BIOETHICS, BIO SAFETY AND INTELLECTUAL PROPERTY RIGHTS syllabus, JNTU (2007-2008)

UNIT I: BIOETHICS

Introduction to Bioethics. Social and ethical issues in Biotechnology

UNIT II: BIOSAFETY I

Definition of Biosafety. Biosafety for human health and environment. Social and ethical issues.

UNIT III: BIOSAFETY II

Use of genetically modified organisms and their release in to the environment. Special procedures for r-DNA based products

UNIT IV: REGULATORY AFFAIRS

Regulatory requirements for drugs and Biologics. GLP. GMP

UNIT V: INTELLECTUAL PROPERTY RIGHTS I

Intellectual property rights, and Intellectual Property protection, patents and methods of application of patents,

UNIT VI: INTELLECTUAL PROPERTY RIGHTS II

Trade Secrets copyrights, Trade Marks, legal implications, farmers rights, plant breeder’s rights.

UNIT VII: INTELLECTUAL PROPERTY RIGHTS III

International and National conventions on biotechnology and related areas.

UNIT VIII

WTO guidelines

TEXT BOOKS:

1. Sasson A, Biotechnologies and Development, UNESCO Publications, 1988.

2. Sasson A. Biotechnologies in developing countries present and future,

UNESCO publishers, 1993.

REFERENCE:

1. Singh K. Intellectual Property Rights on Biotechnology, BCll, New Delhi.