Intellectual Property Rights in Pharmaceutical Industry : Theory and Practice

This book is aimed at pharmaceutical fraternity involving as students, researchers, teachers, regulators, policy makers to understand key aspects of intellectual property matters.  The book is planned for quick understanding of basic concepts leading to practice in pharmaceutical Industry. The book provides clear cut understanding of national and international scenario of IPR matters.Conventional English was used instead of legal language for the sake of initiators in learning IPR matters in pharmaceuticals.·         Major emphasis is relating to pharmaceuticals.·         History of IPR matters at global and national levelsInternational Conventions on IPR matters only relating to pharmaceuticals·         Introduction to every component of IPR with corresponding governing Acts, governing Ministry, and exclusivity periods with pharmaceutical related examples. Objective and role of GATT,  WTO and TRIPS agreement.·         Introduction to The Patents Act, 1970 relating to inventions not patentable, types of patent applications, contents of a patent, patent office procedure timeline, PCT timeline, types of oppositions, types of infringement, expenditure incurred for filing and maintaining patents, rights of patentee, powers of controller of patents, compulsory licensing, and patent agents etc.How to do literature search relating to non-patented and patented information for innovation and patent mining.·         Comparison of principal The Patents Act, 1970 with three amendments. Administration structure, protocol to become a member of WTO and procedure to resolve disputes.·         Relationship of Drug Discovery, Drug regulatory and Market approval processes.Various disputes settled at WTO of India relating to pharmaceuticals.Judgments, case studies, notices relating to pre-grant opposition, post-grant opposition, compulsory licensing, infringements, working of patents, revoke of patents.Above 100 frequently asked questions relating to Patents, Regulatory and Marketing relating to pharmaceuticals.Statistics relating to patent grants at IPO, USPTO, and DMFs at    USFDA relating to India