There is no easier way to put it – the IPO’s Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026 (“2026 Draft Guidelines”) released 15 days ago have severe problems and require substantial reworking. There are many concerning reasons warranting an immediate and thorough revision of this draft for it to avoid disrupting patent law and patent prosecution as we know it. The 2026 Draft Guidelines have misquoted certain statutory provisions, misinterpreted some judicial decisions, misapplied statutory and judicial logic to illustrations where phrasing is incomplete and existing patents have not been cited. Most alarming is the confused references to core patentability criteria throughout tests of novelty, inventive step, prior art, PSITA, Markush claims, Section 3 and unity of inventions. At the outset, we urge all stakeholders to engage with this document and flag its many issues to the office of the CGPDTM.
Roughly a week ago we had alerted our readers that the 2026 Draft Guidelines along with the 2026 Draft Biotech Guidelines had been released, both with an unreasonably short consultation window of 15 days. This unrealistic timeline forced us to choose between the two drafts, and we still maintain that more time is required. Below is a summary of some of the major concerns that we have flagged; there are many more nuances that merit a closer look.
The 2026 Draft Guidelines and the 2026 Draft Biotech Guidelines overlap in substantive explanations on Section 3 but make opposing conclusions in their illustrations, leaving open the possibility of guideline-shopping. The 2026 Draft Guidelines also make no reference to the IPO’s own and recent AI Guidelines, surprisingly not engaging in any manner whatsoever on the impact of AI technologies on pharma patents. It takes an overtly mechanistic view of patent law, with a posturing that completely ignores the use of Section 3 conditions as policy levers that should be read pro-public interest as per the TRIPS Agreement, 1995.
Within the text, the 2026 Draft Guidelines have removed references to IPAB decisions without good reason. Repeated references are made to interim decisions of the courts considering them as binding authority. Instead of referring to landmark case laws, the Draft has used non-authoritative study material of other offices for guidance on critical concepts like industrial applicability. In an attempt to update the Draft, after 12 years, haphazardly all notable case laws that include some test on patentability, whether or not pertaining specifically to pharma patents have been cited. Clumped together, this list contains references to different legal tests with the Draft itself saying nothing about which of the diverging tests might the examiner follow!
Sections 8 and 25, which our readers will agree are important provision in the patent prosecution process, have been left out of the scope of the Draft. On the provisions that have been included, the details are muddled. If one was to actually take serious reference to this document, you would be left confused about what really constitutes a Markush claim because the text itself offers two differing versions, you might also find yourself uncertain about what methodology to follow for a prior art search and how to differentiate it from prior use.
The assessment of novelty in the Draft is particularly problematic because the text has removed its earlier references to ‘inherent anticipation’ and still needs to explain to what extent a generic disclosure precludes a specific disclosure. The Draft offers three different tests, a reference to the Patents Manual, the judicial decision in Ericsson v. Lava and its own six-point checklist. All of these propose different interpretations which can make a lot of difference in the patent examination procedure. In absence of clarification on which authority to follow, the 2026 Draft Guidelines are at a risk of adding to the confusion, rather than resolving it.
We find the same kind of concerns on how the 2026 Draft Guidelines frame the tests for inventive test, industrial applicability and identification of ‘known substance’ under Section 3(d). The Patents Act, 1970 creates statutory distinction between Sections 10(4) and 10(5), which the 2026 Draft Guidelines combine as one undifferentiated inquiry. Most of these distinctions that are absent here, were present in the 2014 Guidelines. The 2026 Draft Guidelines also leave a lot to be desired in explaining pre- and post-grant proceedings such as in recommending timelines in line with statutory provisions.
These Guidelines are an essential point of reference to all stakeholders involved in the pharma-patent ecosystem. They need to be clear on the fundamentals. The Draft 2026 Guidelines fall short on this goal. Among the 70 illustrations added, some of them are incomplete and a few are simply wrong. The importance of the Guidelines in the examination of patent applications cannot be underplayed. Its deficiencies are good reason for stakeholders to engage with it. We urge, again, our readers to spread the word and voice your concerns to the IPO.
Please find below our submitted general and specific comments.
