Selection of a Medicinal Product Name in Russia

 

September 30, 2022

BRACE Law Firm ©

 

Over the past decades, a large number of new medicinal products have been registered globally every year. Under such conditions, universal names that allow healthcare professionals to identify any medicinal product become particularly significant. This significance is explained by the fact that similar names can cause errors during prescription and sale. Furthermore, the economic aspect plays a significant role, as a successful choice of name, if easy to remember, increases sales.

These circumstances necessitated the regulation of rules for selecting medicinal product names at the state and international levels. In this article, we will analyze the procedure for selecting medicinal product names in the Russian Federation and generally accepted international rules.

What are the Types of Medicinal Product Names?

The following names may be used regarding medicinal products:

• International Nonproprietary Name (the "INN"). In certain cases, a chemical or grouping name is used instead of an INN.
• Trade name.
• Grouping name.
• Chemical name.

The procedure for selecting medicinal product names in the Russian Federation was approved by Order of the Ministry of Health of Russia No. 429n dated June 29, 2016 [1] (the "Order No. 429n"). Additionally, to ensure a uniform scientifically grounded approach, the Ministry of Health of Russia developed the Methodological Recommendations "Rational Selection of Names of Medicinal Products" [2] (the "Methodological Recommendations of October 10, 2005"). Let us examine them in more detail.

Procedure for Selecting an INN, Grouping Name, and Chemical Name

International Nonproprietary Name is the name of the active substance of a pharmaceutical substance recommended by the World Health Organization (Part 16 of Article 4 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products")).

The selection of an INN is a complex and lengthy process carried out in accordance with the Selection Procedure approved by a resolution of the WHO Executive Board [3]. The first list of INNs was published in 1953; prior to that, chemical names were used to identify medicines, which caused significant inconvenience due to their highly specific nature.

The INN selection process is conducted in three main stages:

1. Submission of an application to the WHO by an interested party.
2. Expertise of the proposed INN by the WHO expert group for compliance with basic rules and similarity with already published INNs, followed by a 4-month period for accepting objections and comments.

When selecting an INN, the following principles are observed:

• INNs should not be too long or difficult to pronounce and write.
• INNs should not be similar in spelling and pronunciation to medicinal products already in circulation.
• Verbal elements that may trigger an associative link with anatomical or physiological terms, a specific disease, or an expected therapeutic effect are avoided.
• To facilitate translation into other languages, the use of letters that may cause transliteration difficulties is avoided.
• Special stems are used during formation.

3. Selection of the recommended INN, resulting in its publication in specialized editions: the "WHO Drug Information" journal and the WHO international reference book "International Nonproprietary Names for Pharmaceutical Substances. Cumulative List".

Once a recommended INN is published, it may be used in pharmacopoeias, labeling of medicinal products, scientific publications, educational editions, reference materials, or advertising information on medicinal products.

It is important to understand that from the perspective of legal protection, an INN is not an object of exclusive rights and is not subject to registration as a trademark. It is a unique generally accepted designation that the WHO provides for use to all medicinal product circulation entities without restrictions.

An INN is selected for medicines containing only one pharmaceutical substance of chemical origin. INNs are not assigned to herbal and natural products, homeopathic products, or products used for a long period for medical purposes under well-known names. For such cases, grouping or chemical names may be used.

Grouping name is the name of a medicinal product that does not have an INN, or a combination of medicinal products, used to group them under a single name based on the identical composition of active substances (Clause 17.1 of Article 4 of the Law on Circulation of Medicinal Products). A grouping name belongs to the group of nonproprietary names; they may be used without restriction.

A list of grouping names is not legislatively approved in the Russian Federation. As a general rule, a medicinal product is assigned the same grouping name as the active substance from which it is produced. An example of such a grouping name is "Albumin."

For combinations of medicinal products:

• If the medicinal product contains two or more active substances, the grouping name constitutes a listing of their INNs or grouping names of pharmaceutical substances in alphabetical order separated by a "+" sign; for example, [Sulfamethoxazole + Trimethoprim];
• If the pharmacological activity of one or several pharmaceutical substances is auxiliary, its name is indicated at the end of the grouping name in square brackets regardless of alphabetical order.

