COMPULSORY LICENSING

Subject : Economy / Governance

Context :Govt should not hesitate to invoke compulsory licensing of drugs under Patent Act if necessary: Delhi High Court.

Concept :

The Patents Act, 1970 was amended three times in 1999, 2002, 2005 respectively to include the concept of ‘compulsory license’ and these are given in the sections 84-92 of the Indian Patents Act, 1970.
A patent is an exclusive right granted for an invention, whether it is a product or a process which gives a new technical solution to a problem, and this patent is granted for a specific period to the inventor.

What are ‘compulsory licenses’ under the Patents Act?

In simple terms, compulsory licenses are authorizations given to a third-party by the Government 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.
The provisions regarding compulsory licenses are given in the Indian Patents Act, 1970 and in the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement at the International level.
Although this works against the patent holder, generally compulsory licenses are only considered in certain cases of national emergency, and health crisis. There are certain pre-requisite conditions which need to be fulfilled if the Government wants to grant a compulsory license in favor of someone.
Under Indian Patents Act, 1970 the provisions of ‘compulsory license’ are specifically given under Chapter XVI, and the conditions which need to be fulfilled are given is Sections 84-92 of the said Act.

Section 84

At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely:
That the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
that the patented invention is not available to the public at a reasonably affordable price, or
that the patented invention is not worked in the territory of India.

However compulsory licenses may also be granted under ,

Section 92 A– For exports, under exceptional circumstances.
Section 92A– In case of national emergency, extreme urgency of public non-commercial use by notification of the Central Government
Section 92 A (1) – To a country which has insufficient or no manufacturing power in the pharmaceutical sector to address public health.