By

Dr. Gopakumar G. Nair

Advisor to Pharmexcil, India
Gopakumar Nair Associates
Url: www.gnaipr.net
Email: gopanair@gnaipr.net
Ahmedabad, 24th November,
2010

Property Right
INTELLECT PROPERTY RIGHT
Idea Expression COPYRIGHT
Idea Innovation Invention PATENT
Idea Quality + Identity TRADEMARK
Idea Appearance DESIGN

TRADE SECRETS

Idea Keep Confidential

Intellectual property (IP) refers to

creations of the mind: inventions,
literary
symbols,

and

artistic

names,

works,
images,

designs used in commerce.

and
and

Creativity is the ability to

Think / come up with new idea
design new inventions
produce works of art
solve problems in new ways, or
develop a new idea based on an
original knowledge.
novel, or unconventional
approach.

Think Away
From The
Box

Novel &
Inventive

Patent US7395821

Copyright

TM (Amendment)
Bill, 2009 passed
by Rajya Sabha on
10th August, 2010

Trademark
Multi-Haler

Package Insert/
Information Leaflet

Trade Secret
Know-how
7

External
Appearance
Confidential Informn
&
Undisclosed Tech

Design
No. 211208

TRIPS
The TRIPS (Trade Related Aspects
of

Intellectual

Property

Rights)

Agreement came into being with

the establishment of the WTO
(World

Trade

Organization)

effective from 1st January, 1995.

 UN

organization

dedicated

to

promoting the use and protection

of works of the human spirit.
Headquarters in Geneva,
Switzerland.
184 nations as member states.
Manages all IPs.
Training through Academy and

TRIPS Article 27
Patentable Subject Matter

1. Subject to the provisions of paragraphs2 and 3, patents

shall be available for any inventions, whether products or
processes, in all fields of technology, provided that they are
new, involve an inventive step and are capable of industrial
application.
[1]

Subject to paragraph4 of Article65, paragraph8 of

Article70 and paragraph3 of this Article, patents shall be
available
and
patent
rights
enjoyable
without
discrimination as to the place of invention, the field of
technology and whether products are imported or locally
produced.

2. Members may exclude from patentability inventions, the

prevention within their territory of the commercial
exploitation of which is necessary to protect ordrepublic or
morality, including to protect human, animal or plant life or
health or to avoid serious prejudice to the environment,

TRIPS Article 27
Patentable Subject Matter

3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the
treatment of humans or animals;
(b) plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or
animals other than non-biological and microbiological
processes.
However,
Members shall provide for the
protection of plant varieties either by patents or by an
effective suigeneris system or by any combination thereof.
The provisions of this subparagraph shall be reviewed four
years after the date of entry into force of the WTO
Agreement.
[1] For the purposes of this Article, the terms "inventive step"
and "capable of industrial application" may be deemed by a
Member to be synonymous with the terms "non-obvious" and
"useful" respectively.

A patent is a protection given to a

patentee for an invention for a limited
term by the government for disclosing the
invention
Right to exclude others from using your
invention.
Owner has a qualified right to use the
invention

 A conditional grant
Balance of Rights and
Obligations
Subject to other laws of land
Granted to owner of
invention/assignee
(Recent
judgments of HC and SC
takes note of third party interests in
granting / refusing injunctions)

Three Statutory Benchmarks for

Patentability as per the Patents Act,
1970:
1. Novelty
2.

Inventive Step (Section 2(1)(ja))

3. Industrial Applicability (Section

2(1)(ac))

An invention can be patented if it is

NOVEL: Must be New,
Must DISTINGUISH from State of the
Art
(PRIOR ART)
Must have INVENTIVE STEP
Non-obvious to a person Skilled in the
Art
Must have INDUSTRIAL APPLICATION
Must be Useful
Must have Utility
Must not be covered by Sec. 3 and Sec. 4.

THE DIFFERENCES BETWEEN THE

CLAIMED INVENTION and the PRIOR ART are
such that the subject matter as a whole
WOULD NOT HAVE BEEN OBVIOUS at the
time the invention was made to a PERSON
SKILLED IN THE ART, to which the subject
matter pertains.

