INTRODUCTION TO INTELLECTUAL PROPERTY RIGHTS at Pharmexcil, Mumbai 22nd June, 2012 by Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www.gnaipr.net Email: gopanair@gnaipr.net 1 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 2 What is Intellectual Property? Definition by WIPO Intellectual property (IP) refers to creations inventions, literary the and works, and symbols, images, and designs commerce. 3 of mind: artistic names, used in Creativity (Creation Of The Mind) Creativity is the ability to – Think / come up with new idea – Design new “inventions” – Produce “works of art” – Solve problems in new ways, or develop a new idea based on an “original” knowledge. – Novel or unconventional approach. 4 Think Away From The Box Generate Ideas….. And Own Them…..IPR ! 5 6 IP Portfolio Novel & Inventive Patent US7395821 Brand Name Copyright Trademark Multi-Haler™ Package Insert/ Information Leaflet Trade Secret Know-how 7 External Appearance Confidential Informn & Undisclosed Tech Design No. 211208 Product Patents In India 8 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. 9 WIPO • UN organization dedicated to promoting the use and protection of works of the human spirit. • Headquarters in Geneva, Switzerland. • 185 nations as member states. • Manages all IPs. • Training through Academy and Seminars 10 TRIPS – Article 27 Patentable Subject Matter 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. [1] Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 11 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. TRIPS – Article 27 Patentable Subject Matter 3. Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. [1] For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively. 12 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. 13 What is a Patent? A Conditional grant Balance of Rights and Obligations Subject to other laws of land Granted to owner of invention/ assignee 14 Three Statutory Pillars of PATENTABILITY 1. Novelty (new) 2. Inventive Step (non-obvious) (Sec 2(1)(ja)) 3. Industrial Applicability (utility) (Sec 2(1)(ac)) 15 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. 16 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. 17 Inventive Step Section 2(1)(ja): "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge significance or or having both economic and that makes the invention not obvious to a person skilled in the art. 18 Utility / Industrial Application • Be Useful • Must work / be workable • At least one recognized, verifiable and practical end-use 19 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 20 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 21 (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. 22 (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 23 Trademarks Word Mark Device Marks (Signs, Symbols, Logos) Collective Marks Certification Marks Service Marks 24 Trademarks Must be graphically represented Must be distinctive / distinguishable Must not be descriptive Must not be deceptively similar to known /well-known marks /Generics • ORS: ORS-L, ORZ • Cefixime – ZIFI, CEFI, Cefixin Avoid – Geographical Indications / Deities National Leaders / Heroes / Symbols / Laudatory words 25 Notification dated 14th February, 2012 issued by CGPDTM regarding Publication of list of International Non Proprietary Names declared by the WHO 26 Copyrights & Related Rights Copyright is a legal term describing rights given to creators for their literary artistic works. 27 and Copyright - Extension IT Revolution ! Recordings Broadcastings Audio visual works Computer programs Digital databases Internet/web Cable and Satellite T.V. Indian Copyright Amendment Bill Passed by Rajya Sabha on 17th May, 2012 Passed by Lok Sabha on 22nd May, 2012 28 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 (Plagiarism) - Likely to cause Copyright violations. Always acknowledge / obtain prior permission. 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 ! 29 Therapeutic Goods Legislation Amendment (Copyright), 2011 Australia To block frivolous Copyright infringement suits in Pharma / Medicine product inserts. 30 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, Trademarks etc.) 31 G.I. (Geographical Indications) Name or sign used on goods originating from specific geographical origin or location and possess qualities, reputation or characteristics that are essentially attributable to that place of origin. 32 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 33 Industrial Designs 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. 34 Khale Sangeeta 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. 35