The Delhi High Court upheld the rejection of a patent application for 'Co-crystals of Tramadol and Coxibs' due to lack of inventive step, clarifying the threshold for non-obviousness under Section 2(1)(ja). The decision highlights the judiciary's strict scrutiny of pharmaceutical patents.
Delhi HC on Inventive Step in Esteve Pharmaceuticals Patent Case
The Delhi High Court, in an order dated August 7, 2026, dismissed the writ petition filed by Esteve Pharmaceuticals S.A. challenging the rejection of its patent application titled 'Co-crystals of Tramadol and Coxibs'. While the court acknowledged novelty under Section 2(1)(j), it upheld the Controller of Patents and Designs’ finding that the invention lacked an inventive step under Section 2(1)(ja) of the Patents Act, 1970.
The court applied a tiered analysis, noting that the formation of co-crystals using known methods and predictable outcomes did not constitute an inventive advance.
The mere selection of known compounds to form co-crystals, without demonstrating unexpected technical effects, cannot sustain a patent,the bench held. The decision reaffirms the precedent set in Novartis AG v. Union of India, where the Supreme Court underscored the importance of distinguishing between discovery and invention.
For IP practitioners, this judgment serves as a cautionary note against overreaching claims in pharmaceutical formulations. It reinforces the requirement for empirical data demonstrating enhanced efficacy or non-obviousness. As patent offices intensify scrutiny of secondary pharmaceutical inventions, this ruling may influence prosecution strategies and opposition proceedings.
Citations
- Esteve Pharmaceuticals S.A. v. Controller of Patents and Designs, 2026
- Patents Act, 1970, Section 2(1)(ja)
