The pharmaceutical industry is currently one of the Russian economy's high-tech development priorities. According to analytical data, in 2019 the Russian commercial drug market was worth Rb84.3 billion (approximately $1.3 billion), an increase of approximately 7.9% from 2018.
The Russian pharmaceutical market remains an interesting area for foreign investors. Since 2010 eight drug manufacturing plants have been built in Russia by some of the world's largest pharmaceutical companies. At the beginning of 2019, Novartis, Bayer and Sanofi were the leaders of drug sales by volume in Russia.
The development of pharmaceutical production and the expansion of the range of medicines can only take place alongside the development of an appropriate IP protection strategy, particularly for pharmaceutical trademarks.
Selection, clearance and registration
Under the Law on Circulation of Drugs (2018), medicines can be manufactured, stored, imported, exported, advertised, sold and used in Russia only if they are registered by the Ministry of Health (with the exception of special cases) and it has granted a marketing authorisation.
On filing an application for a marketing authorisation, the applicant must indicate the name of the medicine – for example, its international non-proprietary name (INN) or grouping, chemical name or trade name assigned by the developer of the medicine or holder of the marketing authorisation.
The law prohibits the registration of:
- different medicines under the same trade name; and
- the same medicine seeking registration by the same applicant in the form of two or more medicines under different trade names.
Simultaneously, the Civil Code does not restrict the types of medicines for which trademarks can be registered. In obtaining trademark registration, the holder acquires an exclusive right to use the mark for any pharmaceutical product, regardless of its composition or purpose (unless the holder has limited the list of covered products by specifying compositions or purposes). However, the rights holder must comply with the requirements imposed by the Law on Circulation of Drugs when using the trademark for pharmaceutical products.
In 2016 the Ministry of Health adopted the Rules for Rational Choice of Trade Names for Medicines. According to these, an applied-for name must not be identical or confusingly similar to the name of any medicine already registered. Further restrictions include that the name must not be deceptive with respect to the composition and properties of the medicine or manufacturer and must not include designations that are identical or similar to geographical or personal names.
Trademark registration requirements are regulated by Part IV of the Civil Code, which establishes the following grounds for the refusal of registration, including for those marks intended for pharmaceuticals:
- non-distinctive marks or marks consisting only of signs that are generally used to indicate the type of goods;
- marks representing generally used symbols and terms;
- marks representing descriptive indications; and
- marks representing the form of goods covered, determined exclusively or mainly by their nature or purpose.
These provisions do not apply if the mark has acquired distinctiveness through use in Russia (which must be proved with reference to the period of use before the filing date). Further, designations cannot be registered as trademarks if they:
- mislead consumers regarding the nature of the goods or manufacturer; and
- are contrary to public interests, principles of humanity and morality.
The law prohibits the registration of designations that are identical or confusingly similar to earlier trademarks, firm names and commercial designations that are protected in Russia. However, there is no provision directly prohibiting the registration of trademarks that are confusingly similar to prior registered pharmaceutical names. Nevertheless, a trademark can be cancelled on the basis of a prior pharmaceutical name duly registered in the state register. The grounds for cancellation can be the descriptiveness of the trademark or its capacity to mislead consumers in respect of the goods or manufacturer.
In 2015 the Russia Patent and Trademark Office (Rospatent) accepted cancellation actions against the trademarks SULSENA (Russian Registration 377521, 375705) and DISULSEN (Russian Registration 367350), based on the fact that these were confusingly similar to the name of the pharmaceutical substance 'sulsen', which was registered in the State Register of Medicines in 1971. Both trademarks were cancelled due to descriptiveness in respect of one part of the covered goods (which contain or are made of sulsen) and deceptiveness regarding the composition of another part of the covered goods.
When selecting a name for medicines, it is recommended that searches be conducted in the relevant databases, including searches for prior trademarks, firm names and names registered in the State Register of Medicines, to ensure that no potentially conflicting names exist.
Such searches are extremely important, particularly in light of further legislative trends. A draft law is currently under public discussion which will oblige the marketing authorisation applicant to provide the trademark information relating to the medicine for which the marketing authorisation is filed, as well as to issue a written declaration stating that the registration of the medicine will not infringe third parties' rights to trademarks (and inventions).
The Civil Code contains no specific provisions regarding INN regulation. Nonetheless, a trademark will be refused registration where it is identical or confusingly similar to an INN. This approach is confirmed by IP Court practice.
In 2015 Rospatent refused to cancel the trademarks BRAVADIN (in Latin and Cyrillic text) (IR 1086422, 1058997) and disregarded the argument that the marks are derived of and confusingly similar to the INN 'Ivabradine'. However, the IP Court considered Rospatent's decisions to be invalid and cancelled the trademarks, reasoning that they are derived from the INN Ivabradine as a commonly used term which may mislead consumers in respect of the product's nature. The IP Court also declared that trademark registration is contrary to public interest.
