ELUCIDATION OF PATENTABILITY CONSIDERATIONS FOR SGLT-2 AND DPP-4 INHIBITOR ANTI-DIABETIC DRUG PRODUCTS IN INDIA VIS-À-VIS USA

Increasing number of Diabetes mellitus (DM) has become a global public health concern. There are several drug products approved by USFDA and regulatory agency of India for the effective treatment of diabetes mellitus. Subsequently, innovator companies, applied for Patent protection with various primary and secondary attributes of the drug product. Through this Exploratory Research, we precisely investigated drug products which are SGLT-2 and DPP-4 inhibitors by mechanism, and for which the innovator failed to secure grant of patent in India for secondary inventions such as for salt of a compound, crystalline polymorph, combination of drug products, because of objections raised by Controller in view of provisions in Indian Patent Act such as Section 2(1) (j) or (ja), Section 3. On the other hand, innovator could successfully obtain patent grant for corresponding family equivalent patent in the USA despite of objections under USC (102), (103). During our exploratory research, it is observed that the technical advancements and surprising effect which were admissible and considered by the USPTO, was not “Weighed equally” by India patent office in order to justify “enhanced efficacy” or “synergistic effect” of the drug product. It should also to be noted that there is no explicit guidance in the India Patent Act to define consideration limits and acceptance criteria for data with ‘Enhanced efficacy’ or “Synergistic effect”. Hence, there is a need of harmonization of certain provisions of Indian Patent Act with expanded view for considerations of scientific evidence, while evaluating patentability (Novelty and inventive step) for pharmaceutical products.