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. Salient Features of the Book:· 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. ·Possible questions at end of every chapter. ·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. 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