IPO's 2026 Draft Guidelines for Pharma Patents contain misquotations and misinterpretations, say experts. Flawed approach risks disrupting patent examination standards.
Criticism Mounts Over IPO’s Draft Pharma Patent Guidelines
The Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026, issued by the Indian Patent Office (IPO), face strong backlash from legal experts for containing fundamental errors in statutory interpretation and misquoting key provisions.
Analysts have identified misstatements concerning Section 3(d) of the Patents Act, 1970, particularly regarding criteria for 'enhanced efficacy' and the burden of proof. The draft also erroneously conflates procedural and substantive standards, risking inconsistent application across patent offices.
Further concerns include overreach in prescribing evidentiary thresholds beyond the Act and Rules, potentially creating de facto additional grounds for refusal. These flaws, if uncorrected, could lead to arbitrary examination practices and increase litigation.
Stakeholders urge the IPO to comprehensively revise the draft in consultation with domain experts before finalization, to ensure alignment with statutory law and judicial precedent.
Citations
- Patents Act, 1970, Section 3(d)
