The increasing commercial collaboration between U.S. and Indian pharmaceutical companies is indicative of the ways in which U.S. companies are increasing their revenues from India and spreading their development costs. In view of such several development points, Indian pharma body urged U.S. Trade Representative (USTR) to remove India from Priority Watch List.
India has had patent protection, including for medicines, since 1911. The result of this decade long ‘incentive’ for innovation did not produce any innovation in medicines in India; nor did it foster the development of indigenous capability. Foreign companies operated in India very profitably with the monopoly granted by patents, but few new medicines were available and that too at prices that were not affordable for the vast majority of Indians.
The submission by Indian Pharmaceutical Alliance acknowledge that India does not have a formal system of notifying patent holders of marketing approvals of generics. In our opinion, it is infeasible for such a system to be adopted in India as it would require a major overhaul of the legislative framework within which the Drugs Control General (India) functions as well as substantial changes in the organizational structure, functional expertise and staffing of the Central Drugs Standard Control Organization.
"From a pragmatic perspective, the extent of benefit that would be available for U.S. companies if India were to provide for data exclusivity is uncertain. Firstly, not all drugs developed for U.S. companies are introduced in India for commercial reasons, as is the case with many biologicals, or drugs which are granted orphan drug exclusivity. Further, it would be a rare occurrence for the patent term to expire before a period of data exclusivity for new chemical entities.
It is also uncertain how many drugs with new clinical trial investigation exclusivity or orphan exclusivity would find a market in India. We therefore submit that it would be reasonable to require a realistic, data-driven estimate of the extent of actual and potential injury occasioned by the lack of data exclusivity, before concluding that U.S. companies are denied adequate and effective intellectual property protection in India." the IPA said.
This submission is limited to patent issues relevant to the pharmaceutical industry, particularly those which have been noted in the 2016 Special 301 Report and seeks to provide 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 the U.S. pharmaceutical industry which relies on intellectual property protection.
