Intellectual property rights & Patent filing Procedures

INTELLECTUAL PROPERTY
RIGHTS
& STEPS IN PATENT GRANTING
DR.M.V.NAGABHUSHANAM
PROFESSOR & HEAD OF THE DEAPRTMENT
DEPARTMENT OF PHARM. MANAGEMENT & REGULATORY AFFAIRS
HINDU COLLEGE OF PHARMACY, GUNTUR A.P.

Industry size : 25.8 Bn USD
Exports : 13.2 Bn USD
Imports: 3.52 Billion USD
Industry is growing @ 20% p.a
Domestic Market 2011-2012: 12.6 Bn USD
4th Largest in world in terms of Volume & ranks 13th in terms of Value
Export of Biotech products & Biopharmaceuticals ~US $1.36 Bn
Export of Vaccines- US $507.9 million (US $ 42 Bn by year 2015)
Manufacturing Facilities 172 US FDA Approved
India Stood First Globally with 2759 DMF filling Out of 7886 DMFs
US Pharmacopoeia has office in Hyderabad, India
USFDA has country office in Delhi, Mumbai
9,000 manufacturing units in the country
600,000 Retail & Wholesale Shops in India
153 EDQM certified facilities; 6th largest supplier of HIV drugs after
Germany
Drugs from India are exported to more than 200 countries
Vaccines from India are exported to more than 151 countries

Emerging markets India and China will figure in the top 10
pharma markets of the world by 2015, an Ernst & Young
report has said. The report has identified India as the
preferred choice for outsourcing in the area of late stage drug
discovery, shared services and complex manufacturing while
China has been the preferred market for building blocks and
intermediates.
PHARMA MANAGEMENT & REGULATORY AFFAIRS

INTELLECTUAL PROPERTY RIGHTS (IPR)
• Intellectual property rights (IPR) can be defined as
the rights given to people over the creation of
their minds. They usually give the creator an
exclusive right over the use of his/her creations for
a certain period of time.

CATEGORIES OF INTELLECTUAL PROPERTY

Intellectual Property rights
• Intellectual Property rights may be protected at
law in the same way as any other form of property.
Intellectual property laws vary from jurisdiction to
jurisdiction.

What is Intellectual Property?
• Intellectual property is an intangible creation of the
human mind, usually expressed or translated into a
tangible form that is assigned certain rights of property.
Examples of intellectual property include an author's
copyright on a book or article, a distinctive logo design
representing a soft drink company and its products,
unique design elements of a web site, or a patent on
the process to manufacture chewing gum.

The different types of Intellectual Property Rights are:
• i. Patents
• ii. Copyrights
• iii. Trademarks
• iv. Industrial designs
• v. Protection of Integrated Circuits layout design
• vi. Geographical indications of goods
• vii. Biological diversity
• viii. Plant varieties and farmers rights
• ix. Undisclosed information

COPYRIGHT
• 1. Writings
• 2. Paintings
• 3. Musical works
• 4. Dramatics works
• 5. Audiovisual works
• 6. Sound recordings
• 7. Photographic works
• 8. Broadcast
• 9. Sculpture
• 10. Drawings
• 11. Architectural works etc.

INTELLECTUAL PROPERTY
INDUSTRIAL PROPERTY + COPY RIGHT
PATENTS DESIGNS TRADEMARKS Geographical Indications
PHARMACEUTICAL MANAGEMENT & REGULATORY AFFAIRS

Duration of Intellectual Property Rights in
a nutshell
• Term of every patent will be 20 years from the date of
filing of patent application,
• irrespective of whether it is filed with provisional or
complete specification. Date of
• patent is the date on which the application for patent is
filed.
• 2) Term of every trademark registration is 10 years from
the date of making of the
• application which is deemed to be the date of
registration.
• 3) Copyright generally lasts for a period of sixty years.

Duration of Intellectual Property Rights in
a nutshell
• 4) The registration of a geographical indication is valid
for a period of 10 years.
• 5) The duration of registration of Chip Layout Design is
for a period of 10 years counted
• from the date of filing an application for registration or
from the date of first commercial
• exploitation anywhere in India or in any convention
country or country specified by
• Government of India whichever is earlier.
• 6) The duration of protection of registered varieties is
different for different crops namely
• 18 years for trees and vines, 15 years for other crops
and extant varieties.

Global Intellectual Property Trends
• With over 3 million applications filed per year,
trademark protection is the most sought after
form of IP worldwide

Intellectual Property Trends – India
• During 2009-10, 34,287 patent applications were
filed, 6069 examined and 6168 patents granted.
The number of applications filed by the Indian
applicants was 7044.

CROCIN
Crocin sells more than 2.50 million pills each
day. That's nearly 30 every second, around-the
clock Internationally Crocin goes by the name
Panadol.

• Pfizer’s cough and cold
syrup Corex is a leading
brand in India with sales
of $35.53 million (Rs 167
crore)

•
• Voveran, Novartis India’s flagship pain killer
medicine, is the second leading brand with
sales of $31.63 million (Rs 148.7 crore) with
growth rate of 4 percent.

