In the time of this oncoming monsoon, it feels like its raining draft guidelines from the Controller General’s office!
The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has released two new sets of draft guidelines today for the examination of patent applications related to pharmaceutical & biotechnology inventions. These draft guidelines are targeted towards streamlining the patenting procedures of healthcare inventions.
All stakeholders invited to submit their comments or suggestions within 15 days from the date of publication. The submissions should be emailed to cgoffice[dot]in[at]gov[dot]in and llc[dash]ipo[at]gov[dot]in
The Draft Pharmaceutical Guidelines (2026) are a substantial upgrade of the 2014 version. The new draft incorporates key case laws and recent jurisprudence on pharma patents, expands on Markush claims, novelty, inventive-step and reiterates the emphasis on therapeutic efficacy in Section 3(d) scrutinies.
The Draft Biotech Guidelines (2026) are similarly an update of the 2013 version. The new version takes account of new technologies such as CRISPR-Cas9 based DNA editing, bioinformatics, synthetic biology, etc. It incorporates more recent search tools and databases, and expands the understanding of core patent terminology as well as biodiversity compliance rules to the biotech sector.
For convenience, here are the links to the draft guidelines again –
Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (2026)
Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology (2026)
We had recently reported on the call for suggestions by the CG office on draft patent and trademark manuals. Interested stakeholders may check the respective windows for submission of comments on these documents as well.
