Basics of IPR

8/7/2019 Basics of IPR

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BASICS OF IPR

By

Dr. Gopakumar G. Nair

Advisor to Pharmexcil, IndiaGopakumar Nair Associates

Url: www.gnaipr.net

Email: [email protected]

Bengaluru, 18th November, 2010


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GGENERATEENERATE IIDEASDEAS....

AANDND OOWNWN TTHEMHEM....IPRIPR !!

Think Away From The BoxThink Away From The Box


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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


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"Innovation now is more of a relay race

than a marathon..The baton of an ideamight start at a university and move to

multiple companies before being

commercialized."Of course, batons can be dropped along

the way.

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

- Henry Chesbrough, EDCenter for Open Innovation,

Haas School of Business,

University of California, Berkeley


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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.


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TRIPS

Intellectual Property Rights itself isdefined, 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.


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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.


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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


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INTELLECTUAL

PROPERTY RIGHTS

Patents

Trade Marks

Designs

Copyright

Others

QUASI

INTELLECTUAL

PROPERTY RIGHTS

ConfidentialInformation

Know How

Trade Secrets Reputation

IP PORTFOLIO


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Others:-

Data Exclusivity

Brand Loyalty/Goodwill

House Name Client / Customer Lists

Market Intelligence

Test Methods

In-house Stds/Specs

Impurity Profiles

Management Practices

Others:-

G.I, CBD, UPOV,

IC Layouts, Related Rights

Neighboring Rights

Domain Names

IP PORTFOLIO

CONTD..


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PRODUCT PATENTS IN INDIA


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IP PORTFOLIO

Patent US7395821

TrademarkMulti-

Haler

Design

No. 211208

Trade Secret

Know-how

Copyright

TM (Amend) Bill,2009 passed by

Rajya Sabha on

10/08/2010

Novel &Inventive

External

Appearance

Confidential

Informn

&

Undisclosed Tech

Package Insert/

Information

Leaflet


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INNOVATIONS

Sources

Incremental Innovations

Need-based Solutions

Intensive Research

Disruptive inventions

Serendipity

THE EVOLUTION


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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


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FOR

COMPLIANCEWITH TRIPS PROVISIONS

Amendments to Patent Act, 1970

1st Amendment, 1995 / 1999

2nd Amendment, 2002 / 2003

3rd Amendment 2004 / 2005

&

Rules, thereunder.


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WHAT IS APATENT ?

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 theinvention


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A conditional grant

Balance of Rights and Obligations

Subjectto otherlaws of land

Grantedto owner of invention/assignee

(Recent judgments of HC and SC takes note of

third party interests in granting / refusing

injunctions)

WHAT IS A PATENT ?


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ThreeStatutoryBenchmarks for Patentabilityasper

the Patents Act, 1970:

1. Novelty

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

3. Industrial Applicability (Section 2(1)(ac))


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PATENT - PATENTABILITYAn 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.


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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.


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NCE/NME

APIProduct Patent

Process Patent

Me t

ooderivatives Imatinib, Erl

otnib

Formulation

Dosage Forms Tablet, Capsule, etc

Release Profile Controlled, Slow etc.

NDDS - Transdermal Patches,Transmucosal Drug Delivery.

New Use Aspirin (analgesic & blood

thinner)

Famotidine

Tiotidine


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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.


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INDUSTRIAL APPLICATION

(UTILITY)

Be Useful.

Must w

ork / be w

orkable.

At least one recognized, verifiable

and practical end-use.


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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 ToThe Environment;

(c) Mere Discovery OfScientific Principle,

Abstract Theory, Living Thing Or Non-

living Substances(d) Mere Discovery Of New Form, New

Property, New Use Of AKnown Process,

Machine Or Apparatus (EFFICACY)


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(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 OfTreatment.

(j) Plants, Animals, Including Seeds Varieties,

Species, Biological Processes.

Exception: Microorganisms

PATENTS ACT, 1970


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(k) Mathematical Or Business Method Or A

Computer Program Per Se Or

Algorithms;

(l) Literary, Dramatic, Musical Or ArtisticWork, 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

PATENTS ACT, 1970


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INDIAN PATENTS ACT & RULES AS

AMENDED UP-TO-DATE HAVE MANY

FEATURES WHICH ARE CURRENTLY BEINGADOPTED /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)


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PATENTABILITY FILTER

Prior use/ prior publication/ prior disclosure Industrial applicability

Novelty

Non-

obvi

ousness- inventiveness

Sec. 3- Not patentable

Written description / enablement

requirements

Application/ specification/ claims

Patent prosecution

Maintenance / Defense after grant


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PATENT GRANT PROCEDUREFiling 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

Prior art search


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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.


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PPATENTINGATENTING IINN IINDIANDIA

Process Patent

Composition (FDC) Patents

Herbal Patents

Plant Varieties High Potential (PVPFA).

(Fixed Dose Combination)

India has the bestexperience globally; NDDSsubstantially driven by

DPCO / NPPA comparisons.

