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Indian

Indian Patent
Patent Act
Act 1970
1970

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Presentation
outline

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Presentation Outline

Introduction
History of patent in India
Terms & Definitions
Non-patentable Invention
Types of patent
How to apply ?
Procedure for grant of patent
Patent agent
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Presentation Outline
Infringement of the patent
The Patents Amendments Act
Pre-TRIPS Scenario
TRIPS Implementation.
Status of IPI in Product Patent Era
Future Outlook & Challenges
Conclusion

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introduction

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Intellectual property

Creation of Human Mind i.e. it may be of inventions,


industrial designs, artistic work, symbols etc.

IPR- Anything resulting from human intellect is


intellectual property and the right of possession of the
same is IPR.

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What is a patent?

INVENTION
SOLUTION
PROBLEM local laws
novelty
non-obvious
industrial application PATENTABLE

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Advantage of Patenting

Avoids duplication of research.


Keeps abreast with latest development in different fields of
technology.
Helps industry to improve existing technology to produce
cheaper & better product.
Serves as an indicator of achievements in R & D institutions
and ability of individual researcher.
Helps to frame business strategy according to new trend of
technology.
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Patent legislation
Patents Act, 1970-Amended in 1999 , 2002 , 2005
Patents Rules,1972,-Amended in 2003,2005 , 05-05-2006
From 1.1.1995
Mail-Box for pharmaceutical and agrochemicals products
Exclusive Marketing Rights
From 1.1.2000
Patent term increased to 20 years
Definition of invention – inclusion of inventive step
Mandatory compulsory license provision for food, drugs and
chemicals removed
Right of patentee (importation also included)
From 1.1.2005
Product patents for food, chemical and pharmaceutical

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Patent Administration
Headed by – CGPDTM
Four offices are located in four territorial zone.
PATENT OFFICE

CALCUTTA NEW DELHI

CHENNAI
MUMBAI

PIS & IPTI at Nagpur


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International Treaties
India is member of WIPO.
WIPO – Is an international organization, responsible for the
promotion of the protection of IP through out the world.

India is also a member of following International Organization


with respect to patent :-

WTO- with effect from 01-01-1995.


Paris Convention- for the protection of industrial property. with
effect from 07-12-1998.
Budapest Treaty- with effect from 17-12-2001.
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History of indian
Patent

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History of Indian Patent
1856 – Act IV for the protection of inventions based on the
British Patent law of 1852.
1857 – Act IX.
1859 – Act XV Patent monopolies called this exclusive
privileges.
1872 - Patent & Design protection Act.
1911 – The Patent and Design Act.

1970 - The Indian Patent act (Act 39 of 1970) come into


force from 1972.

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History of Indian Patent
1999 – On march 26, 1999 Patent Amendment Act , come
into force from 1st Jan 1995.
2002 - Patent Amendment Act 2002, come into force from
20th May 2003.
2005 - Patent Amendment Act 2005, effective from 01 Jan
2005.
2006 – Patent Amendment Rule on 5th May 2006.

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Terms & DefiniTion

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Terms & Definition
INVENTION – [ Acc. To sec 2 (1)(j) ]
Invention means a new product or process involving an
inventive step & capable of industrial application.
or
It is a conception of new ideas.

INNOVATION – It is application \ adoption of the idea.


e.g. it is the process that moves the idea into market place.

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Terms & Definition
PATENT – A patent is an IPR relating to invention ,
it is a grant of exclusive right, for a limited period,
provided by the govt. to the patentee,
in exchange of full disclosure of his invention, & excluding
other from Making, using, selling, importing the patented
product or process.
COPYRIGHT – The rights of the Author of literary & Artistic
work are protected by the copyright.
For the minimum period of 50 years after the death of the
author.

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Terms & Definition
TRADEMARK – Can be characterized as protection of
distinctive sign or logos & GIs .
Distinctive sign – Which distinguish the goods & services of
one undertaking from those of the other.
GIs – Which identify the goods as originating in a place where
a given characteristic of goods is essentially attributed to its
Geographical origin.
NOVELTY – The essential conduction for patentability, that
what is claimed is new.
ABSOLUTE NOVELTY – A system where by any prior
publication any where , destroys the novelty of a patent.

