New IPR policy retains access to cheap drugs

May 13, 2016 03:00 pm | Updated November 17, 2021 01:51 am IST - New Delhi

The NDA government on Friday announced the long-pending, “all-encompassing” National Intellectual Property Rights (IPR) Policy.

The Policy, to be reviewed every five years, aims to push IPRs as a marketable financial asset, promote innovation and entrepreneurship, while protecting public interest including ensuring the availability of essential and life-saving drugs at affordable prices. Responding to queries about the policy approved by the Cabinet on Thursday night, Union Finance Minister Arun Jaitley said, “Our approach balances consideration of inventability, innovation and public health consideration.”

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, Mr. Jaitley clarified that the policy will ensure that no changes are made in that Section (which prevents ever-greening of drug patents) and the patent-disabling Compulsory Licensing regime.

Ensures safeguard for pharma industry

The IPR policy approved by the Cabinet on Thursday night, 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’ for “lack of sufficient measurable improvements to its IPR framework.” It also comes ahead of Prime Minister Narendra Modi’s U.S. visit in June.

Mr. Jaitley made it clear that the IPR Policy will ensure that no changes are made in the Section (which prevents ever-greening of drug patents) as well as the patent-disabling Compulsory Licensing (CL).

Committed to Doha

In fact, the Policy states “India shall remain committed to the (World Trade Organisation’s) Doha Declaration on Trade Related IPR Agreement (TRIPS) and Public Health.” It also says “India will continue to utilise 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 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, it added.

Government sources said 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.

To ensure strong and effective IPR laws, the Policy states India will engage constructively in the negotiation of international treaties and agreements in consultation with stakeholders.

Government sources said the international treaties and agreements referred to are international IP classification agreements, including the Nice and Vienna Classifications, and not pacts like the Trans Pacific Partnership, which apparently has TRIPS-plus provisions.

Policy at public cost

“The IPR policy is driven by the agenda of IP maximalism, where IP owners’ rights will be maximised at the cost of public interest. This (policy) will influence courts and judges. The policy needs to be opposed from becoming a ‘national’ policy,” said Dinesh Abrol, convenor of the National Working Group on Patent Laws and WTO, a civil society group.

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