The IPO's Draft Guidelines for Examination of Pharmaceutical Patent Applications (2026) face criticism for misquoting statutes and introducing inconsistent standards, prompting calls for comprehensive revision before finalisation.
Flaws Identified in IPO's Draft Pharma Guidelines
The Indian Patent Office’s (IPO) Draft Guidelines for Examination of Pharmaceutical Patent Applications, 2026, have drawn sharp criticism from legal and industry experts for misquoting statutory provisions, misinterpreting Section 3(d) of the Patents Act, 1970, and introducing unworkable standards in novelty and inventive step assessments.
Commentators note that the draft incorrectly equates ‘efficacy’ with mere pharmacological activity, contrary to the Supreme Court’s Novartis and CIPLA precedents. It also imposes rigid data requirements for patentability that exceed existing legal thresholds, potentially discouraging innovation.
The controversy underscores the need for transparent, technically sound policy-making in pharmaceutical IP. Stakeholders are urged to submit detailed objections during the consultation phase. Until revised, the draft should not be used as a basis for examination practices.
Citations
- Patents Act, 1970, Section 3(d)
