Santen Pharmaceutical Co., Ltd. creates and retails ophthalmic medicine. The Company produces an assortment of goods ranging from eye drops to ointments. Santen Pharmaceutical similarly imports lenses, devices, and equipment used by optometrists.
In India, the Pharmaceutical business of Santen Pharmaceutical Co., Ltd. focuses on pharmaceutical preparation containing pyridyl aminoacetic acid compound, prophylactic and/or therapeutic agent containing pyridylaminoacetic acid compound, depot formulations, and use of sirolimus to treat exudative age-related macular degeneration with persistent edema.
Santen Pharmaceutical Co., Ltd. filed a patent application numbered 201617026272 that is titled as PYRIDYLAMINOACETIC ACID COMPOUND AND POLYOXYETHYLENE CASTOR OIL CONTAINING PHARMACEUTICAL COMPOSITION. The patent has been filed in the field of Pharmaceuticals. This Patent Application has been granted as Patent Number 349609. This invention covers a pharmaceutical composition that comprises the pyridylaminoacetic acid compound of the present invention, said pyridylaminoacetic acid compound being stable within the pharmaceutical composition; and a method for improving the stability of the pydridylaminoacetic acid compound within the pharmaceutical composition.
During the patent examination, the patent examiner raised objections under Section 3(d) and 3(e) of the Indian Patents Act. Under Section 3(d) it was stated that the particular compound in the claims is a well-known compound as disclosed in the prior art because no therapeutic efficacy is disclosed in the claims and it does not have any significant improvement or technical advantage to the prior art. Further, under section 3(e) it was stated that since the claims specify a pharmaceutical formulation of active ingredients with pharmaceutically acceptable adjuvant and polyoxyethylene castor oil, which are compositions that are already known in the prior art, no synergistic effect is exemplified by the specification of the same composition. Also, the distinct quantities of the components are not mentioned in the composition, making it a mere admixture.
As a response, the Applicant submitted that for the objection under section 3(d) the composition of the application has a combination of the specified amount of the compound and polyoxyethylene castor oil, exhibits significant synergistic effect in improving the stability of the compound compared to compositions that do not fall within the boundaries of the application. Moreover, the pharmaceutical composition of the application achieves an advantageous effect that unexpectedly and remarkably has high stability in the compound and the polyoxyethylene castor oil.
Further, under section 3(e) it was submitted that the pharmaceutical composition of the invention is a novel composition containing the compound that is effective as a therapeutic agent and the like for glaucoma. It is submitted that since the therapeutic composition of the invention can significantly improve the stability of the compound, it exhibits a significant effect in prolonging the duration that it can be used as a therapeutic agent and the like for glaucoma, compared to therapeutic compositions that do not fall within the boundaries of the application.
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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