H. LUNDBECK A/S Received Patent for ORTIOXETINE MANUFACTURING PROCESS

H. Lundbeck A/S operates as an international pharmaceutical company. The Company researches, manufactures, and sells drugs for the treatment of psychiatric and neurological disorders. The Company focuses on mood disorders, dementia, anxiety, and sleep disorders. Lundbeck does research both in-house and in cooperation with research centers. The Company markets its products worldwide.

In India, the Pharmaceutical business of H. LUNDBECK A/S is focused on Use of an acetylcholinesterase inhibitor and idalopirdine for reducing falls in Parkinson’s disease patients, Use of an opioid receptor antagonist with kappa-activity and vortioxetine for treatment of depressive disorder with melancholic features, Monoclonal anti-alpha-synuclein antibodies for preventing tau aggregation.

H.LUNDBECK A/S filed patent application numbered 7181/DELNP/2015 that is titled as ORTIOXETINE MANUFACTURING PROCESS. This patent application has been granted as Patent Number 316892.

The invention covers Chemical compounds. A process for the manufacture of vortioxetine is provided in which a compound of formula I, formula I is reacted with optionally substituted piperazine and 2,4-dimethylthiophenol(ate) followed by de-complexation.

During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act, wherein the examiner stated that the Claims 1-16 of the alleged invention attract the provision of section 3(d) of the Act, as the said claims pertaining to mere use of a known process for the synthesis of vortioxetine which neither results in new product nor employs any new reactant.

As a response to said objection, the applicant submitted that the instant Application recites a process for the manufacture of vortioxetine or pharmaceutically acceptable salts thereof, which process comprises reacting a compound of Formula. Technical arguments along with graphical representation has been given.

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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