SEM: VI (BT)

L: 03

SUBJECT: IPR BIOETHICS & BIOSAFETY

P: 00

T: 01

COURSE OBJECTIVES:

To have a view at the laws governing biotechnology and IPR, related at national and international
level

To gain knowledge about safety precautions necessary during biotechnological work

To evaluate the ethical perspective of handling biomaterials

COURSE OUTCOMES:

To be aware of rules and regulations setup at international level for various biotechnology related
work so that any further research can be formulated accordingly

To know the social and legal state of the society with respect to genetically engineered products
or other outcomes of biotechnology

Work according to the safety precautions set up by international bodies while handling bio hazardous material
REFERENCES:
Reference Books
1. IPR, Biosafety and Bioethics by Deepa Goel and Shomini Parasha
2. Intellectual property rights by Dr. Reddy
SESSION PLAN
Lecture No.

1. Introduction of IPR

Learning Objectives
The Students will be able to -

Unit

Define IPR and the different

parameters that come under IPR

RL

Describe different types of

Intellectual Property rights and
there subtypes which help in
categorizing the types.

UD

Describe the different types of

patents.

UD

Explain the different copyright laws

and governing body approvals for
various copyrights.

AN

Explain about the different

trademarks used by companies and
how geographical indication allows
the usage of these trademarks.

UD

Describe different IPR infringement

or breach and the effect of those
with a simple case study.

UD

State various laws used to govern

the issuing of the approvals of
copyright patent and trademarks.

AN

Explain how the registration of

designs and plant acts are
implemented and the geographical
variations.

AP

Enlist various International

conventions used in IPR and
Bioethics.

RL

Describe the different conventions

under the Berne conventions
protecting the rights of artist and
the GATT agreement which covers
the International trade and the
policies covered under it.

AN

2. International Scenario

10

CL

AN

AP

AN
AP

Topics Planned

Introduction to Intellectual Property Concept of Intellectual

Property Trademarks, Geographical Indication. Infringement of
IPR.
Its protection and Remedies Licensing and its Types
Kinds of Intellectual Property
1. patents
2. industrial designs
3. trade secrets
Kinds of Intellectual Property
Patents
4. confidential information
5. layout-designs of integrated circuits
Copyrights expression of ideas
2. copyright law
3. Copyright protection
4. copyright non protection
Designs Registered Design
2. Unregistered designs
Trademarks & Geographical Indication
i. Trademark Classification
ii. Trademark Symbols
iii. Other marks
B. Geographical Indication Protection of Geographical
Indication
ii. Rights and Remedies
Infringement of IPR
i. piracy
ii. Trademark Infringement
iii. Registered Design Infringement
Its protection and Remedies Licensing and its Types
i. IPOS Act
ii. Copyright Act
iii. Patent Act
iv. Trademark acts
v. Registered Designs
vi. Plant varieties act
vii. Geographical Designs Act

International Scenario Introduction to the leading international

instruments concerning intellectual property rights.

AN

AP

The Berne Convention

i. Artistic and literal material
ii. Multilateral convention
iii. term of protection
iv. Limitations & regulation
GATT general agreement of tariff and trade

D
Con

i. International trade goods

Association of GATT & WTO for the categorization of goods
11

12

13

14

15

3. Patents

16

17

18

19

20

21

22

4. IPR and Biotechnology

23

24

Enlist INDIAN Patent act and what

were the changes and other acts that
were introduced in the Indian
Industry

RL

Analyze the Universal copy right

protection act and the Paris
convention in protecting rights for
industrial property.

AN

Enlist Trade related specificities on

a global platform and the treaties
related to it.

RL

Explain the role of WIPO for the

grants of patents and how it
monitors local bodies on the same.

AN

Enlist the Budapest treaty and

disclosure discussed for a uniform
international deposit system.

AN

Describe the safeguard deposit

policies and the actual meaning of
the term microorganisms in regards
to the treaty.

UD

Enlist the steps in patents would be

issued seeing the various parts of
the new innovation.

AN

Discuss about the prior pending

patent applications when a new
patent is applied from a common
source.

AP

List the particular areas coming

under patentable and non patentable
category and how it varies from
country to country.

RL

Explain how a researcher can apply

for a patent and the legal aspects
he/she needs to look for while
applying.

UD

Describe the various patent

infringement cases with any case
study.

UN

List how the Biological

patentability works and to which
molecules come under this
category.

RL

Explain correlation of IPR and

biotechnology with the
International bodies scenario.

AN

Describe the farmer and plant

breeder rights for conservation of
pure plant varieties.

