Compulsory Licensing under the Indian Patents Act
SyllabusIssues relating to development and management of Social Sector/Services: health access
A compulsory licence permits a person to use a patented invention without the patentee's consent, while the patent remains valid and the patentee receives remuneration. Under the Patents Act, 1970, such licences are granted by the Controller of Patents on specified statutory grounds and conditions.
Ordinary grounds for grant
Under Section 84, any interested person may apply after three years from the date the patent was granted. A compulsory licence may be granted if the Controller is satisfied that at least one statutory ground exists.
- The reasonable requirements of the public concerning the patented invention have not been satisfied.
- The invention is not available to the public at a reasonably affordable price.
- The patented invention is not worked in the territory of India.
Factors considered by the Controller
The Controller considers the nature of the invention, the time elapsed since the patent grant, the patentee's efforts to use the invention, and the applicant's capacity to work it for public advantage.
- The applicant must ordinarily have first sought a voluntary licence on reasonable commercial terms and failed within a reasonable period, normally not exceeding six months.
- Prior negotiation may be dispensed with in situations such as national emergency, extreme urgency, public non-commercial use, or established anti-competitive conduct.
- The expression “reasonable requirements of the public” covers situations such as unmet demand, failure to develop a market, or working the invention below the fullest reasonably practicable extent.
Special public-interest routes
Under Section 92, the Central Government may notify that compulsory licences are necessary for a patent because of national emergency, extreme urgency, or public non-commercial use. Public-health crises, including epidemics, can justify an expedited procedure.
- Under Section 92A, a licence may be granted for manufacturing and exporting a patented pharmaceutical product to a country with insufficient manufacturing capacity to address a public-health problem, provided that country permits such importation.
- Under Section 90, licence terms must secure reasonable remuneration for the patentee, make the invention available at affordable prices, and generally make the licence non-exclusive and non-assignable.
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