For the representatives of the medical field and the consumers to be able to use a pharmaceutical product, as well as to introduce it to the market, a medicinal product must have a name. The name allows distinguishing the object or the drug having a particular composition, and, in the case of the pharmaceutical industry, reducing the cases of doing harm to the health of the consumers due to confusing.
The Federal Law “On Circulation of Medicinal Products” stipulates the following kinds of the names used in relation to medicinal products and pharmaceutical substances (Paragraph 16-17.1 of Article 4):
- The international nonproprietary name of the medicinal product (hereinafter referred to as the INN) is a name of the active ingredient of a pharmaceutical substance that is recommended by the World Health Organization.
- The trade name of the medicinal product is the name of the medicinal product given to the drug by its developer, holder or owner of the registration certificate.
- A generic name of the medicinal product is the name of the medicinal product that does not have the international nonproprietary name or a combination of the drugs, which is used for the purposes of combining them into a group under the single name based on the same composition of the active ingredients.
Due to the fact that the medicinal products are distributed through retail trade networks, the trademarks may also be used as the name of the drug. In Article 1477 of the Civil Code of the Russian Federation, the trademarks (hereinafter referred to as the TMs) are defined as: “...a designation used for the individualization of the products of legal entities and individual entrepreneurs.” The 5th class of the ICGS is used for the registration of the designations in relation to the drugs.
It follows from the above definitions that they all are the designations used in the pharmaceutical industry, however, they have a different legal status and they differ in their content and the purposes performed. A further analysis allows dividing the concepts into two groups: the first one includes the INNs and the generic names of the drugs; the second one includes the TMs and the trade names of the medicinal products. Such gradation is due to the nature of the designations: the first category of the names performs the task of identifying the active ingredient or substance, and the names of the second category are used for identifying the drug at the commercial markets, i.e. for distinguishing the product among other homogeneous ones (including, according to the composition). It seems possible to assume that the generic names and the trade names, by their nature, are the precursors of the INNs and the TMs, accordingly. Due to this reason, analyzing and comparing the content and the scope of the rights of just the latter concepts will be the most appropriate.
The common features in the registration and the status of the international nonproprietary names of the medicinal products and the trademarks
As it has been noted earlier, in addition to the fact that both kinds are used in the pharmaceutical industry and they are the designations used to identify the medicinal product, the INNs and the TMs also have a number of other similar features. Thus, despite the fact that the designations are checked by the different bodies in order to obtain the status as “valid,” the check stages are almost identical in general:
- Filing an application for the registration of the designation.
- Considering the application, carrying out two stages of an examination: a formal one, which is the check of the compliance of the submitted documents with the necessary conditions, and the substantive examination of the designation, during which it is found out whether the designation complies with the requirements.
- Publishing the claimed designation to get comments and objections.
- If there are no objections and if a positive decision is made during the two stages of the examination, obtaining the status as “valid” for the name and as a result, the emergence of a certain legal protection.
One of the purposes of creating the INNs and the TMs can also be considered as common: both the WHO and the Russian legislator point out to the importance of reducing a risk of confusing the consumers. To achieve the maximum results in this field, there is a bilateral prohibition to the registration of the similar designations: neither the registration of the trademarks being identical to the INNs is allowed, nor the protection of the international nonproprietary names that conflict the already registered TMs is possible.
The differences between the trademarks and the international nonproprietary names of the medicinal products
First of all, it should be mentioned that the concept of the INN has been introduced into the world practice of the WHO, and it is recognized and applied in the Russian Federation in accordance with the norms of the international treaties, to which it is a party. The description of a legal institution of the trademarks is contained in Paragraph 2 of Chapter 76 of Part 4 of the Civil Code of the Russian Federation.
The concepts under consideration differ in a number of the reasons, which can be clearly set forth in the form of a comparative table.
1. The purpose of creating the name.
The INNs are being created to unify the names of the pharmaceutical substances and they are unique in their nature.
Thus, the single name that is valid in the majority of the countries of the world is chosen for each pharmacological substance.
The main task of using the INN is to facilitate the work of the representatives of the medical field and to reduce the risk of confusing the consumers.
The TM is a unique designation that distinguishes the product among other homogeneous ones.
The product is distinguished with the help of the TM, in this case it is the drug, and the TM also helps focusing an attention on the manufacture of the product by a particular manufacturer.
The main purpose of the use of the TM is the emergence of the associative links such as “the product-the manufacture,” “the product-the trademark” among the consumers.
2. The kind of the designation.
The names of the pharmaceutical substances, i.e. the name of these substances or their compounds, may be registered as the INNs.
The word, visual and other elements in the composition of the trademark is allowed. The fantasy designations are considered to be the most “strong” and protectable ones.
3. The body making the decision on the registration of the designation.
The name is approved by the World Health Organization.
The decision on the registration is made by the authorized state body (in Russia, it is Rospatent).
4. The holder of the designation.
The INN becomes public property since the date of its publication, so there is not a particular right holder.
The holder of the rights to the trademark is one or more persons indicated as the right holder in the trademark certificate.
5. The nature and accessibility of the rights for the general public.
The name may be applied by any person without limitation.
Third parties are not entitled to use the designation without a permission of the right holder, except in the particular cases stipulated by the legislation.
6. The validity period of the rights to the designation.
There is the legal protection without limit of time in respect of the approved INN.
The initial period of the protection of the registered trademark is 10 years. Then, upon the holder’s declaration, it is possible to extend the validity period of the certificate for 10 year an unlimited number of times.
The information presented shows that the INN and the TM have a number of similarities and differences, while the most important thing is the main similarity, which is in the purpose of creating the designations, namely: to avoid confusing the consumer and the possible adverse consequences resulting from this.