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Terms & Definition
LOCAL NOVELTY – The principle that a patent can be
invalidated by prior publication only if the publication was in
the country granting the patent.
MIXED NOVELTY - The principle that a patent can be
invalidated by prior printed publication any where in the
world, but by prior use only in the country granting the patent.
AMENDMENT – Alteration made to patent specification
during prosecution or after grant.
BUDAPEST TREATY – The international treaty regulating
the deposition of μ-organism for patent purpose.

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Terms & Definition
COMPULSORY LICENSE – A license which government
authorities or court force the patentee to grant to another party.
CONVENTION COUNTRY – A state which is a member of
Paris convention for the protection of industrial property.
DOHA LICENSE – A compulsory license granted to allow
export of patented pharmaceutical to a developing country.
EXCLUSIVE MARKETING RIGHTS – The right of a person
filing a black box application to exclude competitors until his
application is granted or refused, if certain conditions are met.
FOREIGN FILING – Filing in countries other than the country
of first filing.

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non PaTenTable
invenTion

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Non Patentable Invention
These should be included in sec. 3 & 4 of IPA .
SECTION 3(a)
SECTION 3(b)
SECTION 3(c)
SECTION 3(d)
SECTION 3(e)
SECTION 3(f)
SECTION 3(h)
SECTION 3(i)
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Non Patentable Invention
SECTION 3(j)
SECTION 3(k)
SECTION 3(l)
SECTION 3(m)
SECTION 3(n)
SECTION 3(o)
SECTION 3(p)
SECTION 4

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TyPes of PaTenT

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Types of Patent
1) ORDINARY PATENT - Is one which is granted on the basis
of general & ordinary procedure of application.

2) PATENT OF ADDITION – It is a patent secured for an


improvement or modification of an invention , for which a
patent has already been applied for or granted.

3) PATENT GRANTED UNDER CONVENTION


AGREEMENT.

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How To aPPly ?

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How to Apply ?
Application on Form –1 with covering letter in the name of
controller
Specification Provisional/complete on form –2
Abstract of invention
Statement and undertaking of foreign filing particulars on form-3
- if any
Declaration of inventorship on form- 5
Power of Attorney - if applicable

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THE FEE SCHEDULE
On what payable Form Individual Company
•Prov./Comp spec. 2 1000 4000
•PAGES EXCEEDING 30 - 100 400
•CLAIMS EXCEEDING 10 - 200 800
*Request for extension of time 4 1000/2000/3000 4000/8000/1200

REQUEST FOR EARLY PUBLICATION 9 2500 10000


•Request for Examination 18 2500 10000
•EXPRESS REQUEST FOR EXAMN. 18 3500 14000
*Change of Applicant 6 1500 2000
*Notice of Opposition 7 1000 6000
*Certified Copy\Certificate 1000 4000
*On a petition -- 1500 4000
*Restoration of lapsed patent 15 1500 6000

RENEWAL FEES
3rd to 6th Year(per year) 500 2000
6th to 10th Year—do-- 1500 6000
11th to 15th Year---do--- 3000 12000
16th to 20th year----do--- 5000 20000
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Procedure for
obtaining a Patent

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PROCEDURE FOR GRANT OF PATENT
provisional
provisionalapplication
application Patent
Patentapplication
application

complete
complete specification
specificationapplication
application

Publication
Publication(After
(After18
18month
monthfrom
fromfiling
filingdate
dateororpriority)
priority)

Pre
Pregrant
grantopposition
opposition(from
(from
Request
Requestfor
for No
Norequest
requestfor
for
publication
publicationup
uptotogrant)
grant) examination
examination(within
(within48
48 examination
examination
months
monthsfrom
fromfiling/priority)
filing/priority)

Decision
Decisiontotorefuse
refuse FER
FERwithin
within66month
month Withdrawal
Withdrawalof of
from
fromrequest
requestfor
for application
application
examination
examination
Appeal
AppealtotoIPAB
IPAB
“Placing
“Placingapplication
applicationinin
order
orderfor
forgrant”
grant”(within
(within
12
12month
monthfrom
fromreceipt
receiptofof
FER)
FER)
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Decision
Decisiontotogrant
grant
(notification
(notificationininjournal)
journal)

Post
Postgrant
grantopposition
opposition
(with
(withinin11year
yearfrom
fromdecision
decisiontotogrant)
grant)

Decision
Decisiontotorefuse
refuse Decision
Decisiontotomaintain
maintain

Appeal
AppealtotoIPAB
IPAB
(with
(withininthree
threemonths)
months)

Time
Time for
for grant
grant of
of 88months
monthsminimum
minimum
36
36months
monthsaverage
average
patent
patent
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Duties of patentee
Maintenance of the patent:
Pay renewal fees.
Every year till the end of the term.
Time limit: before end of the proceeding year ( 6 months extn.
Available )
Working of the patents:
Inventions are to be worked in India on commercial scale.
Failing which compulsory license may be issued.

