INTELLECTUAL PROPERTY RIGHTS, BIOSAFETY AND BIOETHICS (Value Added Course)

Paper Code: 
VMBL 501
Credits: 
02
Contact Hours: 
30
Objective: 

Course Outcomes (COs):

Course Outcomes

Learning and teaching strategies

Assessment Strategies

Upon completion of the course the learner will:

CO 142: Identify different attributes of intellectual property rights and their implications in biological research and product development

CO 143: Understand the rationale for and against IPR and especially patents.

CO 144: Evaluate different types of intellectual property rights in general and protection of products derived from biotechnology research and issues related to application and obtaining patents

CO 145: Develop biosafety and plan risk assessment of products derived from recombinant DNA research and environmental release of genetically modified organisms.

CO 146: Defend and modify ethical aspects related to biological, biomedical, health care and biotechnology research

Class lectures

Seminars

Tutorials

Group discussions and Workshops

Question preparation

 

Class test, Semester end examinations, Quiz, Solving problems in tutorials, Assignments, Presentation, Individual and group projects

 

 

 

 

 

 

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: 

SUGGESTED READINGS:

  • 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.

 

e RESOURCES:

 

JOURNALS:

  • Journal of Intellectual Property Rights.
  • Indian Journal of Traditional Knowledge
  • Journal of Biosafety and Biosecurity

 

 

Academic Year: 
2023-2024
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