THE PATENT ACT

SAURAV GHOSHAL

GULAM RAFEY

SATYAJEET SINGH

M.Pharm. Ist Yr. Pharmaceutics

PSIT, Kanpur
 INTRODUCTION TO
INTELLECTUAL PROPERTY
Intellectual Property refers to creation of mind
i.e. inventions, industrial designs for article,
literary & artistic work, symbols etc. Intellectual
property can include
Patents
Trade marks
Copyright
Trade secrets
Geographical indications, etc..
 PATENTS
A patent is a set of exclusive rights
granted by a state (national government)
to an inventor or their assignee for a
limited period of time, excluding others
from making, using, selling, importing the
patented product or process producing
that product for these purposes.
 Objective of Patent
To encourage inventions by
promoting their protection and
utilization so as to contribute to the
development of industries, which in
turn, contributes to the promotion of
technological innovation and to the
transfer and dissemination of
technology.
 History of Patenting in
India
The first patenting related act in India was
passed in 1911 by the name of Patents and
Designs Act, 1911.
Later after independence the Patents Bill
was unsuccessfully introduced before the
Parliament in 1949 & 1965 and finally the bill
was passed in the year 1970 and the act came
into force on 20th April 1970.
The Patent System in India is governed by
the Patents Act, 1970 (No. 39 of 1970) and the
Patents Rules, 2003.
The patents act has been amended several
times in 1974, 1985, 1999, 2002 and in 2005
and the rules have been amended in 2006.
 Patents amendment act 2002
A few important aspects of the Patents
amendment act 2002 are mentioned
below
Hastening the process of patent grant, a
patent is granted within approximately
two years of filing an application.
The inventor had to fill a declaration of
inventorship.
The amendment also made the Indian
patent act GATT compatible.
 The Patents amendment act
2005
Some of the major features of the Patents
amendment act 2005 are
Emphasis on Indigenous manufacturers
Both pre-grant and post-grant opposition avenues
In order to prevent "ever greening" of patents for

pharmaceutical substances, provisions listing out

exceptions to patentability have been suitably
amended so as to remove all ambiguity as to the
scope of patentability.
Product patent has been included in all fields of

technology (that is drugs, food and chemicals)

 WHAT IS PATENTABLE INVENTION
The following criteria must be met by a
product to be patentable.
Novelty:- The matter disclosed in the
specification is not published in India or
elsewhere before the date of filing of the
patent application in India.
Inventive step:- The invention is not obvious to
a person skilled in the art in the light of the
prior publication/knowledge/ document.
Industrially applicable :-The invention must
have industrial applicability
 WHAT IS NOT PATENTABLE:
The following are Non-Patentable inventions within the meaning of the Act:
An invention which is frivolous or which claims anything obviously contrary

to well established natural laws.

An invention the primary or intended use or commercial exploitation of
which could be contrary to public order or morality or which causes serious
prejudice to human, animal or plant life or health or to the environment.
The mere discovery of a scientific principle or the formulation of an

abstract theory (or discovery of any living thing or non-living substances

occurring in nature).
The mere arrangement or re-arrangement or duplication of known devices
each functioning independently of one another in a known way.
A method of agriculture or horticulture .
Any method of performing a mental task or playing a game.
Inventions pertaining to Atomic energy
Computer programs
Plants and animals in whole or any part thereof other than microorganisms

but including seeds, varieties and species and essentially biological

processes for production or propagation of plants and animals.
A literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions.
A presentation of information.
 Patent Office
Head Office Kolkata
Branch offices at
Mumbai
Delhi
Chennai

The Patent Office comes under the Ministry

of Commerce & Industry.
Each of the branch offices have their own fixed
territory and accept application forms from
areas lying within its geographical limits.
 APPLICATIONS FOR PATENTS
An application for a patent may be submitted by:
1. Any person claiming to be the true and first
inventor of the invention.
2.Any person being the assignee of the person
claiming to be the true and first inventor in
respect of the right to make such an
application.
3.By the legal representative of any
deceased person who immediately before his
death was entitled to make such an
application.
 Documents to be submitted along
with patent application
Application Form in duplicate (Form 1)
Provisional or Complete Specification (Form 2) In case of
provisional specification the complete specification
must be filed within 12 months.
Drawing in duplicate if necessary
Abstract of invention in duplicate
Information of Undertaking listing the no., filing date &
current status of each foreign patent application. (form
3) in duplicate
Priority Document
Declaration of Inventorship (form 5)
Power of Attorney if filed through patent agent (form 26)
Fees to be paid in Cash/ Cheque/ DD.
 TYPES OF PATENT APPLICATIONS
Type of patents:- Four types of patents
are granted under the patents Act
1970.
Ordinary patents
Patents of addition
Convention application with
priority date, claiming on the basis of
filing in convention countries
National phase applications
 Patents of addition
The patentee may apply in prescribed
format for the grant of a patent of
addition for the improvement in an
existing patented product or a process.
The patents of addition are granted in
accordance with section 54, such a patent
of addition cant be granted before grant
of the patent for the main invention. The
patent of addition exists for the period for
which the main patent exists.
 Form of application
Every application for a patent shall be for one invention only
and shall be made in the prescribed form and filed in the patent
office.

