International nonproprietary names

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  • © Altacit Global 2009 Email: info@altacit.com

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  • 1. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, INTERNATIONAL Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, NONPROPRIETARY NAMES # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 P.ILANANGAI IP CONSULTANT PATENT DEPARTMENT EMAIL info@altacit.com WEBSITE www.altacit.com
  • 2. INTRODUCTION CHENNAI3rd Floor, ‘Creative Enclave’, • Drugs are generally marketed by their brand names though there is a148-150, Luz Church Road, legal requirement to mention generic names in the labels. Countries Mylapore, Chennai - 600 004. have their own systems of generic nomenclature for pharmaceutical Tel: +91 - 44 - 2498 4821 substances. However owing to the various languages used by BANGALORE Suite 920, Level 9, different national nomenclature systems, there is a need to have a Raheja Towers, 26-27, M G Road, uniform standardized system of generic names that are accepted Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 worldwide, which would help in identifying the composition of a COIMBATORE pharmaceutical substance. BB1, Park Avenue, # 48, Race Course Road, • The WHO administers an international generic nomenclature system Coimbatore - 641018. Tel: +91 - 422 – 6552921 called INNs also known as rINN, for recommended International Nonproprietary Name or pINN for proposed International Nonproprietary Name). • International Nonproprietary Names (INN) facilitates the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized EMAIL and is public property. A nonproprietary name is also known as a info@altacit.com generic name. WEBSITE www.altacit.com
  • 3. THE INN SYSTEM CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, • Initiated in 1950 by a World Health Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 Assembly resolution BANGALORE Suite 920, Level 9, Raheja Towers, • Began operating in 1953 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 • Cumulative list of INN now stands at some COIMBATORE BB1, Park Avenue, # 48, Race Course Road, 7000 names designated since that time Coimbatore - 641018. Tel: +91 - 422 – 6552921 • 120-150 new INN. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 4. AIM OF THE INN SYSTEM CHENNAI3rd Floor, ‘Creative Enclave’, • To provide health professionals with a unique148-150, Luz Church Road, Mylapore, Chennai - 600 004. and universally available designated name to identify each pharmaceutical substance. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, • For the clear identification, safe prescription and Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 dispensing of medicines to patients, and COIMBATORE BB1, Park Avenue, • For communication and exchange of information # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 among health professionals and scientists worldwide. • Nonproprietary names are intended for use in pharma, labeling, product information, advertising and other promotional material, drug regulation and scientific EMAIL info@altacit.com literature, and as a basis for product names, e.g. for WEBSITE generics. www.altacit.com
  • 5. TRADE NAMES AND NONPROPRIETARY NAMES CHENNAI3rd Floor, ‘Creative Enclave’, • Most products available on the market are nowadays148-150, Luz Church Road, Mylapore, advertised, promoted, and identified by a trade name. In Chennai - 600 004. Tel: +91 - 44 - 2498 4821 pharmaceutical field, trade names are used when prescribing, BANGALORE dispensing, selling, promoting, or buying a medicament. Trade Suite 920, Level 9, Raheja Towers, 26-27, M G Road, names are usually selected by the owner of the product and Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 registered in national trademark or patent offices. They are COIMBATORE private property and can be used only with the consent of the BB1, Park Avenue, # 48, Race Course Road, owner of the trademark. Coimbatore - 641018. Tel: +91 - 422 – 6552921 • In most cases brand names are chosen for a finished pharmaceutical product. Therefore, pharmaceutical preparations containing the same active drug substance are frequently sold under different brand/trade names, not only in different countries, but even within the same country. EMAIL contd.. info@altacit.com WEBSITE www.altacit.com
  • 6. CHENNAI3rd Floor, ‘Creative Enclave’, • Various trade names for one substance (example: paracetamol)148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 • Nonproprietary names are intended to be used as public property without restraint. These names are usually designated by EMAIL info@altacit.com national or international nomenclature commissions. WEBSITE contd… www.altacit.com
