SAURAV GHOSHAL

GULAM RAFEY

SATYAJEET SINGH

M.Pharm. Ist Yr. Pharmaceutics

PSIT, Kanpur
 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..
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.
 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.
 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.
 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.
 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)
 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
 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.
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.
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.
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.
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
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 can’t 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.
 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
 Written Description
 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)
 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.
 The patent act confers upon the patentee the
following rights:
A) If the patent is for a product then that can’t
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.
 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.
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
 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.
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
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 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.
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.
(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.
 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.
 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.
 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.
 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.
 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.
 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.
 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
Contravention of secrecy provisions
relating to certain invention
Falsification of entries in register etc.
Unauthorized claim of patent rights
Wrongful use of word ‘patent office’
Practice by non-registered patent agents
Refusal/failure to supply information
Offence by companies
PENALTIES
imprisonment upto 2 year, or fine, or both
imprisonment upto 2 year, or fine, or both
fine upto 1 lakh rupees
imprisonment upto 6 months, or fine or
both
first offence – fine up to 1 lakh rupees
Second or subsequent offence – fine up to
5 lakh rupees
imprisonment upto 6 months, or fine or
both
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 shall be deemed to
be guilty and liable to be proceeded
against punished accordingly.
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 patents Total No. of Indian patents
A01B Soil working in agriculture or forestry 11 11
agriculture machines or implements
A01C Planting, sowing, fertilizing 15 10

A01D Harvesting, mowing 22 14

A01F Processing of harvested produce, 8 4
devices for storing
A01G Horticulture, cultivation, forestry 33 22
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 for 12 17
destruction of noxious animals
A01N Biocides, pest-repellants or 298 192
attractants, plant growth regulators
GROWTH OF PATENTING ACTIVITY DURING
1995–2004 IN AGRICULTURE IN INDIA
 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