Indian Patent Bill May Impede Drug Exports to LDCs

BRIDGES Weekly Trade News Digest is reporting that 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 PropertyRights (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.
Critics have also pointed out that the proposed legislation fails to reform the "cumbersome" compulsory license process of the original legislation in India. They also criticise the 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.

The article concludes that "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."