Ahead of Prime Minister Narendra Modi’s scheduled visit to the United States next week, experts and NGOs in the pharma sector have called upon the Prime Minister not to make any legal or political commitment that compromises flexibilities in the Indian Patents Act for facilitating access to medicines and safeguarding public health, which is based on policies and principles approved by Indian Parliament and is fully consistent with international laws.

NGOs and experts cautioned the Indian government that there will be tremendous pressure on Modi to modify India’s Patents Act by diluting patentability criteria, including those enshrined in Section 3(d) of the Indian Patents Act; limiting the use of compulsory licensing for access to patented medicines through generic production; prohibition of the use of pre and post-grant oppositions that are currently being used to challenge fraudulent patent claims by foreign MNCs; strengthening of IP enforcement, so that the Indian judicial system would police and secure the patent rights of foreign entities; and introduction of ‘data exclusivity’, thus extending patent monopolies and delaying the entry of generics.

The Government of India should not carry out any amendment to the Indian Patents Act to increase patent protection. We strongly urge the Government to proactively use the flexibilities in the Patents Act such as compulsory licence. In fact, smaller developing countries, with much less bargaining power, have issued more compulsory licences than just the one that India has granted, the NGOs said.

The NGOs' apprehensions in this regard stems from union commerce and industry minister Nirmala Sitharaman's recent statement that the government would roll out a revised policy on IPRs.  “India does not have an IPR policy. This is the first time we are coming out with an IPR policy. We are very strong in IPR and we certainly want to protect our interest. IPR policy issues have been hanging for quite a long time and the new policy will give direction in terms of protecting IPRs of India. With the US we have (certain) issues. India has become a brand in terms of pharma. Because India does not have any policy, developed nations are picking holes in India’s IPR laws”, she had said recently.

“We would like to clarify that the statement made by the minister that India does not have an IPR policy is not true. The current Indian IP legal regime represents the policy framework on IPRs which was adopted after considerable debate inside and outside Parliament. The strength of this IPR policy is reflected well in the successful establishment of the Indian pharmaceutical industry within three decades. Until 1995, its success was enabled by the Indian Patents Act, 1970, which limited patent protection to process innovations. After 1995, the success was ensured by Parliament’s decision to take full benefit of the transition period of 10 years available under the WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPS)”, the NGOs said.