Intellectual Property Rights in Pharmaceutical Industry Theory and Practice

"Intellectual Property Rights in Pharmaceutical Industry: Theory and Practice" is an exclusive book shedding light on the fundamental concepts of intellectual property protection, with a special emphasis on pharmaceuticals. The book explores how the importance of intellectual property rights has grown in the last few decades, especially in India, after signing the World Trade Organisation agreement. The book explains how the Indian government has made necessary amendments in the intellectual property laws, built infrastructure, and even introduced topics related to intellectual property rights in the academic curriculum.The book dives deeply into the Indian patent system, with case studies from US and Indian courts serving as examples, to provide a better understanding of the system. The third edition is a result of the major administrative changes observed in the Indian government in recent years.This book is aimed at students, industry professionals, scientists, regulators, and policymakers interested in the pharmaceutical industry. This book serves as a valuable resource for B. Pharm, Pharm D, M. Pharm, and Ph.D. level students, along with other science educational programs in all the Universities of India. On reading this book, the pharmaceutical community will gain a better understanding of the intellectual property protection system, leading to an orientation of research development to ensure intellectual property protection.This book is a must-have for anyone involved in the pharmaceutical industry who wants to understand the nuances of intellectual property protection in India.
Contents:
 1.           Introduction and History of Intellectual Property Rights2.           International Agreements, Treaties and Conventions3.           Introduction to Different Components of Intellectual Property Rights4.           Introduction to Traditional Knowledge and Biological Diversity5.           Introduction to WTO Agreement6.           Trade Related Aspects of Intellectual Property Rights Agreement7.           The Patents Act, 19708.           Surrender, Revocation, Lapse, Restoration of Patent and Register of Patent9.           Expenditure for Application, Follow Patent Office Procedure, Grant of a Patent10.         Application Procedure and Time Line for Grant of Patent through PCT11.         Non-Patented and Patented Literature Search12.         Comparison of the Principal The Patents Act, 1970 with The Three Amendments (1999, 2002, 2005)13.         Differences in The Patents Act, 1970 with other Countries14.         Administrative Structure of WTO, Membership and Dispute Settlement as per TRIPS Agreement15.         Technology Transfer16.          Hatch-Waxman Act of United States-A Relation to Drug Discovery, Regulatory and Market Approval17.         Intellectual Property Validation18.         Intellectual Property Audits19.         National Phase Entry for IP Protection20.         Intellectual Property Litigation Prosecution21.         FAQ s in Pharmaceuticals on Patents - Regulatory - Marketing
About the Authors:
Bayya Subba Rao completed both B. Pharm and M. Pharm from College of Pharmaceutical Sciences, Manipal. He completed P. G. Diploma in Patent Laws from NALSAR University of Law, Hyderabad. He was awarded with Doctorate in Pharmaceutical Sciences degree from Andhra University, Visakhapatnam.             During his 23 years of career he was involved in basic research, process research, teaching, government service at various levels as scientist-II, research chemist, lecturer, associate professor, I/C Principal, patent analyst.  He has to his credit over 50 research, review articles published in National journals and has five copyrights. Currently working in pharmaceutical Industry.            During his career he was involved in synthesis of new chemical entities, synthesis of drug metabolites and chemical process developments.  He developed a process that was later filed for patent and withdrawn.             He was involved in teaching intellectual property rights relating to pharmaceuticals to students at the B.Pharm and M.Pharm levels.
P. V.  Appaji was Emeritus Director General at Pharmaceuticals Export Promotion Council of India (Pharmexcil), set up by Ministry of Commerce and Industry, Government of India. He has initiated his career as an officer at Drugs Control Department, Government of Andhra Pradesh and later as Deputy Commissioner in Department of Chemicals and Petrochemicals, as Director at National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. At Pharmexcil, as chief of organisation, he is actively involved in interacting with Government and the pharmaceutical industry to promote/resolve pharmaceutical export, policy issues and is actively involved in delegations abroad so that pharmaceutical trade barriers at the levels of transit, regulatory, policy making are effectively dealt with.  At NPPA, he was actively involved as chief of evaluation of Drugs Price Control Order/Drug Pricing in the territory of India.  He completed B.Pharm (1970), M.Pharm (1972) and Ph.D (1980) from Nagpur University.  He has guided several Ph.D scholars. He has received Lifetime Achievement Award for his contribution to the pharmaceutical sector from Indian Pharmaceutical Association and others.