BASICS OF IPR By Dr Gopakumar G Nair

BASICS OF IPR By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www. gnaipr. net Email: gopanair@gnaipr. net Bengaluru, 18 th 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 1 st 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 Ø UN organization dedicated to promoting the use and protection of works of the human spirit. Ø Headquarters in Geneva, Switzerland. Ø 184 nations as member states. Ø Manages all IPs. Ø 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 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 US 7395821 Copyright Trademark Multi. Haler™ Package Insert/ Information Leaflet Trade Secret Know-how TM (Amend) Bill, 2009 passed by Rajya Sabha on 10/08/2010 External Appearance Confidential Informn & Undisclosed Tech Design No. 211208

INNOVATIO NS Sources Incremental Need-based Intensive Innovations Solutions Research Disruptive inventions Serendipity THE EVOLUTION

THE EVOLUTION (Indian) Patents Act, 1970 is fast evolving through Jurisprudence (similar to US Laws 35 USC). 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 1 st Amendment, 1995 / 1999 2 nd Amendment, 2002 / 2003 3 rd 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 ? Ø A conditional grant Ø Balance of Rights and Obligations Ø Subject to other laws of land Ø 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 ØNOVEL: Must be New, Must DISTINGUISH from “State of the Art” (PRIOR ART) ØMust have INVENTIVE STEP Non-obvious to a person “Skilled in the Art” ØMust have INDUSTRIAL APPLICATION Must be Useful Must have Utility Ø 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 ØNCE/NME ØAPI ØProduct Patent Tiotidine ØProcess Patent Ø‘Me too’ derivatives – Imatinib, Erlotnib ØFormulation ØDosage Forms – Tablet, Capsule, etc ØRelease Profile – Controlled, Slow etc. ØNDDS - Transdermal Patches, Transmucosal Drug Delivery. ØNew 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) Ø Be Useful. Ø Must work / be workable. Ø 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 Nonliving 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 Ø Ex: Sec 3(d) - Enhanced Efficacy essential for inventiveness in new forms of already known pharma substances. (Gleevec Case) Ø Ex: Sec 3(e) - Synergy required in mere combinations. (Decision of the Controller in application No. IN/PCT/2002/00020/DEL) Ø Ex: Sec 3(f) – Mere arrangement or rearrangement (KSR v Teleflex) Ø 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 Early Publication Prior art search 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 v Inventor & Consumer friendly. (Balance of Rights & Obligations). v Research & Regulatory Exemption during Patent Life (Sec 47(3), Sec. 107 A(a)). v Four Patent Offices in four regions (Unique to India). v IAS - Senior Techno-legal officer appointed as CG. v Patent Office procedures revamped, revitalized, digitalized and made transparent. v Out of box solutions being implemented to expedite office actions. v India becoming ISA / IPEA.

PATENTING IN INDIA Process Patent – Largely used to defend against Sec. 104 A (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) (Benefit Sharing) based) 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 Ø Exclusive right to make, use, sell or import the patented invention. Ø Exclude others from unauthorized use of the patented invention. Ø Grant licenses, Assign rights or enter into agreements. Ø To sue others for infringement. Ø To surrender patent rights. quid pro quo ØDisclosure of the invention ØExemption for research, experimentation, imparting instructions to pupils. ØUse of Inventions for Government’s own purposes or for public services. ØAcquisition of Inventions by Central Government. ØCompulsory License / 3 rd Party use. ØProhibit or Restriction of publication of patent information considered relevant for defense purposes.

CBD CONVENTION ON BIODIVERSITY TRADITIONAL KNOWLEDGE UPOV Plant Varieties Protection Act (Art 27. 3 b) Data Exclusivity (Art 39. 3)

INDUSTRIAL DESIGNS TRIPS Part – II, Sec. 4 Art. 25 & 26 Ø Must appeal to the eye Ø Ornamental or Aesthetic aspect of an article. Ø 3 -D or 2 -D features such as shape or surface, patterns, lines or color. Ø 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. Double Syringe Ø Does not protect any technical features of the article to which it is applied to.

DESIGNS Ø Indian Designs Act, 2000 & Rule, 2001 (amended upto 2008). Ø To promote and protect the design element of industrial production. Ø Aimed to enact a detailed classification of design to conform to the international system and Ø 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 12 th August 2004 2. Design No. 196749 dated 12 th 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 Ø Must be graphically represented Ø Must be distinctive / distinguishable Ø Must not be descriptive Ø 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 antidepressant drug Venz OD of Zydus and Veniz XRof Sun Pharma. Active ingredient---VENlafexine Sec 13: Prohibits registration of INN as TM

RECENT TRADEMARK CASE 4 th 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 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” Ø Avoid verbatim reproduction - Likely to cause Copyright violations. Ø Always acknowledge / obtain prior permission. Ø 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 Ø Shape, size, colour etc. Eg: US patent D 380825 granted to Merck & Co. , Inc. PHARMACEUTICALS IN COPYRIGHT ACT Ø 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 15 th September 2003. Geographical Indications of Goods (Registration & Protection) Act, 1999 Ø Geographical Indications of Goods (Registration & Protection) Rules, 2002 Ø

GEOGRAPHICAL INDICATION What is a Geographical Indication ? Ø It is an indication. Ø It originates from a definite geographical territory. Ø It is used to identify agricultural, natural or manufactured goods. Ø The manufactured goods should be produced or processed or prepared in that territory. Ø It should have a special quality or reputation or other characteristics.

GEOGRAPHICAL INDICATION Examples of Indian GI v Basmati Rice v Darjeeling Tea v Kanchipuram Silk v Alphanso Mango v Nagpur Orange v Kolhapuri Chappal v Bikaneri Bhujia v Agra Petha v Goa Feni v Palakkadan Matta v 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 Property originating from Government Funded Research and Development.

THE INDIAN BAYH DOLE BILL CONTD…. . Salient Features Ø To Promote Creativity and to Provide Incentives for creativity. Ø To provide Access To Innovation to all significant stakeholders For Public Good. Ø Imposes Obligations and creates Rights to optimize the potential of Government in R&D. Ø 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. Ø To increase the responsibility of Universities and Research Institutions to encourage students, faculty and scientists to innovate.

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