India Stays on USTR Blacklist Despite New Patent Law

The Office of the US Trade Representative (USTR) has opted to maintain India's "priority watch" status on intellectual property compliance, despite the country's recent approval of a much tougher patent law.

The USTR's 2005 "Special 301" review justifies its decision on the grounds that existing laws are still inadequate to protect undisclosed test data for use in pharmaceuticals and agrochemical products. The organisation is also especially critical of the enforcement of patents granted under the "mailbox" system, or products for which patents proving novelty were delayed pending India's implementation of TRIPS. According to the USTR, the new Patent Law does not enable those with patents filed under this system to prevent generic drugs from being sold after the date when the patent is granted.

The USTR has pledged to continue to monitor India's progress on protecting test data exclusivity and enforcing patents. For its part, an influential Indian government commission currently studying data exclusivity is due to report by end June. It is expected that — to the likely frustration of innovative drugmakers — the committee will recommend that India provide protection of test data without granting marketing exclusivity, as is the case in some of India's "priority watch" peers, such as Brazil and Argentina.