The developed world is concerned over the deteriorating environment for intellectual property protection in India, particularly of pharmaceutical patents. Both sides of the debate present arguments which they see as legally-endorsed and it is time to place the key issues in perspective, to see what is black and white and what is grey. This is not a fight between the poor and the industry or even between patented medicines and generics. It is a difference of view between those that are investing in research to create intellectual property and those that have no regard for its protection—be they regulators, competitors, legislators or activists.
Pharmaceutical research is cyclical, recurring and commercially-funded. Patents developed historically in order to protect the research cycle and keep it moving. Without patent protection, research would come to a halt. Questions on how long this protection should last can be discussed as a corollary, but we cannot question the rationale for patent protection.
In India, patent protection requires a greater commitment from all stakeholders. The indiscriminate use of compulsory licensing must not be allowed to make a travesty of intellectual property protection. India is the world’s generics power house, but from where did the “seeds” of this industry come? It is not in India’s best interest to allow this debate to be shaped by those who do not see that the commercial and business concerns of both local and multinational pharmaceutical companies are at stake, unless respect for intellectual property rights is built into the regulatory framework in an inviolable manner. Indian regulators have taken some enlightened and encouraging decisions of late. We believe it is time again for this resolve and integrity to be on full display.
In this context, there are some sticking points on which Indian regulators need to take a fair stance. Compulsory licensing is one and Section 3 (d) of the Patents Act is the other. The Indian regulatory framework allows the grant of a compulsory licence under Section 92 of the Indian Patents Act 1970 in circumstances of national emergency or extreme urgency and under Section 84, after 3 years of patent protection, if the patented medicine is not available at a ‘reasonable price’. The issue of a compulsory licence can be an appropriate response to legitimate health emergencies but such a measure cannot serve as a suitable long-term solution to the broader problems of access to medicines. Assessment of the policies and