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A Stumble on the Tightrope?: How the Delhi High Court’s Ruling in Zeria Pharmaceuticals Could Stifle Innovation

  • The Delhi High Court dismissed an appeal for a patent on an intermediate compound under Section 3(d), sparking debate on innovation stifling.
  • The Court held that for patent protection, an intermediate compound must enhance the 'therapeutic efficacy' of the final drug.
  • Concerns were raised that the ruling could discourage innovation in drug manufacturing processes.
  • The Court emphasized on proving the therapeutic efficacy over prior art to satisfy Section 3(d) requirements.
  • It was argued that the Court's test for efficacy overlooked the efficiency contributions of intermediate compounds.
  • The ruling may impact manufacturing processes that optimize costs and time efficiency but not therapeutic efficacy.
  • The potential evergreening risks of patenting intermediate compounds were discussed.
  • The ruling aimed to curb evergreening tactics but might restrict genuine innovation.
  • The Court's decision highlighted the need for a review of how efficacy is evaluated in patent law.
  • Determining the significant improvements in the manufacturing process remains a key criterion for patent eligibility.

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