JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

Various types of Intellectual Property Rights Patentable Subject History of

Indian Patent Protection, Patent filing procedure in India, Opposition- pre-grant opposition and post-grant opposition, Patent filing procedure under PCT, advantages, patent search and literature and Salient features of Indian Patents are discussed in detail.

Course Outcome

The clear information about the patent laws, intellectual property rights and

drug regulation in India and abroad is gained by the students.

UNIT - I

Introduction, Types of Intellectual Property Rights (Patents, Trademarks, Copyrights, Geographical Indications Industrial Designs and Trade secrets), Patentable Subject Matter (Novelty, Non- Obviousness, Utility, enablement and Best mode),

UNIT - II

• a. History of Indian Patent Protection, Rationale behind Patent System, Objectives and Advantages of Patent System, and future challenges. Indian Patents Act 1970, Definitions and Key Terminology, Types of Patent applications, Inventions not patentable (section 3 and 4).
• b. Patent filing procedure in India (Patent Prosecution), Specifications (Provisional and Complete), Claims- types of claims and legal importance of claims, Grant of patent, Rights of Patentee and co-owners
• c. Opposition - pre-grant opposition and post-grant opposition, Anticipation, Infringement, Compulsory Licensing, revocation of patents, and power of Controller.
• d. Patent filing procedure under PCT, advantages, patent search and literature

UNIT - III

• a. Salient features of Indian Patents (Amendments) Act 1999, 2002 and 2005. US and European Patent System,
• b. Background, Salient Features and Impact of International Treaties / Conventions like
• 1. Paris Convention, Berne convention
• 2. World Trade Organization (WTO)
• 3. World Intellectual Property Organization (WIPO)
• 4. Trade Related Aspects of Intellectual Property Rights (TRIPS)
• 5. Patent Co-operation Treaty (PCT), Madrid Protocol

UNIT - IV

• a. PCT Application procedure and review procedure
• b. National phase application procedure for US& EU
• c. Patent prosecution procedure in US and EU
• d. WIPO and its role in IPR
• e. Hatch- Waxman provision for IPR

UNIT - V

• a. Patent in validation process in India, US and Europe
• b. IPR related to copyright, trade mark, trade secret and geographical indication.
• c. Patent application writing
• d. Claim construction and claims. R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS RECOMMENDED BOOKS:
• 1. Research Methodology concepts and cases by Depak Chawla, Neena Sondhi
• 2. Draft manual of Patent Practice and Procedure -2008, The Patent Office, India
• 3. Manual of Patent Office Practice and Procedure -2010
• 4. Original Laws Published by Govt. of India
• 5. Protection of Industrial Property rights by P. Das and Gokul Das
• 6. Law and Drugs, Law Publications by S.N. Katju
• 7. Laws of drugs in India, Hussain
• 8. New drug approval process, 5th edition, by Guarino
• 9. Commercial Manual on Drugs and Cosmetics 2004, 2nd edition
• 10. Drugs and Cosmetics act by Vijay Malik
• 11. Good Manufacturing Practices for Pharmaceuticals, S.H. Wiling, Vol. 78, Marcel Decker.
• 12. fda.org, wipo.int, patentlawlinks.com, hc-sc.gc.ca, ich.org, cder.org
• 13. Current good manufacturing practices for pharmaceuticals by Manohar A. Potdar
• 14. Pharmaceutical Regulatory affairs –selected topics. CVS subhramanyam and J Thimma settee. Delhi, Vallabh Prakashan, 2012 R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)