Amitabh Kant, Ministry of Commerce, India, recently announced the release of a national intellectual property rights (IPR) policy in next two months, which in his words “will be one of the finest in the world”. Yet, in light of its potential influence on access to medicines, it might also be one of the deadliest in the world.Despite the short commenting period, the previous draft received series of statements/critiques/analysis from industry, trade associations, academicians, legal agencies and civil society globally. However, none of these comments were ever made public by the “IPR Think Tank” assigned with drafting the policy. This is despite several requests and RTIs. DIPP (Department of Intellectual Property & Promotion) and the Think Tank kept passing the responsibility to each other.
In light of increasing transparency around IP policy making in India, the leaked final version of the revised policy can be seen here. Page 29 of the original document is missing.
The purpose of bringing out this IPR policy was to address the rising pressure from the US, backed by its multinational pharmaceutical industry. This issue has been extensively covered on this blog before.
On a positive note, the policy emphasizes that any attempt to treat generics as counterfeit should be resisted and explicitly excludes pharmaceuticals from being granted low-barrier utility models. Reaffirming India’s will to continue using flexibilities under the TRIPS agreement, the policy also does not recognize TRIPS plus provisions such as patent linkage. It thus ignores a recent proposal in the Health Ministry to introduce such provisions which would make the Indian drug regulatory authority (CDSCO), the patent police for big pharmaceutical companies against local manufacturers.
However, the policy overall lays stress on the enforcement of IPR, and therefore the adoption of this policy would present a serious threat to the affordability of health products. Overzealous use of enforcement measures, including injunctions, could undermine key TRIPS flexibilities and have a chilling effect on generic competition. The policy does not take into consideration the changing legal scenario in the US which incorporates a more cautious approach to granting of injunctions against direct competitors in public interest. In fact, it does not address the growing number of ex-parte injunctions against APIs (Active Pharmaceutical Ingredient) and formulation producers from the Delhi High Court in violation of Supreme Court guidelines.
The policy contains several measures for a stronger enforcement of IPRs including special courts for patent cases and a taxpayer-funded “Task Force”. These provisions go beyond the WTO’s TRIPS agreement and bear the risk of excessive enforcement of IP. The experience of special patent courts in other countries has not always worked in public interest. In addition, the public will end up subsidizing a task force that will enforce private IP rights, undermining consumer rights and other constitutional rights.
Furthermore, the draft places emphasis on the usage and commercialization of IP as driver for innovation, which is especially doubtful in the case of medicines. Not only did patents lead to stratospheric drug prices in the last years, hindering millions of getting access to the treatments they need, but the system also produces little innovation, especially for diseases that primarily affect the marginalized and the poor. By counting on this approach to innovation, instead of increased efforts in public research, many public problems in India will remain neglected. A pharmaceutical R&D system that manages IP in public interest and delinks from high medicine prices could pave the way for India to contribute to public health solutions adapted to its needs and should thus be envisaged by a “fine IPR policy”.