The IPO’s Draft Guidelines for Examination of Pharmaceutical Patent Applications, 2026 face severe criticism for misquoting provisions and misinterpreting patentability standards, raising concerns over examination consistency and legal accuracy.
Criticism Mounts Over IPO’s Draft Pharma Patent Guidelines
The Controller General of Patents, Designs and Trade Marks has released the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026, which have drawn sharp criticism from legal experts for misquoting statutory provisions and misinterpreting key patentability criteria under the Patents Act, 1970.
Principal concerns include erroneous interpretations of Section 3(d), which deals with the patentability of new forms of known substances. The draft incorrectly suggests that any mere improvement in efficacy is sufficient, potentially diluting the rigorous 'enhanced efficacy' standard established by the Supreme Court in Novartis v. Union of India. Additionally, the guidelines misstate procedures related to data exclusivity and trial data protection, which are not currently codified in Indian law.
The draft also overlooks nuances in inventive step assessment for combination therapies and fails to provide sufficient guidance on sufficiency of disclosure in complex biopharma patents. Experts warn that if adopted in current form, the guidelines could lead to inconsistent examination, increased litigation, and potential non-compliance with TRIPS obligations.
Stakeholders, including generic manufacturers and IP professionals, have called for a complete overhaul before finalization. The controversy underscores the need for rigorous legal and technical vetting of examination manuals, especially in sensitive sectors like pharmaceuticals where public health and innovation intersect.
Citations
- Patents Act, 1970, Section 3(d)
