Section 3(d) is the provision that stopped Novartis patenting a new form of Glivec — and it’s been in the crosshairs ever since. Now the US and Switzerland want to attack it at the WTO through an obscure device: the “non-violation complaint”. Here’s what’s at stake.
Note: At the 2015 (10th) WTO Ministerial and subsequent conferences, the moratorium (suspension) on TRIPS non-violation complaints was extended, and it has continued to be renewed since — so the threat described here did not materialise into live complaints. Confirm the current WTO position.
What Section 3(d) does
Section 3(d) of the Patents Act, 1970 (added by the 2005 amendment) bars patents on a mere new form or new use of a known substance that doesn’t enhance its efficacy. India, as a developing country, prioritised public need — wording 3(d) to meet WTO/TRIPS obligations while keeping a humanitarian eye. The Patent Office has applied it strictly, denying patents to several high-profile drugs for failing the efficacy/inventiveness test.
The landmark: Novartis AG, after a seven-year battle, lost its patent bid for Glivec — the Patent Office and IPAB saw it as a slight modification of a known drug, and the Supreme Court held that, absent evidence of enhanced efficacy, no patent could be granted — also dismissing the claim that 3(d) violates TRIPS.
The new angle: non-violation complaints
Having failed to show 3(d) violates TRIPS, some countries turned to “non-violation complaints” (NVCs) — a GATT-era device letting a WTO member challenge another’s policy not for breaching an obligation, but because a benefit under a WTO agreement has been nullified or impaired by an otherwise WTO-consistent measure. The argument: a plain reading of 3(d) isn’t a violation, but its strict interpretation impairs foreign pharma’s IP benefits, defeating TRIPS’ objective.
NVCs under TRIPS have been suspended since TRIPS began. At the 10th WTO Ministerial (Dec 2015), the US and Switzerland proposed ending that suspension; India and Brazil (with 17 co-sponsors) proposed continuing it.
How an NVC works
Article 64 of TRIPS points to Article XXIII of GATT, requiring three elements: (1) a measure applied by a member; (2) a benefit accruing under a relevant agreement; and (3) nullification or impairment of that benefit/objective by the measure.
The pros and cons
- For lifting the suspension: countries with broad, liberal patent laws (US, Switzerland) find it hard to enforce IP in India’s strict regime; NVCs would discourage members from “creative legislation” that sidesteps TRIPS commitments.
- Against: used carelessly, NVCs become a weapon to challenge developing/least-developed countries’ patent regimes even without any breach — hurting poor countries’ pharma industries, inflating litigation costs, and eroding TRIPS flexibilities. It hands a few giants the power to constrain a government’s ability to address socio-economic problems.
On balance, maintaining the suspension is the sounder course — protecting India’s ability to keep medicines affordable.
The takeaways
- Section 3(d) blocks evergreening — no patents on new forms lacking enhanced efficacy (Novartis/Glivec).
- It survived the direct TRIPS challenge — the SC held 3(d) TRIPS-compliant.
- NVCs are the indirect threat — challenging policy without proving a breach.
- The suspension has held — protecting generics and TRIPS flexibilities.
Frequently asked questions
What does Section 3(d) of the Patents Act do? It bars patents on a mere new form or new use of a known substance that doesn’t enhance its known efficacy — curbing “evergreening” of pharmaceutical patents.
What was the Novartis/Glivec decision? The Supreme Court refused Novartis a patent for a new form of Glivec, holding that without evidence of enhanced efficacy, Section 3(d) barred it — and that 3(d) doesn’t violate TRIPS.
What is a non-violation complaint at the WTO? A challenge to another member’s policy not for breaching an obligation, but because a benefit under a WTO agreement is nullified or impaired by an otherwise WTO-consistent measure.
Are non-violation complaints allowed under TRIPS? They’ve been suspended since TRIPS began, and that suspension has repeatedly been extended — so they remain unavailable for now.
Useful official resources
- The Patents Act, 1970
- WTO — TRIPS Agreement