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BASICS OF IPR
ByDr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: [email protected], 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/