BY INVITATION. IP policy should drive research for self-sufficiency in pharma

The draft of the National IPR Policy envisages intellectual property as an “integral part of India’s overall development policy”. It goes on to suggest that “the idea of being a creator and innovator must capture the imagination of our people to maximise the generation of all genres of IP rights”.

In reality, intellectual property rights (IPR) protection is a tool to manage competition rather than incentivise research and creativity. And there is adequate evidence to show that IP like patents cannot stimulate research especially in areas like diseases disproportionately affecting developing countries.

The proposed policy turns a blind eye to the real working of IP and is anchored on the romantic notion of IP as a tool for creativity and research.

This erroneous understanding of IP directs the vision, objectives and specific policy measures such as the massive campaign to convey the value and benefit of IP, stimulation for IP creation that encourages IP generation; review of existing laws, commercialisation of IP, introduction of new IP laws such as trade secret protection, traditional knowledge, and regulation of IP in public funded research (Bayh Dole model), creation of special courts, etc.

Thus the proposed policy essentially proposes an IP maximalist agenda, which would compromise India’s technological needs in manufacturing and agriculture, even as it threatens the country’s self-sufficiency in critical sectors like pharmaceuticals.

India needs to fill the technology gap to transform itself into an industrialised economy.

The interesting thing about the technology is that, often, it cannot be purchased from the market. The tried and tested pathway is emulation, innovation and invention. A patent law and policy focusing heavily on protection and enforcement of patent rights would act as barrier for technology emulation. Therefore, a technology-dependent country like India should need an IP regime, especially patent regime, to facilitate technology emulation.

The success of the Indian pharmaceutical industry is the best example of this. The Indian Patents Act 1972 prohibited product patent protection to pharmaceutical inventions and provided the legal freedom to emulate the new medicine introduced in the developed country market.

Today, the Indian pharmaceutical industry not only meets more than 90 per cent of the domestic needs, but also supplies affordable medicines to more than 190 countries. Thus, the 1972 Act delivered on “Make in India” in the pharmaceutical sector. The TRIPS Agreement reduced the policy space and makes it difficult but not impossible to pursue the same strategy. Therefore, India should adopt the same legal and policy approach on patent and other IP with minimum changes to fulfil its international obligations in order to replicate the success of the pharmaceutical industry in other sectors such as bio technology.

India changed its original version of the 1972 Act to comply with the WTO TRIPS Agreement law but policy-makers adopted a strategy to use the flexibilities in the TRIPS Agreement to curb the abuse of patent monopoly. This approach succeeded in delivering access to new medicines using various provisions in the Act such as pre-grant opposition or compulsory license.

The result: life-saving medicines are available at a fraction of the patented medicine price. These safeguards have even forced the pharmaceutical giants to grant voluntary licenses, which provide manufacturing and marketing rights in selected countries, to Indian pharmaceutical companies to control the competition. There is a need to optimise use of the safeguards in the Patents Act by providing a set of policy incentives such as tax break or production subsidy to the industry.

It is worrisome that instead of being firm about more use of patent law flexibilities, the proposed policy cautiously says, “the policy space and flexibilities available under the international instruments will continue to be used judiciously”. The proposed policy needs major changes in its approach to transform India from technological dependency to self-sufficiency in critical areas like pharmaceuticals to achieve socio-economic development.

The author is Member, National Working Group on Patent Laws (NWGPL)