Delhi HC Upholds Lack of Inventive Step in Tramadol-Coxibs Co-Crystal Patent

Delhi HC Rejects Pharmaceutical Patent for Lack of Inventive Step

In an order dated August 7, 2026, 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', finding that while the invention satisfied the novelty requirement under Section 2(1)(j), it failed the inventive step criterion under Section 2(1)(ja) of the Patents Act, 1970. The Court endorsed a tiered approach to patentability, holding that absence of inventive step renders further examination unnecessary, even if novelty is established.

The Controller had earlier rejected the application on grounds of obviousness and lack of inventive advancement. The applicant argued that the co-crystal formulation demonstrated improved physicochemical properties over the prior art. However, the Court concluded that the claimed invention was an obvious permutation of known substances without surprising or synergistic effects. It emphasized that mere selection or combination of known compounds, without a technical advancement or economic significance, cannot support a patent.

The Court reiterated that 'the presence of novelty does not automatically entitle an invention to a patent; the inventive step remains an independent and essential gateway.'

This decision reinforces the importance of demonstrating non-obviousness in pharmaceutical patents, particularly in cases involving known molecules. For practitioners, the ruling underscores the need to proactively address inventive step in patent specifications and prosecution, especially in formulation-based claims where the bar for non-obviousness is high.