Reacting to the US Trade Representative’s Special 301 report that placed India yet again on the ‘priority watch list’ of countries with an “unfavourable” Intellectual Property Rights (IPR) regime, Commerce and Industry Minister Nirmala Sitharaman has said India’s IPR policy will not be formulated under any country’s pressure but will be guided by its national interest. The minister has done well to dismiss the US report, which is timed to influence the new IPR policy of the Modi government. India is fully aligned with international IPR standards and there is no need for anyone to question us.
One of the main concerns of the US is about Section 3(d) of India’s Patent Act, which disallows patents for incremental innovations. Earlier this year, the patent application of US-based Gilead for its Hepatitis B drug was rejected by India’s patent office on the grounds that it had no additional efficacy based on this particular section. India has been fighting attempts at ever-greening of patents by global pharmaceutical companies as it could go against the interests of its thriving generic (off-patent drugs) industry and prevent its population from accessing cheap life-saving medicines. The provision of compulsory licensing in public interest, another area of contention by US pharma companies, has been mandated by several international agreements, including the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
India must make it absolutely clear to the US government that there would be no rethink on the provision which mandates higher therapeutic efficacy for a new form of an already patented drug to qualify for a new patent. In fact, it should actively lobby with all developing and developed countries to incorporate a similar provision in their own patent laws. While standing up to US pressure on IPR policy, India must, however, act on, rather than fend off, legitimate criticism. The US trade review’s concerns over spurious and substandard drugs in India must be addressed for the sake of Indians’ own health as well as the credibility and reputation of Indian exports.