BASICS OF IPR

By
Dr. Gopakumar G. Nair
Advisor to Pharmexcil, India
Gopakumar Nair Associates
Url: www.gnaipr.net
Email: gopanair@gnaipr.net
Bengaluru, 18th November, 2010
Think Away From The Box

GENERATE IDEAS…..
AND OWN
THEM…..IPR !
“The test of an innovation,
after all, lies not in its novelty,
its scientific content or its
cleverness. It lies in its success
in the market place”
Peter F. Drucker
 "Innovation now is more of a relay
race than a marathon.….The baton of an
idea might start at a university and move
to multiple companies before being
commercialized.
"Of course, batons can be dropped
along the way”.
- Henry Chesbrough, ED
Center for Open Innovation,
Haas School of Business,
University of California, Berkeley

Source: William M. Bulkeley, Gautam Naik and Justin Scheck Wall Street Journal/Livemint
 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.

 TRIPS
Intellectual Property Rights itself is
defined, in the context of the TRIPS
as a Right given to people over the
Creations Of Their Minds.

It usually gives the Creator an

Exclusive Right over the Use of his
Creations for a Certain Period Of
Time.
 WIPO
 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 Seminars.
 IP EVOLUTION
Property  Right

INTELLECT – PROPERTY – RIGHT

Idea  Expression  COPYRIGHT

Idea  Innovation  Invention  PATENT

Idea  Quality + Identity  TRADEMARK

Idea  Appearance  DESIGN

Idea  Keep Confidential

No Disclosure  TRADE SECRETS
 IP PORTFOLIO

INTELLECTUAL QUASI
PROPERTY RIGHTS INTELLECTUAL
 Patents PROPERTY RIGHTS
 Trade Marks
 Confidential

 Designs
Information
 Know How
 Copyright
 Trade Secrets
 Others
 Reputation
 IP PORTFOLIO
CONTD…..
Others:-
Others:- Data Exclusivity
 G.I, CBD, UPOV, Brand Loyalty/Goodwill
 IC Layouts, House Name
 Related Rights Client / Customer Lists
 Neighboring Rights Market Intelligence
 Domain Names Test Methods

In-house Stds/Specs

Impurity Profiles

Management Practices
PRODUCT PATENTS IN INDIA
 IP PORTFOLIO
Novel & TM (Amend) Bill,
Patent US7395821 2009 passed by
Inventive
Rajya Sabha on
10/08/2010

Copyright
Trademark
Multi-Haler™
Package Insert/
Information Leaflet External
Appearance

Trade Secret Confidential Informn

Know-how Design
&
Undisclosed Tech No. 211208
 INNOVATION THE
S EVOLUTION
Sources

 Incremental Innovations
 Need-based Solutions
 Intensive Research
 Disruptive inventions
 Serendipity
 THE EVOLUTION

 (Indian) Patents Act, 1970 is fast evolving

through Jurisprudence (similar to US Laws
35USC).

 Indian Patent Law & provisions thereof,

being TRIPs plus on Patentability &
being TRIPs plus on Public Interest,
with equitable balance between
Rights & Obligations is fast evolving
as a Model law for LDCs & DCs
 FOR
COMPLIANCE WITH TRIPS’ PROVISIONS

Amendments to Patent Act, 1970

1st Amendment, 1995 / 1999

2nd Amendment, 2002 / 2003
3rd Amendment 2004 / 2005
&
Rules, thereunder.
 WHAT IS A PATENT ?
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

 WHAT IS A PATENT ?
 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))

 PATENT - PATENTABILITY
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.
 NON-OBVIOUS

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.
 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)
 INVENTIVE STEP
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 to a person skilled in the art.
INDUSTRIAL APPLICATION (UTILITY)

 Be Useful.
 Must work / be workable.
At least one recognized, verifiable and
practical end-use.
 PATENTS ACT, 1970
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)
 PATENTS ACT, 1970
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
 PATENTS ACT, 1970
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
 INDIAN PATENTS ACT & RULES AS
AMENDED UP-TO-DATE HAVE MANY
FEATURES WHICH ARE CURRENTLY
BEING ADOPTED / ADAPTED GLOBALLY
 Ex: Sec 3(d) - Enhanced Efficacy essential for inventiveness
in new forms of already known pharma substances. (Gleevec
Case)

 Ex: Sec 3(e) - Synergy required in mere combinations.

