Intellectual property · Issue No. 1, 2023

N. Sinitsyna. Specifics of Trademark Registration for Medical Devices

Definition of a trademark

A trademark is not just a formality but a real opportunity
to protect your brand:

• naming
• logo
• visual identity

But the cost of developing a corporate style is often wasted if it cannot be protected by law.

A trademark (TM) serves to individualize goods; a service mark serves to individualize services.

The following may be registered as trademarks:

• word marks
• combined marks
• figurative marks
• three-dimensional marks
• sound marks
• color marks
  and other designations or combinations thereof

Registration of a trademark

At present, in the Russian Federation only sole proprietors
and legal entities may hold a trademark
(Art. 1478 of the Civil Code of the Russian Federation).

after 29.06.2023

It will become possible to register a trademark for individuals, once Federal Law of 28.06.2022 No. 193-FZ "On Amendments to Part Four of the Civil Code of the Russian Federation" enters into force.

State registration of a trademark is carried out by the federal executive body for intellectual property – Rospatent.

Registration of a trademark

• Application. To formalize rights to a trademark, an application must be filed with Rospatent in accordance with the regulations.
• Certificate. An exclusive right to the trademark is recognized, certified by a trademark certificate.
• Priority date. At the moment the application is filed, a date is recorded for the applicant – the priority date. Once a decision on registration is made, the right to the trademark will be effective precisely from the priority date.
• Term of validity. A trademark is valid for 10 years from the priority date; after that, the right will need to be renewed.

Counterfeit

According to paragraph 4 of Article 1252 of the Civil Code of the Russian Federation, where:

• manufacture
• distribution or other use
• import
• transportation or storage of tangible media

in which a result of intellectual activity or a means of individualization is expressed lead to infringement of the exclusive right to such a result or such a means.

Such tangible media are deemed counterfeit and, by court decision, are subject to withdrawal from circulation and destruction without any compensation, unless other consequences are provided for by the Civil Code of the Russian Federation.

Paragraph 75 of Resolution of the Plenum of the Supreme Court of the Russian Federation
of 23.04.2019 No. 10 "On the Application of Part Four of the Civil Code of the Russian Federation"

Classification of goods and services

Trademarks are always registered in respect of specific goods or services, grouped into classes by common features –
the International Classification of Goods and Services (ICGS).

• 01 – 34 – classes of goods
• 35 – 45 – classes of services

More detail on the various classes can be found at this link: www.mktu.info

Most often, if goods and services fall within the same class, they are similar (homogeneous). But not always.
And conversely, goods and services in different classes may be recognized as similar (homogeneous).

The current edition, ICGS 12, entered into force on 1 January 2023.
It expands the list of pharmaceutical and medical goods, as well as the list of services provided by some persons to meet the needs of third parties.

Classification of goods and services

It is useful for Russian medical device manufacturers to know that the ICGS simplifies the procedure for the protection and defense of their TMs.

Selecting ICGS classes is a complex process that requires excellent theoretical knowledge and proper experience in this field.

Important

Goods and services within a class may be recognized as non-homogeneous, while goods and services in different classes, on the contrary, may be recognized as homogeneous, and accordingly will result in designations being found confusingly similar.

Examples of homogeneity risk

ICGS for medical devices

In the medical device field, classifying goods and services makes the examination process and the detection of infringements more precise when analyzing designations that are confusingly similar.

All these subtleties and nuances need to be known in order to successfully register a TM for your medical devices and thus protect yourself.

The intended purpose of a medical device is one of the main criteria for classifying a product
as a medical device. The use of a medical device must involve its medical purpose.

When registering a TM for medical devices, it is necessary to analyze the suitable ICGS classes carefully.

ICGS classes selected in practice

Main class

• 10 – medical apparatus and instruments

Additional classes

• 05 – pharmaceuticals, medical preparations; sanitary products for medical purposes; dietary supplements for humans and animals; plasters, materials for dressings; material for stopping teeth and dental impressions; disinfectants
• 09 – scientific and research apparatus and instruments, software
• 35 – retail or wholesale sale of medicinal products, veterinary and sanitary preparations and medical supplies

Main reasons for refusal to register a TM for medical devices

The general grounds for refusal of state registration of a trademark are set out in Article 1483 of the Civil Code of the Russian Federation.

The most common grounds for refusing to register a TM for medical devices are

• Incorrect choice of designation
• Similarity to other trademarks

An application for a trademark will fail the examination, and the trademark will not be registered

• If the designation contains a direct indication of the purpose, type or quality of the product.
  The designation is not fanciful (arbitrary) in relation to the goods listed in the application.
  This requirement applies to all trademarks, not only those for medical devices. However, such words may be present in the designation as long as they do not occupy a dominant position in it (they will be indicated in the application as unprotected elements).
• If it coincides with or is similar to TMs of other right holders, or to TM applications filed by other applicants before yours.
  It is important to note that designations in the field of human health are subject to stricter similarity requirements.

