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Contents : Contents * Defination *Federal Food , Drug and Cosmetic Act *Drug Amendment *Kefauver -Harris Amendment *OTC Review *Patent Copy Rights *Trade marks *Product liabilities Drug : Drug A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them. (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Slide 4: (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals (D) articles intended for use as a component of any article specified in clause (D) articles intended for use as a component of any article specified in clause (A), (B), or (C) ;but does not include devices or their components parts or accessories. : Drug Definition Established by FDCA Articles recognized as official by USP, Homeopathic Pharmacopoeia, NF to treat disease. Slide 6: Counterfeit Drug A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness… Without legal authorization Recent increase in counterfeiting of high cost drugs Slide 7: Device instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory Intended to diagnose or treat diseases Slide 8: Labels and Labeling Label: Display of written material on the product’s container and on the outside container or wrapper, if any. Labeling: All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising) Slide 9: Adulterated Drugs If it consists in whole or in part of any filthy, putrid or decomposed substance If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health If the strength differs, or quality or purity fall below label standards Slide 10: Current Good Manufacturing Practice (GMP) A drug is adulterated unless it is manufactured in accordance with GMP GMP establishes minimum requirements for facilities, manufacturing controls, processing , packaging. Pharmacies are not subject to GMP unless they are manufacturing Rx products for resale to other pharmacies, physicians or retail outlets Slide 11: Misbranded Drugs (Definition) If the label is false or misleading Label must contain name/place of business Accurate statement of contents If required information is not displayed as required Label must warn of habit forming drugs Misbranding occurs if one drug is an imitation of another drug More likely with high cost drugs eg Slide 12: Major Federal Drug Laws (Federal means :a system in which state unit under a central authority but are independent in internal affairs.) Food Drug and Cosmetic Act Federal Alcohol Tax Poison Prevention Packaging Act OBRA 90 Controlled Substances Act Slide 13: Sources of Federal Law Constitution U.S. Congress (House of Representatives and Senate) Federal Agencies (FDA, DEA, CMS, FTC…) Courts (Common Law) Slide 14: Regulatory Agencies Oregon Board of Pharmacy Drug Enforcement Administration (DEA) Food and Drug Administration (FDA) Oregon Public Health Services Centers for Medicare and Medicaid Services (CMS) Federal Trade Commission (FTC) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Slide 15: History of Food and Drug Law 1906 Pure Food and Drug Act 1938 Food, Drug, and Cosmetic Act 1951 Durham-Humphrey Amendment 1958 Food Additives Amendment 1960 Color Additives Amendment 1962 Kefauver- Harris Amendment 1976 Medical Device Amendments Slide 16: 1983 Orphan Drug Act 1984 Drug Price Competition/Patent Term Restoration Act 1987 Prescription Drug Marketing Act 1990 Nutrition Labeling and Education Act 1992 Prescription Drug User Fee Act 1994 Dietary Supplement Health and Education Act 1997 Food and Drug Modernization Act Slide 17: 1906 Pure Food and Drug Act 1. Protect public from adulterated and misbranded food and drugs 2. States took limited action to solve problem of interstate commerce 3. Secure a uniform law throughout the U.S. Slide 18: 1938 Food Drug and Cosmetic Act Is current law of the land, as amended. Gave the Federal Govt power to establish product safety, but did not mention efficacy Regulates Drug quality No new drug can be marketed until proven safe under conditions described on the label required all drugs to be labeled with “adequate directions for use” Slide 19: 1951 Durham-Humphrey Amendment Established the category of “prescription” drugs Established the OTC (non-prescription) category of drugs Slide 20: Kefauver-Harris Amendment 1962 Required proof of efficacy and strengthened safety requirements Thalidomide tragedy occurred at this time , in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. Manufacturers had to evaluate pre-1962 drugs for efficacy Led to DESI - Drug Efficacy Study implementation National Academy of Sciences reviewed 50,000 + Rx/OTC Products Established Good Manufacturing Practices (GMP) Strengthened clinical trial safeguards/adverse reaction reporting Slide 21: The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. OTC (Over-the-Counter) Review : OTC (Over-the-Counter) Review The OTC Review is the name