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 levels

International 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

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 19 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 35 research, review articles published in national journals and has five copyrights. 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 were later patented. 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.