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Patent agent

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Patent agent

A Patent agent is a registered person with Indian


Patent Office whose name is entered in the patent
agent register after being declared qualified the patent
agent examination conducted by the patent office.

For the registration as a patent agent. (Form 23)

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Eligibility for registration as patent agents

A person shall be qualified to have his name entered in the


register of patent agents if —
he is a citizen of India;
he has completed the age of 21 years;
he has obtained a degree in science, engineering or
technology from any university established under law.
In addition,—
has passed the qualifying examination prescribed for the
purpose;
has, for a total period of not less than ten years, functioned
either as an examiner or discharged the functions of the
Controller under section 73 .
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infringement of the
Patent

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Infringement of the patent
A patent confers the exclusive right on the patentee to make,
distribute or sell the invention in India. An infringement would
be when any of these rights is violated.
In case of product patent the rights of the patentee are
infringed by anyone who makes or supplies that substance
commercially
In case of process patent, the use of such a method or process
in India by anyone other than the patentee amounts the
infringement.
The following acts of the defendant can amount to infringement:
colourable imitation of patented invention; or
copying essential features of patented invention; or
variation of non-essential features of patented invention; or
Infringe not the whole process Sagar
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but Savale
only a part of it. 37
Acts not Constituting Infringement

Where the patented invention is merely used for the purpose


of experiment or research
or for imparting instruction to pupils, it does not amount to
infringement of patents.
Similarly, any act of making, using or selling a patented
invention solely for development of information required
under any relevant law does not amount to infringement.
Also the importation of patented products by any person from
a person who is duly authorized by the patentee will not
constitute infringement.

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Offences Penalties

Contravention
Contraventionof ofsecrecy
secrecyprovision
provision Imprisonment
Imprisonmentup
upto
to22years,
years,or
or
relating
relatingto
tocertain
certaininvention.
invention. fine
fineor
orboth.
both.

Imprisonment
Imprisonmentup
upto
to22years,
years,or
or
Falsification
Falsificationof
ofentries
entrieson
onregister.
register.
fine
fineor
orboth.
both.

Unauthorized
Unauthorizedclaim
claimof
ofpatent
patentrights
rights Fine
Fineup
upto
toRs.500
Rs.500

Wrongful
Wrongfuluse
useof
ofthe
thewords
words“Patent
“Patent Imprisonment
Imprisonmentup upto
to66months,
months,
office”.
office”. or
orfine
fineor
orboth.
both.

Practice
Practiceby bynon-
non-registered
registeredpatent
patent 11ststoffence-
offence-fine
fineupto
uptoRs.500.
Rs.500.
agent.
agent. 22ndndoffence-
offence-fine
fineupto
uptoRs.2000.
Rs.2000.
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Offences Penalties

Refusal
Refusalor
orfailure
failureto
tosupply
supply Fine
Fineupto
uptoRs.1000.
Rs.1000.
information
informationtotothe
thecentral
central
government
governmentor orto
tothe
theController.
Controller.

Supply
Supplyof
offalse
falseor
oruntrue
untrue Imprisonment
Imprisonmentup upto
to66months,
months,
information
information.. or
orfine
fineor
orboth.
both.

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the Patents amendments

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The Patents (Amendments) Act 1999
To provide the provisions for receiving the
applications for the product patent (mail box).

MAIL BOX:- It will receive & hold product patent


application in the field of Pharmaceuticals and
Agrochemicals.

Provisions for the grant of EMRs.

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The Patents (Amendments) Act 2002

Uniform 20 years term of patent for all inventions.

Scope or non-patentable inventions including traditional


knowledge enlarged.

Publication of all applications after 18 months.

