A patent is an intellectual property right, which is exclusively granted to an inventor, for a specific period, upon his/her invention, to enable him to exclude any other person/third party, from making, using, or selling it off, without his/her consent. The patent system’s goal is to encourage inventors to advance the state of technology by awarding them special rights to benefit from their inventions. An invention relating to a product or a new process, involves an inventive step and is capable of industrial application, can be patented in India. However, The Indian Patents allows for an exception to this right, in the form of compulsory licensing.
The concept of compulsory licensing can be understood as the authorized way by which any particular patented invention can be made, used or sold, without the patent holder’s consent. Section 84 to 94 of the Indian Patents Act allows a person, to apply for a compulsory license over his patented invention, in case the following conditions are fulfilled, namely:
- Non-availability of the patented invention at an affordable price for the public, or
- Non-working of the patented invention in Indian territory or
- Unsatisfactory fulfillment of the reasonable needs of the public.
Apart from the above, in cases of public interest such as national emergencies like the current COVID-19 situation, earthquake, or non-commercial use by the public, such license can be granted by the Controller General of Patents, as soon as a notification regarding any such exceptional circumstances is issued by the Central government. The basic intent behind such a provision is to let everybody enjoy the benefits of a particular invention, thereby promoting the betterment of public health and good. Usually, such licenses are widely used globally by the pharmaceutical companies, so that maximum good can be provided to the people, who require certain medicines and pharmaceutical drugs.
There are certain factors, which the Controller would look upon while considering the application for the grant of compulsory license:
- Nature of invention
- Time gap since the product was sealed
- Measures that have been taken by the patentee/licensee previously to make full use of the invention
- How advantageous is it to the public?
- The risk-taking ability of the applicant to work out and capitalize the invention
- Efforts to obtain a license have been made on reasonable terms and conditions
- Unsuccessful efforts made in the previous 6 months (reasonable period)
Currently, India has been engulfed in the shafts of the deadly COVID-19 pandemic, which has costed the lives of more than a hundred thousand people, in a short period. This is the reason, the recent case of Rakesh Malhotra v GNCTD, saw a call for considering the issuance of a compulsory license for certain essential medicines and medical oxygen, for the treatment of Covid-19 patients, by the Supreme Court. A three-judge bench of the Court took into consideration of the helpless situations of the doctors, patients, and their families, who were running from post to pillar to plead for the supply of certain essential medicines like Remdesivir and medical oxygen and suggested such issuance to give way for local production units to manufacture such medicines, to save the lives of ailing citizens. However, the Central government refused to consider this suggestion owing to not much knowledge regarding the actual effect of the required medicinal drugs and the non-availability of the required raw materials. But, it is important to understand the reason behind such an urgent call. In general circumstances, grant of a compulsory license requires a detailed set of procedure, which is time-taking and lengthy but catastrophes like Coronavirus doesn’t allow even an inch to think and instead needs rapid support to save the lives of millions of people across the country. Thus, this is how compulsory license proves to be an important exception in the field of patent laws.