of the process established in 1972 by the U.S. Food and Drug Administration (FDA) to review the safety and efficacy of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription. purpose of the OTC Review : purpose of the OTC Review FDA Commissioner Charles C. Edwards, M.D., stated that he intended: “. . . to build a permanent system offering all American consumers the best possible assurance that every over-the-counter drug . . . not only is safe and adequately labeled, but that it will do what the manufacturer claims it will do. . . “ Historical background : Historical background FDA assembled panels made up of physicians, pharmacists, and other specialists. Each panel also included two nonvoting members, one for industry and one representing consumers Each panel was charged with examining one or more categories of OTC medicines such as cough and cold, antacids, laxatives Slide 25: The panels were then asked to decide which ingredients to recommend to FDA as: 1) generally recognized as safe and effective (or GRAS/GRAE) 2) not generally recognized as safe or effective, or 3) needing more studies before a GRAS/GRAE determination could be given. Slide 26: After each panel reported its findings to FDA, the information was published for public comment. The results, including FDA’s own reactions, were then published as tentative final monographs with another comment period. FDA then analyzed comments and issued a final monograph. Monograph : Monograph A monograph is a regulatory standard for ingredients. It is a kind of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling . Any OTC medicine that conforms to the monograph may be manufactured and sold without an individual product license. Final monographs are published in the government’s Code of Federal Regulations (CFR). Intellectual Property Rights : Intellectual Property Rights CONCEPT OF PROPERTY Natural object becomes a resource when it satisfies a human want A resource possessed and owned becomes a property A bundle of legal rights linked to ownership and possession of an item (Tangible: related to physical objects) Slide 29: INTELLECTUAL PROPERTY It is the PROPERTY CREATED BY APPLICATION OF HUMAN MIND Intangible (non-physical) in nature- derives value from ideas There is no uniform definition of IP In knowledge age, IP is a key to techno-economic growth Slide 30: IP UBIQUITOUS IN LIFE Articles of food, furniture, clothing, textiles, cosmetics, pharmaceuticals, entertainment gadgets, machinery, books, etc. are all IP protected. Domain of IP is ever expanding with advent of Technology and Globalization : GI, IC topography (local geo)are new additions, Biodiversity are likely additions RATIONALE BEHIND IP : RATIONALE BEHIND IP The creative activity culminating in IP is necessary for socio-economic progress Material incentives and rewards encourage greater creative activity IP rights grant monopoly to ensure rewards The interests of owner and society are balanced by limiting periods of monopoly with obligation to disclose and remedies against abuse of rights Disclosure brings knowledge in public domain NATURE OF IPRs : NATURE OF IPRs Essentially negative rights to stop others from copying or counterfeiting In patents, being first with an invention pre-empts any right of another making same invention independently. In copyrights, the right is diluted as right is over the form of expression and not over idea. IPRs being statutory rights are legally enforceable. They are territorial (ownership) in nature. 7 MAIN IP INSTRUMENTS : 7 MAIN IP INSTRUMENTS Patents Trademarks, Trade Names & Services Marks Geographical Indications Industrial Designs Layout-designs of Integrated Circuits Trade Secrets Copyrights And Related Rights First six are Industrial Property Rights Patents : Patents It is a limited right granted by the state to an inventor in respect of an invention to exclude any other person from practicing the invention i.e. manufacturing, using or selling the patented product or from using the patented process, without due permission. WHAT CAN BE PATENTED? : WHAT CAN BE PATENTED? Inventions in all fields of technology, whether products or processes, if they meet the criteria of Being patentable subject matter; Novelty; Non-obviousness (inventive step); Industrial application (utility). Conditions of Patentability : Conditions of Patentability Novelty: Invention not known to public prior to claim by inventor Inventive Step: Invention would not be obvious to a person with ordinary skill in the art Industrial Application: Invention can be made or used in any useful, practical activity as distinct from purely intellectual or aesthetic one SOME EXCLUSIONS FROM PATENTABILITY : SOME EXCLUSIONS FROM PATENTABILITY Naturally occurring substances/elements; Diagnostic, therapeutic and surgical methods of treatment of