02/03/2026
Strengthening Patent Integrity in India: A Landmark Refusal
The Indian Patent Office, Delhi, has refused Patent Application No. 8004/DELNP/2011 filed by AbbVie Ireland Unlimited Company for the invention titled “Apoptosis-Inducing Agents for the Treatment of Cancer and Immune and Autoimmune Diseases,” primarily covering the compound Venetoclax. The refusal order, dated 31 December 2025, was issued under Section 15 of the Patents Act, 1970, following multiple pre-grant oppositions under Section 25(1).
Among the seven pre-grant opponents, Opponent-4, Archerchem Healthcare Pvt. Ltd., was represented by GNANLex Associates LLP. GNANLex played an active role in the opposition proceedings and hearings, presenting detailed objections concerning lack of novelty, absence of inventive step, non-patentability under Section 3(d), and insufficiency of disclosure.
The Controller concluded that the claimed invention was anticipated by AbbVie’s own earlier patents, constituting prior claiming and an impermissible attempt at evergreening. The application was also found to lack inventive step, as the compound and its claimed genus were obvious in light of extensive prior art.
Further, the claims failed under Section 3(d) due to the absence of evidence demonstrating enhanced therapeutic efficacy, relying primarily on limited in-vitro Bcl-2 binding data. The specification was also held insufficient under Section 10(4), as it did not enable a person skilled in the art to practice the invention across the full scope of the claims without undue experimentation.
Based on these cumulative grounds, the patent application was refused in its entirety.
This decision underscores the critical role of rigorous opposition proceedings for safeguarding patent quality, preventing evergreening, and upholding the integrity of India’s intellectual property framework.