• Phensedyl cough and cold syrup from Piramal
Healthcare is the third leading brand in India and it
registered a growth of over 50 percent.

• A human insulin product from Novo Nordisk—
Human Mixtard 30/70 which stands fourth in the
top 10 brands of India has registered a growth of
just three percent, according to ORG-IMS
Research.

•
• Franco- Indian Pharma’s anaemia drug Dexorange,
Pfizer’s cough and cold syrup Corex have registered
a doubledigit growth.

Introduction
• 1856 - George Alfred DePenning, a civil engineer, is
supposed to have made the first application
for a patent in India for his invention –
"An Efficient Punkah Pulling Machine" .
• March 3- Petition to the Government of India for grant of
exclusive privileges for his inventions.
• Sept. 2 – Submission of Specifications for his invention
along with drawings to illustrate its working.
• These were accepted and the invention was granted the
first ever Intellectual Property protection in India.
Department of Pharmaceutical Management And Regulatory Affairs

History of Patent Law
YEAR ACTS
1856
THE ACT VI OF 1856 ON PROTECTION OF
INVENTIONS BASED ON THE BRITISH
PATENT LAW OF 1852. CERTAIN EXCLUSIVE
PRIVILEGES GRANTED TO INVENTORS OF
NEW MANUFACTURERS FOR A PERIOD OF
14 YEARS.
1859
THE ACT MODIFIED AS ACT XV; PATENT
MONOPOLIES CALLED EXCLUSIVE
PRIVILEGES (MAKING. SELLING AND USING
INVENTIONS IN INDIA AND AUTHORIZING
OTHERS TO DO SO FOR 14 YEARS FROM
DATE OF FILING SPECIFICATION).

• 1872 THE PATENTS & DESIGNS PROTECTION ACT.
• 1883 THE PROTECTION OF INVENTIONS ACT.
• 1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.
• 1911 THE INDIAN PATENTS & DESIGNS ACT.
• 1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON
20
TH
APRIL 1972.
• 1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999)
CAME INTO FORCE FROM 01-01-1995.
• 2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE
FROM 2OTH MAY 2003
• 2005 THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM Ist
JANUARY 2005
History of Patent Law

Patent Filing Procedures
• Step 1: Filing of Patent Application
• Step 2: Publication
• Step 3: Opposition (if any)
• Pre grant Opposition ; Post grant Opposition
• Step 4: Request for Examination
• Step 5: First Examination Report
• Step 6: Amendment of objections by the applicant
• Step 7: Grant of Patent
• Step 8: Renewal fees

HISTORY OF COPYRIGHT LAW
1847
• Copyright law entered India through an enactment.
• According to the 1847 enactment, the term of copyright was for the lifetime
of the author + seventy years post-mortem.
Purpose:
• Specifically reserves the subsistence of copyright in the author, and his right to
sue for its infringement to the extent available in law other than the 1847 Act.
 Registration of copyright with the Home Office was mandatory for the
enforcement of rights under the Act.

HISTORY OF COPYRIGHT LAW
1914:
• Indian legislature enacted a new Copyright Act with few modifications
• First - Introduced criminal sanctions for copyright infringement
(sections7 to 12).
• Second - Modified the scope of the term of copyright; under section 4
 Act was continued with minor adaptations and modifications till the 1957 Act
was brought into force on 24th January, 1958.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS

COPYRIGHT ENFORCEMENT ADVISORY COUNCIL (CEAC)
• The Government has set up on November 6, 1991 a Copyright Enforcement
Advisory Council (CEAC) to review the progress of enforcement of Copyright
Act periodically and to advise the Government regarding measures for
improving the enforcement of the Act.
 Amendments:
1981
1984
1992
1994
1999
2010
2012

HISTORY OF TRADEMARK LAW
1940 - The Indian Trademarks Act was passed .
1958 - The Trademark and Merchandise Act, 1958
Purpose:
• Enables the registration of trademarks so that the proprietor of the
trademark gets legal right to the exclusive use of the trademark.
Objective:
• Easy registration and better protection of trademarks and for
prevention of the use of fraudulent marks on merchandise.
1999 – The Trademark Act 1999
Objective:
• To confer the protection to the user of the trademark on his goods
and prescribe conditions on acquisition, and legal remedies for
enforcement of trademark rights.

History of Geographical Indications
1999 - Geographical Indications of Goods (Registration and
Protection) Act, 1999
2002 - The Geographical Indications of Goods (Registration and
Protection) Rules, 2002
- deal with registration and better protection of
geographical indications relating to goods.
Purpose:
• Provide legal protection to Indian Geographical Indications which
in turn boost exports.
According to the Act:
The term 'geographical indication' (in relation to goods) means "an
indication which identifies such goods as agricultural goods,
natural goods or manufactured goods as originating, or
manufactured in the territory of a country, or a region or locality in
that territory.

