Hanmi Science Co., Ltd. produces pharmaceutical products, including antibiotics, vitamins, and intestinal tonics. The Company further produces beverages and processed soft capsules for different pharmaceutical establishments.
Hanmi Science Co., Ltd. filed a patent application numbered 6694/DELNP/2014 that is titled PHARMACEUTICAL COMPOSITION FOR THE PREVENTION OR TREATMENT OF NON ALCOHOLIC FATTY LIVER DISEASE. The patent has been filed in the field of Pharmaceuticals. This Patent Application has been granted as Patent Number 353431. This invention relates to a pharmaceutical composition for the prevention and treatment of Non-Alcoholic Fatty Liver Disease (NAFLD), including a conjugate prepared by covalently linking an insulinotropic peptide, a non-peptidyl polymer, and an immunoglobulin Fc region. The structure of the invention preserves the in-vivo movements of the peptide at a considerably high degree, and substantially raises the blood half-life, thus hindering triglyceride accumulation which is a basic element of non-alcoholic fatty liver disease. Finally, it can be effectively used for the deterrence and treatment of non-alcoholic fatty liver disease.
During the patent examination, the Patent Examiner raised objections under Section 3(d) of the Indian Patents Act, 1970. It was pointed out that certain claims are directed to the mere use of a known component (an insulinotropic peptide drug conjugate prepared by covalently linking an insulinotropic peptide and an immunoglobulin Fc region via a non-peptidyl polymer as an active ingredient); and mere use of a known method for preventing or treating non-alcoholic liver disease, comprising the phase of implementing it to a subject pharmaceutical structure. In the absence of experiment data, it is unclear whether any unknown technical effect is produced or not.
As a response, the Applicant submitted that the application discloses a pharmaceutical composition comprising an insulinotropic peptide conjugate. The insulinotropic peptide conjugate comprises an insulinotropic peptide, a non-peptidyl polymer, and an immunoglobulin Fc region that is covalently linked to each other. The pharmaceutical composition prevents triglyceride accumulation and is useful for non-alcoholic fatty liver disease. The claims as amended are novel in light of 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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