Novavax, Inc. is a clinical-stage biotechnology enterprise. The Company produces fresh and unique vaccines to deal with an extensive range of infectious diseases all over the world by using proprietary Virus-Like Particle (VLP) technology.
In India, the Pharmaceutical business of Novavax Inc. focuses on functional influenza virus-like particles (VLPs), vaccine compositions having improved stability and immunogenicity, modified RSV F proteins and methods of their use, VLPS derived from cells that do not express a viral matrix or core protein and Adjuvant and Vaccine Compositions.
Novavax Inc. filed a patent application numbered 4361/DELNP/2013 that is titled RABIES GLYCOPROTEIN VIRUS LIKE PARTICLES (VLPS). The patent has been filed in the field of Pharmaceuticals. This Patent Application has been granted as Patent Number 349659. This invention relates to an adjuvant is a non-phospholipid liposome in a method of generating an immune response against a viral infection comprising administering a purified micelle in a pharmaceutically acceptable formulation to a human subject.
During the patent examination, the patent examiner raised objections under section 3(d), 3(e), and 3(i) of the Indian Patents Act, 1970. Under section 3(d) it was stated that the claims indicate a mere use of a known purified micelle comprising one or more rabies vims (RV) glycoproteins. In the absence of experiment data, it is unclear whether any unknown technical effect is produced or not. Under section 3(e) it was stated that in the absence of data demonstrating synergistic effects or any special property resulting from the combination of different components of the composition claimed is a mere admixture resulting only in the aggregation of the properties of the components. Finally, under section 3(i) it was pointed out that the subject matter of the claims relates to a method of generating an immune response against a viral infection comprising administering a purified micelle/ VLP. Thus, it is not patentable.
As a response, the Applicant submitted that under section 3(d) none of the cited documents destroy the novelty of the claimed subject matter, as the amended claims show micellar particles containing a detergent, NP9 and rabies virus G protein, wherein the G Protein Trimeric is novel and inventive over the prior art. For the objection under section 3(e) the Applicant stated the claimed composition is new and it exhibits a superior technical effect as explained under the objection for section 3(d). Finally, for the objection under section 3(i), the Applicant pointed out that the revised claims are linked to a single inventive concept and cannot be objected to on the ground for lack of Unity of Invention.
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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