Naming, classification, and trademark selection: Implications for market success of pharmaceutical products

Even though trademark legislation does not specifically address the needs of the pharmaceutical industry, there are unique rules governing the nomenclature, nonproprietary naming, and trademark choice of pharmaceuticals. In addition, promotion of pharmaceutical products-including the use of trademarks-is tightly regulated, necessitating well-designed premarketing communication strategies to maximize the appropriate use of new products in order to fully realize their commercial value, once marketing authorization has been granted. The commercial value of any given product may be diminished, increased, or maximized depending upon naming choices made early during the development process. Optimum naming choices lead to a high degree of acceptance by the scientific community, medical opinion leaders, and patients, thereby guaranteeing fast and efficient market penetration. Thus, naming, branding, and classification of pharmaceutical products have become issues of increasing strategic importance for their manufacturers and distributors. Clearly, appropriate nonproprietary naming, classification, and trademark selection have the potential to significantly support the desired differentiation and positioning of the emerging new pharmaceutical.

Key Words: Brand name; Trademark; Look-alike-sound-alike drugs; International Nonproprietary Name; Therapeutic class

INTRODUCTION

THE PROCESS OF NAMING is particularly driven by feelings, attitudes, and associations, and the acceptance of a name by the public is hard to predict. Some will simply like it, others will not. The primary objective for the designation of names to merchandising goods is always the same: To create a certain level of uniqueness and to add distinctiveness. This fundamental principle is also applicable to pharmaceuticals.

Pharmaceuticals are identified by their proprietary name (trademark, trade name, or brand name; see below "Trademarks"). Their active ingredients) is(are) described by the International Nonproprietary Name (INN, or generic name). Before the corresponding INN becomes available, code names are often assigned to active compounds, especially in their very early stages of development. Classes of pharmaceuticals (pharmacological classes or therapeutic classes) are defined by their chemical origin, their pharmacological action, their intended medical usage, or by combinations thereof.

The chemical name specifies the molecular structure of the pharmaceutical and is used primarily by researchers. A pharmaceutical's chemical name is long and usually difficult to pronounce and remember. Consumers, physicians, and pharmacists are, therefore, better served by referring to the pharmaceutical's INN. Chemical names, therefore, play little if any role in the pharmaceutical's market success and are not further dealt with here.

Clinical development candidates are often assigned a code name. A typical code consists of letters and numerals combined from abbreviations of the owner's name and an internal numbering system. Depending upon the timing of INN application (see below) and the publication strategy of a compound owner, the code name may be well known in the scientific community. Thus, a wisely selected code name hinting clearly to its owner may positively influence the owner's image, especially if positive clinical research data on the coded compound are being presented at scientific meetings or published in international journals. However, since code names can only bridge the period until a pharmaceutical gets promotion by its INN, its classification, or its brand name, code names will not be specifically addressed in this review article.

As merchandising goods, pharmaceuticals are unique with regard to their long development time (time to market: 8 to 12 years), relatively low success rate (still more than 50% of drug candidates fail during clinical testing), and the strict regulations their producers and marketing authorization holders (MAH) have to adhere to. In addition, real breakthrough drugs, that is, new medical entities exerting novel therapeutic mechanisms, are relatively seldomly developed and face a high degree of competition. (Please note the distinction between a "New Medical Entity" and a "New Molecular Entity" that is defined by the Food and Drug Administration Center for Drug Evaluation and Research as "a compound that can be patented, which has not been previously approved in any form in the US" [1].)

In order to differentiate a novel pharmaceutical from therapeutic standards, appropriate naming and classification is necessary and bears huge marketing potential. The MAH has only limited influence on the designation of the INN by the World Health Organisation (WHO). However, the invention of a novel therapeutic class during the preapproval period can maximize the acceptance of the INN by medical opinion leaders, a prerequisite for winning the "race-to-market" in a steadily growing competitive environment. Once market approval has been granted, a delicate trademark selection may guarantee a fast and efficient market penetration. On top of that, trademarks are of utmost importance once a product has fallen out of patent protection and generics enter the market.

An additionally important aspect to be considered during a pharmaceutical's name selection process is the confusion both potential INN and trademarks can bear, since medication errors as a consequence of mixing up pharmaceuticals can be fatal.

This paper describes the concepts and strategies pharmaceutical companies commonly use to manage pharmaceutical naming, branding, and classification. Success factors will be discussed and, finally, the authors will try to point out perspectives based upon the results obtained.

INTERNATIONAL NONPROPRIETARY NAME OR GENERIC NAME

The INN system was initiated in 1950 by a WHO resolution and began operating three years later. It includes some 7000 substances and is updated annually. WHO handles all the formalities with respect to designation of novel INNs. WHO has installed INN experts (expert advisory panel) who have selected and defined the common "stems" that are currently in use. These common stems represent classes of substances that are pharmacologically related, making it easier for pharmacists, scientists, or medical practitioners to get an idea about which group of substances a given pharmaceutical may belong to (see also "Classification of Pharmaceuticals" below). The manufacturer of a pharmaceutical never owns the pharmaceutical's INN. This generic name is always in the public domain. Once the pharmaceutical's patent expires, other manufacturers may produce a similar pharmaceutical with the same active compound(s), referring to it by its generic name. In order to get final acceptance by WHO, it must be ensured that the INN:

* Does not look or sound too similar to any other generic or brand name,

* Is considered appropriate for the specific pharmaceutical,

* Is "useful," with usefulness being defined by suitability: in routine use; for education by scientific and medical journals; for international use,

* Is short, easy to pronounce, and euphonic,

* Is not misleading or confusing,

* Does not contain prefixes implying a general descriptive adjective, such as new or improved, and

*Includes a stem, or a word common to members of a related group of pharmaceuticals (2).

An INN should also be a single word and should not be inconveniently long. It is imperative that any newly suggested name does not conflict with existing chemical names, other INNs, or trademarks.

Importantly, any manufacturer of a generic drug is allowed to use the INN followed by the company's name as the trademark of the pharmaceutical. This is somewhat exceptional since one of the major objectives of the whole INN system is not to use INNs as a basis for trade names. This applies especially to the use of their common stems since the selection of further names within a series will be seriously hampered by the use of such an INN stem in a brand name.