Xgene Pharmaceutical Co. Limited wholesales drugs. The Company distributes antibiotic drugs, respiratory drugs, cardiovascular drugs, vitamin tablets, health care drugs, and other related products. Xgene Pharmaceutical markets its products throughout China.
Xgene Pharmaceutical Co. Limited filed patent application numbered 3418/DELNP/2011 that is titled as GABA CONJUGATES AND METHODS OF USE THEREOF. This patent application has been granted as Patent Number 316461.
The invention covers Mechanical Engineering compound. A compound comprising an analgesic drug covalently linked to a first moiety via a physiologically labile covalent linker, wherein the first moiety is pregabalin, γ-aminobytyric acid (GABA), gabapentin, baclofen or vigabatrin, and wherein the first moiety is covalently linked via an amino group or a carboxylic acid group thereof to a linker of the structure.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that the alleged compound(s)/composition(s) of claims 1-19 of the present invention has been considered as “same substance” as disclosed in the cited prior art(s) as per section 3(d) of the Act and hence are not allowed.
As a response to the said objection, the applicant submits that section 3(d) of the Act, applies only in respect of the new form of a “known substance” and the Hon’ble IPAB, whose decisions and judgments are binding on the Controller, has held in Fresenius Kabi Oncology Limited vs. Glaxo Group Limited (Order No. 162 of 2013), para.56 that, to raise a challenge or an objection under Section 3(d) of the Act, one has to specifically allege and identify at least the following three:
(i) What is the specific ‘known substance’ in question?
(ii) How and why the claimed molecule(s) or substance(s) is a derivative or is otherwise a new form of a known substance?
(iii) Basis to assert that the alleged ‘known substance’ and the claimed molecule or substance have the same ‘known’ efficacy?
In particular, the Applicant is being asked to provide data on the alleged enhanced efficacy over the ‘known substance’ without being informed the chemical or IUPAC name of the specific ‘known substance’ that the Ld. Controller has referred to. Further, the Ld. Controller has not provided any reasoning to show how and why the claimed compounds are mere derivatives, and there is no identification of the ‘known efficacy’. In addition, the Applicant has already mentioned above, how the compounds of the claimed invention is different from the compounds of the cited documents by way of the recited linker.
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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