The Patents Act, 1970: Human Rights and Environment

1. The rights at stake

A patent is an exclusive right for twenty years to make, use, sell and import the invention (sections 48 and 53). For most technology that raises no human rights issue. It does for four kinds of subject matter: medicines (the right to health, ICESCR Article 12 and Article 21), seeds and agricultural biotechnology (the right to food, ICESCR Article 11), inventions harmful to the environment (Article 48A and the right to a clean environment), and inventions using biological resources and traditional knowledge (communities’ cultural and Article 15(1)(c) rights, CBD Article 8(j)). General Comment 17 asks states to prevent unreasonably high costs for essential medicines and seeds; the Act does this through design rather than rights language.

2. What cannot be patented: section 3

• Section 3(b): “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”. This tracks TRIPS Article 27(2) and is the Act’s environmental clause. Genetic use restriction technologies (“terminator” seeds) are the usual example of what it could exclude.
• Section 3(c): discovery of a living thing or non-living substance occurring in nature.
• Section 3(d): a new form of a known substance that does not result in enhanced efficacy, and new uses of known substances. The anti-evergreening provision.
• Section 3(h): methods of agriculture or horticulture.
• Section 3(i): methods of medical, surgical, diagnostic or therapeutic treatment of humans or animals.
• Section 3(j): plants and animals in whole or part (other than micro-organisms), seeds, varieties and species, and essentially biological processes for their production.
• Section 3(p): an invention which is traditional knowledge or an aggregation or duplication of known properties of traditionally known components.

Novartis AG v. Union of India, 2013 INSC 198. Novartis sought a patent for the beta crystalline form of imatinib mesylate (Glivec), used for chronic myeloid leukaemia. The Supreme Court held that it was a new form of a known substance; that “efficacy” in section 3(d) for a medicine means therapeutic efficacy; and that better bioavailability or physical properties were not shown to give enhanced therapeutic efficacy. The Court read section 3(d) against its legislative history as a response to evergreening and a protection of access to medicines. Generic imatinib had been sold in India at a small fraction of the patented price. The Madras High Court had earlier (2007) rejected the argument that section 3(d) violated TRIPS (not justiciable in Indian courts) or Article 14 (not vague).

3. Examination, disclosure and opposition

• Source disclosure: section 10(4)(d)(ii)(D) requires the specification to state the source and geographical origin of biological material used. Non-disclosure or wrong disclosure is a ground of opposition (section 25(1)(j)) and revocation (section 64(1)(p)).
• Traditional knowledge: anticipation by knowledge, oral or otherwise, within any local or indigenous community is a ground of opposition (section 25(1)(k)) and revocation (section 64(1)(q)). The TKDL gives examiners access to classical texts.
• Pre-grant opposition by any person (section 25(1)) lets patient groups and generic firms challenge secondary patents before grant; it was used in the Glivec case and in many HIV-drug applications.
• Biological Diversity Act, section 6: approval of the National Biodiversity Authority is needed before an IP right is granted on an invention based on Indian biological resources or associated knowledge (Unit IV, topic 3).

4. After grant: limits on the exclusive right

1. Section 83, general principles: patents are granted to encourage inventions worked in India on a commercial scale, not to enable an import monopoly; they must contribute to technological innovation and transfer, should not impede protection of public health and nutrition, and should make the benefit available at reasonably affordable prices.
2. Section 84, compulsory licence after three years from grant, if the reasonable requirements of the public are not satisfied, the invention is not available at a reasonably affordable price, or it is not worked in India. In Bayer Corporation v. Natco Pharma the Controller granted India’s first compulsory licence (2012) for sorafenib tosylate (kidney and liver cancer) on all three grounds, with a royalty of 6 per cent; the IPAB (2013) and the Bombay High Court (2014) upheld it. Later applications (BDR Pharma for dasatinib, Lee Pharma for saxagliptin) were refused for failure to make out the grounds.
3. Section 92: compulsory licences on notification of a national emergency, extreme urgency or public non-commercial use. Section 92A: licences to manufacture and export pharmaceuticals to countries without capacity, implementing the Doha paragraph 6 system.
4. Sections 47 and 100–102: government use, including use in government hospitals and dispensaries, and acquisition of a patent for a public purpose.
5. Section 66: revocation where a patent is mischievous to the State or generally prejudicial to the public.
6. Section 107A: research and regulatory use (the Bolar exception) and parallel imports from an authorised seller.
7. Section 146 and Form 27: patentees must file working statements; after the Patents (Amendment) Rules 2024 these are filed once every three financial years. Working information helps in deciding compulsory licence claims.

The courts and the public interest. In F. Hoffmann-La Roche v. Cipla the Delhi High Court refused an interim injunction against generic erlotinib (single judge 2008, Division Bench 2009), giving weight to the price difference and the public interest in access to a life-saving drug. Later cases have been more willing to grant injunctions where validity is not seriously challenged, so the weight of the public-interest factor varies.

5. Seeds and the right to food

Section 3(j) keeps plants and seeds out of patent law, leaving them to the PPV&FR Act. But genetically engineered traits and micro-organisms can be patented. In Monsanto Technology LLC v. Nuziveedu Seeds Ltd., 2019 INSC 35, the Delhi High Court Division Bench had held Monsanto’s Bt trait patent invalid under section 3(j); the Supreme Court set this aside on the ground that validity needed a full trial, and restored the single judge’s interim order. Seed prices and trait fees for Bt cotton are separately controlled under the Cotton Seeds Price (Control) Order 2015. The case shows two state tools for the right to food working against each other: patent protection for the trait and price control for the seed.

6. Comparative human rights cases

• South Africa: the Pharmaceutical Manufacturers’ Association v. President of South Africa suit against the 1997 Medicines Act amendment (parallel imports and generic substitution) was withdrawn in 2001 after public pressure; the Treatment Action Campaign then won Minister of Health v. TAC (Constitutional Court, 2002) on access to nevirapine.
• Kenya: in Patricia Asero Ochieng v. Attorney General (High Court, 2012) the Anti-Counterfeit Act was held to threaten the right to health so far as it could treat generic medicines as counterfeit.
• Colombia and Brazil have used compulsory licences or their threat for HIV and cancer drugs.

How this is examined

Likely long questions: “Discuss the provisions of the Patents Act, 1970 that protect public health and human rights,” “Section 3(d) and access to medicines: discuss with reference to Novartis,” or “Compulsory licensing as a tool for realising the right to health.” Short notes: section 3(b); section 83; Bayer v. Natco; source disclosure; section 92A. Organise by threshold, examination and post-grant, then evaluate.