2. Flow of Presentation
What are IPRs ?
Why are IPRs important ?
Mechanisms
IPR vs. Regulatory affairs
How are IPRs practically useful for Pharma
students and Researchers?
IPR related treaties.
References
2
3. What are IPRs ?
IPRs stands for “Intellectual Property Rights”.
IPRs are LEGAL rights which are granted to a
person for CREATIONS of the mind or intellect
which have COMMERCIAL VALUE.
The effort in composing a song or directing a
movie is quite different from the developing a
new molecule for therapeutic use or improved
process for manufacturing of a drug . Since
creations of mind differ too much, its not
possible to have only one mechanism to
protect all creations of the MIND.
3
4. Hence ,there are eight well defined mechanisms
to protect creations of the mind
1. Patents
2. Copyrights
3. Trademarks
4. Industrial designs
5. Layout designs of integrated circuits
6. Geographical indications
7. Registration of plants varieties
8. Trade secretes
4
5. Why the word ‘Property’ is used in case of
intellectual property ?
The property is normally associated with
physical objects . On other hand ,there is no
physical object ,when we talk about intellectual
property still the word property is used because
just like conventional property like car ,house
etc , IP also has COMMERTIAL VALUE and
can be Bought and Sold. Hence the word
property is used in case of IP.
IP is intangible i.e., it can be neither seen nor
felt.
5
7. Why are intellectual property rights
important?
The fundamental concept behind all the forms of
intellectual property rights is that THE PERSON
WHO HAS PUT IN ORIGINAL EFFORT ,MUST
BE REWARDED.
This is to encourage INNOVATION and
CREATIVITY ,so that society can prosper and
progress.
If there are no mechanisms to protect and reward
original effort and creativity ,then nobody would
make any effort and society would be the ultimate
loser.
7
8. Illustration:
i. You put in lot of hard work and effort and come
up with a very good invention the moment you
discuss it with someone ,its copied .You can
neither prevent it nor get any credit for all your
hard work . Will you be motivated to come up
with new inventions?
ii. You spend years writing a laboratory manual
.When it is ready, somebody just publishes it and
take all the profit. Will you be motivated to put in
effort again ?
Hence its important that adequate legal
mechanisms are in place to reward original
8
10. IP Laws of India
Act Ministry/Department
The Copyright Act, 1957 Higher Education
The Patents Act, 1970 Industrial Policy & Promotion
The Designs Act, 2000 Industrial Policy & Promotion
The Trade Marks Act, 1999 Industrial Policy & Promotion
The Geographical Indications of Goods (Registration
and Protection) Act, 1999
Industrial Policy & Promotion
The Semiconductor Integrated Circuits Layout-
Design Act, 2000
Information Technology
The Protection of Plant Varieties and Farmers’ Rights
Act, 2001
Agriculture and Cooperation
10
11. PATENTS:
A patent is an exclusive right granted by the
government to the original
inventor/developer/researchers of invention, which
prohibits others from making, using, selling,
importing the claimed invention for a specific period.
11
12. INDIAN PATENT LAW
HISTORICAL DEVELOPMENT
The Act of 1856 based on UK Act Of 1852 -But
withdrawn
The Act of 1859,
The Patterns & Designs Protection Act, of 1872
The Protection of Invention Act, of 1883
The Invention & Designs Act of 1888- Further
Consolidation
The Patents & Designs Act 1911
The Patents Act 1970
This Act has been amended in 1999,2002 and
2005
There are four patent offices in India
Kolkata(Head office), Mumbai, Chennai, Delhi
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13. Patentability
For patentability ,an invention must satisfy
three basic criteria.
Novelty :Must be new and not known
Inventive Step: Non obvious. Must involve
some effort on part of inventor
Industrial application.
If any one is missing, invention will not be
patentable. e.g.: If you mix two formulation to
get new formulation the same will not be
patentable because novelty criteria satisfied
but inventive step is missing . Similarly if you
find a plant which can cure cancer you cannot
13
Novelty
Inventive
Industrial application
14. PROCESS PATENT PRODUCT PATENT CROSS
LICENCING
Exclusive right
is granted only
to the method
or ‘method of
manufacturing
’ and not to the
product
<2005
‘To make,
use, sell or
distribute
such a
product’ in
the country
which grants
the patent.
