About the Book:

"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.

Contents: 

1.           Introduction and History of Intellectual Property Rights

2.           International Agreements, Treaties and Conventions

3.           Introduction to Different Components of Intellectual Property Rights

4.           Introduction to Traditional Knowledge and Biological Diversity

5.           Introduction to WTO Agreement

6.           Trade Related Aspects of Intellectual Property Rights Agreement

7.           The Patents Act, 1970

8.           Surrender, Revocation, Lapse, Restoration of Patent and Register of Patent

9.           Expenditure for Application, Follow Patent Office Procedure, Grant of a Patent

10.         Application Procedure and Time Line for Grant of Patent through PCT

11.         Non-Patented and Patented Literature Search

12.         Comparison of the Principal The Patents Act, 1970 with The Three Amendments (1999, 2002, 2005)

13.         Differences in The Patents Act, 1970 with other Countries

14.         Administrative Structure of WTO, Membership and Dispute Settlement as per TRIPS Agreement

15.         Technology Transfer

16.          Hatch-Waxman Act of United States-A Relation to Drug Discovery, Regulatory and Market Approval

17.         Intellectual Property Validation

18.         Intellectual Property Audits

19.         National Phase Entry for IP Protection

20.         Intellectual Property Litigation Prosecution

21.         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.