Cellix Bio Private Limited operates as a biopharmaceutical company. The Company focuses on designingsnd developing therapies for the treatment of neurological, inflammatory, and metabolic diseases. Cellix Bio manufactures medicines that modulate the disease pathway. Cellix Bio serves customers in India.
In India, the Pharmaceutical business of Cellix Bio Private Limited is focused on Compositions and methods for the treatment of inflammation and pain, Compositions and methods for the treatment of neurological disorders, Compositions and methods for the treatment of multiple sclerosis.
Cellix Bio Private Limited filed patent application numbered 201817045551 that is titled as Compositions and Methods for the Treatment of Cancer. This patent application has been granted as Patent Number 317959.
This invention covers Pharmaceuticals compound. This invention relates to the compounds or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of compounds of formula I, formula II, formula III, formula IV, formula V, formula VI, formula VII and formula VIII and, the methods for the treatment of cancer and infectious diseases may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, lozenge, spray, intravenous, oral solution, buccal mucosal layer tablet, parenteral administration, syrup, or injection. Such compositions may be used to treatment of cancer, neoplasm, infections and skin diseases.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that the compounds of the instant application are structurally similar to cited documents and differ from the examples and preferred embodiment only through the specific choice of the various substituents according to the general formula. No unexpected property which can be attributed to this combination of structural features is indicated in the application. The compounds of the present invention, therefore, appear to be merely alternatives that a person skilled in the art. Therefore, claims 1-8 of the present application attract the provision of section 3(d) of the Act in absence any comparative data (therapeutic efficacy) of the present compound with the cited prior art documents.
As a response to the said objection, the applicant submits that In biological systems, even minor structural modification can lead to a huge variation in the efficacy and safety of the compounds. It is a well-known fact that all existing treatments for cancer have a number of side effects associated with them and there is a constant need for new and improved compounds with better efficacy and safety profiles. Thus, structural modifications cannot be treated as minor modification of similar compounds when comparing their biological and therapeutic usage. The major structural difference of the compounds of the present invention as compared to cited prior arts is the presence of 5’methyl group, which is not merely an obvious structural change as it has not been cited anywhere in the prior art. This distinguishes the compounds of the present invention from the cited prior arts.
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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