The Delhi High Court upheld the rejection of a pharmaceutical patent due to lack of inventive step, despite acknowledging novelty. The ruling clarifies the hierarchy of patentability criteria under Indian law.
Delhi HC Affirms Rejection of Tramadol Co-Crystal Patent
In Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs, the Delhi High Court upheld the rejection of a patent application for 'Co-crystals of Tramadol and Coxibs' on grounds of lack of inventive step. While the Court found the invention to be novel—disagreeing with the Controller on Section 2(1)(j) of the Patents Act—it concurred that the claimed subject matter failed the inventive step threshold under Section 2(1)(ja).
The Court applied a tiered approach, first assessing novelty independently before proceeding to inventive step, reinforcing that novelty is a necessary but insufficient condition for patentability.
Merely because an invention is new does not imply it is non-obvious, noted the Court, underscoring that routine combinations or predictable improvements do not qualify as inventions. The decision draws on established precedent, including Fresenius Kabi v. Abbott, to affirm that synergistic effects must be demonstrated for pharmaceutical co-crystals to merit protection.
This judgment provides clarity for patent practitioners handling pharmaceutical filings, emphasizing rigorous scrutiny of inventive step even when novelty is established. It warns against overreaching claims in incremental innovations, particularly in the co-crystal space. Applicants must now substantiate technical advantages beyond structural novelty to meet India’s inventive threshold, aligning with the statute’s public health safeguards.
Citations
- Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs, 2026