Similarity of goods
In conflicts between trademarks and pharmaceutical names, special attention is paid to the similarity of goods. According to the general point of view, the pharmaceutical field is directly connected with consumer health and therefore a stronger and more specific approach is required to evaluate the similarity between the conflicting names and goods.
In 2018 Rospatent refused the registration of the trademark APIZARTRON (in Cyrillic text) (Application 2016747372) for Class 3 goods (cosmetics). The refusal was based on a prior registered identical pharmaceutical name (registered for a skin ointment) and a prior identical trademark of the same manufacturer for goods in Class 5 (pharmaceutical preparations). Rospatent considered the Class 3 goods to be similar to the protected goods in Class 5, taking into consideration the identity of the conflicting names.
In 2017 Rospatent refused the registration of the trademark VALEODIKRAMEN (in Cyrillic text) (Application 2015737901) and stated that the goods (sedative preparations, for which the registration was claimed) were similar to the biologically active additives covered by a prior similar trademark. Rospatent stated that while biologically active additives cannot be considered to be a kind of medicine, they do have a similar purpose and are applied in the same field for the maintenance of human health.
Non-use cancellation and marketing authorisation revocation
Pharmaceutical trademarks are subject to the same non-use cancellation issues as other trademarks. Russian law provides for a three-year grace period. There is a mandatory pre-trial procedure, where the interested person must file an offer to the rights holder asking for abandonment of the trademark or its assignment. Within the given terms, the dispute may be transferred for consideration before the IP Court.
Where a medicine is not commercialised within three years since its marketing authorisation is issued in Russia, the marketing authorisation may be revoked.
Pharmaceutical trademarks in advertising
Advertising involving pharmaceutical trademarks is governed by the general provisions of Article 5 of the Federal Law on Advertising (13 March 2006, 38-ФЗ), as well as by the special provisions under Article 24.
In particular, according to Article 24, the advertising of medicines should not:
- be addressed to minors;
- cite specific cases of cure or improvement of health (not applied to advertising intended only for medical professionals in specialist publications or events);
- use expressions of gratitude by specific individuals (not applied to advertising intended only for medical professionals in specialist publications or events);
- invoke the results of obligatory clinical trials or examinations as evidence of any advantages of the drug;
- contain the assertion that consumers have certain diseases or health problems;
- give the impression that a healthy person should use the drug (not applied to advertising of preventive drugs);
- give the impression that by using the drug it is unnecessary to consult a doctor;
- guarantee favourable effects of the drug, its safety and effectiveness, and the absence of side effects;
- imply that the drug is a biologically active additive or food supplement or any other product that is not a medicine; and
- imply that safety or effectiveness of the drug is explained by its natural origin.
These special provisions should be carefully considered, since mentioning the pharmaceutical trademark may qualify as the advertising of medicines for which the trademark is registered.
Enforcement of pharmaceutical trademarks
The enforcement of pharmaceutical trademarks is subject to the general provisions of Part 4 of the Civil Code.
The trademark owner may claim:
- a preliminary injunction;
- a ban on the use of the trademark by the defendant;
- seizure and destruction of counterfeit products;
- publication of relevant court decision; and
- damages (actual damage and loss of profit) or compensation (instead of damages).
The following types of compensation may be claimed:
- statutory compensation from Rb10,000 (approximately $150) to Rb5 million (approximately $73,000);
- compensation up to the amount of double the price of the defendant's goods alleged to be counterfeit; and
- compensation up to the amount of double the price of the licence to use the trademark under comparable circumstances.
Administrative cases under Article 14.10 of the Code of Administrative Offences, as a result of raids and seizures, are available in Russia with the involvement of the police or Customs. Such cases may result in the seizure and destruction of counterfeit products, as well as in administrative fines (up to five times the price of the goods held to be counterfeit) on officials and the company.
For regular counterfeit issues, it is highly recommended that the pharmaceutical trademark be recorded in the Customs register of the IP objects. Such recordation is aimed at ensuring regular cooperation with the customs authorities to seize the medicines that are imported without the authorisation of the rights holder.
Russian law also sets out effective options of using unfair competition cases against trademark infringements that may result in an injunction against commercialising the goods, as well as in an administrative fine of between 1% and 15% of the amount of the income, but not less than Rb100,000 (approximately $1,500).
The most serious infringements may be heard as criminal cases as a result of the raids under Article 180 of the Criminal Code (the precondition of which is either repeated trademark infringement or causation of significant damage which, from a criminal law prospective, in Russia is approximately $3,500). Criminal penalties may be imposed only on individuals and may include fines, mandatory or correctional public services works or imprisonment.
Pharmaceutical trademarks are important tools for the pharmaceutical industry from a number of different perspectives. During the whole lifecycle of medicine at issue, the trademark owner should consider all issues in the context of the Russian market.
This article first appeared in World Trademark Review issue 80, published by Globe Business Media Group – IP Division. To view the issue in full, please go to www.WorldTrademarkReview.com
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.