In the year 2003, the Government of Gujarat approved the proposal of the NERF to found the Nirma University, Ahmedabad. Hence, the Nirma University was established under a special Act passed by the Gujarat State Legislative Assembly. The University Grants Commission (UGC) duly recognised the University under the Section 2 (f) of the UGC Act.
Institute of Pharmacy, Nirma University filed patent application numbered 1898/MUM/2012 that is titled PHARMACEUTICAL COMPOSITION AND A PROCESS THEREOF. This Patent Application has been granted as 317306.
The invention covers PHARMACEUTICALS compound. The invention provides a stable pharmaceutical composition for nasal delivery comprising an active pharmaceutical ingredient enduring extensive first pass metabolism in combination with suitable pharmaceutical excipients. The invention also discloses the process of preparation of the same.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that It appears to be a mere discovery of a new form of known composition and hence in the absence of significant improvement in the therapeutic efficacy of the claimed composition said claims are not allowable.
As a response to the said objection, the applicant claims by providing the combined synergistic effects of the ingredients which substantially increases the therapeutic efficacy in a way that it provides; substantially increased entrapment efficiency up to 88.79%, increased bio adhesion up to 76.93%, 4.31 times higher bioavailability compared to oral drug delivery of dosage form, in vitro drug release up to 95% in 12 hours.
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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