ALTACIT GLOBAL ‘Alforneys-ot-Law (Ten 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Mylapore. ‘Chennai - 600 004 Tor +9144 -2498 4821 INTERNATIONAL NONPROPRIETARY NAMES Tal 091-422 — 6552991 P.ILANANGAI4D» WV Alforneys-ctLaw 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Mylapore ‘Chennai - 600 004 Tor +9144 -2498 4821 Prentice Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 c Tal 091-422 — 6552991 AUTACIT GLOBAL INTRODUCTION Drugs are generally marketed by their brand names though there is legal requirement to mention generic names in the labels. Countries have their own systems of generic nomenclature for pharmaceutical substances. However owing to the various languages used by different national nomenclature systems, there is a need to have uniform standardized system of generic names that are accepted worldwide, which would help in identifying the composition of 2 pharmaceutical substance. The WHO administers an international generic nomenclature system called INNs also known as rINN, for recommended International Nonproprictary Name or pINN for proposed Internationa! ae ei al einem aneOs THE INN SYSTEM AUTACIT GLOBAL Al Lan Initiated in 1950 by a World Health Assembly resolution Began operating in 1953 * Cumulative list of INN now stands at some 7000 names designated since that time * 120-150 new INN. oS " ae(Sy AIM OF THE INN SYSTEM AUTACIT GLOBAL ‘Allorneys-atlaw * To provide health professionals with a uniq and universally available designated name identify each pharmaceutical substance. * For the clear identification, safe prescription a dispensing of medicines to patients, and * For communication and exchange of informati among health professionals and _ scienti worldwide.> 29% eo TRADE NAMES AND AITACIT GLOBAL NONPROPRIETARY NAMES ‘Allorneys-atlaw * Most products available on the market are nowadays advertised, promoted, and identified by a trade name. In Tokoot asc son 4421 pharmaceutical field, trade names are used when prescribing. PY tet dispensing, selling, promoting, or buying a medicament. Trade Suite 920, Level 9 ‘Barwa Toners, names are usually selected by the owner of the product anc Bangalore - 560.001 registered in national trademark or patent offices. They are Tol: #81 - 80 - 6546 2400 private property and can be used only with the consent of the owner of the trademark. 42-es) * In most cases brand names are chosen for a_finishec pharmaceutical product. Therefore, pharmaceuticalAUTACIT GLOBAL Allorneys-otlaw ssteiGetiweeee ° Various trade names for one substance (example: paracetamol) 148-150, Luz Church Road, apo. ‘Chennai - 600 004 Tor +9144 -2498 4821 Tal 091-422 — 6552991> WA AUTACIT GLOBAL ‘Allorneys-atLaw ara Foor, lave 148-150, Luz Church Road, chennai 600 004, Ter +91- 44 - 2498 4821 Eel ‘sute 920, Level 9 Raheja Towers, 28.27, MG Ron Bangalore - 60 001 Tel: #91 - 80 - 6546 2400 BB1, Park Avanue, #48, Race Course Road, Coimbatore - 641018, Te 491-422 6552024 Nonproprietary names are designations identify the active pharmaceutical dr substance rather than the final product. The selection of a nonproprietary nan follows established rules so that the nan itself communicates to the medical ar pharmaceutical health professional to whicAUTACIT GLOBAL Allorneys-otlaw arena 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, ylapo ‘Chennai - 600 004 Tor +9144 -2498 4821 Precntici Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 Tal 091-422 — 6552991 SELECTION OF INN The names which are given the status of an INN are selectec by the World Health Organization on the advice of experts from the WHO Expert Advisory Panel on the Internationa! Pharmacopoeia and Pharmaceutical Preparations. The process of INN selection follows three main steps: - a request/application is made by the manufacturer or inventor; - after a review of the request a proposed INN is selectec and published for comments; ~ after a time-neriod for ohiections has lansed. the nameWA AUTACIT GLOBAL Allorneys-otlaw een 2rd Floor, Creative Enclave + INN is designated for the active part of the molecule only. 148-150, Luz Chuteh Road, hates senees avoid the multiplication of entries in cases where several sé ie Sate Stee S esters, etc. are actually used. In such cases, the user of the I Sete oz aa, has to create a modified INN (INNM). [seat cbeg * Ex: mepyramine maleate (a salt of mepyramine with ma Tel 001-60 8546 2400 : acid) ieee * «The primary principles for selection: Coimbatore - 641018, Toi oot 42 — 352921 Distinctive in sound and spelling; Not too long; and> oo ‘Allorneys-atlaw or Tor +9144 -2498 4821 Prentice Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 422 ~ 6352004 AUTACIT GLOBAL Do not select names for mixtures of substances. Do not select for herbal substances (vegetable drug or for homoeopathic products. Do not select names for those substances that have long history of use for medical purposes under we established names such as those of alkaloids (e. morphine, codeine), or trivial chemical names (e. acetic acid).