Compulsory Licensing under the Indian Patents Act

A compulsory licence permits another 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, the Controller of Patents may grant it on specified grounds and conditions. It balances patent rights with public access, especially where essential patented products remain unavailable or unaffordable.

Ordinary grounds for grant

Under Section 84, any interested person may apply after three years from the date the patent was granted. The Controller may grant a compulsory licence if 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.
• Reasonable requirements may remain unsatisfied because of unmet demand, failure to develop a market, or working below the fullest reasonably practicable extent.

Decision and procedural safeguards

Under Section 84, the Controller considers the invention's nature, time elapsed since patent grant, the patentee's efforts to use it, and the applicant's capacity to work it for public advantage.

• The applicant must ordinarily have 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 during a national emergency, extreme urgency, public non-commercial use, or established anti-competitive conduct.
• Under Section 90, the licence must provide reasonable remuneration to the patentee and normally remain non-exclusive and non-assignable.

How it improves access to medicines

Compulsory licensing allows an additional qualified producer to make and supply a patented medicine when the patent holder's supply, price or working of the invention does not meet statutory requirements. Additional production can expand availability and introduce competition, while licence terms must help make the invention available at affordable prices.

• It can address unmet patient demand and inadequate supply without cancelling the patent.
• It can facilitate working of the invention in India and reduce access barriers arising from non-working.
• Because the licence is generally non-exclusive, the patentee retains its rights while another producer may also supply the medicine.
• Its effectiveness still depends on the licensee's manufacturing capacity, regulatory compliance and distribution.

Special public-health routes

Under Section 92, the Central Government may notify that compulsory licences are necessary 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 permit manufacture and export of a patented pharmaceutical product to a country lacking sufficient manufacturing capacity to address a public-health problem, provided that country permits its importation.
• These routes extend access while preserving patent validity and the patentee's entitlement to remuneration.