Hanmi Pharm. Company Ltd. produces pharmaceutical products, including antibiotics, vitamins, and intestinal tonics. The Company also provides beverages and processes soft capsules for other pharmaceutical firms.
Hanmi Pharmaceutical Co. Ltd. filed patent application numbered 10909/DELNP/2013 that is titled as PHARMACEUTICAL COMPOSITION COMPRISING AMIDE DERIVATIVE INHIBITING THE GROWTH OF CANCER CELLS AND NON METALLIC SALT LUBRICANT. This patent application has been granted as Patent Number 316466.
The invention covers Chemical compound. A pharmaceutical composition comprising a compound of formula (I) or a pharmaceutically acceptable salt thereof and a non-metallic salt lubricant, selected from the group consisting of a glyceryl behenate, glyceryl palmitostearate, glyceryl monostearate, glyceryl trimyristate, glyceryl tristearate, sucrose fatty acid ester, palmitic acid, palmitoyl alcohol, stearic acid, stearyl alcohol, fumaric acid, PEG 4000 or PEG 6000, polytetrafluoroethylene, starch, talc, hydrogenated castor oil, mineral oil, hydrogenated vegetable oil and a mixture thereof.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act Claims 1-13 falls within the scope of section 3(d) of The Patents (Amendment) Act, 2005 as it is a new form of known substance (substance includes compounds and compositions both) in respect of the compounds/compositions disclosed by citations because no enhancement in therapeutic efficacy has been described in the description.
As a response to the said objection, the applicant submits that the composition of the present application is not a new form of a known substance, as for the composition of the present application no “known substance” known in the art. The composition as claimed in the present application are not salts, esters, ethers,polymorphs, metabolites, pure form, particle size or isomers of any known compounds disclosed in prior arts. Applicants’ invention lies in the unexpected results that non-metallic salts are useful for enhancing the stability of the compound of formula (I). Applicants are not seeking to patent a new form of a known substance, rather the invention lies in combining the compound of formula (I) with the specific claimed non-metallic salt lubricants, in order to improve the performance of the compound of formula (I). Therefore, the claims of the present application do not even fall within the scope of section 3(d), as the composition claimed in claims 1-13 (re-numbered claims 1-11) of the present application is not a “new form of a known substance”.
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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