Compulsory Licensing In India

INTRODUCTION 

In our everyday life, we commonly hear people saying that 21st century is the century of science and technology, inventions and innovations, advancements and accessibility and many more. No wonder we are even witnessing these terms proving their meaning in context to this modern century. But have you ever wondered that how does any inventions, creations, technological advancements protected? And how they are used and applied?

These inventions and creations and many more are collectively kept under the umbrella of Intellectual Property Rights, commonly abbreviated as IPR. Let us get in little detail.

WHAT ARE INTELLECTUAL PROPERTY RIGHTS?

Intellectual Property Rights, as the words itself speaks, these are the rights given to person for their creative output. The creator is made exclusive right holder for the use of the creation over a specified time period. The exclusive rights extend to different categories such as Patent, Copyright, Trademarks, Industrial Designs, Geographical Indication and many more. Intellectual Property Rights are regulated at global level as well as national level.

At Global level, World Intellectual Property Organization established on 14th July,1967 regulates and formulates intellectual property services, policies, information and aims at encouraging creations and innovations through an effective international system. World Trade Organization formulated a global agreement called TRIPS, is another important step taken for encouraging innovations at global level.It is a multilateral agreement comprising several countries aiming at promoting and protecting intellectual property across the global.

India is a party to the TRIPS agreement and contributed towards global aim. Apart from this, India has vast legal formulations that govern, regulate and protect the categories of IPR. Such as Indian Patent Act, 1970; Copyright Act,1957; Trademarks Act, 1999 etc.

What is Compulsory Licensing?

Compulsory Licensing is a concept under section 84 to 92 of The Patents Act,1970. First let us understand the meaning of Patent. So, patent is an exclusive right given to any invention which may be a product or a process for a specified time.

Basically, once any product is registered under the regulating law, the creator gets exclusive right for the use of that product under his name legally for a specified period of time. But there’s an exception to this convention. The exception is that the government can handover the rights of the product after expiry of a given time period to any other person without the permission of the original creator. This is called compulsory licensing.

However, the handing over of rights from the inventor or creator to the third person cannot happen in a blink of an eye. There are certain conditions which need to be fulfilled for initiating the process of Compulsory Licensing. Section 84 comes into play in this regard. It says that any time after expiration of Three years from the date of grant of  patent of the product, an application by interested person can be made to the Controller of Grant for seeking compulsory license on the patented product on any of the following grounds :-

• That the patented invention is unable to satisfy the reasonable requirements of the public arising out of it.
• that the patented invention is not available at  reasonably affordable price to the public
• that the patented invention is employed outside the territory of India.

Under clause 92 of the said act, compulsory license can be issued the Controller of Grant on notice by central government in situation of either “national emergency” or “extreme emergency” or in cases of “public non-commercial use”.

WHETHER COMPULSORY LICENSING ISSUED IN INDIA?

Through various amendments in the Indian Patent Act, 1970 the concept of Compulsory Licensing was incorporated. The first case of compulsory licensing in India was in 2012. The compulsory licensing was issued to Hyderabad-based Natco Pharma for the production of Nexavar. It is a life saving drug which treats liver and kidney cancer. This drug was developed by Bayer Corporation.

In India, there are several industries such as Distillation and Brewing of alcoholic drinks, Defence equipment, various types of electrical devices, drugs and pharmaceutical etc which require compulsory licensing.

CONCLUSION 

There are different and opposing opinions across the global related to compulsory licensing. On one side, the concept is favoured because affordability and accessibility of drugs and medicines is a major concern in the developing countries but on the other side the competition is opposed by the developed countries. As per them, compulsory licensing would discourage innovations in the pharmaceutical industry. Thus, no wonder why it is a debatable topic.

Recently, this topic got attention in India. In 2020, during the pandemic, central government was suggested to issue compulsory licenses for the manufacturing and production of affordable generic version of the anti-viral drug Remdesivir.