(Decision of the Controller in application No.
IN/PCT/2002/00020/DEL)

 Ex: Sec 3(f) – Mere arrangement or rearrangement (KSR

v Teleflex)

 Ex: Sec 3(d) – Business Method, per se. (In Re Bilski)

 PATENTABILITY FILTER
 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
 PATENT GRANT PROCEDURE
Filing of patent application Prior art search

Early Publication 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
 INDIAN PATENT OFFICE PROCEDURES

 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.

 PATENTING IN INDIA
 Process Patent – Largely used to defend against
Sec. 104A (reversal of burden of Proof)

 Composition (FDC) Patents – India has the best experience

globally; NDDS substantially
(Fixed Dose Combination) driven by DPCO / NPPA
comparisons.

 Herbal Patents – High Potential; negatively impacted by

(Natural product impractical NBA (CBD - BA)
based) (Benefit Sharing)

 Plant Varieties – High Potential (PVPFA).

NCE/NME Drug Discovery Patents

 TRIPS PLUS –
TOUGHER PATENTABILITY
(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 & OBLIGATION/EXEMPTIONS OF
PATENTEE(S)
OBLIGATION/EXEMPTIONS
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
Disclosure of the invention
Exemption for research,
experimentation, imparting
instructions to pupils.
Use of Inventions for
Government’s 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

TRADITIONAL KNOWLEDGE
UPOV
Plant Varieties Protection Act (Art 27.3b)

Data Exclusivity (Art 39.3)

 INDUSTRIAL DESIGNS
 Must appeal to the eye
TRIPS
Part – II,  Ornamental or Aesthetic aspect of an
article.
Sec.4
Art. 25 & 26  3-D or 2-D features such as shape or
surface, patterns, lines or color.
 Industrial designs are applied to products
of industry and handicraft, technical and
medical instruments, watches, jewelry,
house wares, electrical appliances, luxury
items, vehicles, architectural structures,
textile designs.
 Does not protect any technical features of
the article to which it is applied to.
Double Syringe
 DESIGNS
 Indian Designs Act, 2000 & Rule, 2001 (amended upto
2008).
 To promote and protect the design element of industrial
production.
 Aimed to enact a detailed classification of design to
conform to the international system and
 To take care of the proliferation of design related activities
in various fields.
 DESIGN PATENT
Title: A Dispensing Device for Bioassay Method
1. Design No. 196748 dated 12th August 2004

2. Design No. 196749 dated 12th August 2004

Patentees – Khale Sangeeta Shailesh and
Khale Ashok Shamrao
 TRADEMARKS
TRIPS Word Mark
Part – II, Sec.2
Device Marks
Art. 15 to 21
(Signs, Symbols, Logos)
Collective Marks
Certification Marks
Service Marks
 TRADEMARKS
 Must be graphically represented
 Must be distinctive / distinguishable
 Must not be descriptive
 Must not be deceptively similar to known /
well-known marks /Generics
• Frusemide – Lasix/Frusemex
• Cefixime – ZIFI, CEFI, Cefixin
Avoid –
Geographical Indications / Deities
National Leaders / Heroes / Symbols / Laudatory
words
PHARMACEUTICALS IN TRADEMARKS
ACT
While proceeding for Marketing Approval,
adopt caution while choosing Brand Names
Case Study:
Zydus Cadilla v Sun Pharma
Trademark violation suit regarding an anti-
depressant drug
Venz OD of Zydus and
Veniz XR of Sun Pharma.

Active ingredient---VENlafexine

Sec 13: Prohibits registration of INN as TM

 RECENT TRADEMARK CASE
4th May, 2010
Application seeking use of Gandhiji’s image on Montblanc
pens rejected

Solicitor general Gopal

Subramaniam assured the Bench
headed by Chief Justice K G
Balakrishnan that the Centre has
refused permission to Mont Blanc
for use Gandhi's image on their pens
on the ground that use of word or
picture of Mahatma Gandhi being
a national emblem cannot be used
for commercial purpose.
 COPYRIGHTS & RELATED RIGHTS

TRIPS What is Copyright ?

Part – II, Sec.1
Art. 9 to 14 Copyright is a legal term
describing rights given to
creators for their literary
and artistic works.
 COPYRIGHT
What is covered by Copyright ?

The kinds of works covered by copyright

include : literary works such as novels, poems,
plays, reference works, newspapers and computer
programs; databases; films, musical compositions,
and choreography; artistic works such as paintings,
drawings, photographs and sculpture; architecture;
and advertisements, maps and technical drawings.
COPYRIGHT - EXTENSION
IT Revolution !
Recordings
Broadcastings
Audio visual works
Computer programs
Digital databases
Internet/web
Cable and Satellite T.V.
Copyright Amendment Bill, 2010

Amitabh Bachchan to copyright his voice!