UD

AN

AP

AN

Indian Patent Act

Establishment of Act 1970 and amendments.
Rules and regulations
i. For Copyright
ii. for Patents
Universal Copyright Convention
i. Contracting state
ii. Articles I - XVII
The Paris Convention Protection for Industrial property
TRIPS Trade-Related Aspects of Intellectual Property Rights
i. SPECIFIC ISSUES
ii. geographical indication & health
iii. Anel Draft
The World Intellectual Property Rights Organization (WIPO)
Governing body it Implications and rules and regulations.

AP

AP

AN

AP

EV

AN

AP
CR

AN

EV

Budapest treaty Deposit of Microorganisms for the Purposes of

Patent Procedure
i. Disclosure and the Requirement for Deposit
ii. Need for a Uniform International Deposit System
b. International Depositary Authorities and Recognition of Single
Deposit
ii. Deposit and Furnishing of Samples
iii. Safeguard of Deposits
iv. Meaning of the Term Microorganism
Patents - Requirement of patentable novelty
i. Ideas
ii. Research
iii. Technological Advancement with some Inventive Step.
Prior art Pending Patent Applications
i. Novelty
ii. Validity
iii. Clearance
Classifying products as patentable and non-patentable
i. Business method patents
ii. Software patents

Procedure for applying for patent

i. True and first inventor
ii. True and first inventors assignee
iii. Legal representative of deceased true and first inventor or
his/her assignee
Patent Infringement and related case studies
i. Apple vs. Samsung
ii. Novartis pharma vs. Union of India
Biological Patentability
i. plant products
ii. molecules
iii. Drug Patents
IPR and Biotechnology - Congress of the United States, Office of
Technology Assessment, 1990.

AP

EV

Farmers Rights and Plant breeders

rights new varieties of plants
ii. Conserving improving and providing new plant varieties

AP
25

26

Analyze the Biodiversity act and

which all areas it covers.

AN

Describe Biopiracy and how

Biopiracy has led to lot of
infringement.

RL

Biodiversity - Biodiversity Act

Policies implemented by the Act

AP

UD

Biopiracy Reproduce without permission for own benefit

causing Copyright infringement.
ii. unfair free-riding on genetic resources
iii. Unauthorized and uncompensated collection for commercial
ends of genetic resources and/or traditional knowledge.

27

5. Biosafety

28

29

30

31

6. Bioethics

32

33

34

35

36

Bioprospecting Discovery and commercialization of new

products
ii. Indigenous knowledge of Bioactive compounds
iii. Maya ICBG controversy

Enlist prospects of new products

and the knowledge of bioactive
compounds with the famous ICBG
controversy.

AN

Explain the various Biosafety

measure taken to prevent the
contaminants and the famous
Cartagena protocol on Biosafety.

AN

List the different biological safety

cabinets and the risk assessment
methods and ICGEB convention.

RL

List the safety issues concerned

with the use of GMO and LMO and
the risks associated with the use of
these products.

RL

Enlist the various policies of

RCGM and GEAC for the approval
of GMO.

RL
AP

Introduction to Biological Safety Cabinets - Primary Containment

for Biohazards
i. Class III Biosafety cabinet
ii. Class I, II, III, IV Biosafety Level.
iii. Risk Assessment and Groups
iv. ICGEB Convention and acts
Biosafety Levels GMOs Gene patenting
ii.. Bioethical practices related to GMO
iii. Biosafety in Microbiology and Biomedical Laboratory
LMOs Living Modified Organisms
i. Convention on Biological Diversity
ii. Risk assessment of LMO
B. Their environmental impact AIA Agreement
ii. LMOs FFP
Roles of Institutional Biosafety Committee
i. RCGM Rules
ii. GEAC Rules

Enlist the risk associated with the

use of GMO in the food and
agriculture industry.

RL

For GMO applications in food and agriculture

i. Risk analysis assessment and management

Describe Bioethical issues related

to the healthcare food and medicine
Industry.

UD

Explain concerns on the use of

GMO and the commercially
approved GMO crops in the market.

AN

Describe Bioethical issues related

to HUMAN Genome Project.

UD

Explain the effects of Genetically

modified crops on environment and
Human Health

AN

AP

EV
AP

AP

UD
AP

Biosafety - Good Lab Practices

i. ICH guidelines for lab practices
ii. GMP
iii. GLP
iv. Cartagena Protocol on Biosafety

AP
Bioethics - Bioethical issues related to Healthcare
ii. Bioethical issues in medicine, Food & agriculture

AN

AP

Genetic engineering GMO

i. Concerns related to GE foods
ii. Products approved commercially in the market
The Human Genome Project

AP

AP

Genetic Testing Environmental problems Hazards caused by the

Introduction of Genetically Engineered crops producing effects on
Soil and Human Health