basics of ipr by dr. gopakumar g. nair advisor to pharmexcil, india gopakumar nair associates url: ...

BASICS OF IPR

ByDr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: gopanair@gnaipr.netBengaluru, 18th November, 2010

GENERATE IDEAS…..GENERATE IDEAS….. AND OWN AND OWN

THEM…..IPR !THEM…..IPR !

Think Away From The Think Away From The BoxBox

“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”.

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

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

INTELLECTUALPROPERTY

RIGHTS Patents Trade Marks Designs Copyright Others

QUASIINTELLECTUALPROPERTY RIGHTS Confidential

Information Know How Trade Secrets Reputation

IP PORTFOLIO

Others:- Data ExclusivityBrand Loyalty/Goodwill House NameClient / Customer ListsMarket Intelligence Test MethodsIn-house Stds/SpecsImpurity ProfilesManagement Practices

Others:- G.I, CBD, UPOV, IC Layouts, Related Rights Neighboring Rights Domain Names

IP PORTFOLIOCONTD…..

PRODUCT PATENTS IN INDIA

IP PORTFOLIO

Patent US7395821

TrademarkMulti-

Haler™

Design No.

211208

Trade SecretKnow-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

INNOVATIONS

Sources

Incremental Innovations

Need-based Solutions

Intensive Research

Disruptive inventions

Serendipity

THE EVOLUTION

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 / 20033rd 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

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)

WHAT IS A PATENT ?

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 - PATENTABILITYAn invention can be patented if it is

NOVEL: Must be New, Must DISTINGUISH from “State of the

Art” (PRIOR ART)

Must have INVENTIVE STEPNon-obvious to a person “Skilled in the

Art”

Must have INDUSTRIAL APPLICATIONMust be UsefulMust 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.

NCE/NMEAPI Product PatentProcess 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)

Famotidine

Tiotidine

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, 1970What 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

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

PATENTS ACT, 1970

INDIAN PATENTS ACT & RULES AS AMENDED UP-TO-DATE HAVE MANY FEATURES WHICH ARE CURRENTLY

BEING ADOPTED / ADAPTED GLOBALLYEx: 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

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

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 INDIAPATENTING IN INDIA

Process Patent –

Composition (FDC) Patents –

Herbal Patents –

Plant Varieties – High Potential (PVPFA).

(Fixed Dose Combination)

India has the best experience globally; NDDS substantially driven by DPCO / NPPA comparisons.

(Natural product based)

High Potential; negatively impacted by impractical NBA (CBD - BA) (Benefit Sharing)

Largely used to defend against Sec. 104A (reversal of burden of

Proof)

NCE/NME Drug Discovery Patents

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

RIGHTS & OBLIGATION/EXEMPTIONS OF RIGHTS & OBLIGATION/EXEMPTIONS OF PATENTEE(S)PATENTEE(S)

RIGHTSExclusive 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/EXEMPTIONSDisclosure of the inventionExemption 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.quid pro quo

CBD

CONVENTION ON BIODIVERSITY

UPOV

Plant Varieties Protection Act (Art 27.3b)

Data Exclusivity (Art 39.3)

TRADITIONAL KNOWLEDGE

INDUSTRIAL DESIGNSTRIPSPart – 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

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

TRIPSPart – II, Sec.2Art. 15 to 21

Word MarkDevice Marks(Signs, Symbols, Logos)

Collective MarksCertification MarksService Marks

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

PHARMACEUTICALS IN PHARMACEUTICALS IN TRADEMARKS ACTTRADEMARKS ACTWhile 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 CASE4th May, 2010Application 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

TRIPSPart – II, Sec.1Art. 9 to 14

What is Copyright ?

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 - EXTENSIONIT Revolution !

RecordingsBroadcastingsAudio visual worksComputer programsDigital databasesInternet/webCable and Satellite T.V.

Copyright Amendment Bill, 2010

Amitabh Bachchan to copyright his voice!

IPR AND COPYRIGHT

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” / “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 !

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)

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

G.I.(GEOGRAPHICAL INDICATIONS)

TRIPSPart – II, Sec.3Art. 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 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 INDICATIONIndia, 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 INDICATIONWhat 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 inthat territory.It should have a special quality or reputation or other characteristics.

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

GEOGRAPHICAL INDICATION

RECENT GI CASE

• 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.

Tirupati Ladoo

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 BILLCONTD…..

Salient FeaturesTo 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 LINKShttp://

www.patentoffice.nic.in

http://www.wipo.int

http://www.uspto.gov

http://ep.espacenet.com

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