Question

How many compulsory licenses have been granted by the Indian Patent Office?

• A. Six
• B. Four
• C. Two
• D. One

Hint:

Only one compulsory licence has been granted in India: Natco Pharma (2012) For Bayer's cancer drug: Nexavar (Sorafenib Tosylate)

Answer 1

The Correct Option is D

Concept: A compulsory licence permits a third party to manufacture or sell a patented invention without the consent of the patent holder under specific statutory circumstances. The mechanism balances patent rights with public interest.

Step 1: Understand the legal provision. Section 84 of the Patents Act, 1970 allows compulsory licences to be granted when:

• Public requirements are not adequately satisfied.

• The patented invention is not reasonably affordable.

• The invention is not sufficiently worked in India.

Step 2: Examine India's history. India has granted only one compulsory licence since the introduction of the product patent regime.

Step 3: Identify the landmark case. In 2012, the Indian Patent Office granted a compulsory licence to Natco Pharma for producing a generic version of Bayer's patented cancer drug Nexavar (Sorafenib Tosylate). The decision was based on public interest and affordability concerns. Hence, only one compulsory licence has been granted by the Indian Patent Office. Therefore, Option (D) is correct.