Expert group warns India's govt on patents

An expert group set up by India's government to examine the operation of its 2005 Patent Law has warned that restrictions on awarding patents for New Chemical Entities is in violation of the World Trade Organization's Agreement on Trade-Related Intellectual Property Rights (TRIPs), of which India is a signatory.

Under section 3(d) of the Patent Law, drugmakers need to demonstrate improved efficacy for a new product, beyond the "novelty, commercial applicability and non-obviousness" of the TRIPs standard. The constitutional legitimacy of this item of legislation is at the center of a law suit by Swiss drug major Novartis against the Indian authorities for refusing to award a patent for its anticancer drug Gleevec/Glivec (imatinib mesylate; Marketletter February 5).

The expert group headed by RA Mashelkar, a noted intellectual property expert, published its findings in January, having briefed the Ministry of Commerce and Industry at the end of last year. Dr Mashelkar's conclusions have provoked "a fierce debate" in India because the Indian Pharmaceutical Alliance, which is almost exclusively made up of generic drugmakers, found itself in agreement with most of the drug industry's critics, who favor price controls and protectionist measures against foreign drug firms.