&> THE RIGHTS OF EXISTING AITACIT GLOBAL TRADE-MARK OWNERS ‘Allorneys-atlaw 27a Foor In the process of INN selection, the rights of existii trade-mark owners are fully protected. If in the peri of four months following the publication of a propos INN, a formal objection is filed by an interested pers: who considers that the proposed INN is in conflict wi an existing trade-mark, WHO will actively pursue | arrangement to obtain a withdrawal of such | objection or will reconsider the proposed name. . Inne ac the ahiartinn aviete WHA will nat nnklich it 148-150, bu+ ae PROTECTION OF INN AUTACIT GLOBAL Allorneys-otlaw arena 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Tor +9144 -2498 4821 Precntici Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 The World Health Organization collaborates closely ean tee with INN experts and national nomenclature committees 1881, Park Avenue, Coimbatore - 641018, Tal 091-422 — 6552991 to select a single name of worldwide acceptability each active substance that is to be marketed as aAUTACIT GLOBAL Allorneys-otlaw $e aaa iene * During the past few years, INN common stems have been "4-160, tu oni Rou increasingly introduced in trademarks. This hampers the selection of new nonproprietary names within the established system. Given the fact that all INNs should be distinct from BANGALORE spb aca existing INNs and trademarks, this practice causes eagey-290 90 difficulties when selecting a new name. Tol: #81 - 80 - 6546 2400 * There are a large number of brands for a_ single pharmaceutical substance Tei #91422 ~ 6852821 Generic name No. of brands INN amoxycillin 86 vinleurosineAUTACIT GLOBAL Allorneys-otlaw Based on recommendations made by the WHO Exp Committee on the Use of Essential Drugs, a resolution w adopted during the 46th World Health Assembly requesti Member States to arena 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Mylapore Precntici eee * “Enact rules or regulations, as necessary, to ensure tl ah ee oo international nonproprietary names... are always display Tat #84 80-6548 2400 A prominently; * Encourage manufacturers to rely on their corporate name and t lagen taht al international nonproprietary names, rather than trademarks, promote and market multisource products introduced after pats> WA AUTACIT GLOBAL ‘Allorneys-atlaw 27a Foor 148-150, tue USE OF INNs IN INDIA In India, Section 13 (b) of the Trade Marks Act 1999 prohibits the registration of names of chemical elements or INNs which have been declared by the World Health Organization (WHO) and notified by the Registrar of Trade Marks. Nevertheless, there are reported incidents of marketing of drugs undet names that are similar to INNs. The WHO has brought the same to the attention of the Drug Controller General of India. The basic requirementWA AUTACIT GLOBAL ‘Allorneys-atlaw arena 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Mylapore ‘Chennai - 600 004 Tor +9144 -2498 4821 Prentice Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 Tal 091-422 — 6552991 The use of INNs as trademarks constitutes a problem in two ways: use of parts of INNs in trademarks can dilute the INN system by creating confusion in drug nomenclature Secondly, since trademarks enjoy legal protection unlike INNs, the use of INN stems in trademarks may thwart the coining of new INNs in the future using the common stem. where a trademark owner opposes the INN. This is because in the selection of INNs it is ensured that the rights of trademark owners are not affected through INNs. Use of INNs to coin brand names«> =. PREVENTION OF REGISTRATION OF CERTAIN ALTACIT GLOBAL ‘Allorneys-atlaw TRADEMARKS BY SOME INDIAN COMPANIES 27a Foor * The WHO demanded that the applications for registration of brand names, like Tiotrop, Guapride. Dipride and Pride by companies Sun Pharma. Ajanta Pharma, Divus Lab and First Care Pharm respectively should not be entertained. * Also, WHO asked the DCGI to prevent approval o! brand name Riluzole by Rajvi Vipul Bhagat. Mumbai as Riluzole is an INNs. 148-150, tueWA AUTACIT GLOBAL ‘Allorneys-atlaw arena 2rd Floor, Creative Enclave 148-150, Luz Chuteh Road, Mylapore ‘Chennai - 600 004 Tor +9144 -2498 4821 Prentice Suite 920, Lave 9 Raheja Towers, 2627, WG Ron Bangalore - 60 001 Tol: #81 - 80 - 6546 2400 Tal 091-422 — 6552991 CONCLUSION While selecting INNs it is ensured that these are not similar tc trademarks. WHA Resolution 46.19 of 1993 exhorts Member States to develop legal and policy regimes to address this need. Thougt WHA Resolution 46.19 is non-binding in nature, India has substantially implemented its requirements under Section 13 (b) ot the Trade Marks Act, 1999. Nevertheless, no INN has been notified by the Trade Marks Registry in the Trade Marks Journal. The Controller General of Patents, Designs and Trade Marks has finally published a list of International Non-Proprietary Names as declared by the World Health Organization which can be viewed ir this link http://ipindia.nic.in/list_INN_08February2012.pdfWw AUTACIT GLOBAL Allorneys-otlaw arena 2rd Floor, Creative Enclave 148-150, Luz Church Road, Mylapore. ‘Chennai - 600 004 Tor +9144 -2498 4821 Suite 920, Lave 9 THANK YOU #48, Race Course Road, Coimbatore - 641018, Tal 091-422 — 6552991