IPO’s Draft Guidelines for Pharmaceutical Patent Examination face criticism for statutory misquotations and misinterpretations. Experts warn they could disrupt prosecution if not substantially revised.
Criticism Mounts Against IPO's Draft Pharmaceutical Patent Guidelines
The 2026 Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, issued by the Indian Patent Office (IPO), are under intense legal scrutiny for containing misquotations of statutory provisions and flawed interpretations of established patentability criteria under the Patents Act, 1970. Legal experts and industry stakeholders have raised alarms that the draft, if implemented, could destabilize patent prosecution in the pharmaceutical sector.
Critical issues highlighted include incorrect references to Sections 3(d) and 3(b), misapplication of the inventive step standard, and overreach in excluding certain categories of chemical modifications from patentability without clear statutory basis. The draft's rigid approach to formulations and polymorphs could also discourage innovation in drug delivery and bioavailability improvements.
'These guidelines risk substituting policy preference for legal interpretation, undermining the balance between public interest and innovation incentives,' said one analyst.
For practitioners, the draft raises concerns about predictability in examination outcomes and increased grounds for opposition or invalidation. The IPO is under pressure to revise the guidelines following consultation with legal and scientific experts to ensure alignment with both domestic law and international obligations under TRIPS.
Citations
- Patents Act, 1970, Sections 3(b), 3(d)
