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, Designs and Trademarks (CGPDTM) in the past few weeks (see here and here). The notification of the new draft of the Pharmaceutical Guidelines was released on September 4, 2026 with a very short, and frankly unrealistic, comments submission deadline of 15 days.
The general theme that is common in all these notifications is that the internal IPO documents are being updated after decades of silence. Other than the new Draft Patent Manual for which comments could be submitted in 30 days, all other new drafts come with a 15 day deadline. Praharsh and I find that the short span of 15 days could at best result in an abstract and cursory engagement with the developments that have been happening for close to twelve years!
The present Pharmaceutical Guidelines were enforced in 2014. The proposed new Draft suggests incorporation of a decade worth of case laws. A meaningful consultation would have to engage with the questions of substantive changes proposed to the criteria of patentability and information disclosure, discuss the appropriateness of reliance on SEP case laws like Ericsson v. Lava and others which could be subject to appeals, consider the absence of recognition of possible overlap with other Guidelines such as the Guidelines for the Use of Artificial Intelligence in Patent Examination Procedures.
While the document is primarily for internal IPO processes, patent prosecution plays a vital role and Guidelines such as these offer critical information to stakeholders across the board from drug originator companies to generics producers and ultimately has ripple effects all the way to patient groups. The Draft, thus, deserves a conscious deliberation for which, again, 15 days are not nearly enough.
Praharsh and I have requested the IP Office to extend this timeline to at least 60 days.
Please find below our submitted general comment. We strongly urge interested stakeholders to engage with this issue, voice your own thoughts and concerns, and also communicate with the IP Office.