Disclosure of source and geographical origin of biological


material made compulsory.
Establishment of appellate board .
Compulsory license provisions strengthened .
Harmonization with PCT provisions.
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The Patents (Amendments) Act 2005

Has introduced product patent protection for


pharmaceuticals from 1 January, 2005.
Hence unless otherwise authorized, Indian generic
companies cannot produce new drugs developed
abroad.
Definitions of certain terms redefined.
Rationalization of opposition procedure-introduction of
pre-grant representation and post – grant opposition.
Provisional protection from the date of publication.

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The Patents (Amendments) Act 2005

Compulsory license for manufacture and export of


pharmaceutical products to any country having
insufficient or no manufacturing capacity
Parallel import from anywhere
Harmonization with PCT
Rationalization and simplification of procedure
Sealing request dispensed with, increase in the grace period
from 6 to 12 months
Early publication and examination. publication in patent
office journal
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Pre-TRIPS Scenario
Weak infrastructure
Inadequate manpower
Low international exposure
Low filing of IP applications
Manual operations
Slow processing
Lack of awareness

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TRIPS ImPlemenTaTIon

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Modernization Plan-I
The First phase US $ 34 million started in 2002 which
included
Construction of IP Buildings at four places
Computerization
Digitization of IP Records
Human Resource Development
Awareness creation
Upgradation of Library Facilities.
National Institute of Intellectual Property Management set
up at Nagpur.

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Modernization Plan-II
The Second Phase US$ 80 million began in 2008 which
include:
Complete automation of IP Offices
Online processing and services
Increased transparency
Bilateral Cooperation Agreements with 8 countries namely
Australia, USA, UK, Germany, Japan, France, EPO and
Switzerland to promote innovation, IP and foster
Cooperation.

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STaTuS of IndIan
PhaRmaceuTIcal InduSTRIeS
In PRoducT PaTenT eRa

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Status of IPI in Pre-Product Patent Era

Product patents in drugs abolished in 1972.


Remarkable growth of pharmaceutical industry since then.
India and Japan: only two countries where western MNCs
do not dominate.
Drug prices among the lowest in the world
Source of good quality cheap drugs for the rest of the world.
Size of India’s pharmaceutical market is $ 4.9 billion (2003).
This constitutes about 1% of the global pharmaceutical
sales and about 10% of total generic market in the world.

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Status of IPI in Product Patent Era

India is one of the top five manufacturers of bulk drugs &


among top 20 pharmaceutical exporters
Strengths of IPI
Cost competitiveness.
Strong manufacturing base – 70 plus USFDA approved manufacturing
facilities.
Good infrastructural facilities for R&D.
Strong marketing distribution network.
Projected exports of domestic pharma products-
$4 billion by 2010
$6 billion by 2015

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Status of IPI in Product Patent Era

India as a global outsourcing hub for:


Pharma R&D outsourcing: More than 100 MNCs setting up R&D labs.
IPR services outsourcing: More than half a dozen companies set up
facilities in India to provide IPR related services.
Product patent protection will not have any negative
consequences. In fact it will have some beneficial effects:
Remarkable growth of pharmaceutical exports “is the
result of the confidence built up in our industry due to
our progressive adherence to our IP commitments.”

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Future Outlook & Challenges
Emergence of India as leading country in Global Pharmaceutical
Market
Export to be the major thrust of the Industry
Evolving of Bio-pharmaceutical Market likely to emerge as one of
the largest producer of Vaccines
Biotech Market estimated to reach $5 billion by 2010
More Investment required in R&D
Clear Guidelines required on OTC Drugs.
Quality Management System

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REFERENCES
Philip W. Grubb “Patent for chemicals Pharmaceuticals and
Biotechnology” Oxford University Press, 4th edition.

Timothy M. Swanson “Intellectual property rights and


Biodiversity Conservation” Cambridge University Press-1995.

Dr. B.S. Kuchekar , Mr. A.M. Khadatare & Mr. Sachin C.Itkar
“Forensic Pharmacy” Nirali prakashan, 7th edition-2008.

N.K. Jain “A text book of forensic pharmacy” Vallabh


prakashan, 6th edition-2006.
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• www.ipindia.nic.in
• http://patentoffice.nic.in
• www.indianpatent.org.in
• www.aptdc.com
• www.apipr.org
• www.nrdcindia.com
• http://ipindiaonline.gov.in
• www.sciencedirect.com
• www.wikipedia.com

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