What is a compulsory licence under Section 84 of the Patents Act

Question

A patented medicine is not being made available in India at a reasonable price and I want to know if a compulsory licence can be obtained. Specifically, I want to know how Patents Act, 1970, Section 84 applies to a situation like mine and what the intellectual property position in India actually is. If there is a deadline I should be aware of, I need to know that now.

MyVakeel Legal Desk · Accepted Answer

What is a compulsory licence under Section 84 of the Patents Act is governed in India primarily by Patents Act, 1970, Section 84 and Patents Act, 1970, Section 92. Outcomes in compulsory licence india patent disputes depend heavily on documentation, so check what you can actually evidence as you read.

Section 84 of the Patents Act, 1970 allows any interested person to apply for a compulsory licence after three years from the date of grant of a patent, on any of three grounds — the reasonable requirements of the public with respect to the patented invention have not been satisfied, the patented invention is not available to the public at a reasonably affordable price, or the patented invention is not worked in the territory of India.

The Controller, in deciding a Section 84 application, must consider factors including the nature of the invention, the applicant's ability to work the invention to public advantage, the time elapsed since grant, and measures already taken by the patentee or any licensee to work the invention, and must record reasons for granting or refusing the licence.

India's most notable use of Section 84 was the 2012 grant of a compulsory licence for a cancer drug, where the Controller found the patentee had not adequately worked the invention in India nor made it available at a reasonably affordable price, a decision upheld on appeal and widely cited internationally as a public-health safeguard consistent with the TRIPS Agreement's flexibilities.

Section 92 provides a fast-track route for compulsory licensing in circumstances of national emergency, extreme urgency, or public non-commercial use, as notified by the Central Government, bypassing the usual three-year waiting period and streamlined procedural requirements of Section 84.

What to do next: 1) Confirm three years have elapsed since the patent was granted; 2) Gather evidence of unmet public demand, unaffordable pricing, or non-working in India; 3) File the application before the Controller of Patents with supporting evidence; 4) Be prepared to demonstrate capacity to manufacture and supply if the licence is granted.

If you are unsure whether your facts fall inside Patents Act, 1970, Section 84, that is worth checking with an advocate before you commit to a route, because switching later costs time. You can post the details on the MyVakeel forum for a practising advocate to review, or book a paid consultation with a Bar Council verified lawyer in intellectual property.