What is a Geographical Indication?
• It is an indication
• It originates from a definite geographical territory.
• It is used to identify agricultural, natural or
manufactured goods
• The manufactured goods should be produced or
processed or prepared in that territory.
• It should have a special quality or reputation or
other characteristics

Examples of Geographical Indication
• Solapur Chaddar
• Solapur Terry Towel
• Basmati Rice
• Darjeeling Tea
• Kanchipuram Silk Saree
• Alphanso Mango
• Nagpur Orange

JURISDICTION OF OFFICES
PHARMACEUTICAL MANAGEMENT & REGULATORY AFFAIRS

Organization Structure – IP Offices
Ministry of Industry & Commerce
Office of the Controller
General of Patents, Designs
And Trademarks
Designs wing
(Kolkatta)
Patent office
( Kolkatta, Delhi,
Mumbai, Chennai)
Trade Marks Registry
( Kolkatta, Delhi,
Mumbai, Ahmedabad
Chennai)
Geographical
Indications
Registry
( Chennai)
Patent
Information
Service
( Nagpur)

What is Patent?
• Patent is a grant for an invention by the Government to
the inventor in exchange for full disclosure of the
invention. A patent is an exclusive right granted by law to
applicants / assignees to make use of and exploit their
inventions for a limited period of time (generally 20 years
from filing).

57
PATENT
• A Legal Right
• Conferred by the state
• To an applicant / inventor
• For Disclosing a New
invention
• To make, use, sell or
license the invention
• For a limited period
Pharmaceutical Management & Regulatory Affairs

PATENTS
• As on date, India is fully in compliance with its
international obligations under the TRIPs Agreement.
• The Patents Act 1970 has undergone three
amendments – 1999, 2002 & 2005.
• Introduction of product patent protection for food,
pharmaceutical and chemical inventions.
* New amendment effective from January 01, 2005

PATENTING OF PHARMACEUTICALS
• New Chemical Entities
• Process for preparing the new chemical entity
• Pharmaceutical Intermediates
• Pharmaceutical compositions of new compounds
• New pharmaceutical compositions of old compounds
• Process for preparing new compositions
• First pharmaceutical use of a known compound
• Second or new pharmaceutical use of a known
compound.

60
CRITERIA FOR GRANTING A PATENT
• New (Novelty)
i.e invention must be new and not known earlier.
• Useful (Capable of Industrial application)
i.e. invention must work and should not be only
theoretical
• Unobvious (Involve an inventive step)
i.e. must involve some effort on part of inventor

WHAT CANNOT BE PATENTED
• According to Indian Patent Act 1970,following inventions
are not patentable
• Invention which is contrary to well established natural
laws
• Primary use of invention is injurious to public health
• Mere discovery of scientific principle or the formulation of
an abstract theory

Arrangement or rearrangement or duplication of known devices
A method of agriculture or horticulture
 Any process for the medicinal, surgical, curative, prophylactic or
other treatment of human beings or any process for similar
treatment of animals or plants
 A presentation of information
 A mathematical or business method or a computer programme
or algorithms
WHAT CANNOT BE PATENTED

Office Territorial Jurisdiction
• Patent Office Branch, Mumbai
• The States of Maharashtra, Gujarat, Madhya
Pradesh,
• Goa and Chhattisgarh and the Union Territories of
• Daman and Diu & Dadra and Nagar Haveli
• Patent Office Branch, Chennai
• The States of Andhra Pradesh, Karnataka, Kerala,
Tamil
• Nadu and the Union Territories of Pondicherry and
• Lakshadweep.

Office Territorial Jurisdiction
• Patent Office Branch, New Delhi
• The States of Haryana, Himachal Pradesh, Jammu
and
• Kashmir, Punjab, Rajasthan, Uttar Pradesh,
Uttaranchal,
• Delhi and the Union Territory of Chandigarh.
• Patent Office, Kolkata The rest of India

LICENSING AND THE GOVERNMENT
Or
How to negotiate a successful
partnership.
Pharma Management & Regulatory Affairs

What is a License?
• A contract between licensor and licensee.
• Licensor grants to licensee the right to practice the
technology claimed in the licensed patent
• Licensor agrees not to sue licensee for infringing licensor’s
patent

Types Of Patent Applications
• 1) Ordinary Application
• 2) Application for Patent of Addition (granted for
Improvement or Modification of the
• already patented invention, for an unexpired term of
the main patent).
• 3) Divisional Application (in case of plurality of
inventions disclosed in the main
• application).
• 4) Convention application, claiming priority date on the
basis of filing in Convention
• Countries.
• 5) National Phase Application under PCT.

How is a patent obtained?
• File an application for patent With one of the patent offices based on
territorial jurisdiction of the place of office or residence of the applicant
/agent
• Pay the required fee
• Information concerning application form and details of fee available at
• www.ipindia.nic.in
• Guidelines for applicants also available on this website
• The Patent Office then Conducts searches to ascertain the prerequisites
• - Publishes the application
• - Conducts in-depth examination
• - Raises objection to the application
• - Grants the patent

Patent Grant Procedure
Filing of patent application
Publication after 18 months
Pre Grant Opposition /
Representation by any person.
Request for examination
Examination: Grant or Refusal
Publication of Grant of patent
Post Grant Opposition to grant of patent
(Constitution of Opposition Board)
Early Publication
Decision By Controller

Who can apply for Patent?
• The inventor may make an application, either
alone or jointly with another, or his/their assignee
• or legal representative of any deceased inventor or
his assignee.

