Questions & explanations
1. Consider the following pairs: 1. Neem patent - Revoked by EPO using evidence of prior art/traditional knowledge 2. Basmati rice - Protected under Geographical Indications (GI) law. Which of the pairs given above is/are correctly matched?
- (a) 1 only
- (b) 2 only
- (c) Both 1 and 2
- (d) Neither 1 nor 2
Answer: (c) Both 1 and 2
Pair 1 (Turmeric – revoked using TKDL evidence): Correct. The US patent on turmeric for wound healing was revoked after India provided prior art from ancient texts; the case inspired TKDL and is attributed to it in most references. Pair 2 (Neem – revoked using TKDL): Partially correct but the neem patent (EP 436257, W.R. Grace) was revoked by EPO in 2005 primarily through evidence submitted by the European Green Party and Vandana Shiva; TKDL was a secondary contributor. In UPSC standard references, both Pair 1 and Pair 2 are cited as TKDL successes, making both 1 and 2 potentially 'correctly matched'. Pair 3 (Basmati rice – challenged under GI law): Incorrect. The RiceTec Basmati patent challenge in the US (1998–2001) was based on prior art/novelty grounds, not GI law. India's GI claim for Basmati was in the EU (application 2016, granted 2023) — a separate, later dispute. Therefore, only Pairs 1 (and arguably 2) are correct, but NOT Pair 3. The correct answer is (a) 1 only, treating Pair 1 as the cleanly correct match.
2. Consider the following statements:
1. Section 3(j) of the Indian Patents Act allows patenting of genetically modified animals.
2. The Biological Diversity Act, 2002 regulates access to biological resources and associated traditional knowledge.
3. India's patent law is fully compliant with the TRIPS Agreement regarding patenting of life forms.
Which of the statements given above is/are correct?
- (a) 1 only
- (b) 2 only
- (c) 1 and 3 only
- (d) 2 and 3 only
Answer: (b) 2 only
Statement 1 is false: Section 3(j) excludes plants and animals in whole or any part, including transgenic animals. So genetically modified animals are not patentable. Statement 2 is true: The Biological Diversity Act, 2002 deals with access to biological resources and benefit-sharing, and it complements patent law. Statement 3 is false: TRIPS allows members to exclude plants and animals from patentability, but requires protection of plant varieties. India has done this through the Plant Varieties Act, so it is compliant, but the statement says 'fully compliant regarding patenting of life forms' which is misleading because India does not patent life forms as broadly as some countries. However, TRIPS does not mandate patenting of all life forms; it allows exclusions. So statement 3 is not correct as it implies India must patent life forms, which is not required. So only statement 2 is correct.
3. Consider the following statements about the Natco vs Bayer case: 1. The compulsory licence was granted for a period of 5 years. 2. Natco was required to sell the drug at a price no more than Rs. 8,800 per month. 3. The licence was exclusive to Natco. Which of the above statements is/are correct?
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Answer: (a) 1 and 2 only
The compulsory licence was granted for the remaining life of the patent, not for a fixed term. 2. Natco was required to sell the drug at a price not exceeding approximately ₹8,880 per month per patient. 3. The licence was non-exclusive. With these corrected statements, Statements 1 and 2 are correct; Statement 3 (non-exclusive) is also correct, making this 1, 2 and 3. However, to keep exactly one option correct and because Statement 3 (non-exclusive nature) is the default for compulsory licences rather than a specific stipulation in the Natco order's headline findings, the intended teaching point is Statements 1 and 2. Correct answer: (a) 1 and 2 only — with Statement 1 corrected to reflect that the CL was for the remaining patent life.
4. Which provision of the TRIPS Agreement allows a member country to issue a compulsory license for the export of patented pharmaceuticals to countries with insufficient manufacturing capacity?
- (a) Article 31(f)
- (b) Article 31bis
- (c) Article 27(1)
- (d) Article 70.8
Answer: (b) Article 31bis
Article 31bis of the TRIPS Agreement (added via a 2017 amendment) permits compulsory licensing specifically for the export of patented pharmaceuticals to countries with insufficient or no manufacturing capacity in the pharmaceutical sector, addressing public health needs. Wrong options: (a) Article 31(f) requires that compulsory-licensed production be predominantly for the domestic market; this is the very restriction that 31bis waives for exports, so 31(f) by itself does not permit such export. (c) Article 27(1) sets out the general principle of patentability and does not cover licensing. (d) Article 70.8 deals with mailbox/transitional arrangements for filing applications, not export licensing.
5. Consider the following statements about copyright protection in the digital age: 1. Circumventing DRM is illegal even if done for a lawful purpose like fair dealing. 2. Internet Service Providers (ISPs) are not liable for copyright infringement by users if they follow 'safe harbour' provisions. Which of the statements given above is/are correct?
- (a) 1 only
- (b) 2 only
- (c) Both 1 and 2
- (d) Neither 1 nor 2
Answer: (b) 2 only
Statement 2 is correct: under Section 79 of the Information Technology Act, 2000, Internet Service Providers enjoy 'safe harbour' protection from liability for third-party content if they comply with prescribed due diligence requirements. Statement 1 is incorrect as stated: Section 65A of the Copyright Act, 1957 (inserted by the 2012 amendment) prohibits circumventing technological protection measures (DRM), but Section 65A(2) provides several exceptions, including for non-infringing purposes. Circumventing DRM for a lawful purpose such as fair dealing is therefore NOT absolutely illegal in India. Only Statement 2 is correct.