humans or animals; Plants and animals other than μ-organisms; Essentially biological processes for production of plants or animals; Inventions whose use is contrary to public order or morality. Ideas, methods for business, playing games, performing mental acts Advantages Of A Patent To The Public : Advantages Of A Patent To The Public KNOWLEDGE OF INVENTION ADDS TO SCIENTIFIC BACKGROUND FORMING BASE FOR FURTHER RESEACH REASONABLE ASSURANCE FOR COMMERCIALIZATION PATENT- OPEN TO PUBLIC FOR USE AFTER ITS TERM EXPIRES Alternative to Drug Patents: Publicly Financed Research : Alternative to Drug Patents: Publicly Financed Research National Institutes of Health get $30 billion a year The Free Market Drug Act (FDMA) $30 billion for 10 competing research companies All research findings are placed in the public domain – all drugs sold as generics All results published and made publicly available $1 billion prize fund to reward outstanding breakthroughs Industry can still get patents and compete with drugs developed through FDMA Patent Grant Procedure (In Brief) : Patent Grant Procedure (In Brief) Filing of PATENT APPLICATION EXAMINATION & NOVELTY SEARCH ACCEPTANCE OR REFUSAL NOTIFICATION OF “ACCEPTANCE” IN THE GAZETTE OF INDIA (part III section 2) OPPOSITION (if any) GRANT OF A PATENT TRADEMARKS : TRADEMARKS TRADEMARK, SERVICE MARK, and TRADE NAME Distinctive symbols, signs, logos that help consumer to distinguish between competing goods or services. A trade name is the name of an enterprise which individualizes the enterprise in consumer’s mind. Legally not linked to quality. In fact, linked in consumer’s mind to quality expectation. Slide 42: To register a trade mark , the mark must be:- distinctive, and, not deceptive, or contrary to law or morality, and, not identical or similar to any earlier marks for the same or similar goods. CRITERIA OF TM PROTECTABILITY : CRITERIA OF TM PROTECTABILITY Non-deceptive ( to avoid misleading) Not contrary to public order, morality Special Requirements A mark is registered for specified classes of goods or services. TYPES OF MARKS : TYPES OF MARKS Well Known Trade Mark Collective Mark: Proprietor is an association of persons, which is legally not a partnership Certification Mark: Does not indicate origin of goods but certifies the goods as conforming to certain characteristics (quality, ingredients, geographical origin etc.) e.g. ISI, AGMARK, Hallmark etc. What is protected and what’s not? : What is protected and what’s not? Right to use TM in relation to goods/ services as registered are protected (If TM consists of several parts, protection is for TM as a whole) State Emblems, Official Hallmarks, Emblems of Intergovernmental Organizations cannot be used as TM. Forms of TM : Forms of TM Visual: Words, letters, numerals, devices including drawings and symbols or 2-D representations of object or a combination of two or more of these, colour combinations or colour per se, 3-D sign as shape of goods or packaging. Audio: Sounds, Musical Notes Olfactory: Smells GEOGRAPHICAL INDICATIONS : GEOGRAPHICAL INDICATIONS What is GI? Many goods possess their peculiar properties due to their geographical origin. GI is the best method to indicate the geographical origin of goods and services. Many agricultural products (tea, rice); dairy products (cheese), wines and spirits (Champagne) owe their special quality and reputation to their geographical place of growth or processing Protection of GI : Protection of GI GI is not owned by a single owner Any producer in the region can use the GI on the product provided it is prepared by the norms set out for the use of that GI. GI is registered in the national register and is similar to the certification mark identifying the origin of the good. Govt. can register GI in the international register maintained by WIPO for world wide protection. It is an offence to use false GI on goods Industrial Designs : Industrial Designs What are Industrial Designs? The ornamental or aesthetic aspect of an article that enhances visual appeal and differentiates product. e.g. 3-D features of shape or surface as of a perfume bottle, 2-D patterns of lines, shapes and colours as on a bed sheet Criteria for Protection as ID : Criteria for Protection as ID New and Original Capable of mass production or application on an article of utility Not contrary to public order or morality The shape should not be determined merely by the functionality of the good Comparison of ID against TM : Comparison of ID against TM ID Has to be integral part of product Should be original and new but need not be distinctive TM Is applied on the product but need not be embodied in it. Should be distinctive Slide 52: ID Protection Protects commercial exploitation of the design idea through products/articles that embody it or reproduce it and not the articles