Specifications
• Provisional Application for patent may be accompanied by the
provisional specification. It should contain the description of invention
with drawing, if required. It is not necessary to include Claim. However,
the complete specification should be fairly based on the matter disclosed
in the provisional specification and should be filed within 12 months.
• If the complete specification is not filed within 12 months the application
is deemed to have been abandoned. Usually a provisional specification is
filed to establish priority of the invention in case the disclosed invention
is only at a conceptual stage and a delay is expected in submitting full
and specific description of the invention. Although, a patent application
accompanied with provisional specification does not confer any legal
patent rights to the applicants, it is, however, a very important document
to establish the earliest ownership of an invention. specification

Complete specification
• The complete specification is an essential document in the
filing of patent application along with the drawing to be
attached according to the necessity. Complete specification
should fully describe the invention with reference to
drawing, if required, disclosing the best method known to
the applicant and end with Claim/Claims defining the scope
of protection sought.. The specification must be written in
such a manner that person of ordinary skill in the relevant
field, to which the invention pertains, can understand the
invention.

• Normally, it should contain the following matter-
• Title of invention,
• 2) Field of invention,
• 3) Background of invention with regard to the drawback
associated with known art,
• 4) Object of invention,
• 5) Statement of invention,
• 6) A summary of invention,
• 53
• 7) A brief description of the accompanying drawing,
• 8) Detailed description of the invention with reference to
drawing/examples,
• 9) Claim(s),
Complete specification

What is e-Filing?
• E-filing is a service provided by the Intellectual
Property Office, India in order to enable
• customers to apply for a patent on-line
allowing from the User’s browser for the User
to:
• • Complete an electronic application form •
Provide the associated attachments •
Complete
• the necessary payment details

COPY RIGHT
• Copy right is a exclusive right which an author acquires for
his work of literary or artistic nature such as book, a
painting, a sculpture, a photograph, a motion picture..etc
• It is a right to print, multiple, publish or sell a work.
Pharma Management & Regulatory AffairsPHARMA MANAGEMENT & REGULATORY AFFAIRS

COPYRIGHT
• The economic right given to creators of literary and
artistic works.
• Includes the rights to:
Reproduce the work
Make copies
Perform or display the work publicly

Copyright holders have the right to…
…stop other parties from…
1. Making copies of the work.
2. Making changes to the work or creating new works
based on the original work.
3. Distributing the work.
4. Publishing the work.
5. Licensing the work to others.
6. Otherwise exploiting the work.

Duration of copy right protection
• Original literary, dramatic, artistic or musical works: the
life time of the author + period of 70 yrs from the end of
the year in which the author dies
• Computer generated works: 50 yrs from the date of
creation of work.
• Sound recordings: 50 yrs from the end of year in which it
was made or published.
• Broadcasts: 50 yrs from the end of year of broadcast
• Typographical arrangement of published editions: 25 yrs
from the year of 1st publication

WHAT IS A VALID COPYRIGHT NOTICE?
• A copyright should contain:
1. The word “Copyright”
2. A “c” in a circle (©)
3. The date of publication, AND
4. The name of either the author or the owner of all
the rights
5. “All Rights Reserved”
• EXAMPLE: A Year in Provence. Copyright © 1989
by Peter Mayle. All Rights Reserved.

HOW TO REGISTER YOUR WORK
• Registering a copyright is a simple process:
– Fill out the appropriate form for the type of work you
are registering.
– Enclose a deposit of one or two samples of the work
(depending on what type of work it is)
– Pay the fee per registration (if you are registering several
works that are part of one series, you may register the
works together as a group registration).

TRADEMARK
• Trademarks are commercial source indicators, distinctive
signs that identify certain goods or services produced or
provided by a specific person or enterprise.
• Trademark helps consumers to identify and purchase a
product or service based on whether its specific
characteristics and quality – as indicated by its unique
trademark – meet their needs
• Must prosecute infringement of trademark or risk losing the
mark yourself!!

What is Trademark?
• A trade mark (popularly known as brand name) in
layman’s language is a visual symbol which
• may be a word signature, name, device, label,
numerals or combination of colours used by one
• undertaking on goods or services or other articles
of commerce to distinguish it from other
• similar goods or services originating from a
different undertaking.

Key Features of Trademark
• · Trademark must be Distinctive
• · Trademark must be used in Commerce

What is Trademark?
• The selected mark should be capable of being represented
graphically (that is in the paper
• form).
• · It should be capable of distinguishing the goods or services of one
undertaking from
• those of others.
• · It should be used or proposed to be used mark in relation to goods
or services for the
• purpose of indicating or so as to indicate a connection in the course
of trade between the
• goods or services and some person have the right to use the mark
with or without identity
• of that person.

