"Compulsory licensing under the Patents Act, 1970 remains a remedy more theoretical than practical." Critically examine this statement in light of recent judicial interventions on patented cancer drug pricing.

Section 84 of the Patents Act, 1970 permits a compulsory licence (CL) three years after grant if public requirements are unmet, the price is not reasonably affordable, or the patent is not worked in India [1]. Yet India has granted only one CL in five decades — a gap the Kerala High Court's Ribociclib proceedings expose sharply.

Why the remedy appears largely theoretical

• Locus standi gap: only an interested party — in practice a willing generic manufacturer — can apply. A patient cannot trigger Section 84 directly, which is why the Kerala HC's suo motu case In Re Exorbitant Pricing of Life Saving Patented Medicines has run for years without a CL applicant for Ribociclib (Novartis) [3].
• Solitary precedent: the Controller's 2012 order for Natco v. Bayer (Sorafenib/Nexavar) cut monthly cost from about ₹2.8 lakh to ₹8,880 — but no CL has followed since [2].
• Executive caution: DPIIT was merely directed to consider the representation; no licence was issued, reflecting sensitivity to trade pressure and investment signalling [3].
• Evidentiary weakness: patchy Form 27 working statements make non-working and unaffordability hard to prove.

Where it retains practical force

• Deterrent value: the Natco outcome, upheld on appeal, created a bargaining shadow encouraging voluntary licences and tiered pricing [2].
• Reserve powers intact: Section 92 government-use in extreme urgency remains available, and TRIPS as read with the Doha Declaration (2001) protects this flexibility [4][1].
• Judicial persistence: converting a deceased petitioner's plea into suo motu proceedings, impleading a new patient, and seeking expert opinion on Palbociclib substitutability keep systemic scrutiny alive [3].
• Parallel routes deliver: DPCO, 2013 ceiling prices under NPPA [5] and PM-JAY helped cut out-of-pocket expenditure from 62.6% to 39.4% between 2014-15 and 2021-22 [6].

The statement holds in practice, not in law: the power exists but lacks an activating agent. Time-bound DPIIT disposal, credible Form 27 enforcement, price negotiation and patent pools for oncology drugs can convert Section 84 from a dormant deterrent into a working guarantee of the Article 21 right to health, advancing SDG-3.