Even as the PhRMA continues to flog India for its TRIPS-compliant IPR regime, the Indian Pharmaceutical Alliance (IPA), which consists of 20 pharmaceutical companies that collectively account for close to 85 per cent of private sector investment on pharmaceutical R&D in India, has addressed many of these issues in its 2016 Special 301 submission to the USTR.
In its submission to the USTR, IPA secretary general D G Shah stated that the submission provides information and perspectives that may aid the USTR in determining whether India denies adequate and effective protection of intellectual property rights (IPR) or denies fair and equitable market access to US persons who rely on intellectual property protection related to the pharmaceutical industry.
Some long-standing substantive grievances of US companies relating to India’s IPR regime remain. These are mainly the compulsory licensing provision in Section 84 and the prohibition on grant of patents to new forms of known substances without therapeutic benefit in Section 3(d) of the Patents Act. American innovator companies are also concerned by the alleged lack of data exclusivity. India’s stance is that the current patent regime is fully TRIPS-compliant and strikes the appropriate balance between the grant of monopoly patent rights and public health imperatives, the IPA in its submission to the USTR said and added that the it has presented further data to suggest that the gulf between the US and Indian patent regimes may not be as wide as perceived in terms of outcomes for patentees. More than other approaches, data-driven dialogue may narrow the divide.
Innovation-led American pharmaceutical companies are striking deals with Indian companies to gain access not only to the Indian market but also to the developing world. As such deals are based on expectations of mutual benefit, their number has the potential to increase rapidly, making a significant difference to the revenues of American companies directly, or through their subsidiaries in India. Indian companies are investing in manufacturing facilities in the US so that they can better access their most important market. This also serves to create jobs in the US. If these ‘green shoots’ of collaboration are allowed time and space to grow, they will contribute to clearing the air of past acrimony and help accelerate the momentum of engagement between the US and India at the policy level, the IPA further said.
Regarding another issue of procedural irritants relating to patents, the IPA in its submission commented that recent developments in India suggest that the procedural irritants relating to patents which have been highlighted to the USTR in the past are being seriously addressed. Specific steps have already been taken to strengthen the Patent Office. The Supreme Court of India has interpreted the Patents Act to remove apprehensions of abusive multiplicity of challenges to the validity of a patent. Important legislation is now in place to speed up the resolution of commercial disputes, including those relating to intellectual property rights. Judicial enforcement of patent rights has strengthened with a number of injunctions being granted to prevent infringement of pharmaceutical patents even before the infringement has occurred.