Compulsory Licensing of Drugs & Pharmaceuticals
“ My idea of a better-ordered world is one in which medical discoveries would be free of patent and there will be no profiteering from life or death.” – Indira Gandhi
From her address to the World Health Assembly in Geneva May 6, 1981
COVID-19 put a challenge to the whole world and it also highlights the issue of public health and the human rights of people across the globe. It affected all spheres and sectors across the globe and the intellectual property regime is not the exception.
The research group are engaged in the development of drugs. Some of the drugs approved for the clinical trials by WHO already possess patent protection like Remedesivir and attempts have been also made by some other countries like china to patent similar Covid-19 treatment drugs. It highlights the issue of abuse of the exclusive right of the patent holder. To address this problem various international instruments and treaties were signed by the nations for compulsory licensing of patents. It is important to note that the pharmaceuticals company incurred a heavy cost in developing drugs. But the cost incurred for the development of drugs is not more than the human lives.
Compulsory Licensing is recognized as a legal measure against patent abuse and the public health problem. One of the important reasons for granting compulsory licensing is to make medicine available and affordable to poor countries. During this time period, the pharmaceutical company should be more focused on saving lives rather than making a profit.
Nature of Patent Right
A patent is an exclusive right granted to the patent holder on the new product or process involving an inventive step and capable of industrial application for a minimum period of 20 years. Patentee holds the exclusive right to use, manufacture and sale of the product. In the absence of the competing product in the market, the patent holder enjoys a monopoly and sometimes it leads to the abuse of their dominant position in the market.
Compulsory Licensing of Patent
Since patents grant exclusive rights to the patent holder, it is necessary to limit the power of the patent holder. Compulsory Licensing of the patent involves the use of the patented product and process without the patent holder’s consent. When a patent is granted to the pharmaceutical company it may lead to an increase in the price of the patent, due to the research and innovation and time involved in the development of drugs. High prices of drugs make medicine unaffordable to developing and under-developed countries. Granting compulsory license help the state to put the cap on the prices of the drugs and provide access to essential drugs.
India and the TRIP’s
India is one of the member countries that sign the TRIPS Agreement which is implemented in 2005. Before becoming the member country of TRIPS, India does not grant a patent for drugs. This was the time when the generic pharmaceuticals industry flourished in India irrespective of the strict patent regime in India. One of the major advantage of generic drugs that it is available at cheap prices and the disadvantage of compulsory licensing is that new and innovative drugs are not launched in India. To solve this problem, India signed the TRIPS agreement in 1995.
India is a leader in the pharma industry but this situation changes after the TRIPS regime. Pharmaceuticals patenting in India is of special relevance to the current issue of public health because the Indian pharmaceuticals company is the important supplier of the low priced drugs in the market. After signing the TRIPS Agreement, a patent on a product can also be granted in India. This leads to an increase in the hold on the availability, accessibility, quantity and price value of drugs. But this situation is sometimes abused by the patent holder and to counter this situation, TRIPS provides the provision of compulsory licensing.