"Secret" compulsory license hearings in India for Roche's Tarceva under TRIPs rule

A hearing by the Indian Patent Office to approve a compulsory license application under a rarely-used provision of the World Trade Organization's agreement on Trade-Related Intellectual Property Rights (TRIPs) has been delayed from the end of February, in order to allow Swiss drug major Roche the opportunity to plead for the right to attend the full hearing. At stake is the patent in India for the cancer drug Tarceva (erlotinib). The Indian firm lobbying for the opportunity to manufacture a generic version of the lung cancer therapy is Hyderabad-based Natco Pharma, for export to neighboring Nepal.

The application was submitted to the Patent Controller's Office by Natco under Section 9a of the 2005 Indian Patent Act, which was designed to incorporate WTO standards to the Indian legal process. Another element of the same law was the subject of a lengthy and ultimately unsuccessful law suit by fellow Swiss drug major Novartis, this time over the IPO's refusal to award intellectual property protection for the oncology medicine Glivec/Gleevec (imatinib mesylate; Marketletters passim).

The TRIPs mechanism, which allows for a compulsory license to be issued, is different from that adopted by the authorities in Thailand for the overriding of patents for antiretroviral, oncology and cardiovascular disease agents (Marketletters passim). The 2001 Doha accord, which amended the TRIPs process, allows a patent grab by one country for the specific purpose of filling an order for the drug from a less-developed nation lacking the production capacity to manufacture generic drugs domestically.