themselves. Integrated Circuit Layout Designs : Integrated Circuit Layout Designs What is Layout Design? Layout of transistors and other circuit elements, including lead wires connecting such elements and expressed in any manner in a semiconductor integrated circuit (IC). Slide 54: Why to protect? IC Layouts are creations of human mind; There is lot of investment of time and money in the creation but copying is very cheap; Fertile area with new circuit designs made every day to cater for miniaturization and novel applications. Slide 55: Why special protection? There may not be novelty so cannot be patented; Copyright protection does not return the investments since commercial life of a design is limited. Protection is against… : Protection is against… Act of reproducing a layout design fully or in parts; Importing, selling or distributing commercially a protected layout design or IC incorporating it. But identical design created independently by third party is not prohibited Trade Secret : Trade Secret The best kept secret till date Some inventions, data, information cannot be protected by any of the available means of IPRs. Such information is held confidential as a trade secret Trade secret can be an invention, idea, survey method,manufacturing process, experiment results, chemical formula, recipe, financial strategy, client database etc. Slide 58: When Trade Secrets are preferred? When invention is not patentable; Patent protection is limited to 20 years, when secret can be kept beyond that period; When cost of patent protection are prohibitive; When it is difficult to reverse engineer How to guard Trade Secret? : How to guard Trade Secret? . Restricting number of people having access to secret information Signing confidentiality agreements with business partners and employees Using protective techniques like digital data security tools and restricting entry into area where trade secret is worked or held National legislations provide protection in form of injunction and damages if secret information is illegally acquired or used. Copyright : Copyright Copyright protects literary and artistic works e.g. Books, lectures, dramatic and musical works, choreography, cinematography, drawings, paintings, architecture, sculpture, photographs, illustrations, maps, plans sketches etc. This is automatic right created with the creation of work and no registration is required Rights covered under CR : Rights covered under CR Moral Rights : Author’s right of paternity. Non-alienable. Economic Rights : Rights to exploit the work. e.g. Rights of translation, rights of performance, rights of reproduction etc. These rights can be transferred, assigned, licensed for economic benefits. Slide 62: Who are the Authors? Writer/writers of the book; Painter; Music composer; Translator; Cinematographer; Photographer etc Duration of Protection : Duration of Protection For books and other works of arts it is 50 to 70 years after the death of the author (the laws of different countries vary); For photographic work 25 years from making the work; For cinematic works 50 years after making the work available to public. Exceptions to Protection (Free Use or Fair Deal : Exceptions to Protection (Free Use or Fair Deal Quotations for commentary; Illustration for Teaching; Current News Reporting etc. Free Use is decided by amount of work used and its economic implications to the right holder. The mention of original author/source is must. International Agreements : International Agreements Paris convention for the protection of Industrial Property (1883) Berne convention for protection of Literary and Artistic Works (1886) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) (1994) Emerging Issues in IPR : Emerging Issues in IPR Traditional Knowledge and Expression of Culture (Folklore) Biodiversity and Genetic Resources Electronic Commerce; Internet Domain Names; Protection of databases, software Conclusion : Conclusion Patents and copyrights are forms of government intervention which are intended to serve a public purpose There are enormous inefficiencies associated with patents and copyrights Patents and copyrights encourage antisocial rent-seeking behavior There are alternatives; they must be debated Thank you! : Thank you! You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
