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Protection of USAN and INN Stems

Stems and Trademarks

With the growing number of USAN/INN and brand names, the possibility of conflicts between nonproprietary names, between trademarks, and between trademarks and nonproprietary names has increased significantly.  A frequent source of conflict in the latter category is the practice of piggybacking on the USAN/INN, which is the incorporation of the official nomenclature stems, or clearly recognizable parts of stems, in the trademark.  If trademark registration is obtained for names containing an officially reserved stem, the freedom of the USAN and the INN programs to select further nonproprietary names in the same series of substances is seriously diminished.

Selection of trademarks, unlike the nonproprietary name, is not under the jurisdiction of the USAN or INN programs.  Therefore, the good will and respect of the manufacturers for current nomenclature guidelines is necessary to support and maintain the integrity and full potential of official nomenclature programs.  The USAN Council adheres to the principle stated in the Federal Food, Drug and Cosmetic Act, Section 508(A), which states that "In no event...shall the Secretary establish an official name so as to infringe a valid trademark."  It is incumbent upon the manufacturers to likewise refrain from infringing on official drug nomenclature stems for use in trademarks.  This point was commented upon in the USAN remarks relative to WHO Resolution WHA 46.19. 

In 1993, the WHO Executive Board placed Resolution WHA 46.19 before the World Health Assembly (WHA) seeking to encourage the WHO member states to intensify their efforts to discourage manufacturers from devising trademarks derived from recommended International Nonproprietary Names (rINN) and from including INN stems in the trademarks.  Resolution WHA 46.19 was adopted by the 46th WHA on May 12, 1993.  Resolution WHA 46.19 was discussed by the USAN Council on Jan. 28, 1994.  The USAN Council agreed in principle with the Resolution statements and supported the premises stated in the Resolution.

The expression of general support from WHA Resolution 46.19, although in keeping with the historical support by the USAN Council for harmonization of global drug nomenclature policies, has led to a misapprehension of USAN Council views in some United States-based and multinational pharmaceutical corporations and associations.  A statement of the USAN Council's views is provided in blockquote below each section of the WHA Resolution.

The following combined statement was approved by the Council on Jan. 22, 1996. 

WHO Resolution WHA 46.19

Nonproprietary Names for Pharmaceutical Substances

The Forty-sixth World Health Assembly Requests Member States:

(1)  "to enact rules or regulations, as necessary, to ensure that International Nonproprietary Names (or the equivalent nationally approved generic names) used in labeling and advertising of pharmaceutical products are always displayed prominently"

The principle that the USAN be prominently displayed is not an issue in this country; this has been required by the Federal Food, Drug & Cosmetic Act for more than three decades.  Section 502(E) requires for labeling that:  "The established name...is printed prominently and in type at least half as large as that used theron for any proprietary name or designation for such drug..."

(2)  "to encourage manufacturers to rely on their corporate name and the International Nonproprietary Names, rather than on trademarks, to promote and market multisource products introduced after patent expiration"

The USAN Council recognizes that trademarks constitute intellectual property for their holders.  The USAN Council encourages manufacturers of multisource prescription drug products, other than those who obtained the original NDA approvals, to rely on the USAN and their corporate names in marketing such products instead of creating additional trademarks.  Nevertheless, the USAN Council recognizes that the use of trademarks is common and valuable in marketing over-the-counter drug products and is often useful in special cases with prescription drug products.  Such special cases may arise when, for example, 1) there are difference in bioavailability between a drug product marketed by an innovator firm and a later version introduced by the same or another firm, 2) drug products, containing the same drug substance but with different uses, are introduced.

(3)  "to develop policy guidelines on the use and protection of International Nonproprietary Names, and to discourage the use of names derived from, and particularly names including established INN stems as trademarks"

The USAN Council discourages the use in trademarks of substantial portions of USAN and established USAN stems.  This practice is an infringement on USAN and an impediment to the work of the USAN Council in establishing new USAN in a class of drugs.  It should be noted that USAN Council attempts to avoid establishing USAN that are in conflict with US and foreign trademarks as well as other nonproprietary names of drugs.  Furthermore, the USAN Council is cognizant of the Federal Food, Drug and Cosmetic Act, Section 508(A), which states, in part, "In no event...shall the Secretary establish an official name so as to infringe a valid trademark."