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TWO CHEERS FOR PATENTS

THE PASSAGE OF the Patents (Amendment) Bill, 2005, in the Lok Sabha on Tuesday is not just proof of the political strength of the United Progressive Alliance Government. It is also a practical demonstration of the positive legislative effects that a healthy dose of negotiation between the Congress and the Left can produce. To borrow from patent jargon, the process was commendable even if one still has misgivings about the product. Under the Trade-related aspects of the Intellectual Property Rights (TRIPS) agreement, India was obliged to legislate a major change in its domestic patent law so that protection is provided not just to the holders of specified processes but to products as well. The country has fulfilled different aspects of its obligations in this regard, notably by amending the 1970 Patents Act in 1999 and 2002. To the extent the National Democratic Alliance Government failed to build in all the safeguards and protections allowed by TRIPS, one might even say India over-fulfilled its commitments. But to make the Patents Act fully TRIPS-compliant, it was also necessary to extend the new patent protection to pharmaceutical products by January 1, 2005. As the deadline approached last year, the Manmohan Singh Government hurriedly promulgated an ordinance based entirely on the draft Bill prepared by the NDA regime. And when Parliament met for the Budget session in February, it was this ordinance based on an admittedly flawed original Bill that was sought to be legislated.

That this deficient Bill has now been amended — in good but not complete measure — is largely thanks to the Bharatiya Janata Party's opportunism in declaring its opposition to the changes it had itself drafted. This had the effect of obliging the UPA Government to fall back on the Left, which in turn insisted that the Bill be strengthened to include vital safeguards to protect the access of poor people in India and other developing countries to affordable drugs. As matters stand, the Bill has built in some safeguards against "evergreening," whereby unscrupulous drug companies seek to extend the life of existing patents by introducing minor variations. The Bill stipulates that only a "new entity" involving "one or more inventive steps" will fit the criterion of a patentable pharmaceutical substance. This language improves on the earlier formulation but still falls short of a specific definition of "new entities." On compulsory licensing of life-saving drugs and pre-grant opposition, the Bill has incorporated the necessary safeguards. Finally, the unnecessary restrictions on the export of patented drugs manufactured generically in India under compulsory licence to less developed countries — such as the sale to African nations, at much lower prices, of anti-retrovirals to combat AIDS — have been removed.

Although a happy compromise of sorts was reached on patent law, it is hard not to feel unease over the continuing failure of governments in India to notify the landmark Plant Variety Protection and Farmers' Rights Act in keeping with the TRIPS deadline of protecting plant breeders' rights by January 1, 2005. If the pharmaceutical industry lobby has pressed for the current Patents Bill, the multinational seeds lobby has prevented the Farmers' Rights Act from entering into force notwithstanding its passage by both Houses of Parliament in 2001. The UPA Government has committed itself to referring the question of defining "new entities" and prohibiting the patenting of micro-organisms (which is not even mandated by TRIPS) to an expert committee. What is crucial is that public health experts fully conversant with the issues involved in patenting micro-organisms (such as genes and viruses) must be involved in this process, which must not be left to Commerce Ministry bureaucrats and patent lawyers. Finally, the Government must not treat TRIPS as a closed chapter. There is a process of review and India must effectively and persuasively advocate a much greater relaxation of key Articles relating to public health.

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