Jubilant Generics Limited is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Other businesses including Drug Discovery & Development Solutions and India Branded Pharmaceuticals.
In India the Pharmaceutical business of Jubilant Generics Limited is focused on preparation of exametazime, Disintegrant free composition of Cinacalcet, preparation of apixaban and intermediates, pharmaceutical composition of Cinacalcet.
Jubilant Generics Limited filed patent application numbered 8188/DELNP/2013 that is titled as PROCESS FOR PRODUCING ARIPIPRAZOLE IN ANHYDROUS TYPE I CRYSTALS. This patent application has been granted as Patent Number 316557.
The invention covers Chemical compound. This invention involves an improved process for the preparation of anpiprazole in anhydrous Type I crystals, substantially free of other polymorphic forms of aripiprazole via improved drying technique.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that Aripiprazole as claimed in claim 8-9 according to the process of claim 1 fall u/s 3(d) of the patents act, 1970 (as amended), unless they demonstrate a greater technical effect and/or differ significantly in properties w.r.t the known compound.
As a response to the said objection, the applicant submits that as indicated above the claimed process was not previously known. Further, it is submitted that applicant has performed various experiments which is evident in the various Examples of the specification.
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