Jubilant Life Sciences 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. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non-sterile products through 6 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US.
In India, the Pharmaceutical business of Jubilant Organosys Limited is focused on dihalopyridines, sulphoxide compounds, pyridine, bisphosphonic acids, novel polymorphic forms of Fluvastatin sodium
Jubilant Organosys Limited filed patent application numbered 553/DEL/2009 that is titled PROCESS FOR PRODUCING RIZATRIPTAN OR ITS PHARMACEUTICALLY ACCEPTABLE SALT. This patent application has been granted as Patent Number 307012.
The invention covers pharmaceutical. The invention involves a process for producing rizatriptan benzoate, wherein the process comprising reacting l-[(4-aminophen-l-yl)methyl]-1H-l,2,4-triazole of formula (V) or a salt thereof with a diazotizing agent and then, reducing the diazotized product followed by cyclization with 4-N,N-dimethylamino butyraldehyde or a carbonyl protected form thereof to give rizatriptan and converting the resultant rizatriptan to rizatriptan benzoate, with or without isolation of rizatriptan, wherein the obtained rizatriptan benzoate is having dimer impurity less than 0.1% and purity more than 99.5% .
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act, wherein the examiner stated that the Claim(s) (1-12) are statutorily non-patentable and mere known process in respect of the process.
As a response, the applicant raised technical and scientific arguments.
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