Section 2(1)(ja):
"inventive step" means a feature of an
invention

that

involves

technical

advance as compared to the existing

knowledge

or

having

economic

significance or both and that makes

the

invention

not

obvious

person skilled in the art.

to

 Be Useful
Must work / be workable
At least one recognized, verifiable
and practical end-use

 Prior use/ prior publication/ prior

disclosure
Industrial applicability
Novelty
Non-obviousness- inventiveness
Sec. 3 - Not patentable
Written description / enablement
requirements
Application/ specification/ claims
Patent prosecution
Maintenance / Defense after grant

What is not Patentable

(a) Frivolous, Contrary To Natural Laws
(b) Contrary To Public Order Or Morality,
Prejudice To Human, Animal Or Plant
Life Or Health Or To The Environment;
(c) Mere Discovery Of Scientific Principle,
Abstract Theory, Living Thing Or
Non- living Substances
(d) Mere Discovery Of New Form, New
Property, New Use Of A Known Process,
Machine Or
Apparatus (EFFICACY)

What is not Patentable

(e) Mere Admixture (SYNERGY)
(f) Mere Arrangement, Re-arrangement,
Duplication of known devices.
(g) Omitted (Testing Methods)
(h) Method Of Agriculture Or Horticulture;
(i) Method Of Treatment.
(j) Plants, Animals, Including Seeds
Varieties, Species, Biological Processes.
Exception: Microorganisms

What is not Patentable

(k) Mathematical Or Business Method Or A
Computer Program Per Se Or
Algorithms;

(l) Literary, Dramatic, Musical Or Artistic

Work,
Other Aesthetic Work
(m) Mere Scheme, Rule, Method Of
Performing
Mental Act, Playing Game;
(n) A Presentation Of Information;
(o) Topography Of Integrated Circuits;
(p) Traditional Knowledge

When to file :Earliest as Provisional Application

Could continue working &
file Complete Specification later
To establish Priority Date
- To establish early Ownership
- To Pre-empt Others
-Complete specification to be filed within
12 months of filing Provisional
Application
-

Title
Technical Field
Background and Prior Art
Current Problem / Drawback / Gap
Solution to the problem/improvement
Summary of Invention
Detailed Description
Experiments/Trials/Examples (incld. Tabular
column if any)
Claims
Abstract

1) Optional-Early Publication
OR
18 months publication (automatic)
2) Request for Examination
3) First Examination Report
4) Responses to & fro
5) Acceptance for Grant OR Rejection
6) Patent Term 20yrs from date of filing.

Filing of patent application

Early Publication

Prior art search

Publication after 18 months

Request for examination

Pre Grant Opposition /
Representation by any person.

Examination: Grant or Refusal

Publication of Grant of patent
Post Grant Opposition to grant of patent
(Constitution of Opposition Board)
Decision By Controller

 Inventor & Consumer friendly. (Balance of Rights &

Obligations).
Research & Regulatory Exemption during Patent Life
(Sec 47(3), Sec. 107A(a)).
Four Patent Offices in four regions (Unique to India).
IAS - Senior Techno-legal officer appointed as CG.
Patent Office procedures revamped, revitalized,
digitalized and made transparent.
Out of box solutions being implemented to
expedite
office actions.
India becoming ISA / IPEA.

Prior Art
State of the Art
Patentability (Novelty & Obviousness)
Patent Validity / Expiration
Legal Status
Infringement Analysis to Avoid / to Sue
Freedom to Market
Opposition
Potential Partners for Licensing In/ Licensing
Out,
Alliances, M&A
Working Around
Patent Watch / Monitor Patent
Patent Family

 Only National Filing

Only Convention filing (US /EU etc.)
(With
National + Convention Country

permission)

National + US + EU
Only PCT

Any or all 142 States

(With

National + PCT

permission)

Any or all 142 States

INTELLECTUAL PROPERTY RIGHTS

ARE TERRITORIAL

 Provisional Application
Complete Application
Convention Application
Application for Patent of Addition

(CIP)
Cognate Application
Divisional Application
PCT International Application
PCT National Phase Application

(Balance against unfair monopoly)

1. Inventive Step & Sec 3
2. Pre & Post grant opposition
3. Revocation through IPAB
4. Counter-claim for revocation in an
infringement suit.

COMPULSORY LICENSING
GOVERNMENT USE

RIGHTS
Exclusive right to make,
use, sell or import the
patented invention.
Exclude others from
unauthorized use of the
patented invention.
Grant licenses, Assign
rights or enter into
agreements.
To sue others for
infringement.
To surrender patent rights.

quid pro quo

OBLIGATION/EXEMPTION
S
Disclosure of the invention
Exemption for research,
experimentation, imparting
instructions to pupils.
Use of Inventions for
Governments own purposes or
for public services.
Acquisition of Inventions by
Central Government.
Compulsory License / 3rd Party
use.
Prohibit or Restriction of
publication of patent information
considered relevant for defense
purposes.

CBD
CONVENTION ON BIODIVERSITY
UPOV
Plant Varieties Protection Act
Data Exclusivity

GNAs

Sources

Incremental Innovations

Need-based Solutions

Intensive Research

Disruptive inventions

Serendipity

Famotidine

NCE/NME
API
Product Patent
Tiotidine
Process Patent
Me too derivatives Imatinib, Erlotnib
Formulation
Dosage Forms Tablet, Capsule, etc
Release Profile Controlled, Slow etc.
NDDS - Transdermal Patches,
Transmucosal Drug Delivery.
New Use Aspirin (analgesic & blood
thinner)