Compulsory licenses are authorizations given to a third-party by the Controller General to make, use or sell a particular product or use a particular process which has been patented, without the need of the permission of the patent owner. This concept is recognized at both national as well as international levels, with express mention in both (Indian) Patent Act, 1970 and TRIPS Agreement.
The Indian Patent Act, 1970 provides that after three years from the date of the grant of a patent, any person can apply for the compulsory license, on certain grounds:
Indian Patent Act, 1970 authorizes the central government to issue a compulsory license at any time after the grant of the patent, in the case of:
The debate on compulsory licensing has become important especially after the COVID-19 pandemic when the entire world realized that the availability of vaccines and medicines cannot be restricted to the developed world alone. The richest countries have cornered about 80 percent of vaccine supplies so far.
In this light, a large number of LDCs and developing countries, including India, have expressed a view that the IP waiver for vaccines should be extended, without any changes in language or scope, to diagnostics and therapeutics as well as these were equally important for fighting the pandemic.
Compulsory licensing has now become the hope for financially challenged patients in underdeveloped countries. India needs this provision owing to the economic condition of the majority population. But the challenge is that on one hand, it has to comply with the international standards of patent protection and on the other, it has to safeguard public health.
Compulsory licensing holds immense importance as it is essential to cover the existing disparity in access to vaccines between the rich and poor world. Without these measures, fighting or preventing future pandemics would become impossible.
At all times, the provision of compulsory licensing must be used judiciously as it is an exception and flexibility to the general rule of patent. The judicial approach with respect to grant of compulsory license is that the provision is for public welfare and not a tool to diminish the rights of the patent holders. There must a balance between thee rights and making use of the product for welfare purposes.