A compulsory license (CL) is a legal mechanism that allows a third party to use a patented invention without the consent of the patent holder. In India, this mechanism is primarily used to ensure public access to essential goods, such as medicines, at affordable prices.

Role in Promoting Public Health, Innovation, and Access to Essential Medicines:

The concept of compulsory licensing is more relevant in healthcare and pharmaceuticals. Governments or authorized agencies can bypass patent holders' rights for public health benefits if patented products, such as life-saving drugs, are unavailable or unaffordable.

• Public Health: CLs have played an important role in making available affordable medicines for diseases like HIV/AIDS, cancer, and tuberculosis in India.

• Innovation: While CLs can be viewed as restricting the exclusive rights of patent holders, they also spur further innovation in that patents are directed toward broader social and economic needs rather than just commercial interests.

• Access to Medicines: In India, CLs have been a key tool in making critical medicines available at prices the general public can afford without compromising the fundamental rights of inventors.

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The Legal Framework for Compulsory Licensing in India

Indian Patents Act, 1970 is the backbone of Indian Patent law and provides the legal foundation to CL. The Act contains many provisions related to CLs and the most important ones can be found in:

• Section 84: This section specifically relates to the general provision relating to the grant of compulsory license.

• Section 92: Relates to the granting of CLs in case of public health emergencies or other national crises.

• Section 100: Dealing with exportation of patented medicines under compulsory licensing arrangements to the countries suffering from public health crises

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Types of Compulsory Licenses in India

Section 84: General Compulsory License

Conditions for Grant:

• The patent is not worked in India (not manufactured, used, or sold).

• The reasonable requirements of the public are not satisfied.

• The patented product or process is not available at a reasonable price.

• Period of the License and Conditions of Use: A compulsory license can be granted for a period of time and on conditions that include the payment of royalties to the patent holder. The license may be subject to a review and could be revoked or altered depending on the circumstances.

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Section 92: Government Use and Public Health Emergency

Conditions Under Which the Government Can Issue CL Without the Consent of the Patentee:

In cases like public health emergencies (epidemics, pandemics) or other national interest cases, the Indian government can give a compulsory license without any form of negotiation with the patent holder. The provision was exploited during the COVID-19 pandemic for vaccine and treatment manufacture.

Some examples of emergency situations, like pandemics and health crises:

• COVID-19 Pandemic: During the COVID-19 crisis, India invoked Section 92 to authorize the production of vaccines and critical treatments under compulsory licensing provisions.

• HIV/AIDS Crisis: Compulsory licenses for antiretroviral drugs were granted to make HIV/AIDS medications more affordable and widely available.

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Section 100: Compulsory License for Exporting to Countries with Health Crises

This provision allows India to issue compulsory licenses for the manufacture of patented medicines that can be exported to other countries facing public health emergencies, even if the country's laws would otherwise prohibit such licenses. It is in accordance with the Doha Declaration, which provides for the export of medicines under compulsory licenses to other countries to meet public health emergencies.

International Framework and Agreements

1. Agreement on Trade-Related Aspect of Intellectual Property Rights

India, as a WTO member, is bound by the TRIPS Agreement that mandates minimum standards for the protection of intellectual property, such as patents. However, it offers some flexibility to countries for the issuance of compulsory licenses when certain conditions are met, specifically regarding public health.

2. Doha Declaration on TRIPS and Public Health (2001)

The Doha Declaration reaffirmed the use of compulsory licensing by WTO members as a right to provide for public health. While it explicitly permits countries to obtain compulsory licenses to manufacture or supply essential medicines during public health emergencies, such licenses derogate patent rights.

To sum up, comulsory licensing is likely to play an increasing role in ensuring access to affordable medicines, particularly during public health emergencies. The Indian judiciary and Patent Office will continue to balance intellectual property rights with public health needs. India remains a global leader in using compulsory licensing, influencing international patent policy and helping improve access to medicines worldwide, especially in developing countries.

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FAQs related to Compulsory License in India

Q1. What is a Compulsory License?

A compulsory license (CL) is an authorization of a third party to use a patented invention without the patentee's consent, generally to make essential products available to the public, such as medicines. CLs in India are administered under the Indian Patents Act, 1970. These can be granted due to reasons such as failure of public demand or because it is out of reach.

Q2. What is the difference between a Compulsory License and a Voluntary License?

Voluntary License: Patent holder gives permission to another party to use the patent, usually in return for a fee. Compulsory License: The government grants this license without the permission of the patent holder; usually given to deal with a health crisis or a patent is not being exploited for commerce.

Q3. What is the Scope in Which the Government Can Impose a CL?

A CL may be granted in such instances as Public health emergency such as pandemics and epidemics, Non-working of patents (patent not being used in India),Affordability issues (high prices of life-saving medicines)

Q4. Can a Compulsory License Be Revoked?

Yes, a compulsory license can be revoked or modified if the licensee fails to meet conditions (e.g., royalty payments).,The patent holder starts meeting public needs. The government reviews the license terms.

Q5. How Are Royalty Rates Determined in a Compulsory License?

Royalty rates are determined based on factors such as the economic value of the patent.

Market conditions and affordability, Public health considerations, especially for essential medicines.