(Natural product

based)

High Potential; negatively impactedby impractical NBA (CBD - BA)

(Benefit Sharing)

Largely used to defend against

Sec. 104A (reversal of burden of Proof)

NCE/NME Drug Discovery Patents


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TRIPS PLUS

TOUGHER PATENTABILITY

1. Inventive Step & Sec 3

2. Pre & Post grant opposition

3. Revocation through IPAB

4. Counter-claim for revocation in an infringement suit.

(Balance against unfair monopoly)

COMPULSORY LICENSINGCOMPULSORY LICENSING

GOVERNMENT USEGOVERNMENT USE


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RRIGHTSIGHTS & O& OBLIGATIONBLIGATION/E/EXEMPTIONSXEMPTIONS OOFF PPATENTEEATENTEE((SS))

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.

OBLIGATION/EXEMPTIONS

Discl

osure

of the inventi

on

Exemption for research,

experimentation, imparting

instructions to pupils.

Use of Inventions for

Government

sown purp

oses

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.quid pro quo


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CBD

CONVENTION ON BIODIVERSITY

UPOV

Plant Varieties Protection Act (Art 27.3b)

Data Exclusivity (Art 39.3)

TRADITIONAL KNOWLEDGE


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INDUSTRIAL DESIGNS

TRIPSPart II,

Sec.4Art. 25 & 26

Must appeal to the eye

Ornamental or Aesthetic aspect of

an article.

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


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DESIGNS

Indian Designs Act, 2000 & Rule, 2001 (amendedupto 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.


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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 andKhale Ashok Shamrao


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TRADEMARKS

TRIPS

Part II, Sec.2

Art. 15 to 21

Word Mark

Device Marks

(Signs, Symbols, Logos)Collective Marks

Certification Marks

Service Marks


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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

TRADEMARKS

Avoid Geographical Indications / Deities

National Leaders / Heroes / Symbols /

Laudatory words


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PPHARMACEUTICALSHARMACEUTICALS IINN TTRADEMARKSRADEMARKS AACTCT

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 ofZydus and

Veniz XR of Sun Pharma.

Active ingredient---VENlafexine

Sec 13: Prohibits registration of INN as TM


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RECENTTRADEMARK CASE

4th May, 2010

Application seeking use of Gandhijis image on

Montblanc pens rejected

Solicitor general Gopal

Subramaniam assured the Benchheaded by Chief Justice K G

Balakrishnan that the Centre has

refused permission to Mont Blanc

foruse Gandhi's image on theirpens

on the ground that use of word orpicture of Mahatma Gandhi being

a national emblem cannot be used

for commercial purpose.


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COPYRIGHTS & RELATED RIGHTS

TRIPS

Part II, Sec.1

Art. 9 to 14

What is Copyright ?

Copyright is a legal termdescribing rights given

to creators for their

literary and artistic

works.


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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.


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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!


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IPR AND COPYRIGHT

Avoid verbatim reproduction - Likely to cause

Copyright violations.

Always acknowledge / obtain prior permission.

Abstract / Summary may be written in ones

own language / qu

ote the s

ource.

Copyright / All rights reserved

Do not use, reprint, reproduce or distribute without prior permission

Quoting Medical References from Journals and Books

Copyright violations could lead to

criminal/civil suits

Could lead to imprisonment too !


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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.)


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RECENT COPYRIGHT CASES

Chetan Bhagat Vs 3 Idiots

Oct, 2010 - Kolkata HC declares that Sa Re GaMa has the right to grant License.

April 2010 - Kolkata HC restrains the use ofthe song Apni Toh Jaise Taise from Laawaris

in the movie Houseful.


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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)


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Shape, size, colour etc.

Package Inserts /

Information Leaflet

Eg: US patent D380825

granted to Merck & Co.,

Inc.

PHARMACEUTICALS IN DESIGN ACT

PHARMACEUTICALS IN COPYRIGHT ACT


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G.I.

(GEOGRAPHICAL INDICATIONS)

TRIPS

Part II, Sec.3

Art. 22 to 24

Geographical Indications of goods

are defined as that aspect of

industrial property which refer to

the geographical indication

referring to a country or to a placesituated therein as being the

country or place oforigin of that

product. Typically, such a name

conveys an assurance of quality

and distinctiveness which isessentially attributable to the fact

of its origin in that defined

geographical locality, region or

country.


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GEOGRAPHICAL INDICATION

India, as a member of the World TradeOrganization (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


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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 goo

ds should be pr

oducedor processed or prepared in that territory.

It should have a special quality or reputation

or other characteristics.


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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



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RECENT GI CASE

October, 2010 - Rectificati

on Petiti

on 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 Courtchallenging the grant of GI for Tirupati laddu.

Sept, 2009 - GI granted toTirumala-Tirupati

Devasthanams.

Tirupati Ladoo


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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.



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CONTD..

Salient Features

To Promote Creativity and to Provide Incentives forcreativity.

To provide Access To Innovation to all significantstakeholders For Public Good.

Imposes Obligations and creates Rights tooptimize thepotential of Government in R&D.

To promote collaboration between government, privateenterprises and non-government organizations; toPromote Commercialization of IP generated out of

Government funded R&D and to promote the culture ofinnovation in the country.

To increase the responsibility of Universities andResearch Institutions to encourage students,faculty and scientists to innovate.


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USEFUL LINKS

http://www.patentoffice.nic.in

http://www.wipo.int

http://www.uspto.gov

http://ep.espacenet.com

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

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Basics of IPR

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