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 TRADE SECRETS No Disclosure

IP PORTFOLIO
INTELLECTUAL PROPERTY RIGHTS Patents Trade Marks Designs Copyright Others
QUASI INTELLECTUAL PROPERTY RIGHTS Confidential Information Know How Trade Secrets Reputation

IP PORTFOLIO CONTD..
Others: G.I, CBD, UPOV, IC Layouts, Related Rights Neighboring Rights Domain Names Others:Data Exclusivity Brand Loyalty/Goodwill House Name Client / Customer Lists Market Intelligence Test Methods In-house Stds/Specs Impurity Profiles Management Practices

PRODUCT PATENTS IN INDIA

IP PORTFOLIO
Novel & Inventive

Patent US7395821

TM (Amend) Bill, 2009 passed by Rajya Sabha on 10/08/2010

Copyright
Package Insert/ Information Leaflet

Trademark MultiHaler
External Appearance Confidential Informn & Undisclosed Tech

Trade Secret Know-how

Design No. 211208

INNOVATIO NS
Sources
Incremental Need-based Intensive

THE EVOLUTION

Innovations Solutions

Research inventions

Disruptive

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 knowledge that or involves having technical economic advance as compared to the existing 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

 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)

INDIAN PATENTS ACT & RULES AS AMENDED UP-TO-DATE HAVE MANY FEATURES WHICH ARE CURRENTLY BEING ADOPTED / ADAPTED GLOBALLY

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)

India has the best Composition (FDC) Patents experience globally; NDDS (Fixed Dose Combination) substantially driven by DPCO / NPPA comparisons. Herbal Patents High Potential; negatively (Natural product impacted 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) 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. Disclosure of the invention Exemption for research, experimentation, imparting instructions to pupils. Use of Inventions for Governments 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

TRADITIONAL KNOWLEDGE
UPOV Plant Varieties Protection Act (Art 27.3b) Data Exclusivity (Art 39.3)

INDUSTRIAL DESIGNS
TRIPS Part II, Sec.4 Art. 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
TRIPS Part II, Sec.2 Art. 15 to 21

Word Mark Device Marks

(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 ACTApproval, While proceeding for Marketing

adopt caution while choosing Brand Names
Case Study: Zydus Cadilla v Sun Pharma Trademark violation suit regarding an antidepressant 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 Gandhijis 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 Part II, Sec.1 Art. 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 - 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 ones 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.

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)

DISTINCTION AND DEGREE OF PROTECTION

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)

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 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 Government Property originating from

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.

http://

USEFUL LINKS

www.patentoffice.nic.in http://www.wipo.int http://www.uspto.gov http://ep.espacenet.com http://ipindia.nic.in/girindia/