IPO’s Draft Guidelines for Examination of Pharmaceutical Patent Applications, 2026, face sharp criticism for misquoting statutory provisions and misinterpreting Section 3(d) of the Patents Act. Experts warn the draft could undermine patent stability and prosecution consistency if adopted without revision.
Experts Flag Flaws in IPO’s Draft Pharmaceutical Patent Guidelines
The Indian Patent Office’s (IPO) recently released Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026 have drawn strong criticism from legal scholars and IP practitioners. The draft has been accused of misquoting statutory provisions—particularly Section 3(d) of the Patents Act, 1970—and introducing subjective interpretations that could disrupt established examination practices.
One core concern is the redefinition of 'enhanced efficacy' in Section 3(d), which bars evergreening. Critics argue the draft erroneously conflates therapeutic efficacy with mere physicochemical improvements, potentially excluding legitimate innovations. Additionally, the draft introduces new evidentiary thresholds not grounded in statute or precedent, raising fears of arbitrary rejections and procedural inconsistency.
The Guidelines must reflect judicial interpretations, not expand or narrow statutory requirements through administrative fiat.
Practitioners are advised to submit formal objections during the consultation period. The final version may significantly affect prosecution strategies for pharmaceutical clients, particularly in formulation and polymorph patents. Clarity and alignment with Supreme Court and IPAB jurisprudence remain critical.
Citations
- Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026
