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Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances
(1997; 41 pages) View the PDF document
Table of Contents
Open this folder and view contents1. General introduction
Open this folder and view contents2. Elements in the INN system
Open this folder and view contents3. Principles for selection of INNs
View the document4. Protection of INNs
Open this folder and view contents5. How to apply for an INN
View the document6. References for supporting material
View the documentAnnex 1: Background information on the INN programme
View the documentAnnex 2: General principles for guidance in devising international nonproprietary names for pharmaceutical substances
View the documentAnnex 3: List of common stems used in the selection of INNs
View the documentAnnex 4: Specific groups of biological compounds
View the documentAnnex 5: WHA46.19 - Nonproprietary names for pharmaceutical substances
View the documentAnnex 6: Procedure for the selection of international nonproprietary names for pharmaceutical substances
View the documentAnnex 7: Applications for INNs through national authorities (addresses)
View the documentAnnex 8: INN request form
 

4. Protection of INNs

Lists of both proposed and recommended INNs are sent together with a note verbale by the Director-General to WHO Member States (at present 191), to national pharmacopoeia commissions and to other bodies designated by Member States. In his note verbale, the Director-General of the World Health Organization requests that Member States should take such steps as are necessary to prevent the acquisition of proprietary rights on the name, including prohibiting registration of the name as a tradename.

Over the years, the need to maintain the integrity of the INN system has become urgent. This is reflected in the following extract from the Fifth Report of the WHO Expert Committee on the Use of Essential Drugs which met in November 19911:

“The procedure for selecting INNs allows manufacturers to contest names that are either identical or similar to their licensed trade marks. In contrast, trade mark applications are disallowed, in accordance with the present procedure, only when they are identical to an INN. A case for increased protection of INNs is now apparent as a result of competitive promotion of products no longer protected by patents. Rather than marketing these products under generic name, many companies apply for a trade mark derived from an INN and, in particular, including the INN common stem. This practice endangers the principle that INNs are public property; it can frustrate the rational selection of further INNs for related substances, and it will ultimately compromise the safety of patients by promoting confusion in drug nomenclature.”

1 WHO Technical Report Series, No. 825, 1992.

These concerns were debated during the sixth International Conference of Drug Regulatory Authorities (ICDRA), in Ottawa, in October 1991.

Based on recommendations made by the WHO Expert Committee on the use of Essential Drugs the resolution WHA46.19 on Nonproprietary Names for pharmaceutical substances was adopted in May, 1993 during the Forty-sixth World Health Assembly requesting Member States to:

“enact rules or regulations, as necessary, to ensure that international nonproprietary names (or the equivalent nationally approved generic name used in the labelling and advertising of pharmaceutical products are always displayed prominently;

to encourage manufacturers to rely on their corporate name and the international nonproprietary names, rather than on trade-marks, to promote and market multisource products introduced after patent expiration;

to develop policy guidelines on the use and protection of international nonproprietary names, and to discourage the use of names derived from INNs, and particularly names including established INN stems as trade-marks.”

In the Director General's note verbale attention is drawn to this resolution concerning the use and protection of International Nonproprietary Names (INNs). The full text of the resolution is reproduced in Annex 5.

As a matter of principle, it may thus be recommended that trade marks should not be derived from INNs. In particular, the intentional incorporation of meaningful INN stems in trade marks should be avoided.

Similarly, inclusion of elements from biochemical nomenclature (like -feron from interferon, or -leukin from interleukin) in trade marks in anticipation is discouraged since these elements are likely to be utilized as stems within the INN nomenclature. Their inclusion in trade marks could pre-empt the logical development of the INN nomenclature.

In accordance with resolution WHA46.19, registration of an INN together with a firm's name is perfectly acceptable, as long as it does not prevent another manufacturer from using the same approach.

 

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