IPR Ensures Safeguards for Indian Pharma Industry

IPR Ensures Safeguards for Indian Pharma Industry

The policy comes in the backdrop of the US Trade Representative (USTR), in its annual (2016 edition) Special 301 Report (on the Global State of IPR Protection and Enforcement) retaining India on the ‘Priority Watch List’ this year for “lack of sufficient measurable improvements to its IPR framework.” Though the U.S. concerns include the “rejections” of patent applications for innovative pharmaceutical products due to “unpredictable” application of Section 3(d) of the (Indian) Patents Act, the policy ensure that no changes are made in that Section (which prevents ever-greening of drug patents) and the patent-disabling Compulsory Licensing( CL) regime.

In fact, the IPR Policy states “India shall remain committed to the (World Trade Organization’s) Doha Declaration on (WTO’s) Trade Related IPR Agreement (TRIPS) and Public Health”. There was, however, a bit of apprehension that mention of Doha Declaration and flexibility would mean there would be attempts to find loopholes in TRIPS in order to favour pharmaceutical companies. It also says “India will continue to utilize the legislative space and flexibilities available in international treaties and the TRIPS Agreement.” These flexibilities include the sovereign right of countries to use provisions such as Section 3(d) and CLs for ensuring the availability of essential and life-saving drugs at affordable prices.

The IPR Policy says that to have strong and effective IPR laws, which balance the interests of rights owners with larger public interest, steps could be taken — including review of existing IP laws — to update and improve them or to remove anomalies and inconsistencies. The review will be done in consultation with stakeholders. The changes in the laws will be those relating to the Rules on patents, trademarks, copyrights and other IPRs, but the changes will not go beyond India’s commitments at the WTO-level.