Syllabus (MICROBIOLOGY)

Course Type: MAJ-15

Semester: 8

Course Code: BMCBMAJ08T

Course Title: BIOSAFETY AND INTELLECTUAL PROPERTY RIGHTS (IPR)& BIOETHICS (THEORY)

(L-P-Tu): 5-0-1

Credit: 4

Practical/Theory: Theory

Course Objective: 1. To study the biosafety rules and regulations. 2. To learn about the different IPRs and their importance. 3. To provide a basic idea about bioethicsand biopiracy.

Learning Outcome: Upon successful completion of the course the candidate will be able to- 1. Know the good microbiological practices and importance of biosafety. 2. Understand the regulation of GMOs/LMOs at national and international level. 3. Understand the concept of different types of IPRs. 4. Acquainted with bioethical concepts.

MAJOR COURSE 02

COURSE TITLE: BIOSAFETY AND INTELLECTUAL PROPERTY RIGHTS (IPR)& BIOETHICS (THEORY)

TOTAL HOURS: 60 CREDITS:4

Unit 1. Introduction to biosafetyNo. of Hours: 10

Concept of Biosafety, Containment- Types; Biological Safety Cabinets; Different levels of Biosafety, Biosafety levels of specific microorganisms; Biosecurity, Bioterrorism

Unit 2. National and International RegulationsNo. of Hours: 12

National and International regulatory bodies, Regulation of LMOs/ GMOs at National level: RDAC, RCGM, IBSCs, GEAC, SBCC, DLC; Cartagena protocol on Biosafety; Applications, Risk assessment and management of LMOs/ GMOs

Unit 3. Introduction to Intellectual Property No. of Hours: 15

Concept of Intellectual Property- Types, Patents (Classification of patents, patent filing procedures, infringement), Trademarks, Copyright & Related Rights, Industrial Design, Geographical Indications, Plant Breeders’ Rights, Traditional knowledge, Trade secret, Domain names

Unit 4. Agreements and Treaties No. of Hours: 10

Establishment and functions of GATT and TRIPS agreement; Madrid agreement; Hague agreement; WIPO treaties; Budapest treaty; PCT, Indian patent Act 1970 and recent amendments

Unit 5. Bioethics No. of Hours: 13

Introduction to ethics and bioethics, framework for ethical decision making. Ethical conflicts in biological sciences - interference with nature, bioethics in health. Artificial reproductive technologies, prenatal diagnosis, Ethics in transplantation and stem cell research, Human and animal experimentation, Agricultural biotechnology - Genetically engineered food, environmental risk, labelling. Protection of environment and biodiversity– biopiracy, bioprospecting

SUGGESTED READING

1. Bare Act, 2007.Indian Patent Act 1970 Acts & Rules, Universal Law Publishing Co. Pvt.Ltd., New Delhi.
2. Kankanala C (2007). Genetic Patent Law & Strategy, 1st Edition, Manupatra Information Solution Pvt. Ltd. New Delhi.
3. Mittal, D.P. (1999). Indian Patents Law, Taxmann, Allied Services (p) Ltd.
4. Singh K K (2015). Biotechnology and Intelectual Property Rights: Legal and Social Impliocations, Springer India.
5. Goel D &Prashar S (2013). IPR, Biosafety and Bioethics. Pearson
6. Senthil Kumar Sadhasivam and Mohammed Jaabir, M. S. 2008. IPR, Biosafety and biotechnology Management. Jasen Publications, Tiruchirappalli, India.
7. Biotechnology in the Welfare of Mankind –Ali Khan
8. Sasson A., Biotechnologies in developing countries present and future, UNESCO Publishers, 1993
9. Singh K., Intellectual Property Rights on Biotechnology, BCIL, New Delhi.
10. Ganguli, P. (2001). Intellectual property rights: Unleashing the knowledge economy. New Delhi: Tata McGraw-Hill Pub.
11. Senthil Kumar Sadasivam and Mohammed Jaabir M. S. (2008). IPR, Biosafety and Biotechnology Management, Jasen Publications, India.