The International Nonproprietary Names of the medicinal products (INN) — what it means as applicable to the registration of a trademark
The introduction of the International Nonproprietary Names (hereinafter referred to as the INN) into the world practice began in 1950 with an adoption of the Resolution WHA 3.11. by the World Health Organization. Three years later, the first list of the INN was published, and currently, according to the WHO data, the number of such names is about 8 thousand.
In Russia, the procedure for the application of the INN is specified in the provisions of the Federal Law of 12.04.2010 No. 61-FZ “On Circulation of Medicinal Products.” According to Paragraph 16 of Article 4 of the above normative act: “An International Nonproprietary Name of a medicinal product is a name of the active ingredient of a pharmaceutical substance that is recommended by the World Health Organization.”
To grant the legal protection to the INN, the WHO must consider the application, carry out an examination of the designation, make a decision on the approval of its results and publish the decision. During this period of time (approximately 26 months), the offered name is outside the legal status of the INN and it acts as a National Nonproprietary Name (hereinafter referred to as the NNN). In practice, the differences between the INN and the NNN are only in the territory covered by the rights – the latter are protected only within the country, and in the validity period (the protection of the NNN is valid up till the recognition of the designation as an international one).
A detailed analysis of the WHO resolutions and the domestic legal documents in the field of pharmaceuticals allows identifying a number of the features determining the international nonproprietary name:
- It is a unique name of the pharmaceutical substance.
- The registration of only one INN is allowed in respect of one pharmaceutical substance.
- This designation is approved and recommended by the WHO, and therefore, it is recognized worldwide and it is applied in different countries of the world.
- The INN is a subject of the public domain and it can be used by any person, who is engaged in the manufacture and circulation of drugs without any restrictions.
- Due to the general recognition of the nonproprietary names of the medicinal products, they play a role of the universal international designations.
Thus, the INN is a publicly available and world-famous name of the pharmaceutical substance, which makes it possible to simplify the work of the representatives of the pharmaceutical and medical spheres and to avoid some possible confusion and errors.
The role of the International Nonproprietary Names of drugs in the registration of trademarks
Taking into account the oversupply of the products in all branches, including the pharmaceutical one, the manufacturers of the drugs prefer to release the products to the consumer market under a trademark, i.e. the registered designation with the elements of a fantasy nature.
The use of the INN allows physicians identifying correctly the pharmaceutical substance incorporated in the drug, whereas the trademark allows consumers identifying the product.
In order to simplify the examination of the trademarks claimed in respect of the drugs in Russia, Rospatent has created and approved the Instruction for the use of the WHO database containing the information on the International Nonproprietary Names. The document contains the tasks for which fulfillment the trademarks and the International Nonproprietary Names are created: “... the INN, unlike the trademarks, serve to identify not the product itself and its manufacturer, but to identify the active substances in the composition of the drug.” The spheres of the application of the concepts under consideration become obvious: one concept identifies the drug from the point of view of its pharmacological composition and it is intended to determine the active ingredients incorporated in the drug. Another concept distinguishes the medicinal product in order to identify it among other drugs with the homogeneous composition and it is intended to identify directly the quality of the product.
If we consider the INN regarding their influence on the trademarks that are created and registered, the following can be highlighted:
- At the moment of the development of the designation, it is possible to use the INN as a basis for creating a fantasy word element in the composition of the trademark. For example, the trade name Ribamidil(R) is used for the drug having the general INN Ribavirin.
- At the step of the substantive examination of the trademark, among other things, the specialist shall check the designation as to the compliance with the requirements of Subparagraph 2 of Paragraph 1 of Article 1483 of the Civil Code of the Russian Federation: “The state registration as the trademarks shall not be allowed in respect of the designations, which do not have a distinctive ability or which consist only of the elements that: ... are the general symbols and terms.” And also Subparagraph 1 of Paragraph 3 of Article 1483 of the Civil Code of the Russian Federation: “The state registration as the trademarks shall not be allowed in respect of the designations being or containing the elements that are: false or capable of confusing the consumer regarding the product or its manufacturer.” It is obvious that the INN are the general designations, and their incorrect use can confuse the consumer. Due to these reasons, the experts pay an increased attention to a comparative analysis of the claimed trademarks and the INN recognized by the WHO.
- The International Nonproprietary Names may be incorporated in the trademark as an unprotected element in accordance with Article 1483 of the Civil Code of the Russian Federation: “... the elements that cannot be registered as a trademark may be incorporated as an unprotected element provided that they do not occupy a dominant position in it.”
Summing up, the following foundational circumstances should be noted:
- The INN is a unique name of the pharmacological substance that can be used by any person, on any territory, without any restrictions as to time.
- When creating the trademark, the manufacturer may be guided by the INN in order to create the fantasy word element.
- When checking the designation claimed for the registration as a trademark in respect of class 05 of the ICGS (pharmaceutical products, medicines and veterinary drugs, etc.), the experts carry out a comparative search for the novelty of the word element of the trademark using, inter alia, the INN Database represented on the WHO website.