect public interest in emergencies.
The amended legislation also fails to use flexibilities on account of unorganised patents law space, particularly where patent renewal and enforcement are concerned. This would have allowed the government to protect India's interests, with flexibility regarding scope of patentability, disclosure, and length of patent protection.
Given that the extension period of patent protection is disadvantageous to Indian industry and consumers, it could have used provisions of patent renewal to extract suitable bargains. It is permissible to raise patent renewal fees steeply with the increase in patent life. In situations where the patents offer absolute monopoly to the patentee, the renewal fees can be raised at the very start of the patent life. Many European nations use this space even today. Patents for pharmaceutical products in India particularly required this protection.
It appears that the people of India will have to wait for the third amendment. Meanwhile, the battle for economic sovereignty and people-oriented development must continue. There should be no complacency at the level of mobilisation of public opinion on this important issue.
Dinesh Abrol is a researcher working on the issues of science and technology policies at the National Institute of Science, Technology and Development Studies