Every application under this section shall state that the

applicant is in possession of the invention and shall name the
owner claiming to be the true and first inventor; and where the
person so claiming is not the applicant or one of the applicants,
the application shall contain a declaration that the applicant
believes the person so named to be the true and first inventor.

Every such application (not being a convention application)

shall be accompanied by a provisional or a complete
specification

 PROVISIONAL AND COMPLETE

SPECIFICATION

Provisional Specifications: It is a document in a

prescribed form containing a description of essential
features of the invention. Where an application for a patent
is accompanied by a provisional specification, a complete
specification shall be filed within twelve months from the
date of filing of the application, and if the complete
specification is not filed the application shall be deemed to
be abandoned. The provisional specifications normally
contains following parts:

Title
WrittenDescription
Drawings, if necessary
Sample Or Model, if required
Complete Specification: A complete specification is
document in a prescribed form and shall:-
1. Fully and particularly describe the invention and its
operation or use and the method by which it is to be
performed.
2. Disclose the best method of performing the invention
which is known to the applicant and for which he is entitled
to claim protection.
3. A claim or claims defining the scope of the invention for
which protection is claimed.
The complete specifications have the following parts:
Title
Abstract
Written Description
Drawings, if necessary
Sample or model, if required
Enablement and best mode
Claims
Deposit (microbes)
 Examination of application
When the complete specification has been submitted
in respect of an application for a patent, the application and
the specification shall be referred by the Controller to
an Examiner for making a report to him in respect of the
following matters, namely:-
Whether the application and the specification are in

accordance with the requirements of this Act .

Whether there is any lawful ground of objection to the grant

of the patent under this Act with regard to the application.

and any other matter which may be prescribed.

The Examiner to whom the application and the specification

relating thereto are referred shall ordinarily make the report
to the Controller within a period of eighteen months from
the date of such reference.
 Rights of Patentee:
The patent act confers upon the patentee the
following rights:
A) If the patent is for a product then that cant
be made, used, offered for sale or imported for
these purposes without the consent of the
patentee.
B) If the patent is for a process the patentee has
the right to prevent third parties from using
that process, and from the using, offering for
sale, selling or importing products obtained
from that process without his consent.
 Terms of Patent
Under the World Trade Organization's (WTO)
Agreement on Trade-Related Aspects of Intellectual
Property Rights, patents should be available in WTO
member states for any inventions, in all fields of
technology, and the term of protection available
should be a minimum of twenty years. However
different types of patents may have varying patent
terms.

In India the term of every patent granted after the

commencement of the Patents Amendment Act, 2002,
and all other existing patents shall be 20 years from
the date of filing the application.
 SURRENDER OF PATENT
In order to surrender his patent a
patentee has to give notice to the
Controller in the prescribed manner.
The registrar then informs all
concerned persons and on hearing
the patentee and any opposition, if
he feels he may allow the surrender
of the patent
 REVOCATION OF A PATENT
A patent may be revoked by the High Court or
an Appellate Board on any of the following
grounds:
The specifications claimed in the application

have already been given in a prior

application.
The patent was granted to a person who is

not entitled to apply for it.

The patent was granted wrongfully.
The patent was obtained by false

representation.
 How does a patent expire
A patent can expire in the following ways:

A) The patent has lived its full term.

B) The patentee has failed to pay the renewal fee.

C) The validity of the patent has been successfully

challenged by an opponent by filing an opposition
either with the patent office or with the courts.

As soon as the patent expires anybody can use it

without the permission of the original inventor
Example of a Patent of a circuit
OPPOSITION TO GRANT OF PATENT
 FEES
1)The fees payable under section 142 in respect of
the grant of patents and applications therefore,
and in respect of other matters for which fees
are required to be payable under the act shall
be as specified in the first schedule.

2)The amount of the fees varies from 1000-4000.