Order No. 429n establishes a prohibition on using designations identical to previously registered ones, differing in composition and action, or graphically and/or phonetically identical to such name or confusingly similar to it, as a grouping name.

Furthermore, to unify the rules for compiling grouping names within the EAEU member states, the Board of the Eurasian Economic Commission developed recommendations [4]. The key provisions of the recommendations are as follows:

Grouping names of medicinal products must be selected so that they differ from existing trade names to exclude the possibility of copyright infringement. The use of individual letters or numbers, as well as hyphens, should be avoided. It is desirable to exclude locants and brackets from the chemical name. The document also contains specifics on compiling grouping names for specific groups of products: stereoisomers, radioactive substances, and specific groups of biological substances (peptides, proteins, enzymes, hormones, monoclonal antibodies, and others).

Chemical name of a medicinal product is a name reflecting the composition and structure of the medicinal substance. It is assigned in accordance with the nomenclature of the International Union of Pure and Applied Chemistry (IUPAC). Chemical names are not frequently applied in practice as they represent a complex term understood only by chemistry specialists. For example, 5,5-diallylbarbituric acid. They are more often indicated in the instructions for use (package insert) of the medicine in addition to the INN.

Note that there are exceptions that do not have any of the indicated names. As an example, the medicinal product Solcoseryl, the instructions for use of which list only the trade name and the active substance: deproteinized hemodialysate from the blood of dairy calves.

Procedure for Selecting a Trade Name of a Medicinal Product

Trade name of a medicinal product is the name assigned by its developer, holder, or owner of the registration certificate (Marketing Authorization) of the medicinal product (Clause 17.1 of Article 4 of the Law on Circulation of Medicinal Products). Unlike an INN, the trade name of a medicinal product generally identifies the product upon its release into civil circulation.

Despite the above, trade names also cannot be chosen arbitrarily. Order No. 429n establishes the following rules for selecting a trade name:

• INNs cannot be used as a trade name. Exceptions are cases of (a) using the international nonproprietary name without abbreviations in the trade name of the medicinal product, and (b) using the international nonproprietary name in the trade name of the medicinal product simultaneously with the firm name of the organizations specified in their constituent documents. In this case, the firm name is indicated after the international nonproprietary name.
• The trade name must not mislead the consumer regarding the composition, properties, and (or) action of the medicinal product, or its manufacturer.
• The trade name of a medicinal product must not contain designations and (or) elements contradicting public interests, principles of humanity, and morality.
• The trade name must not contain profanity, words, and expressions not corresponding to the norms of the Russian literary language, as well as designations identical to or having graphic and (or) phonetic similarity with official names of particularly valuable cultural heritage objects of the Russian Federation, objects of world cultural or natural heritage, geographical names, or proper names.
• The use of the following as a trade name for a newly registered medicinal product is not permitted:
  • Identical to the name of a previously registered medicinal product;
  • Identical to the name of a previously registered medicinal product (e.g., floxan – floxal; abufen – ibufen; pinovit – pikovit; eclin – ecalin; okoden – acodin);
  • Confusingly similar to the name of a previously registered medicinal product.

To assess under this criterion, the Methodological Recommendations of October 10, 2005, contain a Methodology for checking names for graphic and phonetic similarity. A name is considered similar to another name if it is associated with it as a whole, despite individual differences. Similarity of names can be sound (phonetic) or graphic (visual). Signs of sound similarity include: the presence of close and coinciding sounds; the presence of coinciding syllables and their arrangement, the proximity of the composition of vowels or consonants, the number of syllables, etc. The general rule is that when counting the letters (characters) constituting the words, the differences must amount to 3 or more letters (characters) in any combination.