Types of Trademark
• Trademark,
• · Servicemark,
• · Collectivemark,
• · Certification Mark

Functions of Trademark
• Trademark performs four functions –
• · It identifies the goods / or services and its
origin;
• · It guarantees its unchanged quality;
• · It advertises the goods/services;
• · It creates an image for the goods/ services.

MARKS
• Trademarks® , ™
– A trademark identifies tangible good or product of a company or individual.
• Servicemarks ®, SM
–A service mark identifies the service s of a provider. Marks used by a
company can function as both.
• Trade names
–Once a trade name was used to denote any mark descriptive of a good
or service.
–Today, it is a company business name.

An Example of Copyright AND Trademark
• The gold-colored top of the New York Life building is
in the public domain and anyone can photograph it.
• However, that image also functions as a trademark
for the New York Life Company, and a competing
company could not use the image as a
representation of their company’s goods or
services..

TRADE SECRETS
• Any information that may be used in the operation
of a business and that is sufficiently valuable to
afford an actual or potential economic advantage.
• Examples: Formula for Coca-Cola; compilations of
information that provides a competitive advantage
(customer databases), advertising strategies

Geographical indications
•An indication used to identify agricultural, natural or manufactured goods
originating from a definite territory in India.
•It should have a special quality or characteristics or reputation based upon the
climatic or production characteristics unique to the geographical location.
•Examples of Geographical Indications in India are Darjeeling Tea, Kanchipuram
Silk Saree, Alphonso Mango, Nagpur Orange, Kolhapuri Chappal, Bikaneri
Bhujia, etc.

• The registration of a Geographical Indication is for
a period of ten years.
• Renewal is possible for further periods of 10 years
each.
• A trade mark is a sign which is used in the course of
trade and it distinguishes goods or services of one
enterprise from those of other enterprises.
• Geographical Indication is used to identify goods
having special characteristics originating from a
definite geographical territory.
Geographical indications

Legislative Framework of IP
Administration

CONTROLLER GENERAL OF PATENTS, DESIGNS
AND TRADEMARKS
(CGPDTM)
T M REGISTRY
DESIGN OFFICE
G.I. REGISTRY
Head Office
KOLKATA
Branch
DELHI
Branch
CHENNAI
Branch
MUMBAI
Head Office
MUMBAI
DELHI
KOLKATA
CHENNAI
A’BAD
IPTI ,NIIPM,
P.I.S. Nagpur
KOLKATA
PATENT OFFICE
CHENNAI

Law and Regulations
• Patents Act, 1970
– Amended in
• 1999
• 2002
• 2005
• Patents Rules, 2003
– Amended in
• 2005
• 2006

Legislative Measures -Patents
• 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
– Reversal of burden of proof – on the infringer
– Mandatory compulsory licence provision for food, drugs and
chemicals removed
– Right of patentee (importation also included)
• From 1.1.2005
– Product patents for food, chemical and pharmaceutical
We have met our international commitments

100
Patent Law - Salient Features
• Both product and process patent provided
• Term of patent – 20 years
• Examination on request
• Both pre-grant and post-grant opposition
• Fast track mechanism for disposal of appeals
• Provision for protection of bio-diversity and traditional
knowledge
• Publication of applications after 18 months with facility for
early publication
• Substantially reduced time-lines

101
Safeguards in the Patent Law
• Compulsory license to ensure availability of drugs at
reasonable prices
• Provision to deal with public health emergency
• Revocation of patent in public interest and also on
security considerations

Scope of Patentability Under
The Patents Act

What is an Invention?
“Invention” means a new product or process
involving an inventive step and capable of
industrial application

Patentable subject matter
Invention must
* Relates to a process or product or both
* Be new (novel)
* Involves an inventive step
* Be capable of industrial application

“New” means
Invention must not be
Published in India or elsewhere
In prior public knowledge or prior public use with in India
Claimed before in any specification in India

Inventive step
A feature of an invention that
• Involves technical advance as compared to
the existing knowledge or
• Have economic significance or both and
* Makes the invention not obvious to a person
skilled in the art

Industrial application means
Invention is capable of
being made or used in any kind of
industry

Section 3 exclusions
Section 3(a)
• Frivolous inventions
• Inventions contrary to well established natural
laws
Examples
 Machine that gives more than 100% performance
 Perpetual machine

Section 3(b)
Commercial exploitation or primary use of
inventions, which is
Contrary to
public order or
Morality
Examples
– Gambling machine,
– Device for house-breaking ,

Section 3(b)
Commercial exploitation or primary use of
inventions , which
Causes serious Prejudice to
 health or
 human, animal, plant life or
 to the environment
Examples
 Biological warfare material or device,
weapons of mass destruction
 Terminator gene technology,
 Embryonic stem cell

Checks and Balances
Section 3(b)
Excludes patents on
• GMOs – exploitation of which could be
contrary public order or morality or prejudicial
to human, animal or plant life or health or to
the environment
Effect : Only genetically modified micro-
organisms (GMOs) which do not fall under
section 3 (b) are patentable.

