Impact of IPR on Development, Health, Agriculture and Indigenous Peoples

1. Development

The question is whether strong IP helps or hinders a developing country. The argument for: it attracts foreign investment and licensing, rewards domestic innovators and builds a knowledge economy. The argument against: most patents in developing countries are held by foreign firms, so the rents flow out; strong rights block the imitation through which today's rich countries industrialised (the US, Switzerland and Japan all had weak protection in their early growth). The UK Commission on Intellectual Property Rights (2002) concluded that developing countries should calibrate IP to their circumstances and use the flexibilities in TRIPS. WIPO adopted a Development Agenda in 2007 with 45 recommendations, committing it to take development into account in its norm-setting.

India used the transition periods in TRIPS Article 65 to delay product patents for pharmaceuticals until 2005. The 1970 Act's process-patent regime had let Indian firms reverse-engineer drugs, and India became a major supplier of generic medicines. That history is the strongest evidence for calibrated protection.

2. Health and access to medicines

Patents on medicines raise prices during the term. The issue became acute in the late 1990s over HIV/AIDS drugs; in 1998 pharmaceutical companies sued South Africa over its Medicines Act and withdrew the case in 2001 after public protest.

• Doha Declaration on the TRIPS Agreement and Public Health (WTO Ministerial Conference, 14 November 2001): TRIPS “does not and should not prevent members from taking measures to protect public health”; each member has the right to grant compulsory licences and to determine the grounds; each may decide what is a national emergency; and each may choose its own regime of exhaustion.
• Paragraph 6 problem. Countries without manufacturing capacity cannot use a compulsory licence. The 2003 waiver decision, made permanent as Article 31bis (in force 2017), lets a member produce under compulsory licence for export to such countries. India implemented this in section 92A of the Patents Act.

Indian measures: section 3(d) excludes new forms of known substances without enhanced therapeutic efficacy, applied in Novartis AG v. Union of India, 2013 INSC 198, to refuse a patent on the beta crystalline form of imatinib mesylate (Glivec); pre-grant opposition by any person (s.25(1)); compulsory licences (s.84), first granted to Natco for Bayer's sorafenib (Controller, 2012, upheld by the IPAB in 2013 and the Bombay High Court in 2014); the Bolar exception and parallel imports (s.107A); and price control under the Drugs (Prices Control) Order. Critics in the US and EU have called these measures non-compliant; India's answer is that each is a flexibility TRIPS allows.

3. Agriculture

TRIPS Article 27(3)(b) lets members exclude plants and animals from patents but requires protection of plant varieties “either by patents or by an effective sui generis system or by any combination thereof.” India chose a sui generis system: the Protection of Plant Varieties and Farmers' Rights Act, 2001, which protects breeders but also gives farmers the right to save, use, sow, re-sow, exchange, share and sell farm produce including seed, except branded seed of a protected variety (see the PPV&FR note). India did not join UPOV 1991, which would limit that farmers' privilege.

Patents enter through biotechnology. Section 3(j) excludes plants and animals in whole or in part, seeds and essentially biological processes, but not micro-organisms. In Monsanto Technology LLC v. Nuziveedu Seeds Ltd., 2019 INSC 35, the Delhi High Court Division Bench had held that Monsanto's patent on the nucleic acid sequence carrying the Bt trait was not patentable under s.3(j). The Supreme Court set that aside, holding that validity could not be decided summarily on a counter-claim, restored the single judge's interim order, and sent the suit for trial. The case shows the tension between patents on genetic traits and the seed-price controls the government imposes on Bt cotton.

The PepsiCo potato dispute (2019) showed the farmer side: PepsiCo sued Gujarat farmers for growing its registered variety, withdrew after protest, and the PPV&FR Authority later revoked the registration; that order has since been litigated in the Delhi High Court.

4. Indigenous peoples and traditional knowledge

Traditional knowledge (TK) about medicinal plants, agriculture and crafts is held collectively, passed down orally and often not “new”. Patent law does not protect it, but outsiders could patent products derived from it, which is called biopiracy. Indian examples:

• Turmeric. A US patent (1995) on turmeric for wound healing was revoked in 1997 after CSIR produced ancient texts showing the use was known.
• Neem. A European patent on a neem-based fungicide was revoked by the EPO (2000, confirmed on appeal 2005) for lack of novelty.
• Basmati. RiceTec's US patent (1997) on rice lines was narrowed after Indian challenge, and the dispute drove the GI Act.

Responses:

1. Defensive. The Traditional Knowledge Digital Library (TKDL), built by CSIR from 2001, puts classical texts in a form patent examiners can search, and access agreements have been signed with major patent offices. Section 3(p) of the Patents Act excludes inventions that are TK or an aggregation of known properties of traditional components; s.25(1)(k) and s.64(1)(q) make anticipation by TK, oral or otherwise, a ground of opposition and revocation.
2. Disclosure. Section 10(4)(d)(ii)(D) requires the specification to disclose the source and geographical origin of biological material used; non-disclosure is a ground of opposition and revocation (s.25(1)(j), s.64(1)(p)). Section 6 of the Biological Diversity Act, 2002 requires approval of the National Biodiversity Authority before applying for IP based on Indian biological resources or associated knowledge.
3. Access and benefit-sharing. The Convention on Biological Diversity (1992) recognises sovereign rights over genetic resources and calls for prior informed consent and fair benefit-sharing; the Nagoya Protocol (2010) gives this a working framework. The Kani tribe's benefit-sharing arrangement over the Jeevani herbal formulation in Kerala is the standard example.
4. International norms. The UN Declaration on the Rights of Indigenous Peoples (2007), Article 31, recognises indigenous peoples' right to maintain and protect their TK and traditional cultural expressions. In May 2024 WIPO members adopted the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, which requires patent applicants to disclose the origin of genetic resources and associated TK used in a claimed invention.
5. Positive protection through geographical indications for crafts and products of tribal regions.

How this is examined

Q2 of 2024 in exactly these terms. Use four headings. Under each give one international instrument, one Indian provision and one case: Doha and Novartis; Article 27(3)(b), PPV&FR and Monsanto; CBD, TKDL and the turmeric patent. Open with the development debate and close with the balance above.