 IPR AND COPYRIGHT
Quoting Medical References from Journals and Books

“Copyright” / “All rights reserved”

“Do not use, reprint, reproduce or distribute without prior
 permission”
Avoid verbatim reproduction - Likely to cause
Copyright violations.
 Always acknowledge / obtain prior permission.
 Abstract / Summary may be written in one’s own
language / quote the source.

Copyright violations could lead to

criminal/civil suits
Could lead to imprisonment too !
Be Aware / Beware of the Web / Domain in
the new global regime.

× Use of internet for selling / marketing

× Downloading from Internet (except for personal

use)

MUST ALWAYS HONOUR IPRs

(Copyrights, Patents etc.)
 RECENT COPYRIGHT CASES

Chetan Bhagat Vs 3 Idiots

• Oct, 2010 - Kolkata HC declares that Sa Re Ga Ma

has the right to grant License.
• April 2010 - Kolkata HC restrains the use of the song
Apni Toh Jaise Taise’ from ‘Laawaris’ in the movie
‘Houseful’.
 DISTINCTION AND DEGREE OF
PROTECTION
Copyright – Expression of ideas
– Protection is specific and its
protection scope is fairly narrow
(Narrow Protection)

Patents – novel idea itself when applied and

useful.
– can cover a relatively broader scope
including various applications or
programs.
(Broad Protection incl. Equivalence)
 PHARMACEUTICALS IN DESIGN ACT
 Shape, size, colour etc.

Eg: US patent D380825

granted to Merck & Co., Inc.

PHARMACEUTICALS IN COPYRIGHT ACT

 Package Inserts /
Information Leaflet
 G.I.
(GEOGRAPHICAL INDICATIONS)
Geographical Indications of goods are
TRIPS defined as that aspect of industrial
Part – II, Sec.3 property which refer to the geographical
Art. 22 to 24 indication referring to a country or to a
place situated therein as being the
country or place of origin of that
product. Typically, such a name conveys
an assurance of quality and
distinctiveness which is essentially
attributable to the fact of its origin in
that defined geographical locality, region
or country.
 GEOGRAPHICAL INDICATION
India, as a member of the World Trade Organization
(WTO), enacted the Geographical Indications of Goods
(Registration & Protection) Act, 1999 has come into
force with effect from 15th September 2003.

 Geographical Indications of Goods

(Registration & Protection) Act, 1999
 Geographical Indications of Goods

(Registration & Protection) Rules, 2002

 GEOGRAPHICAL INDICATION

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.
 GEOGRAPHICAL INDICATION
Examples of Indian GI
 Basmati Rice
 Darjeeling Tea
 Kanchipuram Silk
 Alphanso Mango
 Nagpur Orange
 Kolhapuri Chappal
 Bikaneri Bhujia
 Agra Petha
 Goa Feni
 Palakkadan Matta
 Navara Rice
 RECENT GI CASE
Tirupati Ladoo

• October, 2010 - Rectification Petition filed with GI Registry.

• June, 2010 - Madras High Court dismissed the petition on the
grounds that alternate remedy of rectification under the GI Act has
not been exhausted.
• Oct, 2009 - PIL filed by J Mohanraj in Madras High Court
challenging the grant of GI for ‘Tirupati laddu’.
• Sept, 2009 - GI granted to Tirumala-Tirupati Devasthanams.
 THE INDIAN ‘BAYH DOLE’ BILL

Public Funded R&D (Protection, Utilization and

Regulation of Intellectual Property) Bill, 2008.

A Bill to Organize, Promote, and Regulate the Public

Availability of Intellectual Property originating from
Government Funded Research and Development.
 THE INDIAN BAYH DOLE BILL
CONTD…..
Salient Features
 To Promote Creativity and to Provide Incentives for creativity.
 To provide Access To Innovation to all significant stakeholders For
Public Good.
 Imposes Obligations and creates Rights to optimize the potential of
Government in R&D.
 To promote collaboration between government, private enterprises
and non-government organizations; to Promote Commercialization
of IP generated out of Government funded R&D and to promote
the culture of innovation in the country.
 To increase the responsibility of Universities and Research
Institutions to encourage students, faculty and scientists to
innovate.
 USEFUL LINKS
http://www.patentoffice.nic.in
http://www.wipo.int
http://www.uspto.gov
http://ep.espacenet.com
http://ipindia.nic.in/girindia/