BY4016 IPR, Biosafety And Entrepreneurship Syllabus:

BY4016 IPR, Biosafety And Entrepreneurship Syllabus – Anna University PG Syllabus Regulation 2021

UNIT I IPR

Intellectual property rights – Origin of the patent regime – Early patents act & Indian pharmaceutical industry – Types of patents – Patent Requirements – Application preparation filing and prosecution – Patentable subject matter – Industrial design, Protection of GMO’s IP as a factor in R&D,IP’s of relevance to biotechnology and few case studies.

UNIT II AGREEMENTS, TREATIES AND PATENT FILING PROCEDURES

History of GATT Agreement – Madrid Agreement – Hague Agreement – WIPO Treaties – Budapest Treaty – PCT – Ordinary – PCT – Conventional – Divisional and Patent of Addition – Specifications – Provisional and complete – Forms and fees Invention in context of “prior art” – Patent databases – Searching International Databases – Country-wise patent searches (USPTO,espacenet(EPO) – PATENT Scope (WIPO) – IPO, etc National & PCT filing procedure – Time frame and cost – Status of the patent applications filed – Precautions while patenting – disclosure/non-disclosure – Financial assistance for patenting – Introduction to existing schemes Patent licensing and agreement Patent infringement – Meaning, scope, litigation, case studies

UNIT III BIOSAFETY

Introduction – Historical Backround – Introduction to Biological Safety Cabinets – Primary Containment for Biohazards – Biosafety Levels – Biosafety Levels of Specific Microorganisms – Recommended Biosafety Levels for Infectious Agents and Infected Animals – Biosafety guidelines – Government of India.

UNIT IV GENETICALLY MODIFIED ORGANISMS

Definition of GMOs & LMOs – Roles of Institutional Biosafety Committee – RCGM – GEAC etc. for GMO applications in food and agriculture – Environmental release of GMOs – Risk Analysis – Risk Assessment – Risk management and communication – Overview of National Regulations and relevant International Agreements including Cartegana Protocol.

UNIT V ENTREPRENEURSHIP DEVELOPMENT

Introduction – Entrepreneurship Concept – Entrepreneurship as a career – Entrepreneurial personality – Characteristics of successful Entrepreneur – Factors affecting entrepreneurial growth – Entrepreneurial Motivation – Competencies – Mobility – Entrepreneurship Development Programmes (EDP) – Launching Of Small Enterprise – Definition, Characteristics – Relationship between small and large units – Opportunities for an Entrepreneurial career – Role of small enterprise in economic development – Problems of small scale industries – Institutional finance to entrepreneurs – Institutional support to entrepreneurs.

REFERENCES

1. Bouchoux, D.E., “Intellectual Property: The Law of Trademarks, Copyrights, Patents, and Trade Secrets for the Paralegal”, 3rd Edition, Delmar Cengage Learning, 2008.
2. Fleming, D.O. and Hunt, D.L., “Biological Safety: Principles and Practices”, 4th Edition, American Society for Microbiology, 2006.
3. Irish, V., “Intellectual Property Rights for Engineers”, 2nd Edition, The Institution of Engineering and Technology, 2005.
4. Mueller, M.J., “Patent Law”, 3rd Edition, Wolters Kluwer Law & Business, 2009.
5. Young, T., “Genetically Modified Organisms and Biosafety: A Background Paper for Decision- Makers and Others to Assist in Consideration of GMO Issues” 1st Edition, World Conservation Union, 2004.
6. S.S Khanka, “Entrepreneurial Development”, S.Chand & Company LTD, New Delhi, 2007.