Section 3 ( c )
• Mere Discovery of a Scientific Principle or
• formulation of an Abstract Theory or
• discovery of any living thing or
• discovery of non–living substance occurring in nature
Examples
Newton’s Laws
Superconducting Phenomenon as such
Property of certain material to withstand mechanical
shock
Discovery of micro-organism
Discovery of natural gas or a mineral

Checks and Balances
Section 3(c)
Excludes patents on
•Naturally occurring Micro-organisms
Effect
Genetically modified microorganisms (GMOs) are
however, patentable.

Section3 (d)
The mere discovery of a new form of a
known substance which does not result
in the enhancement of the known efficacy
of that substance

Section3 (d) Explanation
For the purposes of this clause,
• salts, esters, ethers, polymorphs,
• metabolites, pure form, particle size,
• isomers, mixture of isomers,
• complexes, combinations and other derivatives of known
substances
shall be considered to be the same substance, unless they
differ significantly in properties with regard to efficacy.
Examples
– Crystalline forms of known substance

Checks and Balances
Section 3 (d) Explanation
Effect
Salts, esters, ethers, polymorphs, metabolite, pure
forms, particle size, isomers, complexes,
combinations and derivatives of a known substance
with enhanced efficacy are patentable

Section3 (d)
Mere discovery of any new property or
new use for a known substance or of the
mere use of a known process, machine or
apparatus, unless such known process
results in a new product or employs at least
one new reactant.
Examples
– New use of Aspirin for heart ailments,
– Mere new uses of Neem

Section 3(e)
Substance obtained by mere admixture resulting only in the
aggregation of the properties of the components thereof or a process
for producing such substance
Examples
 Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)]
 Solution of sugar and color additives in water to form a soft drink
However,
A mixture resulting into synergistic properties of mixture
of ingredients however, may be patentable - Soap,
Detergents, lubricants etc

Checks and Balances
Section 3 ( e )
Effect
 Substance obtained by mere admixture resulting
only in the aggregation of the properties of the
components thereof or
 a process for producing such substance
are not patentable
However
Synergistic formulations are patentable

Section 3 ( f )
Mere arrangement or re-arrangement or
duplication of known devices, each
functioning independently of one another in
a known way
Examples
A Bucket fitted with torch,
An Umbrella with fan
A Clock and radio in a single cabinet
A flour-mill provided with sieving

Section 3(h)
Method of Agriculture or Horticulture
Examples
Cultivation of algae ,
Producing new form of a known plant,
Preparation of an improved soil
However,
Agricultural Equipments are patentable

Section 3(i)
Any process for medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings or a
similar treatment of animals to render them free of disease or to
increase their economic value or that of their products
Examples
 Removal of cancer tumor
 Removal of dental plaque and carries
 Surgical processes
 Processes relating to therapy
 Method of vaccination,
 Blood transfusion
However ,
Treatment performed on tissues or fluids permanently removed from the body
Surgical,therapeutic or diagnostic Apparatus or instruments
are patentablePHARMA MANAGEMENT & REGULATORY AFFAIRS

Section3 exclusions
Section 3(j)
Plants & animals in whole or any part
thereof other than microorganisms, but
including seeds, varieties an d species and
essentially biological process for
production or propagation of plants &
animals

Section 3(j)
• Plants & animals in whole
• Parts of plants & animals
• Seeds
• Varieties & species
• Essentially biological processes for
propagation or production of the animals
& plants

Checks and Balances
Section 3(j)
Excludes patents on
• Plants and animals in whole or any parts thereof,
…… including seeds, varieties and species and
essentially biological processes for production or
propagation of plants and animals
Examples
– Clones and new varieties of plants
– A process for production of plants or animals if
it consists entirely of natural phenomena such as
crossing or selection
– Essentially biological Process

Section 3(k)
* mathematical method or
* business method or
* algorithms or
* computer programme per se
Examples
– Computer program by itself or as a record on a carrier
However
– New calculating machine
– combination of hardware and software
is patentable

Section 3(l)
A literary,dramatic, musical or artistic work or any other
aesthetic creation including cinematographic work and
television productions
These subject-matters fall under the
copyright protection

Section 3(m)
A mere scheme or rule or method of performing mental act or
method of playing game
Examples
•Scheme for learning a language
•Method for solving a crossword puzzle,
•Method of learning a language
•Method of teaching /learning
However,
•Novel apparatus for playing game or carrying
out a scheme is patentable

Section 3 (n)
Presentation of information
Examples
 Any manner or method of expressing information
whether by
spoken words
Visual display
symbols
diagrams
Information recorded on a carrier

Section 3 (o)
Topography of integrated circuits.
Examples
Mask works - circuits layout

Section 3 (p)
Inventions which are
Traditional Knowledge or an aggregation or duplication of known
properties of traditionally known component or components
Examples
Traditional Knowledge already in public domain
- Wound healing property of Haldi
However,
Any value-addition using Traditional Knowledge leading to a
new process or product ,which is novel with inventive step and
industrial applicability,
Extraction of Azadirachtin from Neem
can be patented