Let us consider an example from judicial practice. A Company filed a lawsuit against the Ministry of Health of Russia to compel the issuance of a Marketing Authorization for the medicinal product "Sealex@ Sildenafil". As established during the court hearing, the Company applied to the Ministry of Health of Russia for registration of a medicinal product under the trade name "Sealex@". Based on the results of the medicinal product quality expertise, it was established that a dietary supplement is sold in the pharmacy network under the identical trade name "Sealex Forte", which may pose a potential danger due to the possibility of confusing the dietary supplement with the medicinal product. To eliminate the risk of error, the Company decided to change the name by including the INN: "Sealex@ Sildenafil". However, a positive expert opinion was not received in the final form, and the issuance of the registration certificate for the product was refused, which served as the grounds for appealing to the court.

The court indicated that the certificate of registration for the dietary supplement had not been annulled or revoked. The names of the dietary supplement and the medicinal product are confusingly similar. According to Clause 13 of Order No. 429n, the trade name of a medicinal product must not mislead the consumer regarding the composition, properties, and (or) action of the medicinal product, or its manufacturer. The court refused to satisfy the claim [5].

Additionally, the Methodological Recommendations of October 10, 2005, contain a number of additional requirements for the trade name, such as:

• Different names for different dosage forms of the same medicinal product are not recommended;
• The dosage form of the product is not included in the name of the medicinal product;
• It is not recommended to use identical names for combined medicinal products differing in composition or dosage ratio;
• It is not recommended to fully reproduce names of diseases and symptoms of diseases, anatomical, and physiological terms in the names of the medicinal product.

The Methodological Recommendations of October 10, 2005, also formulate Linguistic approaches to forming trade names of medicinal products.

Compliance with these requirements is assessed by the Commission of Experts of the FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of Russia as part of the expertise of the quality of the medicinal product and the benefit-risk ratio of the use of the medicinal product for medical use.

The Board of the Eurasian Economic Commission developed the Guideline on the Selection of Trade Names of Medicinal Products for EAEU member states [6]. It recommends registering a medicinal product under a single trade name in all Eurasian Economic Union member states. It also contains a procedure for harmonizing trade names in EAEU countries and recommendations for assessing trade names of medicinal products. Criteria applied when assessing trade names of medicinal products:

1. Public safety and health. The possibility of confusing the name in printed or written form, or in its pronunciation, with the trade name of another medicinal product is assessed. When assessing probability, aspects such as indications for use; patient population; dosage form, dosage, and route of administration, including potentially new ones; conditions of prescription and dispensing; orphan status; and potential harm to the patient in case of confusion are taken into account.

When conducting the assessment, the expert organization must assess the possibility of confusing both registered medicinal products and medicinal products for which the validity of registration certificates has been suspended or terminated in the territory of EAEU member states. The possibility of misleading the consumer, including through the similarity of the product name with the names of pharmaceutical companies, if this may lead to incorrect perception of information about the medicinal product, is also subject to assessment.

In addition to the above, linguistic features of the proposed name are also assessed. For example, the possibility of difficulty in pronouncing the proposed trade name in the state languages of the member states. The use of abbreviations and numbers is allowed, except in cases where there is a possibility of confusing them with the dosage and (or) dosage regimen. It is not recommended to compose a name entirely of an arbitrary set of capital letters or numbers, or to include punctuation marks and mathematical signs (except for the signs "-", "+", and "/") in it.

When assessing safe use, labeling and packaging design are also taken into account, as the display of the trade name of the medicinal product on printed material may increase the degree of similarity with another trade name.

2. Application of INNs in proposed trade names of medicinal products. To exclude the risk of assessing a trade name against commonly accepted ones, it is recommended to check the proposed trade name of the medicinal product:

• For potential similarity with the INN of the active substance included in the composition of the given medicinal product or with other INNs;
• For the inclusion of an INN stem in the proposed trade name of the medicinal product.

Correlation Between the Concepts of Trade Name and Trademark

The question of the correlation between a trade name and a trademark is of interest.

In accordance with Chapter 76 of the Civil Code of the Russian Federation, a trademark is a designation serving to individualize the goods of legal entities or individual entrepreneurs. Verbal, graphic, three-dimensional, and other designations or their combinations may be registered as trademarks. The exclusive right to a trademark is certified by a trademark certificate issued by the Federal Service for Intellectual Property (Rospatent). Registration of trademarks is voluntary.