3) The fees, payable under the act may either be

paid in cash or may be sent by bank draft or
cheque payable to the controller of patents.
 Renewal
Renewal fee is to be paid only from the third year
onwards and is to be paid before the expiry of the
second year from the date of patent. Renewal fee is
payable only after patent grant. All the renewal fees,
which accumulate before the grant of patent, are paid
upon patent grant and within three months from the
date of recordal (the date, on which a patent is recorded
in the Register of Patents). Subsequent renewal fees are
due to be paid on or before the anniversary of the date
of patent. Six months grace period is available to pay
renewal fees on payment of monthly surcharge. Failure
to pay renewal fees leads to cessation of patent on the
date on which the renewal has been due.
 REGISTER OF PATENTS
A register of patent is kept at the patent office which contain:
The name and addresses of grantees of patents.
Notification of assignments and transmissions of patents,
of licences under patents, and of amendments, extensions,
and revocation of patents.
Particulars of such other matters affecting the validity or
proprietorship of patents as may be prescribed.
The register is kept under the control and management of
the controller .at all convenient times, the register shall be
open to inspection by the public and certified copies duly
sealed, of any entry in register, shall be given to any
person on payment of the prescribed fee. The register shall
be prima facie evidence of any matter required or
authorized by or under this Act to be entered therein.
 Rectification of
register
(1)The Appellate Board may, on the application of any person
aggrieved
(a) by the absence or omission from the register of any entry; or
(b) by any entry made in the register without sufficient cause; or
(c) by any entry wrongly remaining on the register; or
(d) by any error or defect in any entry in the register,
make order for the making, variation or deletion, of any entry therein
as it may think fit.
(3)Notice of any application to the Appellate Board shall be given in
the prescribed manner to the Controller who shall be entitled to
appear and be heard on the application, and shall appear if so
directed by the Board.
(4)Any order of the Appellate Board rectifying the register shall
direct that notice of the rectification shall be served upon the
Controller in the prescribed manner who shall upon receipt of such
notice rectify the register accordingly.
 Patents and post GATT scenario
The period after the GATT saw a number of changes in world trade
and the Indian Patents Law was no exception. The Indian patent law
has been amended to suit the needs of the GATT. Today Indian is in
position to produce more than 100 bulk drug which is worth 5000
core. and there formulation is about 10,000 core, the country is
almost self sufficient and whole export of pharmaceutical is much
higher than that of import.
But after the DUNKEL AGREEMENT (post GATT) the
MNCs have been given an edge over other as they would import
product without having setup their own manufacturing unit in India.
The result would be that India would end up being a
tailender in the field of production of modern drug. The GATT
Agreement will endanger the manufacturing activities of the Indian
Manufacturers as 20 yrs of product and process patent will allow
absolute monopoly of MNCs.
Prices of drugs in post GATT period
Though the prices of drugs in India
are quite low and they are not
expected to shoot up considerably in
near future due to proper checks.
However drugs which are used for
the treatment of diseases like AIDS,
Cancer, etc.. are expected to cost
high because their patents are held
by the MNCs.
 INTERNATIONAL TREATIES

India is a member-state of World Intellectual Property

Organization (WIPO), an International Organization, responsible
for the promotion of the protection of intellectual property
throughout the world. India is a member of the following
International Organizations and Treaties in respect of Patents:
a) World Trade Organization (WTO) with effect from 01-01
-1995.
b) Convention establishing World Intellectual Property
Organization, (WIPO).
c) Paris Convention for the protection of Industrial Property with
effect from Dec.7, 1998.
d) Patent Co-operation Treaty (PCT) with effect from Dec.7,
1998.
e) Budapest Treaty with effect from 17th December, 2001.
 WITHDRAWAL OF PATENT
APPLICATION
The application for patent can be withdrawn at
least 3(Three) months before the first publication
which will be 18(Eighteen) months from the date
of filing or date of priority whichever is earlier.
The application can also be withdrawn at any
time before the grant of the patent.
The application withdrawn after the date of
publication, cannot be refiled as it is already laid
open for public inspection. However, application
withdrawn before the publication can be refiled
provided it is not opened to public otherwise.
 RESTORATION
Application for restoration of a patent
that lapses due to non-payment of
renewal fees must be made within 18
months of lapse. The application is to
be filed in the appropriate office
according to the jurisdiction.
 REQUEST FOR PERMISSION TO
FILE ABROAD
If any application is to be filed abroad
,without filing in India ,it should be made
only after taking a written permission from
the Controller .The request for permission
for making patent application outside India
shall be made in Form-25 along with a fee
of Rs 1000/- or Rs 4000/- for natural
person and other than natural person
respectively. A gist of invention should also
be filed along with the Form-25.
 Ownership of patent
In most countries, both natural persons and corporate
entities may apply for a patent. In the United States,
however, only the inventor(s) may apply for a patent
although it may be assigned to a corporate entity
subsequently and inventors may be required to assign
inventions to their employers under a contract of
employment. In most European countries, ownership of an
invention may pass from the inventor to their employer by
rule of law if the invention was made in the course of the
inventor's normal or specifically assigned employment
duties, where an invention might reasonably be expected
to result from carrying out those duties, or if the inventor
had a special obligation to further the interests of the
employer's company.
OFFENCES PENALTIES
Contravention of secrecy provisions imprisonment upto 2 year, or fine, or
relating to certain invention both

