NIPER is a premier center of distinction in training, research, and entrepreneurial learning. The interdisciplinary curriculum and ethnic array at NIPER stimulate the spirit of innovative research and all-round growth of its students. The institute is geographically located to form a symbiotic link with Pharmaceutical industries, Medical centers, and technological academies.
In India, the chemical business of NIPER focuses on nanocrystalline solid dispersion compositions and the process of preparation thereof, the process for the preparation of ring-substituted 8-aminoquinoline analogs as antimalarial agents, and one-pot synthesis of [2,8-Bis (trifluoromethyl)-4-quinolinyl]-2-pyridinylmethanone, a mefloquine intermediate.
NIPER filed a patent application numbered 2202/DEL/2011 that is titled as FOLIC ACID CONJUGATED POLYMERIC NANOPARTICLES FOR ORAL DELIVERY OF BIOACTIVE AGENTS. The patent has been filed in the field of Chemicals. This Patent Application has been granted as Patent Number 347594.
This invention covers a pharmaceutical nano-formulation for oral delivery of bioactive agents comprising folic acid conjugated to biodegradable polymeric nanoparticles. The said nano-formulation improves bioavailability and enhances the efficacy of orally delivered bioactive agents by enhancing intracellular uptake from the gastrointestinal tract (GIT). The invention also provides a process for preparing the folic acid conjugated polymeric nanoparticles.
During the patent examination, the patent examiner raised objections under Section 3(e) of the Indian Patents Act pointing out that the said claims define a mere admixture resulting only in the accumulation of the components thereof. It is not indistinct if the shared agents act in conjunction to render a technical effect that is more than just the summation of the two or more agents, or whether the mixture is, in fact, a mere juxtaposition with no communication of the agents. Further, the examiner also raised objections under Section 3(d) of the Act, where the claims and cited documents define a mere use of known processes and cannot be allowed.
As a response, the Applicant submitted that to fulfill section 3(e) of the Act, the claimed nano-formulations exhibits properties that are synergistic. The components of the components interact together in a manner to provide stability to the formulation upon oral administration for insulin and thus finally resulting in enhanced efficacy. Further, the Applicant submitted that the pending process claims as well as the amended process claimed are beyond the purview of Section 3(d) of the Act. The invention claimed a novel process, which was not disclosed in any cited documents.
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.
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.