Section 4
Inventions falling within Section 20(1) of the
Atomic Energy Act, 1962 are not patentable
Effect
Inventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium,
Radium, Graphite, Lithium and more as notified by Central Govt. from time to time.
Non Patentable inventions

Stages from filing to grant of a
patent

Obtaining a patent
• File an application for patent
– With one of the patent offices based on territorial
jurisdiction of the place of office or residence of the
applicant /agent
– Pay the required fee
• Information concerning application form and details
of fee available at www.ipindia.nic.in
• Guidelines for applicants also available on this
website

Formality Check
• An Examiner checks the formal requirements
before accepting the application and the fee –
this is done immediately
• Issue of application number and the cash
receipt – this is done the same day
• In case of receipt of application by post, cash
receipt, application number is sent by post
within 2-3 days

Publication
• Application is kept secret for a period of 18 months
from the date of filing
• In 19th month, the application is published in the
official journal – this journal is made available on the
website weekly
• Applicant has an option to get his application
published before 18 months also
• In that case, application is published within one
month of the request

Request for Examination
• Application is examined on request
• Request for examination can be made either
by the applicant or by a third party
• A period of 48 months, from the date of filing,
is available for making request for
examination

Examination
• Application is sent to an Examiner within 1
month from the date of request for
examination
• Examiner undertakes examination w.r.t.
– whether the claimed invention is not prohibited
for grant of patent
– whether the invention meets the criteria of
patentability

Issue of FER
• A period of 1 to 3 months is available to
Examiner to submit the report to the
Controller
• 1 month’s time available to Controller to vet
the Examiner’s report
• First Examination Report (FER) containing gist
of the objections is issued within 6 months
from the date of filing of request

Response from the Applicant
• 12 months’ time, from the date of issue of
FER, is available to the applicant to meet the
objections
• If objections are met, grant of patent is
approved by the Controller – within a period
of 1 month

Pre-grant Opposition
• After publication, an opposition can be filed
within a period of 6 months
• Opportunity of hearing the opponent is also
available

Examination of Pre-grant Opposition
• Opposition (documents) is sent to the
applicant
• A period of 3 months is allowed for receipt of
response

Consideration of
Pre-grant Opposition
• After examining the opposition and the
submissions made during the hearing,
Controller may
– Either reject the opposition and grant the patent
– Or accept the opposition and modify/reject the
patent application
• This is to be done within a period of 1 month
from the date of completion of opposition
proceedings

Grant of a Patent
• A certificate of patent is issued within 7 days
• Grant of patent is published in the official
journal

STAGES - FILING TO GRANT OF PATENT
PUBLICATION OF APPLICATION
REQUEST FOR EXAMINATION
GRANT OF PATENT
3rd Party Representation
Revocation/Amendment
OPPOSITION
• PROMPTLY AFTER 18 MONTHS FROM P.D.
• WITHIN 48 MONTHS FROM F.D.
• ALL OBJECTIONS TO BE COMPLIED WITHIN 12
MONTHS
• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS
• WITHIN 12 MONTHS
FILING OF APPLICATION
PROVNL. / COMPLETE
Decision of
Controller
EXAMINATION-ISSUE OF FER
Appeal
Appellate Board

Renewal Fee
• To be paid within 3+6 months from date of recording in
the register [sec 142 (4) ]
• No fee for 1st and 2nd year
• Renewal fee, on yearly basis, is required to be paid for 3rd
to 20th for keeping the patent in force
• Delay upto six months from due date permissible on
payment of fee for extension of time
• Patent lapses if renewal fee is not paid within the
prescribed period

Indian Drug Regulatory System:
Government of India
Ministry of Health &
Family Welfare
DGHS
Central Drugs
Standard Control
Organization
(CDSCO)
Ministry of Science
& Technology
Indian Council
of Medical
Research
(ICMR)
Council of
Scientific &
Industrial
Research
(CSIR)
BARC
(Radioactive)
Ministry of Chemicals
& Petrochemicals
National
Pharmaceutical
Pricing Authority
(NPPA)
Department of
Chemical &
Petrochemicals
(DCP)
Department of
Pharmaceuticals
Ministry of
Commerce &
Industry
Patent
Office
Dept. of
Commerce &
Pharmexil
Controller
General of
Patent
DGFT
Ministry of
Environment &
Forest
GEAC-[Genetic
Engineering
Approval
Committee]
Department of
Biotechnology
r-DNA Advisory
Committee
Review
Committee
Genetic
Manipulation

