“Enhancement of known efficacy”: Meaning and impact

Enhancement of known efficacy is an important requirement under section 3 d for grant of a new form or a composition originating from a known substance. Efficacy in context of pharmaceuticals has been defined by FDA as “A drug is effective if it has “the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labelling thereof” and by Cochrane”. It generally considered to include Clinical Effectiveness, Comparative Performance, Dosage & Bioavailability, Patient Outcomes. In Indian patent law, merely demonstrating pharmacokinetic advantages like bioavailability is not enough to satisfy Section 3(d). A drug must show a direct therapeutic benefit beyond the known substance to be patentable.