By virtue of Article 13 of the Law on Circulation of Medicinal Products, as a general rule, all medicinal products are subject to state registration. During state registration, the name of the medicinal product, including the trade name, is entered into the State Register of Medicinal Products. The authorized federal executive body performing this state function is the Ministry of Health of the Russian Federation. Circulation of the aforementioned medicinal products without state registration is prohibited.

At the same time, trade names may be patented as a trademark and will be an object of legal protection as an intellectual property object. Note that the largest number of judicial disputes regarding names of medicinal products is related to granting them legal protection or its early termination. Let us consider examples from judicial practice.

A Company appealed to the court with an application to invalidate the decision of Rospatent refusing to satisfy an objection against granting legal protection in the territory of the Russian Federation to the trademark BRAVADIN. As established during the consideration of the case, the right holder registered a trademark with the verbal element BRAVADIN, executed in a standard font in capital letters of the Latin alphabet. However, this trade name has confusing similarities with the INN Ivabradine, which is capable of misleading the consumer regarding the goods. Taking into account the indicated circumstances, the court concluded that the registration of the trademark BRAVADIN contradicts public interests and unreasonably endows the right holder with certain advantages. The court recognized the granting of legal protection in the territory of the Russian Federation to the verbal trademark "BRAVADIN" as invalid [7].

In another case, a Company filed a lawsuit against the trademark right holder for the early termination of legal protection of the trademark due to its non-use. As established by the court, the defendant was the right holder of the trademark Regastim for a medicinal product for the treatment of diseases of the gastrointestinal tract. As established during the court proceedings, the product with such a name did not pass registration with the Ministry of Health of the Russian Federation, and therefore was not introduced into economic circulation. The plaintiff, in turn, registered and has been manufacturing for a long time the product "Regast", used for treating patients infected with the human immunodeficiency virus.

According to Clause 1 of Article 1486 of the Civil Code of the Russian Federation, the legal protection of a trademark may be terminated early due to the non-use of the trademark continuously for 3 years.

In the court hearing, the right holder referred to the fact that the trademark was not used due to circumstances beyond its control: the duration of the clinical trial procedure and the subsequent registration of another medicinal product with a similar name during this period. The court decided that the implementation of preparatory actions does not testify to the presence of obstacles beyond the will of the right holder for using the trademark. Furthermore, the court concluded that the verbal elements REGAST and REGASTIM possess similarity and are associated with each other as a whole. At the same time, by virtue of Clause 14 of Order No. 429n, the use of a trade name for a newly registered medicinal product that is confusingly similar to the name of a registered medicinal product is not permitted.

Considering that the right holder did not prove the fact of using the trademark, nor the presence of valid reasons beyond its control preventing its use for 3 years, while the plaintiff confirmed its interest in the early termination of legal protection of the disputed trademark, the court satisfied the claim [8].

Summarizing the above, we note the significance of introducing the International Nonproprietary Name, as well as the necessity of state regulation of the procedure for selecting medicinal product names. Only compliance with all established rules will allow guaranteeing consumer safety and the economic success of medicinal product production.

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References

[1] Order of the Ministry of Health of Russia No. 429n dated June 29, 2016, On Approval of the Rules for Rational Selection of Names of Medicinal Products for Medical Use.

[2] Approved by the Ministry of Health and Social Development of the Russian Federation on October 10, 2005.

[3] International Nonproprietary Names: revised procedure. Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances. EB115.R4, WHO, Geneva, 2005.

[4] Recommendation of the Board dated April 23, 2019, No. 13 On the Rules for Compiling Grouping Names of Medicinal Products.

[5] Resolution of the Arbitration Court of the Moscow District dated March 30, 2018, No. F05-422/18 in case No. A40-85202/2017.

[6] Recommendations of the Board of the Eurasian Economic Commission dated January 29, 2019, No. 2 On the Guideline on the Selection of Trade Names of Medicinal Products.

[7] Ruling of the Supreme Court of the Russian Federation dated June 7, 2017, No. 300-ES17-6756 in case No. SIP-538/2015.

[8] Resolution of the Presidium of the Intellectual Property Court dated December 16, 2021, No. S01-1714/2021 in case No. SIP-58/2021.