Course Objectives

• To introduce the biosafety regulations and ethical concepts in biotechnology
• To emphasize on IPR issues and need for knowledge in patents in biotechnology

Learning Outcomes

1.Interpret the basics of biosafety and bioethics and its impact on all the biological sciences and the quality of human life

2.Recognize the importance of biosafety practices and guidelines in research

3.Comprehend the benefits of GM technology and related issues

4. Recognize the importance of protection of new knowledge and innovations and its role in business

Course Syllabus

 Module I: Introduction to Intellectual  Property (6hrs)

Historical perspectives and need for the introduction of Intellectual Property RightTypes of IP: Patents, Trademarks, Copyright & RelatedRights, Industrial Design, Traditional Knowledge, Geographical Indications, Protection of GMOs IP as a factor in R&D.

Practice: Assessment of risk during laboratory research

 Module II: Agreements and Treaties (5hrs)

History of GATT & TRIPS Agreement; Madrid Agreement; Hague Agreement; WIPO Treaties; Budapest Treaty; PCT; Indian Patent Act 1970 & recent amendments.

Practice: Risk Assessment of Biotechnology Products

  Module III: Basics of Patents (6hrs)

Fundamentals of patents, copyrights, geographical indications, Types of patent applications: Ordinary, PCT, Conventional, Divisional and Patent of Addition; Specifications:Provisional and complete; designs and layout, trade secrets and traditional knowledge, trademarks, protection of plant varieties and farmers’ rights and biodiversity protection.

Practice: Biosafety During Industrial Production

Module IV: Patent filing procedures (6hrs)

National & PCT filing procedure; Time frame and cost; Status of the patent applications filed; Precautions while patenting–disclosure/non-disclosure; financial assistance for patenting-introduction to existing schemes, Patent licensing and agreement Patent infringement- meaning, scope, litigation

Practice: Protection of Biotechnological Inventions

Module V Biosafety(6hrs)

Introduction; Historical Background; Introduction to Biological Safety Cabinets; Primary Containment for Biohazards; Biosafety Levels; Biosafety Levels of Specific Microorganisms; Recommended Biosafety Levels for Infectious Agents and Infected Animals;

Practice: Planned Introduction of GMOs

Module VI :Biosafety guideline( 6hrs)

Government of India; Definition of GMOs & LMOs; Roles of Institutional Biosafety Committee, RCGM, GEAC etc. for GMO applications in food and agriculture; Environmental release of GMOs; Risk Analysis; Risk Assessment; Risk management and communication; Overview of National Regulations and relevant International Agreements including; Cartegana Protocol.

Practice: Patenting of Genes and DNA sequences

Module VII:Bioethics(5hrs)

Ethical implications of biotechnological products and techniques. Social and ethical implications of biological weapons.

Text Books:

1. Deepa GoelShomini Parashar,IPR, Biosafety and Bioethics,Pearson Education India
2. Kankanala C., Genetic Patent Law & Strategy, 1st Edition, Manupatra Information Solution Pvt. Ltd

Reference Books:

1. S Chawla,Introduction to Plant Biotechnology oxford and ibh publishing,third edition

     2 Neeraj Pandey and Khushdeep Dharni ,“Intellectual Property Rights” ; 1 edition PHI Learning

Session Plan

Session 1

Historical perspectives and need for the introduction of Intellectual Property Right

Intellectual Property rights 

Session 2

Types of IP: Patents, Trademarks, Copyright & RelatedRights, Industrial Design
Types of intellectual property

Session 3

Traditional Knowledge, Geographical Indications,
traditional knowledge
Geographical indication

Session 4

Protection of GMOs IP as a factor in R&D;
GMOs 

Session 5(Practice)

Assessment of risk during laboratory research

risk assessment

Session 6

History of GATT & TRIPS Agreement
GATT

Session 7

Madrid Agreement; Hague Agreement
Madrid Protocol

Hargaue agreement 

Session 8(Project)

The role of IPR in the protection of Biodiversity in international overview.

Session 9

WIPO Treaties; Budapest Treaty; PCT;

WIPO
budapest treaty
PCT

Session 10

Indian Patent Act 1970 & recent amendments

patent act

Plant variety and farmers right act

Session 11 (Practice)

Risk Assessment of Biotechnology Products

biotechnology risk assesment

Session 12

Fundamentals of patents, copyrights, geographical indications

patent,GI
patent,copyright

Session 13

Types of patent applications: Ordinary, PCT, Conventional, Divisional and Patent of Addition; Specification

patent application

filing of patent in india

Session 14(Project)

Biotechnology patents and the problem of non-obviousness, a global perspective

Session 15

trade secrets and traditional knowledge, trademarks

trade marks
trade mark
trade secrets

Session 16

protection of plant varieties and farmers’ rights and biodiversity protection

ppv

Plant variety and farmers right act

Session 17

protection of plant varieties and farmers’ rights and biodiversity protection

PPV

Session 18(Practice)

Biosafety During Industrial Productioni

Biosafety 

Session 19

National & PCT filing procedure; Time frame and cost;

patent filling

filing of patent in india

Session 20

Status of the patent applications filed; Precautions while patenting–disclosure/non-disclosure

Status of the patent applications filed;

Session 21(Project)

Biotechnology patenting, difference between USA and Indian Perspective.

Session 22

financial assistance for patenting-introduction to existing schemes,

Session 23

Patent licensing and agreement

patent liscencing

Session 24(Project)

The role of IPR in protection of Biodiversity.

Session 25

Patent infringement- meaning, scope, litigation

Patent infringement

Session 26

Biosafety Levels of Specific Microorganisms;

biosafety levels

Session 27

Primary Containment for Biohazards; Biosafety Levels;

containment

Biological safety

Session 28(Project)

Traditional knowledge and patent issues: with reference to Basmati, Neem, Turmeric, and Golden rice.

Session 29

Historical Backround; Introduction to Biological Safety Cabinets

Biosafety cabinet

Session 30

Recommended Biosafety Levels for Infectious Agents and Infected Animals;

Biosafety from microorganism

Session 32(Project)

Black Biology-A threat to Biosafety and Biodefense

Session 33

Definition of GMOs & LMOs

GMO and LMO

Session 34

Roles of Institutional Biosafety Committee, RCGM, GEAC

GEAC IBCs

Session 35

GMO applications in food and agriculture

GMOs in agriculture

Session 36

Environmental release of GMOs

Enviromental issues

Session 37(Project)

Biosafety for global Society

Session 38

Risk Analysis; Risk Assessment; Risk management and communication;

Risk assesment

Session 39

Overview of National Regulations and relevant International Agreements including; Cartegana Protocol.

cartagena Protocol

Session 40(Project)

understanding Environmental risk assessment of GMO- The importance regulation and monitoring

Session 41

Ethical implications of biotechnological products and techniques

Ethical issues

Session 42

Social and ethical implications of biological weapons.

Bioweapons

Session 43(Project)

The involvement of nano-drug delivery in biosafety issues

Case Studies

Case Studies