INTELLECTUAL PROPERTY RIGHTS

Presented by C.Pradeep Kumar (M.Pharm)

M Pharmacy 2nd SemesterDepartment Of Pharmaceutics, UCPSc, Warangal.

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

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.

4

Hence ,there are eight well defined mechanisms to protect creations of the mind

1. Patents2. Copyrights3. Trademarks4. Industrial designs 5. Layout designs of integrated circuits6. Geographical indications7. Registration of plants varieties8. Trade secretes

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.

6

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.

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 thinkers and innovators and prevent unauthorized duplication.

9

Mechanisms For Intellectual Property Protection

1. Patents2. Copyrights3. Trademarks4. Industrial designs 5. Layout designs of integrated circuits6. Geographical indications7. Registration of plants varieties8. Trade secretes

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.

12

INDIAN PATENT LAWHISTORICAL 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

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 patent it.

Novelty Inventive

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)

1972199920022005

15

What is patentable ? Invention Products (API, Intermediates, Polymorphs etc) Machines Composition of matter (e.g. pharmaceuticals) Processes (Chemical, mechanical) Designs

16

FRIVOLOUS

INVENTIONS

CONTRARY TO

NATURAL LAWS

MERE DISCOVERY OF A SCIENTIFIC PRINCIPLE OR FORMULATION

OF AN ABSTRACT THEORY

METHOD OF AGRICULTURE

OR HORTICULTUR

ESURGERY

OPERATION TREATMENT

16

What is not patentable?

17

TRADITIONAL KNOWLEDGE OR

WHICH IS AN AGGREGATION OF

KNOWN OR DUPLICATION OF

KNOWN PROPERTIES

CHANGING THE APPEARANCE OF

HUMAN BODY usingCOSMETICS

ATOMIC ENERGY,RADIO

ACTIVE SUBSTANCES,MINING , EXTRACTTION.

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

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.

COPY RIGHT

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

RIGHTSOF TRANSLATION

RIGHTSOF PERFORMANCE

RIGHTSOF REPRODUCTION

MOTIONPICTURE RIGHTSBROADCASTING 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 yearsFee: 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.

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.

23

Trade marks

Name

Logotype

Symbol

Slogan

Shape

Color

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.

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.

26

Consumer Products

27

Pharmaceutical Product

28

Textile & Jewellery

29

Benefits1.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 formTerm: Maximum term is 15 years

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.

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.

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

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

Registrar of

geographical

indicationsChennai

===

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.

DistinctivenessUniformityStabilityNovelty

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)

ONLY 5 PERSONS IN THE WORLD ARE SAID TO KNOW THE FORMULA

WHICH HAS BEEN KEPT IN

ATLANTA,GEORGIA

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.

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

38

IPR related treaties GATT/TRIPS and WTO

DOHA Declaration

Hatch-Waxman Act

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

40

ANY QUERIES

41