The PCT International application was published on May, 2009 and a first examination report was issued on February 18,2014, following which a hearing was held on October 27, 2015, on technical objections of non-patentability of the claimed subject matter and lack of novelty and obviousness under various sections of the Patents Act, 1970.
The Patent Office said that the compound mentioned is already known and a revised claim submitted after hearin claims succinate salt of the said compound and claimed it as novel. The authoirity observed that a new salt of known compound can not be regarded as inventive unless the new salt exhibit any superior effect or surprising result.
"The claim of the above salt in a single weekly dose of 50 mg clearly indicate that invention, if any, lies in the administration of the drug dosage but not in the drug or its formulation. The first page of the specification clearly reveals that the field of the instant invention relates to method of administering compounds to inhibit dipeptidyl peptidase IV as well as method of treatment only, which is not patentable under section 3(i) of the Act," said an order by Soumen Ghosh, Deputy Controller of Patents & Designs of Patent Office, Kokata.
The claim 1, which was revised, and all dependant claims can not be considered to involve an inventive step or to have overcome the non-patentability criteria imposed under section 3(d), 3(e) of the Patents Act, said the order. The claims also fall under secton 3(i) of the act, indirectly, it added.
While Section 3(d) says that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, are not inventions within the meaning of the Act. According to 3(e), a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not an invention within the Act and Section 3(i) says that any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products, are not an invention as per the Act.
DPP-IV inhibitors are considered as useful agents for the treatment of diabetes, more particularly, type 2 diabetes mellitus. The specification given by the company to the Patent office details about several variations of the inhibitor.
