BASICS OF IPR

By
Dr. Gopakumar G. Nair
Advisor to Pharmexcil, India
“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
 WORLD ECONOMY : THE PARADIGM SHIFT

Agri. Industrial Knowledge

Economy Economy Economy

Land Capital Innovation

Machinery Applied research
Labour Science &
Management
Technology
IPR
3
Think Away From The Box

GENERATE IDEAS…..
AND OWN THEM…..IPR !
 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
Information
 Designs
 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-
Package Insert/ Haler™
Information External
Leaflet Appearance

Trade Secret Confidential

Know-how Informn Design
& No. 211208
Undisclosed Tech
 INNOVATIONS THE 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.
PHARMA INNOVATIONS !!!

22
 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
(Fixed Dose Combination) substantially driven by
DPCO / NPPA comparisons.

 Herbal Patents – High Potential; negatively impacted

(Natural product by 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)
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/EXEMPTIONS
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.
 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
Double Syringe features of the article to which it is
applied to.
 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
TRIPS are defined as that aspect of
Part – II, Sec.3 industrial property which refer to
Art. 22 to 24 the geographical 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.
 USEFUL LINKS

http://www.patentoffice.nic.in

http://www.wipo.int

http://www.uspto.gov

http://ep.espacenet.com

http://ipindia.nic.in/girindia/