Morepen Laboratories Limited develops, manufactures and markets generic drugs and pharmaceutical formulations for domestic and international customers. The Company’s products are available in a variety of formulations, including tablets, capsules, injections, ointments, syrups, and powders. Morepen’s products include Loratadine, Fluvastatin, Montelukast, and Fexofenadine.
In India, the Pharmaceutical business of Morepen Laboratories Limited is focused on Process for the preparation of amorphous atorvastin calcium salt (2:1).
Morepen Laboratories Limited filed patent application numbered 2300/DEL/2014 that is titled as IMPROVED PROCESS FOR REMOVAL OF 3-AMINO-4-(2,4,5-TRIFLUOROPHENYL) BUTANOIC ACID IMPURITY IN SITAGLIPTIN PHOSPHATE. This Patent Application has been granted as Patent Number 317954.
The invention covers Chemical compound. An improved process for the preparation of Sitagliptin base, having low 3- amino-4-(2,4,5-trifluorophenyl) butanoic acid impurity (Amino TFPBA; Formula 5) content.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that the claim 1-10 is not patentable u/s 3(d) of the Act, appears to be “mere use of a known process” and fall under the said clause. Hence not patentable.
As a response to the said objection, the applicant submits that the amended claims refer to a novel process for the preparation of Sitagliptin phosphate with reduced impurity content which is normally around 0.5-1.0% by various processes described in prior art. Hence in order to compete in various regulated markets where impurity limits are very stringent, there was a need of cost effective process of Sitagliptin phosphate which give consistent good quality high enantiomeric purity along with proper yields.
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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