drug regulatory affairs aSGuest58448 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 4323 Category: Education License: All Rights Reserved Like it (6) Dislike it (1) Added: August 03, 2010 This Presentation is Public Favorites: 7 Presentation Description No description available. Comments Posting comment... By: rac21mishra (7 month(s) ago) hello sir!!!!!!!!!! could you plz send me detail information related to drug regulatory affairs.....at my id i.e rac21mishra@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: smishri (7 month(s) ago) Hi friend, niceone presentation, can u send me on smishri_2007@rediffmail.com. thanks Saving..... Post Reply Close Saving..... Edit Comment Close By: raxy (7 month(s) ago) hi sir pls send me this ppt Saving..... Post Reply Close Saving..... Edit Comment Close By: thotasharath (8 month(s) ago) what r u saying just say regulatory affairs Saving..... Post Reply Close Saving..... Edit Comment Close By: sasi_90 (9 month(s) ago) THANK U. Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Welcome to seminar on : Welcome to seminar on Drug Regulatory Affairs By Kailas chate (m.pharm 1yr.) Contents : Contents * Defination *Federal Food , Drug and Cosmetic Act *Drug Amendment *Kefauver -Harris Amendment *OTC Review *Patent Copy Rights *Trade marks *Product liabilities Drug : Drug A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them. (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Slide 4: (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals (D) articles intended for use as a component of any article specified in clause (D) articles intended for use as a component of any article specified in clause (A), (B), or (C) ;but does not include devices or their components parts or accessories. : Drug Definition Established by FDCA Articles recognized as official by USP, Homeopathic Pharmacopoeia, NF to treat disease. Slide 6: Counterfeit Drug A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness… Without legal authorization Recent increase in counterfeiting of high cost drugs Slide 7: Device instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory Intended to diagnose or treat diseases Slide 8: Labels and Labeling Label: Display of written material on the product’s container and on the outside container or wrapper, if any. Labeling: All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising) Slide 9: Adulterated Drugs If it consists in whole or in part of any filthy, putrid or decomposed substance If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health If the strength differs, or quality or purity fall below label standards Slide 10: Current Good Manufacturing Practice (GMP) A drug is adulterated unless it is manufactured in accordance with GMP GMP establishes minimum requirements for facilities, manufacturing controls, processing , packaging. Pharmacies are not subject to GMP unless they are manufacturing Rx products for resale to other pharmacies, physicians or retail outlets Slide 11: Misbranded Drugs (Definition) If the label is false or misleading Label must contain name/place of business Accurate statement of contents If required information is not displayed as required Label must warn of habit forming drugs Misbranding occurs if one drug is an imitation of another drug More likely with high cost drugs eg Slide 12: Major Federal Drug Laws (Federal means :a system in which state unit under a central authority but are independent in internal affairs.) Food Drug and Cosmetic Act Federal Alcohol Tax Poison Prevention Packaging Act OBRA 90 Controlled Substances Act Slide 13: Sources of Federal Law Constitution U.S. Congress (House of Representatives and Senate) Federal Agencies (FDA, DEA, CMS, FTC…) Courts (Common Law) Slide 14: Regulatory Agencies Oregon Board of Pharmacy Drug Enforcement Administration (DEA) Food and Drug Administration (FDA) Oregon Public Health Services Centers for Medicare and Medicaid Services (CMS) Federal Trade Commission (FTC) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Slide 15: History of Food and Drug Law 1906 Pure Food and Drug Act 1938 Food, Drug, and Cosmetic Act 1951 Durham-Humphrey Amendment 1958 Food Additives Amendment 1960 Color Additives Amendment 1962 Kefauver- Harris Amendment 1976 Medical Device Amendments Slide 16: 1983 Orphan Drug Act 1984 Drug Price Competition/Patent Term Restoration Act 1987 Prescription Drug Marketing Act 1990 Nutrition Labeling and Education Act 1992 Prescription Drug User Fee Act 1994 Dietary Supplement Health and Education Act 1997 Food and Drug Modernization Act Slide 17: 1906 Pure Food and Drug Act 1. Protect public from adulterated and misbranded food and drugs 2. States took limited action to solve problem of interstate commerce 3. Secure a uniform law throughout the U.S. Slide 18: 1938 Food Drug and Cosmetic Act Is current law of the land, as amended. Gave the Federal Govt power to establish product safety, but did not mention efficacy Regulates Drug quality No new drug can be marketed until proven safe under conditions described on the label required all drugs to be labeled with “adequate directions for use” Slide 19: 1951 Durham-Humphrey Amendment Established the category of “prescription” drugs Established the OTC (non-prescription) category of drugs Slide 20: Kefauver-Harris Amendment 1962 Required proof of efficacy and