Why it is important for India to defend its IPR

DG SHAH | Updated on November 14, 2014

An employee holds a pen behind his back inside the dedusting unit at the Lupin Ltd. pharmaceutical plant in Salcette, Goa, India, on Friday, Feb. 7, 2014. Lupin, founded by billionaire Desh Bandhu Gupta, expects to gain share in the U.S. amid increased regulatory oversight and curbs on competitors including Ranbaxy Laboratories Ltd. Photographer: Dhiraj Singh/Bloomberg   -  Bloomberg

15/06/2013 MUMBAI: D.G Shah, secretary-general, Indian Pharmaceutical Alliance on June 15, 2013. Photo: Paul Noronha   -  PAUL NORONHA

The Office of the United States Trade Representative (USTR) is currently engaged in the Out-of-Cycle Review (OCR) of India’s intellectual property rights (IPR) regime, tracking its “progress” since March 2014. This article addresses the OCR and why it is important for India to defend its IPR regime.

This exercise began with the annual review in March 2014 on the state of IPR protection and enforcement in India. The review was undertaken by the USTR pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (19 USC. § 2242).

The review reflects the US Administration’s resolve to encourage and maintain adequate and effective IPR protection and enforcement worldwide.

These are important pointers to the source of disagreements between the US and India. The USTR evaluates each country’s IPR laws and practice by its own standards and practice.

It is a different matter that some of these are questioned by its own Supreme Court. But, the USTR insists that India must pass their test.

The Trade Related Intellectual Property Rights (TRIPs) Agreement, ratified by some 195 countries, also lays down standards of protection and norms for enforcement. However, the USTR does not go by the universally accepted standards and norms. Instead, it reviews laws and practices of India against the US laws and practice.

Negative advocacy

The 2014 Annual Review of India by the USTR may be seen in the backdrop of a vicious campaign launched by Pfizer Inc. against India in March 2013.

It filed a Written Testimony before the House Ways and Means Subcommittee on Trade – Hearing on US-India Trade Relations – alleging inadequate protection and enforcement of IPRs in India.

The forces backed by Pfizer, including the most powerful special interest lobby group, Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organisation (BIO), Global Intellectual Property Centre (GIPC), etc, continued the virulent negative advocacy campaign against India and its pharmaceutical industry, building up a case for downgrading India. The PhRMA in its 2014 submission to the USTR sought to downgrade India to Priority Foreign Country (PFC), the worst offender status, with a view to pressurise India to amend its patent law.

Their focus was on compulsory licensing, patentability, data exclusivity and patent linkage. However, the USTR did not downgrade India. We do not know reasons for not downgrading India to PFC from the Special Watch List status.

Instead, the USTR opted for an easier option of stalling the 2014 Review to September 2014. It is called Out-of-Cycle Review (OCR).

The credit probably goes to the change of Government in New Delhi and its combative spirit; strong representations by various academic and civil society groups; as well as a spirited defence of India’s laws and practice by the powerful domestic pharma lobby group Indian Pharmaceutical Alliance (IPA).

However, the PhRMA lobby did not give up its efforts to force the USTR to get India to amend its IPR regime or face action, which may ultimately lend two countries in the trade war.

It is apparent that the PhRMA lobby is determined to push for an IPR regime that suits the commercial interest of its members.

This lobby may use the renewed efforts to revive a strategic partnership between the two countries to its advantage. India needs to guard against any such effort to not only protect access to affordable medicines but also its pharmaceutical industry.

The writer is CEO, Vision Consulting Group and Secretary General, Indian Pharmaceutical Alliance

Published on November 14, 2014

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