Patents in India: Section 3(d), compulsory licences and TRIPS
Why in news: On 16 October 2026 the Ayush Ministry cited a CGPDTM report counting 4,077 Ayush patent applications and 711 grants between FY 2014-15 and FY 2025-26.
The Patents Act, 1970 gives a 20-year monopoly only to new, inventive and industrially applicable inventions. Section 3(d) refuses patents on new forms of known substances without enhanced efficacy, and sections 84 to 92 allow compulsory licences. The law is in focus after an official report counted 4,077 Ayush patent applications filed since 2014-15.
Syllabus: GS2 · Health, Education & Human Resources; GS3 · IT, Space, Biotech & IPR; GS2 · Groupings & Agreements
Why this matters for UPSC
GS3 intellectual property rights and GS2 health: Prelims can ask what Section 3(d), sections 84 to 92 and the TRIPS Agreement provide; Mains, how patent law balances innovation, access to medicines and traditional knowledge.
In short
A patent under the Patents Act, 1970 is a 20-year exclusive right over a new, inventive and industrially applicable invention, limited by public-health safeguards.
India's patent law should reward genuine invention while Section 3(d), compulsory licences and prior art defences keep medicines affordable and traditional knowledge free.
Why it matters
A cancer patient buying imatinib in India can choose cheaper generic versions because the Supreme Court refused Novartis a fresh patent on a new crystal form of the drug in 2013; Indian firms could keep selling the medicine at a fraction of the patented price. Patent rules decide how soon such copies reach chemists here and in developing countries that buy medicines from India. They also decide who earns from new ideas: a vaidya, a university laboratory or a startup can license a genuinely new formulation, while a remedy communities have long used cannot be fenced off by a foreign patent. The larger question is how a developing country rewards inventors without pricing out the poor.
Prelims pointers
- Section 25, Patents Act: anyone may oppose before grant; any person interested may oppose within one year of publication of the grant.
- Section 3 non-inventions include methods of agriculture or horticulture, medical treatment processes, computer programmes per se, and plants and animals other than micro-organisms.
- Section 53: a patent lasts 20 years from the filing date and lapses earlier if the renewal fee is not paid.
- Section 84: any person interested applies to the Controller, not the government; the Controller decides the licence and its terms.
- Section 92A: compulsory licences to make and export patented medicines to countries with insufficient manufacturing capacity.
- Section 107A: making or using a patented invention to generate data for regulatory approval is not infringement.
- TRIPS Article 33: patent protection must run at least 20 years from the filing date.
- Doha Declaration: HIV/AIDS, tuberculosis, malaria and other epidemics can count as a national emergency or extreme urgency.
Practise a UPSC-style question
With reference to Section 3(d) of the Patents Act, 1970, consider the following statements:
1. The present form of the clause was substituted by the Patents (Amendment) Act, 2005.
2. Polymorphs and isomers of a known substance are treated as the same substance unless they differ significantly in efficacy.
3. A mere new use for a known substance is patentable if the new use has commercial significance.
Which of the statements given above is/are correct?
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Show the answer
Answer: (a) 1 and 2 only
Answer: (a) 1 and 2 only. Section 3(d) was rewritten in 2005 and its Explanation treats derivatives as the same substance; a mere new use stays unpatentable.
Statement 1: correct. The clause as it stands was substituted by the Patents (Amendment) Act, 2005, effective 1 January 2005, alongside the opening of product patents.
Statement 2: correct. The Explanation to Section 3(d) lists salts, esters, ethers, polymorphs, isomers and other derivatives as the same substance unless efficacy differs significantly.
Statement 3: incorrect. Section 3(d) excludes the mere discovery of any new use for a known substance; commercial value does not turn it into an invention.
Eliminate: Statement 3 makes a mere new use patentable, which Section 3(d) expressly denies, so it is incorrect. Out: (b), (c), (d).
Trap: Sounds right. Economic significance appears in the definition of inventive step, so commercial value feels like it should save a new use, but Section 3(d) has no such exception.
Remember: Section 3(d): a new form of a known substance needs enhanced efficacy; a mere new property or new use is never an invention.
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