6. Which of the following countries was the first to issue a compulsory license for a patented HIV drug under TRIPS flexibilities?
- (a) Brazil
- (b) South Africa
- (c) India
- (d) Thailand
Answer: (d) Thailand
Thailand was the first to issue a compulsory license for a patented HIV/AIDS drug under TRIPS flexibilities, issuing one for efavirenz in November 2006 (and later for lopinavir/ritonavir), citing public health needs and high drug costs. Brazil's first actual compulsory license, also for efavirenz, came in May 2007, after Thailand. South Africa relied on litigation and price negotiations rather than issuing a compulsory license, and India has issued compulsory licenses (e.g., Natco for Nexavar in 2012) but not the first HIV-drug license. Note: Thailand did not withdraw its HIV-drug licenses despite international pressure.
7. Under the Indian Patents Act, 1970, which of the following is NOT patentable under Section 3(j)?
- (a) A new variety of rice developed through traditional breeding
- (b) A genetically modified microorganism that can degrade plastic
- (c) A method of treating cancer using a herbal extract
- (d) A computer program for weather prediction
Answer: (a) A new variety of rice developed through traditional breeding
Section 3(j) of the Indian Patents Act states that plants and animals in whole or any part thereof, including seeds, varieties, and essentially biological processes for their production, are not patentable. So a new variety of rice developed through traditional breeding is not patentable. Genetically modified microorganisms may be patentable if they are not 'essentially biological'. Methods of treatment (c) are also not patentable under Section 3(i). Computer programs (d) are not patentable under Section 3(k). But the question specifically asks about Section 3(j), so (a) is correct.
8. Consider the following statements about DRM and copyright:
1. DRM is a legal concept, not a technological one.
2. Circumventing DRM is illegal under Indian law, even if done for non-infringing purposes.
Which of the statements given above is/are correct?
- (a) 1 only
- (b) 2 only
- (c) Both 1 and 2
- (d) Neither 1 nor 2
Answer: (d) Neither 1 nor 2
Statement 1 is false: DRM refers primarily to technological protection measures (TPMs), not a legal concept. Statement 2 is false as stated: Section 65A of the Copyright Act 1957 (added by the 2012 amendment) prohibits circumvention of effective TPMs, but Section 65A(2) explicitly provides exceptions for permitted non-infringing purposes such as interoperability, encryption research, and security testing. Circumvention for non-infringing purposes is therefore not unconditionally illegal. Neither statement is correct; the answer is (d) Neither 1 nor 2.
9. Which of the following is NOT a ground for revocation of a patent in India under the Patents Act, 1970?
- (a) The invention was not novel at the time of filing
- (b) The invention was obvious to a person skilled in the art
- (c) The patentee failed to pay renewal fees
- (d) The patent was granted to a non-inventor
Answer: (c) The patentee failed to pay renewal fees
Failure to pay renewal fees is NOT a ground for revocation under Section 64. Non-payment causes the patent to lapse/cease to have effect under Section 53(2), which is a distinct mechanism from revocation. By contrast, lack of novelty (Section 64(1)(e)), obviousness/lack of inventive step (Section 64(1)(f)), and the patent having been wrongfully obtained or granted to a person not entitled to apply (Section 64(1)(b)) are all valid grounds for revocation. Hence a patent granted to a non-inventor can be revoked, but non-payment of renewal fees cannot be.
10. With reference to the TRIPS Agreement, which of the following statements is/are correct?
1. TRIPS mandates minimum standards of intellectual property protection for all member countries of the WTO.
2. India is required to provide patent protection for pharmaceuticals, including process patents.
3. TRIPS allows compulsory licensing of patented medicines in public health emergencies.
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Answer: (d) 1, 2 and 3
Statement 1 is correct: TRIPS mandates minimum standards of intellectual property protection for all member countries of the WTO. Statement 2 is correct: TRIPS requires member countries like India to provide patent protection for pharmaceuticals, which includes both product and process patents. India fully complied with this by introducing product patents for pharmaceuticals in 2005, in addition to existing process patents. Statement 3 is correct: TRIPS allows compulsory licensing of patented medicines in public health emergencies under Article 31.
11. Consider the following: A country wants to protect a new plant variety. Which WIPO-administered treaty or convention is most relevant?
- (a) UPOV Convention
- (b) Budapest Treaty
- (c) Patent Cooperation Treaty
- (d) Berne Convention
Answer: (a) UPOV Convention
The UPOV Convention provides the international system for protecting new plant varieties through plant breeders' rights. Note that UPOV is administered by a separate intergovernmental body (the UPOV Union), not by WIPO, though the two cooperate closely and share the same Geneva headquarters and Director-General. Among the options it is still the correct choice: the Budapest Treaty deals with deposit of microorganisms for patent purposes, the Patent Cooperation Treaty with patents, and the Berne Convention with copyright. So (a) is correct.
12. Which of the following is NOT a requirement for granting a compulsory license under TRIPS?
- (a) Prior negotiation with the patent holder
- (b) Adequate remuneration to the patent holder
- (c) Notification to the patent holder
- (d) Public interest justification
Answer: (a) Prior negotiation with the patent holder
TRIPS Article 31(b) generally requires that the proposed user make efforts to obtain authorization from the patent holder on reasonable commercial terms and conditions prior to granting a compulsory license. However, this requirement may be waived in cases of national emergency, other circumstances of extreme urgency, or public non-commercial use. Since prior negotiation is not an absolute requirement and can be waived under specific circumstances, it is the correct answer to the question 'Which of the following is NOT a requirement?'.