strengthened safety requirements Thalidomide tragedy occurred at this time , in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. Manufacturers had to evaluate pre-1962 drugs for efficacy Led to DESI - Drug Efficacy Study implementation National Academy of Sciences reviewed 50,000 + Rx/OTC Products Established Good Manufacturing Practices (GMP) Strengthened clinical trial safeguards/adverse reaction reporting Slide 21: The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. OTC (Over-the-Counter) Review : OTC (Over-the-Counter) Review The OTC Review is the name of the process established in 1972 by the U.S. Food and Drug Administration (FDA) to review the safety and efficacy of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription. purpose of the OTC Review : purpose of the OTC Review FDA Commissioner Charles C. Edwards, M.D., stated that he intended: “. . . to build a permanent system offering all American consumers the best possible assurance that every over-the-counter drug . . . not only is safe and adequately labeled, but that it will do what the manufacturer claims it will do. . . “ Historical background : Historical background FDA assembled panels made up of physicians, pharmacists, and other specialists. Each panel also included two nonvoting members, one for industry and one representing consumers Each panel was charged with examining one or more categories of OTC medicines such as cough and cold, antacids, laxatives Slide 25: The panels were then asked to decide which ingredients to recommend to FDA as: 1) generally recognized as safe and effective (or GRAS/GRAE) 2) not generally recognized as safe or effective, or 3) needing more studies before a GRAS/GRAE determination could be given. Slide 26: After each panel reported its findings to FDA, the information was published for public comment. The results, including FDA’s own reactions, were then published as tentative final monographs with another comment period. FDA then analyzed comments and issued a final monograph. Monograph : Monograph A monograph is a regulatory standard for ingredients. It is a kind of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling . Any OTC medicine that conforms to the monograph may be manufactured and sold without an individual product license. Final monographs are published in the government’s Code of Federal Regulations (CFR). Intellectual Property Rights : Intellectual Property Rights CONCEPT OF PROPERTY Natural object becomes a resource when it satisfies a human want A resource possessed and owned becomes a property A bundle of legal rights linked to ownership and possession of an item (Tangible: related to physical objects) Slide 29: INTELLECTUAL PROPERTY It is the PROPERTY CREATED BY APPLICATION OF HUMAN MIND Intangible (non-physical) in nature- derives value from ideas There is no uniform definition of IP In knowledge age, IP is a key to techno-economic growth Slide 30: IP UBIQUITOUS IN LIFE Articles of food, furniture, clothing, textiles, cosmetics, pharmaceuticals, entertainment gadgets, machinery, books, etc. are all IP protected. Domain of IP is ever expanding with advent of Technology and Globalization : GI, IC topography (local geo)are new additions, Biodiversity are likely additions RATIONALE BEHIND IP : RATIONALE BEHIND IP The creative activity culminating in IP is necessary for socio-economic progress Material incentives and rewards encourage greater creative activity IP rights grant monopoly to ensure rewards The interests of owner and society are balanced by limiting periods of monopoly with obligation to disclose and remedies against abuse of rights Disclosure brings knowledge in public domain NATURE OF IPRs : NATURE OF IPRs Essentially negative rights to stop others from copying or counterfeiting In patents, being first with an invention pre-empts any right of another making same invention independently. In copyrights, the right is diluted as right is over the form of expression and not over idea. IPRs being statutory rights are legally enforceable. They are territorial (ownership) in nature. 7 MAIN IP INSTRUMENTS : 7 MAIN IP INSTRUMENTS Patents Trademarks, Trade Names & Services Marks Geographical Indications Industrial Designs Layout-designs of Integrated Circuits Trade Secrets Copyrights And Related Rights First six are Industrial Property Rights Patents : Patents It is a limited right granted by the state to an inventor in respect of an invention to exclude any other person from practicing the invention i.e. manufacturing, using or selling the patented product or from using the patented process, without due permission. WHAT CAN BE PATENTED? : WHAT CAN BE PATENTED? Inventions in all fields of technology, whether products or processes, if they meet the criteria of Being patentable subject matter; Novelty; Non-obviousness (inventive