IPR
Topic 128 TRIPS Plus Waivers
Topic 128 — TRIPS-Plus and TRIPS Waivers
TRIPS-PLUS refers to provisions in bilateral/regional treaties that go BEYOND TRIPS minimum standards — typically pushed by developed countries (US, EU, Japan) to extend IP protection. TRIPS WAIVERS are exceptions/derogations from TRIPS obligations — typically pursued by developing countries for specific public interest concerns. India's strategic position has been clear: OPPOSE TRIPS-PLUS provisions; ADVOCATE TRIPS WAIVERS for public health. The MC12 DECISION (17 June 2022) on COVID-19 vaccines was the most significant TRIPS waiver achievement in recent history — co-led by India + South Africa initially proposing in October 2020. India's Section 3(d) anti-evergreening, Section 84 compulsory licensing, and parallel imports preserve TRIPS flexibilities. Common TRIPS-Plus provisions: PATENT TERM EXTENSION beyond 20 years; DATA EXCLUSIVITY for pharmaceutical test data; STRICTER COMPULSORY LICENSING beyond TRIPS Article 31; PATENT LINKAGE between marketing approval and patent status; ISDS (Investor-State Dispute Settlement); EXPANDED BORDER MEASURES; STRONGER ISP/INTERMEDIARY OBLIGATIONS; GI EXPANSIONS beyond TRIPS Article 22. India's 2014 NATIONAL IPR POLICY explicitly states position. India's NEGOTIATING POSITION has consistently rejected TRIPS-Plus in bilateral FTAs. Recent multilateral developments: ARTICLE 31bis (2017) — first WTO trade agreement amendment; MC12 Decision (June 2022); 30 Years TRIPS celebrated 2024; WIPO Treaty on IP/Genetic Resources/Traditional Knowledge (May 2024). India's strategic outcomes: Section 3(d) upheld in Novartis 2013; Bayer-Natco 2012 successful compulsory licence; IPAB abolition 2021 (administrative reform); Patents Amendment Bill 2022 (modernisation). The 2023-2025 reforms continue. This topic walks through TRIPS-Plus provisions, India's opposition, TRIPS waivers, and India's international IP advocacy.
1. TRIPS-Plus Framework
A. Definition
✅ What is TRIPS-Plus? TRIPS-Plus refers to: · Provisions in bilateral/regional treaties. · Going BEYOND TRIPS minimum standards. · Pushed by developed countries. · Often opposed by developing countries. Driven by: · US Free Trade Agreements. · EU Economic Partnership Agreements. · Japanese FTAs. · Pharmaceutical industry advocacy. · Brand protection associations. OPPOSED BY: · India. · Brazil. · South Africa. · Most developing countries. Reasons for opposition: · Reduces TRIPS flexibility. · Increases drug prices. · Restricts public health measures. · Limits generic competition. · Reduces national autonomy. |
B. Common TRIPS-Plus Provisions
Provision | TRIPS Standard | TRIPS-Plus |
|---|---|---|
Patent term | 20 years (Article 33). | Extension for regulatory delay. |
Data exclusivity | Article 39.3 (limited). | 5-10 years pharma data exclusivity. |
Compulsory licensing | Article 31 framework. | Restricted grounds, narrower scope. |
Patent linkage | Not in TRIPS. | Marketing approval linked to patent. |
Border measures | Article 51 limited. | Expanded scope (in-transit, etc.). |
ISP liability | Limited intermediary framework. | Stricter obligations. |
GI scope | Article 22 framework. | Expanded protection. |
Three-step test | Article 13 framework. | Strict interpretation of fair use. |
2. Patent Term Extension
A. TRIPS Standard
- Article 33 — minimum 20 years from filing.
- No mandatory extension for regulatory delay.
- Members' choice on additional extensions.
B. TRIPS-Plus Demand
- Patent term extension for regulatory approval delay (typically 5 years).
- Particularly for pharmaceuticals.
- Effectively extends patent monopoly.
- Reduces generic competition.
C. India's Position
- NO patent term extension provided.
- Section 53 Patents Act — 20 years from filing.
- Section 142(4) — date of patent.
- Strategic decision — preserves generic competition.
3. Data Exclusivity
A. TRIPS Article 39.3
TRIPS Article 39.3 — Pharmaceutical Test Data "Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use." |
B. TRIPS-Plus Demand
- 5-10 years data exclusivity.
- Generic manufacturers prevented from using originator data.
- Effectively delays generic entry.
- Particularly aggressive in US/EU FTAs.
C. India's Position
- NO data exclusivity in India.
- Section 39.3 TRIPS minimum sufficient.
- Generic competition preserved.
- Strategic public health considerations.
4. Patent Linkage
A. The Concept
- Marketing approval (drug regulator) linked to patent status.
- Generic drug cannot be approved if patent exists.
- Originator effectively gains additional protection.
- Common in US (Hatch-Waxman framework).
B. India's Position
- NO patent linkage in India.
- Indian Drug Controller (CDSCO) does not check patent status.
- Generic + originator can compete on regulatory approval.
- Subsequently patent infringement litigation possible.
5. India's Compulsory Licensing
A. India's Robust Framework
- Section 84 — three grounds (reasonable requirements + affordability + working).
- Section 92 — government use for emergency.
- Section 100 — government use without licence.
- Bayer-Natco 2012 — successful application.
- Subsequent applications evaluated.
B. TRIPS-Plus Restrictions
- Demands narrower compulsory licensing grounds.
- Restrictions on local working requirements.
- Stricter affordability evaluation.
- Limitations on importation.
C. India's Position
- Maintains comprehensive compulsory licensing framework.
- Article 31 + Article 31bis fully utilized.
- Strategic public health considerations.