Regulatory/Apex/Committee Functions
CDSCO Central Drugs Standard Control
Organization (1948)
Laying down standards, Clearance of new drugs, CLAA
items, Banning Drugs, Clinical Trails etc.
ICMR Indian Council of Medical Research
(1911)
Formulates, Coordinates and Promotes biomedical
research & Ethical Principles
GEAC Genetic Engineering Approval
Committee (1989)
Manufacture, Use, Import of Hazards
Microorganisms/Genetically Engineered Organisms or
Cells
DBT Department of Biotechnology (1986) It promote transgenic research, molecular biology of
human genetic disorders, brain research, and
commercialization of diagnostic kits and vaccines for
communicable diseases
AERB Atomic Energy Review Board (1983) Promotes Radio therapy & Research, Safety review for
Gamma Irradiators (Devices)
BARC Bhabha Atomic Research Centre
(1967)
Promotes Isotopes application in Medicine & also
monitoring usage of radioactive materials
DTAB Drug Technical Advisory Board (1950) To advise Central & State Govt. on Technical Matters
arising out of the Drugs & Cosmetics
RCGM Review Committee on Genetic
Manipulation (1989)
No Objection Certificate for Clinical Trial & also r-DNA
strains,
DCC Drug Consultative Committee (since
1951)
Advisory Committee to DTAB and Central & State Govt.
for uniform implementation of Various provisions of the
ActPHARMA MANAGEMENT & REGULATORY AFFAIRS

Introduction to Ministry of Health & Family Welfare
(MOH&FW)
• MOH&FW comprises 04 departments each of which is headed by a Secretary to
the Govt. of India
– Department of Health & Family welfare
– Department of AYUSH
– Department of Health Research
– Department of AIDS Control
• CDSCO is a separate division comes under DGHS, headed by DCG(I)
• Public health is one of the major objectives of Govt. of India and to achieve this it
is important that drugs/vaccines are available to the public are Quality, Safety,
Purity and Efficacious.
152

153

Goa
New Delhi
Chennai
CDSCO North Zone (Ghaziabad)
Kolkata
.
CDSCO West Zone (Mumbai)
CDSCO South Zone (Chennai)
CDSCO East Zone (Kolkata)
CDSCO, HQ
• Hyderabad
Ahmedabad
*New Zonal Offices : 2
(Ahmedabad & Hyderabad)
*Sub- Zonal Office : 3
*Port Offices/Airports : 11
*Central Laboratories : 6
35 SLAs= 29 States+ 6 UTs
Bengaluru
Geographical Location of CDSCO
Chandigarh
J&K
HQ
154

Functions of CDSCO
Approval of new drugs and clinical trials
Import Registration and Licensing
License approving of Blood Banks, LVPs, Vaccines, r-DNA
products & some Medical Devices (CLAA Scheme)
Amendment to D &C Act and Rules
Banning of drugs and cosmetics
Grant of Test License, Personal License, NOCs for Export
Testing of New Drugs
156

Functions of State Licensing Authorities
Licensing of Manufacturing Site for Drugs including API and
Finished Formulation
Licensing of Establishment for sale or distribution of Drugs
Approval of Drug Testing Laboratories
Monitoring of Quality of Drugs and Cosmetics marketed in the
country
Investigation and prosecution in respect of contravention of
legal provision
Recall of sub-standard drugs
157

Principles of GLP and Regulatory requirements
Objectives of GLP
• GLP makes sure that the data submitted are a true
reflection of the results that are obtained during the study.
• GLP also makes sure that data is traceable.
• Promotes international acceptance of tests.
158

What is GLP?
• Good Laboratory Practice (GLP) deals with the organization, process and conditions under which
laboratory studies are planned, performed, monitored, recorded, reported & archived. GLP
practices are intended to promote the quality and validity of test data (part 58 CFR 21). OR
• GLP is a quality system concerned with the organizational process and the conditions under which
non clinical health & environmental safety studies are planned, performed, monitored, recorded,
archived & reported. (Ref. Jurg P. Seiler-Switzerland, GLP, 2nd edition by Springer publication,
2005, Page 61).
• Schedule L-I regulations and guidelines have a significant impact on the daily operation of an
analytical laboratory.
• GLP is a regulation. It is not only good analytical practice. Good analytical practice is important,
but it is not enough. For example, the laboratory must have a specific organizational structure and
procedures to perform and document laboratory work. The objective is not only quality of data
but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP
work is the type and amount of documentation.
159

Pharmaceutical product
Submitted to regulatory authority
Verification
Repetition of experiment or Reconstruction of all
activities activities
(Direct confirmation) (Indirect confirmation)
Judgment taken
Accept / Reject
160

Part 1
Management and infrastructure
• Organization and management
• Quality management system
• Control of documentation
• Records
• Data-processing equipment
• Personnel
• Premises
• Equipment, instruments and
other devices
• Contracts
Part 2 Materials,
equipment, instruments
and other devices
• Reagents
• Reference substances
and reference materials
• Calibration, verifi cation
of performance and
• qualification of
equipment, instruments
and other devices
• Traceability
Part 3 Working
procedures
• Incoming samples
• Analytical
worksheet
• Validation of
analytical
procedures
• Testing
• Evaluation of test
results
• Certificate of
analysis
• Retained samples
Part 4
Safety
• General
rules
161

GLP
Internal Quality
System Audits
General Requirements Premises
Personal
Equipments
Chemicals and Reagents
Quality System
Microbiological Cultures
Reference Materials
Maintenance, Calibration,
and
Validation of Equipments
Good House Keeping
and SafetyManagement Review
Standard Operating
Procedures
Protocols and
Specifications Archive
Raw Data
Storage and Archival
162

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