  • 7. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, • Nonproprietary names are designations to identify the active pharmaceutical drug Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, substance rather than the final product. Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 • The selection of a nonproprietary name COIMBATORE BB1, Park Avenue, follows established rules so that the name # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 itself communicates to the medical and pharmaceutical health professional to which the active drug substance belongs. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 8. SELECTION OF INN CHENNAI3rd Floor, ‘Creative Enclave’, • The names which are given the status of an INN are selected148-150, Luz Church Road, Mylapore, by the World Health Organization on the advice of experts Chennai - 600 004. Tel: +91 - 44 - 2498 4821 from the WHO Expert Advisory Panel on the International BANGALORE Pharmacopoeia and Pharmaceutical Preparations. Suite 920, Level 9, Raheja Towers, • The process of INN selection follows three main steps: 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 - a request/application is made by the manufacturer or COIMBATORE inventor; BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. - after a review of the request a proposed INN is selected Tel: +91 - 422 – 6552921 and published for comments; - after a time-period for objections has lapsed, the name will obtain the status of a recommended INN and will be published as such if no objection has been raised. Since the name is available in the public domain it may be used freely. EMAIL However, it should not be registered as a trade-mark since this info@altacit.com would prevent its use by other parties. WEBSITE www.altacit.com
  • 9. HOW CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, • INN is designated for the active part of the molecule only, to Mylapore, Chennai - 600 004. avoid the multiplication of entries in cases where several salts, Tel: +91 - 44 - 2498 4821 esters, etc. are actually used. In such cases, the user of the INN BANGALORE Suite 920, Level 9, has to create a modified INN (INNM). Raheja Towers, 26-27, M G Road, Bangalore - 560 001. • Ex: mepyramine maleate (a salt of mepyramine with maleic Tel: +91 - 80 - 6546 2400 acid) COIMBATORE BB1, Park Avenue, # 48, Race Course Road, • The primary principles for selection: Coimbatore - 641018. Tel: +91 - 422 – 6552921 Distinctive in sound and spelling; Not too long; and Not liable to confusion with other names in common use. Ex: ac: anti-inflammatory agents, ibufenac derivatives -coxib for COX-2 inhibitors, a type of anti- inflammatory EMAIL info@altacit.com drugs (e.g. celecoxib) WEBSITE contd.. www.altacit.com
  • 10. CHENNAI3rd Floor, ‘Creative Enclave’, • Do not select names for mixtures of substances.148-150, Luz Church Road, Mylapore, Chennai - 600 004. • Do not select for herbal substances (vegetable drugs) or for homoeopathic products. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, • Do not select names for those substances that have a Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 long history of use for medical purposes under well- COIMBATORE BB1, Park Avenue, established names such as those of alkaloids (e.g. # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 morphine, codeine), or trivial chemical names (e.g. acetic acid). EMAIL info@altacit.com WEBSITE www.altacit.com
  • 11. THE RIGHTS OF EXISTING TRADE-MARK OWNERS CHENNAI3rd Floor, ‘Creative Enclave’, • In the process of INN selection, the rights of existing148-150, Luz Church Road, Mylapore, Chennai - 600 004. trade-mark owners are fully protected. If in the period of four months following the publication of a proposed Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, INN, a formal objection is filed by an interested person 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 who considers that the proposed INN is in conflict with COIMBATORE an existing trade-mark, WHO will actively pursue an BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. arrangement to obtain a withdrawal of such an Tel: +91 - 422 – 6552921 objection or will reconsider the proposed name. As long as the objection exists, WHO will not publish it as a recommended INN. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 12. PROTECTION OF INN CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE • The World Health Organization collaborates closely BB1, Park Avenue, # 48, Race Course Road, with INN experts and national nomenclature committees Coimbatore - 641018. Tel: +91 - 422 – 6552921 to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade-marks should neither be derived from INNs nor contain common stems used in INNs. EMAIL contd.. info@altacit.com WEBSITE www.altacit.com
  • 13. CHENNAI3rd Floor, ‘Creative Enclave’, • During the past few years, INN common stems have been148-150, Luz Church Road, Mylapore, increasingly introduced in trademarks. This hampers the Chennai - 600 004. Tel: +91 - 44 - 2498 4821 selection of new nonproprietary names within the established BANGALORE system. Given the fact that all INNs should be distinct from Suite 920, Level 9, Raheja Towers, existing INNs and trademarks, this practice causes 26-27, M G Road, Bangalore - 560 001. difficulties when selecting a new name. Tel: +91 - 80 - 6546 2400 COIMBATORE • There are a large number of brands for a single BB1, Park Avenue, # 48, Race Course Road, pharmaceutical substance Coimbatore - 641018. Tel: +91 - 422 – 6552921 Generic name No. of brands INN amoxycillin 86 vinleurosine contd.. