INTELLECTUAL PROPERTY RIGHTS, BIOSAFETY AND BIOETHICS

Paper Code: 
24VBTE501
Credits: 
02
Contact Hours: 
30
Objective: 

This course will enable the students to understand ethical perspectives and moral obligations related to biotechnology. It also imparts knowledge on intellectual property and its legalities. The objective of this course is to create awareness on legal rights, responsibilities, regulatory affairs and ethical standpoint of intellectual assets in the field of biological research and gain Knowledge of working principles in a laboratory taking all safety measures, handling of live cultures, disposal of infectious material.

 

6.00
Unit I: 
Introduction to IPR

Introduction to intellectual property; types of IP: patents, trademarks, copyright & related rights, industrial design, traditional knowledge, geographical indications.

 

 

6.00
Unit II: 
Patenting

Basics of patents: types of patents; Indian Patent Act 1970; WIPO Treaties; Budapest Treaty; Patent Cooperation Treaty (PCT); filing of a patent application; fee structure, time frames; types of patent applications.

 

6.00
Unit III: 
Biosafety

Biosafety and Biosecurity - introduction to biological safety cabinets; primary containment for biohazards; biosafety levels; recommended biosafety levels for infectious agents and infected animals

6.00
Unit IV: 
National and international regulations

International regulations – Cartagena protocol, OECD consensus documents and Codex Alimentarius; Indian regulations – EPA act and rules, guidance documents, regulatory framework – RCGM, GEAC, IBSC.

 

6.00
Unit V: 
Bioethics

Introduction; bioethics in health care; Bioethics in research; Bioethics in Agricultural biotechnology.

 

 

ESSENTIAL READINGS: 

●      Ganguli, P. (2001). Intellectual Property Rights: Unleashing the Knowledge Economy. New Delhi: Tata McGraw-Hill Pub.

●      National IPR Policy, Department of Industrial Policy & Promotion, Ministry of Commerce, GoI Complete Reference to Intellectual Property Rights Laws. (2007). Snow White Publication Oct.

●      Kuhse, H. (2010). Bioethics: an Anthology. Malden, MA: Blackwell.

●      Office of the Controller General of Patents, Design & Trademarks; Department of Industrial Policy & Promotion; Ministry of Commerce & Industry; Government of India. http://www.ipindia.nic.in/

●      Karen F. Greif and Jon F. Merz, Current Controversies in the Biological Sciences -Case Studies of Policy Challenges from New Technologies, MIT Press

Recombinant DNA Safety Guidelines, 1990 Department of Biotechnology, Ministry of Science and Technology, Govt. of India

REFERENCES: 
  • Wolt, J. D., Keese, P., Raybould, A., Fitzpatrick, J. W., Burachik, M., Gray, A., Wu,
  • F. (2009). Problem Formulation in the Environmental Risk Assessment for Genetically Modified Plants. Transgenic Research, 19(3), 425-436. doi:10.1007/s11248-009-9321-9
  • Craig, W., Tepfer, M., Degrassi, G., & Ripandelli, D. (2008). An Overview of General
  • Features of Risk Assessments of Genetically Modified Crops. Euphytica, 164(3), 853-880. doi:10.1007/s10681-007-9643-8
  • Guidelines for Safety Assessment of Foods Derived from Genetically Engineered Plants. 2008.

 

 

Academic Year: 
2024-2025
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