Falsification of entries in register etc. imprisonment upto 2 year, or fine, or

both
Unauthorized claim of patent rights fine upto 1 lakh rupees
Wrongful use of word patent office imprisonment upto 6 months, or fine
or both
Practice by non-registered patent first offence fine up to 1 lakh rupees
agents
Second or
subsequent offence fine up to 5 lakh
rupees

Refusal/failure to supply information imprisonment upto 6 months, or fine

or both
Offence by companies the company as well as every person
in charge of, and responsible to, the
company to conduct of its business at
the time of commission of offence
SCENARIO OF BIOTECHNOLOGICAL PATENTING IN
INDIA

The field of Biotechnology is rapidly advancing. Ever

since the report of the first successful cloning of a
sheep named Dolly in early 1997, advances in
genetic engineering have gained attention globally.
Biotechnological inventions are concerned with
processes occurring in living matter including
animals, plants or microorganisms, the products so
obtained and their industrial application. The field of
their application is broad and covers, for example,
the use of fungi in the bakery, wine and antibiotic
industries, bacteria for the manufacture of vaccines,
plant extracts and the like.
WHAT IS PATENTABLE IN BIOTECHNOLOGY

A Protein
Patent protection for a protein may be granted if, not been previously
characterized, has been isolated from a natural resource in pure form. A novel
or known protein obtained via recombinant DNA technology may be
patentable. E.g. a hormone expressed from a recombinant vector.
Micro-organisms
A new strain of micro-organism produced artificially this may include a
micro-organism transformed by a recombinant vector.
A micro-organism newly isolated in pure form from a natural source.
A novel product produced by a micro-organism is patentable e.g.
antibiotics
If a product produced by the micro-organism is known, the process of
producing the product using the micro-organism may be patentable.
Molecular Biological Techniques
Novel techniques/processes for producing a particular product
(protein/clone) may be patentable.
A known process used to produce a novel product is generally not
patentable.
Cell Lines
Yes, if artificially produced.
DNA, RNA, Amino Acid Sequences
Random isolated sequences generally will not be patentable if they have no
utility, i.e. they have no known use at the date of filing the application.
A Gene
Newly isolated genes in pure form.
A gene to which alterations have been made.
A gene in recombinant form.
A Plant or Animal
At present, there is much controversy over the patentability of plants and
animals.
In many countries, it has generally been considered that an animal or plant
or a process for producing an animal or plant is not patentable. However,
views on this are changing and a number of patents have already been
granted. E.g. the Harvard Oncomouse.
Plant varieties may be protected in most industrial countries by way of Plant
Variety Rights also called Plant Patents.
NUMBER OF PATENTS AND INDIAN CONTRIBUTION IN
BIOTECHNOLOGY
PATENTING SCENARIO IN AGRICULTURE

India has always been an agricultural

country and this even reflects in patenting
activity. The International Patents
Classification (IPC) system provides data on
the comparative patenting in various fields
in various countries. IPC classifies
agricultural patents into 10 categories.
Some facts obtained from IPC data are:
Agricultural patents constitute ~2% of total
patents in India.
 The No. of patents applied for in various categories in agriculture
as indicated by IPC data for the period of 1994-2005

IPC Class Class title Total No. of Total No. of Indian

patents patents
A01B Soil working in agriculture or 11 11
forestry agriculture machines
or implements
A01C Planting, sowing, 15 10
fertilizing
A01D Harvesting, mowing 22 14
A01F Processing of harvested 8 4
produce, devices for storing
A01G Horticulture, cultivation, 33 22
forestry
A01H New plants or processes for 11 8
obtaining them, plant
reproduction
A01J Manufacture of dairy products 9 4
A01K Animal husbandry, rearing or 30 16
breeding animals, new breeds
A01M Catching, trapping apparatus 12 17
for destruction of noxious
animals
A01N Biocides, pest-repellants or 298 192
GROWTH OF PATENTING ACTIVITY DURING 19952004
IN AGRICULTURE IN INDIA
 REFERENCE
N. K Jain Textbook of Forensic
Pharmacy
B. M. Mittal Textbook of Forensic
Pharmacy
www.indiajuris.com
R. Tiwari, G. Tiwari et.al. Management
of intellectual property rights in India:
An updated review
 N K
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