>2005
Prevents a
person in
commercially
utilizing the
process without
the consent of
original patent
holder.
Alternate
process
developed is
very efficient
and the
product is very
useful having
commercial
value(joint
agreement)
1972
1999
2002
2005
14
15. What is patentable ?
Invention
Products (API, Intermediates, Polymorphs
etc)
Machines
Composition of matter
(e.g. pharmaceuticals)
Processes
(Chemical, mechanical)
Designs
15
17. TRADITIONAL
KNOWLEDGE OR
WHICH IS AN
AGGREGATION OF
KNOWN OR
DUPLICATION OF
KNOWN PROPERTIES
CHANGING THE
APPEARANCE OF
HUMAN BODY using
COSMETICS
ATOMIC
ENERGY,RADIO
ACTIVE
SUBSTANCES,MININ
G , EXTRACTTION.
17
THE MERE DISCOVERY OF A NEW USE,NEW PROPERTY OR NEW
PROCESS OR NEW USE OF A MACHINE OR NEW PROCESS
UNTILL SUCH PROCESS LEADS TO NEW PRODUCT OR
EMPLOYS ATLEAST ONE REACTANT.(NEW USE OF A
TURMERIC, NEW USE OF ASPIRIN)
18. How long does it take to get a
patent ?
By Normal route : 30 months (2.5 years)
Application is filled and published after 18
months in journal of patent office.
After that examination is requested by applying fee
and completed within 12 months . Some times it
will take 24 months to get a patent.
By Fast route:12-15 months approximately.
Early publication is requested within 3-4 months and
examination may be completed in 6-12 months.
TERM OF PATENT: 20 YEARS
18
19. Copyrights
Copyrights are a set of exclusive rights granted
by law to the creators and producers of forms
of creative expressions such as literary,
musical and cinematographic works.
The best forms of copyrights are authored or
edited books and audio or video cassettes
,which cannot be produced without the
permission of the person.
19
20. What are the subject matters
covered under the copyright Act?
Literary work RIGHTS COVERED UNDER
COPYRIGHT
Dramatic & Musical Work
Artistic Work
Cinematograph film
Sound recordings
Computer softwares
20
RIGHTSOF
TRANSLATION
RIGHTSOF
PERFORMANCE
RIGHTSOF
REPRODUCTION
MOTIONPICTURE
RIGHTS
BROADCASTING
RIGHTS
21. What is the tenure of the
copyright ?
The tenure of the copyright is the life of the author /
artist + 50 years after death.
Broadcasting =25 years
Fee: Rs.50/-for literary, dramatic or musical and
artistic works.
Registration : Registrar of copyright , New Delhi.
Who is the first owner of the copyright ?
Author of the work
Artist of the Artistic Work
In case of cinematograph film and sound
recordings the Producer is the First owner.
21
22. Trademark
A Trademark is word or a symbol adopted and
used by a manufacturer or a merchant to
identify his goods and distinguish them those
manufactured or sold by others.
Biotechnological vectors, laboratory
equipments and devices and pharmaceutical
products bears a trademark which identify a
company making/marketing it.
22
24. Benefits:
Trademarks are a vital and quickly recognized
symbols of corporations and their products.
Enhance the market value of a product
bearing a trademark.
Basic purpose is to identify goods as belonging
to a particular manufacturer so that he gets the
benefit of maintaining a particular level of
excellence.
Term : Initial protection period is 10 years and
renewed
Fee : Rs.2500/- to registrar of trademark
,Bombay (HO), Kolkata.
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25. Industrial Designs
Industrial Designs refer to specific shape,
configuration, surface, Pattern or combination
thereof which produce an aesthetic impression of
the article.
The aesthetic considerations which constitute
coverage of industrial designs
e.g:1.Design of a ball pen, consisting of particular
color and body shape
2. Design of particular bottle used
for packaging a
pharmaceutical product.