step); Industrial application (utility). Conditions of Patentability : Conditions of Patentability Novelty: Invention not known to public prior to claim by inventor Inventive Step: Invention would not be obvious to a person with ordinary skill in the art Industrial Application: Invention can be made or used in any useful, practical activity as distinct from purely intellectual or aesthetic one SOME EXCLUSIONS FROM PATENTABILITY : SOME EXCLUSIONS FROM PATENTABILITY Naturally occurring substances/elements; Diagnostic, therapeutic and surgical methods of treatment of humans or animals; Plants and animals other than μ-organisms; Essentially biological processes for production of plants or animals; Inventions whose use is contrary to public order or morality. Ideas, methods for business, playing games, performing mental acts Advantages Of A Patent To The Public : Advantages Of A Patent To The Public KNOWLEDGE OF INVENTION ADDS TO SCIENTIFIC BACKGROUND FORMING BASE FOR FURTHER RESEACH REASONABLE ASSURANCE FOR COMMERCIALIZATION PATENT- OPEN TO PUBLIC FOR USE AFTER ITS TERM EXPIRES Alternative to Drug Patents: Publicly Financed Research : Alternative to Drug Patents: Publicly Financed Research National Institutes of Health get $30 billion a year The Free Market Drug Act (FDMA) $30 billion for 10 competing research companies All research findings are placed in the public domain – all drugs sold as generics All results published and made publicly available $1 billion prize fund to reward outstanding breakthroughs Industry can still get patents and compete with drugs developed through FDMA Patent Grant Procedure (In Brief) : Patent Grant Procedure (In Brief) Filing of PATENT APPLICATION EXAMINATION & NOVELTY SEARCH ACCEPTANCE OR REFUSAL NOTIFICATION OF “ACCEPTANCE” IN THE GAZETTE OF INDIA (part III section 2) OPPOSITION (if any) GRANT OF A PATENT TRADEMARKS : TRADEMARKS TRADEMARK, SERVICE MARK, and TRADE NAME Distinctive symbols, signs, logos that help consumer to distinguish between competing goods or services. A trade name is the name of an enterprise which individualizes the enterprise in consumer’s mind. Legally not linked to quality. In fact, linked in consumer’s mind to quality expectation. Slide 42: To register a trade mark , the mark must be:- distinctive, and, not deceptive, or contrary to law or morality, and, not identical or similar to any earlier marks for the same or similar goods. CRITERIA OF TM PROTECTABILITY : CRITERIA OF TM PROTECTABILITY Non-deceptive ( to avoid misleading) Not contrary to public order, morality Special Requirements A mark is registered for specified classes of goods or services. TYPES OF MARKS : TYPES OF MARKS Well Known Trade Mark Collective Mark: Proprietor is an association of persons, which is legally not a partnership Certification Mark: Does not indicate origin of goods but certifies the goods as conforming to certain characteristics (quality, ingredients, geographical origin etc.) e.g. ISI, AGMARK, Hallmark etc. What is protected and what’s not? : What is protected and what’s not? Right to use TM in relation to goods/ services as registered are protected (If TM consists of several parts, protection is for TM as a whole) State Emblems, Official Hallmarks, Emblems of Intergovernmental Organizations cannot be used as TM. Forms of TM : Forms of TM Visual: Words, letters, numerals, devices including drawings and symbols or 2-D representations of object or a combination of two or more of these, colour combinations or colour per se, 3-D sign as shape of goods or packaging. Audio: Sounds, Musical Notes Olfactory: Smells GEOGRAPHICAL INDICATIONS : GEOGRAPHICAL INDICATIONS What is GI? Many goods possess their peculiar properties due to their geographical origin. GI is the best method to indicate the geographical origin of goods and services. Many agricultural products (tea, rice); dairy products (cheese), wines and spirits (Champagne) owe their special quality and reputation to their geographical place of growth or processing Protection of GI : Protection of GI GI is not owned by a single owner Any producer in the region can use the GI on the product provided it is prepared by the norms set out for the use of that GI. GI is registered in the national register and is similar to the certification mark identifying the origin of the good. Govt. can register GI in the international register maintained by WIPO for world wide protection. It is an offence to use false GI on goods Industrial Designs : Industrial Designs What are Industrial Designs? The ornamental or aesthetic aspect of an article that enhances visual appeal and differentiates product. e.g. 3-D features of shape or surface as of a perfume bottle, 2-D patterns of lines, shapes and colours as on a bed sheet Criteria for Protection as ID : Criteria for Protection as ID New and