INTELLECTUAL PROPERTY RIGHTS (CUTM2003)

Teacher

Rasmita Jena

Category

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Course Name :INTELLECTUAL PROPERTY RIGHTS 

 

Code(Credit) : CUTM2003(4-0-0)

Course Objectives

This course is designed to impart skilled knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs.

CO PO mapping

CO PO mapping:

CO Statements PO MAPPING
CO-1 Student gets basic skill on gross morphology, structure and functions of various organs of the human body. PO1, PO11
CO-2 Describe the various homeostatic mechanisms and their imbalances. PO1, PO11
CO-3 Identify the various tissues and organs of different systems of human body. PO1, PO11
CO-4 Perform the various experiments related to special senses and nervous system. PO8, PO11
CO-5 Appreciate coordinated working pattern of different organs of each system. PO1, PO11

Learning Outcomes

This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs

Course Syllabus

MODULE-I

1. Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search. Parts of patents. Filling of patents. The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent.

MODULE-II
2 . Role of GATT, TRIPS, and WIPO

MODULE-III
3. Brief introduction to Trademark protection and WHO Patents. IPR’s and its types, Major bodies regulating Indian Pharmaceutical sector.

MODULE-IV
4. Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA

MODULE-V
5. Regulatory requirements for contract research organization. Regulations for Biosimilars.

Session Plan

Session 1

Definition, Need for patenting, Types of Patents

PATENT (1)

Session 2

Conditions to  be satisfied by an invention to be patentable

PDF-PATENT (1)

Session 3

Introduction to patent search. Parts of patents

PDF-PATENT SEARCH

Session 4

Filling of patents. The essential elements of patent

PDF-FILING OF PATENTS

Session 5

Guidelines for preparation of laboratory note book

PDF-LAB NOTE BOOK

Session 6

Non-obviousness in Patent.

PDF-NON-OBVIOUSNESS IN PATENT PROCESSING

Session 7

Role of GATT

PDF-GATT

Session 8

Role of TRIPS

PDF-TRIPS

Session 9

Role of WIPO

PDF-WIPO

Session 10

Brief introduction to Trademark protection 

PDF-trade mark

Session 11

WHO Patents.

PDF-PATENT (1)

Session 12

IPR’s and its types

PDF-IPR AND ITS TYPES

Session 13

Types of IPR

PDF-IPR AND ITS TYPES

Session 14

Major bodies regulating Indian Pharmaceutical sector.

PDF-Major regulating bodies

Session 15

Brief introduction to CDSCO

PDF-USFDA

Session 16

Introduction to WHO

PDF- WHO

Session 17

Brief introduction to USFDA

PDF-USFDA

Session 18

Brief introduction to EMEA

EMEA (1)

Session 19

Brief introduction to TGA

PDF-TGA

Session 20

Brief introduction to MHRA

PDF-MHRA

Session 21

Brief introduction to MCC

PDF-MCC

Session 22

Brief introduction to ANVISA

PDF-ANVISA

Session 23

Regulatory requirements for contract research organization.

PDF-regulatory requirement for contract research organization

Session 24

Regulatory requirements for contract research organization.

PDF-regulatory requirement for contract research organization

Session 25

Regulations for Biosimilars.

PDF-regulations for biosimilar

Recommended Books

1. Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol 57, 2nd Edition
2. Applied Production and Operation Management By Evans, Anderson and Williams
3. GMP for pharmaceuticals Material Management by K.K. Ahuja Published by CBS publishers
4. ISO 9000-Norms and explanations
5. GMP for pharmaceuticals- Willing S.H. Marcel and Dekker

Our Main Teachers

Rasmita Jena

Assistant Professor
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