Kissei Pharmaceutical Co. Ltd. produces and sells various types of prescription drugs. The Company’s primary commodity is for cholesterol, high blood pressure, digestion, allergy, circulatory and respiratory ailments, and Parkinson’s.
In India, the Chemical business of Kissei Pharmaceutical Co. Ltd. focuses on preventive or remedy for intrauterine late embryonic development or pregnancy toxemia, piperidino-3,4-dihydrocarbostyril compounds, and aromatic amidocarboxylic acids and pharmaceutical compositions thereof.
Kissei Pharmaceutical Co. Ltd. filed a patent application numbered 10349/DELNP/2015 that is titled as a-SUBSTITUTED GLYCINEAMIDE DERIVATIVE. The patent has been filed in the field of Chemicals. This Patent Application has been granted as Patent Number 349838. This invention covers a compound represented by the general formula (I) or a pharmaceutically acceptable salt thereof.
During the patent examination, the patent examiner raised objections under Section 3(d), 3(e), and 3(i) of the Indian Patents Act, 1970. Under section 3(d) it was pointed out that the absence of experimental data makes the claimed compound unclear and the composition thereof act to provide an enhancement of the known efficacy of a known compound. Under section 3(e) the synergistic composition should show unexpectedly new properties or better efficacy than a mere aggregation of the properties of its components. This does not validate a composition claim. Finally, under section 3 (i) the claims relate to a method of treatment as barred by the Patent (Amendment) Act, 2005, and hence were not allowed.
As a response, the Applicant submitted that under section 3(d), the Learned Controller acknowledged the novelty of the compound(s) of formula (I) as claimed, hence it may be regarded as a new entity, per se, and not merely a new form of a known substance. For the objection under section 3(e), the Applicant pointed out that the objected claims were deleted and thus the objection raised on the said claim was no longer applicable. Finally, under the objection for section 3(i), the Applicant recorded that the claims were amended to waive the objection.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
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