Original Capable of mass production or application on an article of utility Not contrary to public order or morality The shape should not be determined merely by the functionality of the good Comparison of ID against TM : Comparison of ID against TM ID Has to be integral part of product Should be original and new but need not be distinctive TM Is applied on the product but need not be embodied in it. Should be distinctive Slide 52: ID Protection Protects commercial exploitation of the design idea through products/articles that embody it or reproduce it and not the articles themselves. Integrated Circuit Layout Designs : Integrated Circuit Layout Designs What is Layout Design? Layout of transistors and other circuit elements, including lead wires connecting such elements and expressed in any manner in a semiconductor integrated circuit (IC). Slide 54: Why to protect? IC Layouts are creations of human mind; There is lot of investment of time and money in the creation but copying is very cheap; Fertile area with new circuit designs made every day to cater for miniaturization and novel applications. Slide 55: Why special protection? There may not be novelty so cannot be patented; Copyright protection does not return the investments since commercial life of a design is limited. Protection is against… : Protection is against… Act of reproducing a layout design fully or in parts; Importing, selling or distributing commercially a protected layout design or IC incorporating it. But identical design created independently by third party is not prohibited Trade Secret : Trade Secret The best kept secret till date Some inventions, data, information cannot be protected by any of the available means of IPRs. Such information is held confidential as a trade secret Trade secret can be an invention, idea, survey method,manufacturing process, experiment results, chemical formula, recipe, financial strategy, client database etc. Slide 58: When Trade Secrets are preferred? When invention is not patentable; Patent protection is limited to 20 years, when secret can be kept beyond that period; When cost of patent protection are prohibitive; When it is difficult to reverse engineer How to guard Trade Secret? : How to guard Trade Secret? . Restricting number of people having access to secret information Signing confidentiality agreements with business partners and employees Using protective techniques like digital data security tools and restricting entry into area where trade secret is worked or held National legislations provide protection in form of injunction and damages if secret information is illegally acquired or used. Copyright : Copyright Copyright protects literary and artistic works e.g. Books, lectures, dramatic and musical works, choreography, cinematography, drawings, paintings, architecture, sculpture, photographs, illustrations, maps, plans sketches etc. This is automatic right created with the creation of work and no registration is required Rights covered under CR : Rights covered under CR Moral Rights : Author’s right of paternity. Non-alienable. Economic Rights : Rights to exploit the work. e.g. Rights of translation, rights of performance, rights of reproduction etc. These rights can be transferred, assigned, licensed for economic benefits. Slide 62: Who are the Authors? Writer/writers of the book; Painter; Music composer; Translator; Cinematographer; Photographer etc Duration of Protection : Duration of Protection For books and other works of arts it is 50 to 70 years after the death of the author (the laws of different countries vary); For photographic work 25 years from making the work; For cinematic works 50 years after making the work available to public. Exceptions to Protection (Free Use or Fair Deal : Exceptions to Protection (Free Use or Fair Deal Quotations for commentary; Illustration for Teaching; Current News Reporting etc. Free Use is decided by amount of work used and its economic implications to the right holder. The mention of original author/source is must. International Agreements : International Agreements Paris convention for the protection of Industrial Property (1883) Berne convention for protection of Literary and Artistic Works (1886) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) (1994) Emerging Issues in IPR : Emerging Issues in IPR Traditional Knowledge and Expression of Culture (Folklore) Biodiversity and Genetic Resources Electronic Commerce; Internet Domain Names; Protection of databases, software Conclusion : Conclusion Patents and copyrights are forms of government intervention which are intended to serve a public purpose There are enormous inefficiencies associated with patents and copyrights Patents and copyrights encourage antisocial rent-seeking behavior There are alternatives; they must be debated Thank you! : Thank you!