The 2026 Draft Guidelines released by India’s Patent Office contain multiple textual errors, conflicting tests, and gaps that risk creating confusion in patent examination of pharmaceuticals. Stakeholders are urged to review and submit corrections.
The draft misquotes statutes, misapplies judicial reasoning, and mixes divergent legal tests, creating uncertainty for examiners and applicants.
Important topics—Markush claims, novelty tests (including inherent anticipation), Section 3(d) analysis, inventive step, industrial applicability, and prior-art methodology—are inconsistently framed or contradicted across the draft.
The consultation window of 15 days is widely seen as too short for meaningful engagement on a document that updates a decade of case law and examination practice.
# What this is about India's Controller General of Patents, Designs and Trademarks (CGPDTM) released Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026. The draft aims to update the prior 2014 guidance by incorporating more recent case law and explanatory material. The document was published with a 15-day window for comments.
# Main problems identified The critique identifies three linked categories of problems: factual and textual errors, inconsistent legal tests, and procedural omissions.
# Why this matters Guidelines guide examiners and shape prosecution strategy. Conflicting tests or unclear standards can lead to inconsistent examination outcomes, increased litigation, and uncertainty for applicants and public-interest actors concerned with access to medicines. The conflation of distinct statutory provisions and the use of non-authoritative materials risk procedural unfairness and legal error in examination outcomes.
# Specific problem areas to watch
# Suggested next steps for stakeholders Stakeholders should review the draft closely and submit focused comments to the CGPDTM identifying textual errors, internal contradictions, missing statutory distinctions, and incorrect illustrations. The critique emphasizes that the 15-day consultation period is inadequate for considered responses and recommends extension to allow meaningful engagement.
# Bottom line The 2026 Draft Guidelines attempt a major update but contain errors, conflicting tests, and omissions that could increase confusion rather than provide clarity. Careful revision and a longer consultation period are necessary before these guidelines are used as authoritative instruction for patent examination in pharmaceuticals.
A few days ago, we had informed our readers that they could participate in the open call for comments and suggestions on the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (2026). Several such notifications have been released by the office of the Controller General of Patents, D
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[This post is authored by Rishabh Upadhyay. Rishabh is an LL.M. candidate at the Faculty of Law, Delhi University, having completed his undergraduate legal studies at the Faculty of Law, Banaras Hindu University. His interest lies in intellectual property jurisprudence, with particular emphasis on Patent Law, Access to
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