24th November 2004

INDIAN PATENT LAW CHANGES FACE RESISTANCE

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On 24 November, officials from the United Progressive Alliance (UPA), the ruling coalition in India, met with left-wing parties to discuss the Patent Amendment Bill, scheduled to be tabled in the Indian parliament next month. The proposed amendments will address the obligation under the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), effective in India as of 1 January 2005, to introduce product patents to medicines and agro-chemicals.

However, critics of the new legislation describe some of its elements as “TRIPS-plus clauses” that do not fully take advantage of flexibilities available under TRIPS in order to safeguard accessibility and availability of drugs and medicines. Most notably, the bill does not fully incorporate the 30 August decision of the TRIPS Council on aiding countries without manufacturing capacity to access medicines (see ,BRIDGES Weekly 4 September 2004), since it makes the granting of compulsory licenses for export purposes contingent upon the existence of a compulsory license for importation in the purchasing country. This could make it impossible for LDCs to import drugs from India. Since LDCs do not have to provide patents on pharmaceutical products until 2016, many of them do not have patent law institutions capable of issuing compulsory licenses.

Health rights advocacy group Affordable Medicines and Treatment Campaign (AMTC) also pointed out that the Bill fails to reform the “cumbersome” compulsory license process of the original legislation in India. They also criticised the amendment bill for proposing to extend patent protection to new uses of known drugs — a level of protection not required by the TRIPS Agreement, and one that could allow pharmaceutical companies to maintain monopoly control over a drug long after their original patent expires. AMTC also criticised the bill for drastically curtailing public scrutiny of the process through which drugs are granted marketing approval, arguing that this threatens the public interest.

The timing of the new legislation is also a matter of contention, with the government vowing to comply with international patent laws while the opposition cautions against hurrying through “legislation for which the country might have to pay a heavy price later”.

The process India is going through is likely to be replicated in a number of developing countries that have to bring their patent legislation into compliance with the WTO TRIPS Agreement.

ICTSD Reporting; “India Govt To Introduce Drug Patents Bill In Parliament,” DOW JONES, 18 November 2004; “Left to oppose patent law changes,” INDIA NEWS, 23 November 2004; “Letter from the Affordable Medicines Treatment Campaign to India’s National Human Rights Commission,” AMTC/HUMAN RIGHTS WATCH, 11 October 2004.