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29. Benefits
1.Prevent unauthorized copy of an original
design. On account of better aesthetic ,the
design may lead to enhanced commercial
value of a product.
2.Protection period is sufficiently long ten years
and can be renewed for another five years by
payment of fee.
Precaution
Ensure registration before disclosure in any
form
Term: Maximum term is 15 years
29
Design act,1911. Industrial design act,2000. w.e.f. 11-5-2001
30. Layout Design Of Integrated
Circuits
Def: Layout design for integrated circuits refer to
the specific manner in which transistors and other
circuitry elements of an integrated circuits are
laid out in a semiconductor IC and includes lead
wires connecting such elements.
The act of protection of the layout design of
integrated circuits came into force on 4th sep
2000 and called the SICLD act,2000.
The administration/ dept for implementation in
India is Department of communication and
information technology ,government of India.
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31. Benefits:
Protection of effort and investment in design
and improvement of circuits.
Recognition of original effort.
Term:10 years from date of filing or known date
of commercialization whichever is earlier.
Registration : By making an application to
Registrar, SICLD, New Delhi , India.
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32. Geographical Indications
Geographical indications of goods are defined
as that aspect of intellectual property which
relate goods or products originating from a
particular region situated in a particular
country.
They are used to identify three categories of
goods- agricultural, natural or manufactured.
E.g.: Nagpur oranges, Basmati rice, Darjeeling
tea
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33. Benefits:
It confers legal protection to goods produced in
a particular region
Enhance commercial value and increases
market visibility for the product
Prevent unauthorized use of a registered
geographical indication by others
Promotes economic prosperity of producers of
goods from a particular geographical territory.
Term: 10 years validity for one time
registration
33
Registrar of
geographic
al
indications
Chennai
===
34. Plant breeder’s right
These are legal rights granted by the govt for
protection of plant varieties, rights of farmers
and plant breeders.
Protection of the plant varieties in India is
covered under The Plant Varieties And
Farmers Right Bill 1999 which got status of act
in 2001.
Benefits: Promote the greater biodiversity.
Term:15 years for annual crop ,18 years for
trees.
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Distinctiveness
Uniformity
Stability
Novelty
35. Trade Secret
Trade secret refer to proprietary information having
commercial application and value.
Formulas, patterns, methods, programs,
techniques, processes or compilation of
information. E.g. : Coca cola and soft drinks
formulae, Microbial technologies are protected as
undisclosed information or trade secret.
Benefits: No fee, no expiry ,monopoly for almost
unlimited period.
Precautions: Ensure back up by proper
documentation (Confidentiality).
A common law used in the protection of trade
secrets is NDA(NON DISCLOSURE AGREEMENT)
OR A CDA(CONFIDENTIALITY AGREEMENT)
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ONLY 5
PERSONS IN THE
WORLD ARE
SAID TO KNOW
THE FORMULA
WHICH HAS
BEEN KEPT IN
ATLANTA,GEORG
IA
36. IPRs Vs Regulatory issues
IPRs: IPRs are legal rights associated with
property which is of intellectual nature i.e.
thoughts and ideas.
Regulatory issues: These are legal regulations
associated with manufacturing and which are
enforced by the government to ensure the safety
and quality of pharmaceutical products.
IPRs focus on encouraging innovations and new
developments , Regulatory issues deal primarily
with ensuring safety and quality of pharmaceutical
products.
36
37. Significance of IPRs for
Researchers
Prevent duplication of work
E.g.: PhD project failures.
Help researchers to focus on commercially
relevant research
E.g.: To make research project become
industry favorite.
Help in revenue generation
Help in identification of career opportunities
Stimulate creativity
37
39. References
IPR Handbook for pharma students and
researchers by Parikshit Bansal,P.no:1-45
IPRs and Development in India , Pharma Times,
Vol 44-No 07_July 2012,P.no:19-22.
The theory and Practice of Industrial Pharmacy,
Drug regulatory Affairs, Page no: 874 to 880.
www.wipo.int
www.ipindia.nic.in
www.patentdocs.org
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