CURRENT AFFAIRS | 17 APRIL 2026
CLAT GK + CONSTITUTIONAL LAW & RELEVANT AREA
A joint investigation by the International Consortium of Investigative Journalists and the Indian Express has spotlighted the affordability crisis around Merck’s flagship immunotherapy drug Keytruda (pembrolizumab). In India, a single vial costs roughly Rs 1.5 lakh, with a full course running over six months. The underlying patent on pembrolizumab is valid until 2028, blocking cheaper biosimilar entry.
This is shaping up to be the next big India-IP story after Novartis AG v UoI (2013) and Bayer v Natco (2012). For CLAT 2027, expect a passage on Section 3(d) of the Patents Act 1970 (the anti-“evergreening” provision), TRIPS Article 31 on compulsory licensing, the Doha Declaration 2001 on public-health flexibilities, and the right-to-health jurisprudence under Article 21.
Constitutional & Legal Framework
Patents Act 1970, Section 3(d) is India’s bulwark against “evergreening” — new forms of a known substance are not patentable unless they show “enhanced therapeutic efficacy”. Famously upheld in Novartis AG v UoI (2013), which denied a patent on Glivec (imatinib mesylate beta-crystalline form).
Section 84 allows any interested person, after three years from grant of a patent, to seek a compulsory licence if the patented invention is unworked, unaffordable or unavailable. India’s first compulsory licence was granted in Bayer v Natco (2012) for the cancer drug Nexavar (sorafenib), cutting price by over 97 per cent.
TRIPS Agreement Article 31 permits WTO members to grant compulsory licences subject to procedural safeguards (adequate remuneration, non-exclusive, predominantly for domestic market). Article 33 requires minimum 20-year patent term.
Doha Declaration 2001 affirmed that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health”, expressly endorsing compulsory licensing and parallel imports.
Right to health under Article 21: Paschim Banga Khet Mazdoor Samity v State of West Bengal (1996) held denial of emergency medical aid violates the right to life. Bandhua Mukti Morcha (1984) laid the earlier foundation.
Why This Matters for CLAT 2027
The Keytruda story converges constitutional law, IP law and international trade law in one CLAT-ready package. Candidates should keep three distinctions sharp:
- Section 3(d) is NOT anti-innovation — it only bars patents on minor tweaks of known molecules designed to extend monopoly. This is the “evergreening” frame CLAT passages love.
- Biosimilars are not generics. Generics are exact chemical copies of small-molecule drugs; biosimilars are “highly similar” versions of biological drugs produced in living cells, requiring 4-8x longer to develop.
- Compulsory licence ≠ patent revocation. The patent remains; a third party gets a non-exclusive licence on royalty.
- Doha Declaration 2001 is persuasive but not binding in itself — its weight flows from WTO member consensus.
Key Facts at a Glance
| Provision / Case | Import |
|---|---|
| Patents Act Sec 3(d) | Bars evergreening; requires enhanced efficacy |
| Patents Act Sec 84 | Compulsory licence after 3 years |
| Novartis AG v UoI (2013) | Glivec patent denied; Sec 3(d) constitutional |
| Bayer v Natco (2012) | India’s first compulsory licence (Nexavar) |
| TRIPS Art 31 / 33 | Compulsory licensing / 20-year term |
| Doha Declaration 2001 | Public-health flexibilities endorsed |
| Paschim Banga Khet Mazdoor (1996) | Right to emergency medical aid under Art 21 |
Mnemonic: PATENT
Pembrolizumab · Affordability crisis · TRIPS Art 31 · Evergreening blocked by Sec 3(d) · Novartis 2013 · Treatment access
Practice Quiz — 10 CLAT-Style Questions
Click an option to reveal the answer and explanation.
With Keytruda’s patent cliff due in 2028, expect a new wave of compulsory-licence applications under Section 84. Attempt the quiz above to lock in the doctrine before the next CLAT sectional.
