Karo Pharma AB operates a drug research and development company. The Company develops precision drugs to treat major diseases in the field of nuclear receptors. Karo Pharma works within many therapeutic areas including men and women’s health, cardiovascular diseases, metabolic disorders and dermatology.
In India, the Pharmaceutical business of Karo Pharma AB is focused on Substituted pyrazoles as estrogen receptor ligands, Estrogen receptor ligands, Novel Estrogen Receptor Ligands, Indole Derivatives and Their Use as Thyroid Receptor Ligands.
Karo Bio AB filed patent application numbered 2555/DELNP/2012 that is titled as A COMPOUND OF FORMULA (I) WHICH ARE ESTROGEN RECEPTOR LIGANDS. This Patent Application has been granted as Patent Number 318180.
This invention covers Chemical compound. The present invention relates to a compound of formula (I) or a pharmaceutically acceptable ester, amide, solvate or salt thereof, including a salt of such an ester or amide, and a solvate of such an ester, amide or salt, wherein R1 , R2 , R3 , R4 , R5 , R6 , R7 , R8 , R9 and R10 are as defined in the specification.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act 1-13 fall under section 3(d) of the Patents (Amended) Act, 2005 as the said claims defines new usen and/or new form of the known compound (as cited by the prior art documents as described in the report). In the absence of experimental data, it is not clear if the claimed compound and the composition thereof act to provide an enhancement of the known efficacy i.e., demonstrate a greater technical effect and/or differ significantly in properties w.r.t the known compound.
As a response,
1. Firstly, it is respectfully submitted that the amended claims 1 to 13 are directed towards novel and inventive compounds per se, and not towards any new uses, and those compounds are not derivatives or new forms of known compounds. The compounds of formula (I) of the present invention have an oxidised carbon group at the R2 position. Having this type of group at this position was not previously known, nor could it have been envisaged in view of the prior art. The claimed compounds are not derivatives or new forms of known compounds. They are in fact new compounds.
2. Secondly, it is respectfully submitted that the claimed compounds of the present invention have enhanced efficacy over known compounds with structural similarities.
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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