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 14. CHENNAI3rd Floor, ‘Creative Enclave’, • Based on recommendations made by the WHO Expert148-150, Luz Church Road, Committee on the Use of Essential Drugs, a resolution was Mylapore, Chennai - 600 004. adopted during the 46th World Health Assembly requesting Tel: +91 - 44 - 2498 4821 Member States to BANGALORE Suite 920, Level 9, Raheja Towers, • "Enact rules or regulations, as necessary, to ensure that 26-27, M G Road, Bangalore - 560 001. international nonproprietary names… are always displayed Tel: +91 - 80 - 6546 2400 prominently; COIMBATORE BB1, Park Avenue, # 48, Race Course Road, • Encourage manufacturers to rely on their corporate name and the Coimbatore - 641018. Tel: +91 - 422 – 6552921 international nonproprietary names, rather than trademarks, to promote and market multisource products introduced after patent expiration; • Develop policy guidelines on the use and protection of international nonproprietary names, and to discourage the use of EMAIL names derived from INNs, and particularly names including info@altacit.com INN stems in trademarks." WEBSITE www.altacit.com
  • 15. USE OF INNs IN INDIA • In India, Section 13 (b) of the Trade Marks Act, CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. 1999 prohibits the registration of names of chemical Tel: +91 - 44 - 2498 4821 elements or INNs which have been declared by the BANGALORE Suite 920, Level 9, Raheja Towers, World Health Organization (WHO) and notified by 26-27, M G Road, Bangalore - 560 001. the Registrar of Trade Marks. Nevertheless, there Tel: +91 - 80 - 6546 2400 COIMBATORE are reported incidents of marketing of drugs under BB1, Park Avenue, # 48, Race Course Road, names that are similar to INNs. The WHO has Coimbatore - 641018. Tel: +91 - 422 – 6552921 brought the same to the attention of the Drug Controller General of India. The basic requirement of Section 13 (b) of the Trade Marks Act, 1999 is that INNs must be notified by the Registrar. EMAIL contd… info@altacit.com WEBSITE www.altacit.com
  • 16. CHENNAI3rd Floor, ‘Creative Enclave’, • The use of INNs as trademarks constitutes a problem in two148-150, Luz Church Road, Mylapore, ways: use of parts of INNs in trademarks can dilute the INN Chennai - 600 004. Tel: +91 - 44 - 2498 4821 system by creating confusion in drug nomenclature. BANGALORE Secondly, since trademarks enjoy legal protection unlike Suite 920, Level 9, Raheja Towers, INNs, the use of INN stems in trademarks may thwart the 26-27, M G Road, Bangalore - 560 001. coining of new INNs in the future using the common stem, Tel: +91 - 80 - 6546 2400 where a trademark owner opposes the INN. This is because in COIMBATORE BB1, Park Avenue, the selection of INNs it is ensured that the rights of trademark # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 owners are not affected through INNs. • Use of INNs to coin brand names INN Stem Brand Name Company vinleurosine -osine Virosine DR Ranbaxy EMAIL info@altacit.com WEBSITE www.altacit.com
  • 17. PREVENTION OF REGISTRATION OF CERTAIN TRADEMARKS BY SOME INDIAN COMPANIES CHENNAI3rd Floor, ‘Creative Enclave’, • The WHO demanded that the applications for148-150, Luz Church Road, Mylapore, Chennai - 600 004. registration of brand names, like Tiotrop, Guapride, Dipride and Pride by companies Sun Pharma, Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, Ajanta Pharma, Divus Lab and First Care Pharma 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 respectively should not be entertained. COIMBATORE BB1, Park Avenue, • Also, WHO asked the DCGI to prevent approval of # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 brand name Riluzole by Rajvi Vipul Bhagat, Mumbai as Riluzole is an INNs. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 18. CONCLUSION CHENNAI3rd Floor, ‘Creative Enclave’, • While selecting INNs it is ensured that these are not similar to148-150, Luz Church Road, Mylapore, trademarks. WHA Resolution 46.19 of 1993 exhorts Member States Chennai - 600 004. Tel: +91 - 44 - 2498 4821 to develop legal and policy regimes to address this need. Though WHA Resolution 46.19 is non-binding in nature, India has BANGALORE Suite 920, Level 9, substantially implemented its requirements under Section 13 (b) of Raheja Towers, 26-27, M G Road, the Trade Marks Act, 1999. Nevertheless, no INN has been notified Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 by the Trade Marks Registry in the Trade Marks Journal. COIMBATORE BB1, Park Avenue, • The Controller General of Patents, Designs and Trade Marks has # 48, Race Course Road, Coimbatore - 641018. finally published a list of International Non-Proprietary Names as Tel: +91 - 422 – 6552921 declared by the World Health Organization which can be viewed in this link http://ipindia.nic.in/list_INN_08February2012.pdf. Hopefully this publication will be followed up by an official notification, following which Trade Mark Examiners will be mandated to examine pharmaceutical trademarks for any similarities to the INNs published in the list. Any names which are identical to EMAIL those on the INN list will not be registered as a pharmaceutical info@altacit.com trademark. WEBSITE www.altacit.com
  • 19. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, THANK YOU # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com