S & K Biopharma, Inc. researches and develops new drugs. The Company has created and marketed brain diagnostic treatment drugs, central nervous system diagnostic drugs, and various other drugs. SK Biopharmaceuticals reached consumers that are spread worldwide.
In India the Chemical business of S & K Biopharma, Inc. focuses on Treatment for obesity, methods for treating fibromyalgia syndrome, treatment of sleep-wake disorders, treatment of Cataplexy, and methods for Treating or Preventing Fatigue.
S & K Biopharma, Inc. filed a patent application numbered 9815/DELNP/2014 that is titled LACTOFERRIN FUSION PROTEIN AND METHOD FOR PRODUCING SAME. The patent has been filed in the field of Chemicals. This Patent Application has been granted as Patent Number 349314. This invention relates to a fusion protein formed with a protein or peptide comprising a neonatal Fc receptor (FcRn)-binding region and lactoferrin or a fragment thereof comprising N-lobe or C-lobe region, or a variant thereof having an additional element selected from a signal peptide and a tag sequence, wherein the fusion protein has no hinge region.
During the patent examination, the patent examiner raised objections under Section 3(d), and 3(e) of the Indian Patents Act, 1970. Under Section 3(d), it was cited that the subject matter of the claims indicates a new use or the new form of a known process/ substance. Under Section 3(e), it was cited that subject-matter of claims describes a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof and the complete specification fails to provide any specific technical effect or synergistic effects produced by the combination of different components of the claimed compositions.
As a response, the Applicant submitted that under Section 3(d) the experiment result shows the improved efficacy of the invention. The fusion protein of the amended claims is not a combination of known substances, but rather a new protein wherein lactoferrin or a fragment thereof is fused to a protein or peptide comprising an FcRn-binding region, and wherein the fusion protein has no hinge region. Subsequently, under Section 3(e) the applicant submitted that the composition of the invention is not a mere admixture, but instead a composition based upon single key constituent having properties which are unique and novel. The expression “composition” has been used because of the usage of the routine carrier or excipient necessary to formulate such composition.
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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