Delhi High Court upheld the rejection of a patent for 'Co-crystals of Tramadol and Coxibs' for lack of inventive step, while affirming novelty. The decision clarifies the threshold for non-obviousness in pharmaceutical innovations.
Delhi HC Upholds Patent Rejection for Tramadol-Coxib Co-crystals
On August 7, 2026, the Delhi High Court delivered a nuanced ruling in Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs, applying a tiered assessment to the patentability of 'Co-crystals of Tramadol and Coxibs'. While the Court found the invention novel under Section 2(1)(j) of the Patents Act, 1970, it upheld the Controller's rejection on grounds of lack of inventive step under Section 2(1)(ja).
The Court emphasized that mere discovery of a new form of a known substance — even if it results in improved physicochemical properties — does not automatically satisfy the inventive threshold unless there is a technical advance or economic significance that is non-obvious. The applicant failed to demonstrate a surprising or synergistic effect beyond what would be expected by a person skilled in the art.
"Mere crystallization techniques, without unexpected efficacy or therapeutic advantage, do not amount to an invention,"
This judgment reinforces established Indian jurisprudence on pharmaceutical patents, particularly post-Nova and Ranbaxy, where the bar for secondary inventions remains high. For practitioners, the decision underscores the need to robustly establish inventive step with empirical data and comparative studies, especially in co-crystal and polymorph-based patent applications. It may deter speculative 'evergreening' attempts while encouraging genuine innovation.
Citations
- Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs (2026)
- Section 2(1)(ja), Patents Act, 1970