- Resists narrower bilateral framework.
6. TRIPS Waivers
A. Concept
- Exceptions/derogations from TRIPS obligations.
- Specific public interest concerns.
- Limited duration usually.
- Adopted by WTO General Council/Ministerial Conference.
- Pursued by developing countries.
B. Major TRIPS Waivers
Waiver | Year | Purpose |
|---|---|---|
Doha Declaration 2001 | November 2001 | Public health flexibilities. |
August 2003 General Council Decision | 30 August 2003 | Interim CL for export. |
Article 31bis amendment | 23 January 2017 | Permanent solution for CL for export. |
MC12 Decision (COVID vaccines) | 17 June 2022 | COVID vaccines patent waiver. |
LDC Pharmaceutical Patents Extension | Various | LDC transitional periods extended. |
7. The MC12 Decision — Major Recent Waiver
📖 MC12 Decision on COVID-19 Vaccines (17 June 2022) Background — COVID-19 pandemic 2020-2022. Massive global vaccine inequity. India + South Africa proposed TRIPS waiver in October 2020. Negotiations — Multi-year negotiations at WTO TRIPS Council. Strong opposition from US/EU initially. Developing country coalition pushed for waiver. MC12 Decision — Adopted at 12th WTO Ministerial Conference, Geneva, 17 June 2022. Provisions: · Limited COVID-19 vaccines waiver. · 5-year duration. · Eligible developing countries. · Procedural simplifications for compulsory licensing. · Specific scope clarifications. Limitations: · Limited to COVID vaccines (not therapeutics/diagnostics). · Specific procedural framework. · 5-year duration (not permanent). · Specific eligibility criteria. Subsequent Discussions: · February 2024 — TRIPS Council could not reach consensus on extension. · Continued debate. Significance: · Most significant TRIPS waiver since Article 31bis (2017). · India + South Africa lead role. · Demonstrates TRIPS flexibility framework. · Public health pandemic response precedent. · India's diplomatic success. |
8. India's 2014 National IPR Policy
A. Foundational Position Statement
✅ India's National IPR Policy 2016 (Adopted 12 May 2016) — Key Positions 7 Strategic Pillars: 1. IP AWARENESS 2. IP GENERATION 3. IP LEGAL FRAMEWORK 4. IP ADMINISTRATION + MANAGEMENT 5. IP COMMERCIALISATION 6. IP ENFORCEMENT + ADJUDICATION 7. HUMAN CAPITAL DEVELOPMENT INTERNATIONAL POSITIONING: · "Acceding to multilateral conventions in line with national interest." · Maintains TRIPS flexibilities. · Selective treaty membership. · No automatic TRIPS-Plus acceptance. · South-South cooperation strong. STRATEGIC AUTONOMY: · "Robust IP system with appropriate flexibilities." · "Effective use of TRIPS flexibilities." · "Strengthening IP awareness." |
9. India's Recent IP Reforms
A. Significant Reforms (2020-2025)
Reform | Year | Significance |
|---|---|---|
IPAB Abolition | 4 April 2021 | Streamlining IP appeals. |
HC IP Divisions | Delhi 2021; Madras April 2023 | Specialized IP adjudication. |
Patents Rules 2024 | 2024 | Simplified examination. |
CRI Guidelines 2025 | 29 July 2025 | Modern AI/software framework. |
Cinematograph (Amendment) Act 2023 | 2023 | Anti-piracy provisions. |
DPDP Act 2023 | 11 August 2023 | Data protection framework. |
Mediation Act 2023 | 2023 | IP dispute resolution. |
Income Tax Act 2025 | 1 April 2026 | Modernised IP taxation. |
B. Strategic Direction
- Strengthening domestic IP framework.
- Maintaining TRIPS flexibilities.
- Selective treaty engagement.
- Public health primacy.
- Innovation incentivization balanced.
10. Strategic Considerations
✅ For Indian negotiators — eight points For FTA negotiations, OPPOSE patent term extension. For FTA negotiations, OPPOSE data exclusivity beyond TRIPS. For FTA negotiations, MAINTAIN compulsory licensing flexibility. For FTA negotiations, AVOID patent linkage. For FTA negotiations, NARROW ISDS scope. For multilateral, ADVOCATE TRIPS waivers when appropriate. For South-South cooperation, STRENGTHEN coalition. For domestic framework, REINFORCE Indian IP architecture. |
✅ For Indian businesses — six points For pharmaceutical innovation, leverage Section 3(d) framework. For generics manufacturing, leverage compulsory licensing. For software/AI, leverage CRI Guidelines 2025. For trademarks, leverage Madrid Protocol. For designs, leverage Hague Geneva Act. For international expansion, leverage PCT. |
11. Memory Aid — Quick Recall
✅ Quick Recall — TRIPS-Plus and Waivers TRIPS-Plus — provisions beyond TRIPS minimum. Common TRIPS-Plus: patent term extension; data exclusivity; stricter CL; patent linkage; ISDS. India OPPOSES TRIPS-Plus consistently. India NO patent term extension. India NO data exclusivity. India NO patent linkage. India ROBUST compulsory licensing (Sections 84, 92, 100). India's National IPR Policy 2016 (12 May 2016). TRIPS Waivers — public health flexibilities. Doha Declaration 2001 — major waiver. August 2003 Decision — interim CL for export. Article 31bis (23 January 2017) — first WTO trade agreement amendment ever. MC12 Decision (17 June 2022) — COVID vaccines waiver. India + South Africa proposed waiver October 2020. India's Section 3(d) — anti-evergreening. India's Section 84 — compulsory licensing. India's Bayer-Natco 2012 — first and only successful CL. |
🎯 EXAM POINTERS — TOPIC 128
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