Civil Code of the Russian Federation, Article 1483

Grounds for refusal of state registration of a trademark

The following may not be registered as trademarks: designations that are identical or confusingly similar to:

• Trademarks of other persons applied for registration in respect of homogeneous goods and having an earlier priority, if the application for state registration of the trademark has not been withdrawn, has not been deemed withdrawn, and no decision to refuse state registration has been made on it
• Trademarks of other persons protected in the Russian Federation, including under an international treaty of the Russian Federation, in respect of homogeneous goods and having an earlier priority

A designation is considered confusingly similar to another designation if it is associated with it as a whole, despite individual differences – designations that produce a similar overall impression, despite some differences in their constituent elements, are recognized as similar.

When analyzing a designation, it should be taken into account

that in most cases the consumer is unable to compare two marks and is guided by the general impression of a mark seen earlier.

The comparison is made between an already registered trademark and the designation you want to put into circulation.

Identical. Coincide in all elements, match completely.

Confusingly similar. Associated with each other as a whole, despite individual differences.

Important. To establish similarity, the goods and services must be homogeneous – account is taken of the kind (type) of goods, their purpose, the type of material they are made of, the conditions of sale of the goods, the range of consumers and other features.

Civil Code of the Russian Federation, Article 1483

Grounds for refusal of state registration of a trademark

Confusion is possible if, as a whole, despite individual differences, the disputed designation may be perceived by the persons concerned as the corresponding trademark, or if the consumer may believe that the designation is used by the same person or by persons connected with the person who owns the trademark.

The likelihood of confusion between the trademark and the disputed designation is determined on the basis of the degree of similarity of the designations and the degree of homogeneity of the goods for the persons concerned.

In this case, confusion is possible even with a low degree of similarity but identical (or close) goods, or with a low degree of homogeneity of the goods but identity (or a high degree of similarity) of the trademark and the disputed designation.

Paragraph 162 of Resolution of the Plenum of the Supreme Court of the Russian Federation
of 23.04.2019 No. 10 "On the Application of Part Four of the Civil Code of the Russian Federation"

What is the "3 letters" rule: what to consider when registering a TM

As stated earlier, for designations related to medicine, stricter rules apply for determining confusing similarity, since the goods for which such TMs are registered are directly related to human health.

To determine similarity between designations related to human health, the examination tacitly applies the Methodological Recommendations on the Rational Choice of Names of Medicinal Products: the difference between trademarks must be more than 3 letters.

"Rational Choice of Names of Medicinal Products. Methodological Recommendations"
(approved on 10.10.2005 by the Ministry of Health and Social Development of the Russian Federation)

When counting the letters (characters) that make up the words, the differences between the medical names being compared must amount to 3 or more letters (characters) in any combination.

This is important! The features of the designated goods give rise to additional conditions for examining trademarks, which are aimed at minimizing the risk of misleading the consumer as to the characteristics and properties of the goods, their manufacturer, and the consequences of using these categories of goods.

During examination at Rospatent, the expert analyzes the designation for compliance with the requirements of the law, being guided by the documents binding on the expert.

The courts have repeatedly noted that "the said Methodological Recommendations are not among the regulatory legal acts on the basis of which designations are examined for identity and similarity of trademarks, are advisory in nature and concern specifically medicinal products and their state registration."

For example, Resolution of the Presidium of the Intellectual Property Court of 17.02.2020 No. S01-1614/2019 in case No. SIP-515/2019

However, if your designation is refused registration, you still have to get as far as court –
and that takes time and money.

Therefore, when choosing your designation, you should nevertheless take these methodological recommendations into account, since the expert who will examine your trademark application may be guided by them (especially in respect of ICGS class 05).

Civil Code of the Russian Federation, Article 1483

Grounds for refusal of state registration of a trademark

A common mistake of applicants registering a TM is also an incorrect choice of designation (in violation of the mandatory requirements of the law).

State registration as trademarks is not permitted for designations that lack distinctive character or that consist only of elements:

• that have become generally used to designate goods of a certain type
• that are generally accepted symbols and terms
• that characterize goods, including indicating their type, quality, quantity, property, purpose, value, as well as the time, place and method of their production or sale
• that constitute the shape of goods which is determined exclusively or mainly by the property or purpose of the goods

*the said elements may be included in a trademark as unprotected elements if they do not occupy a dominant position in it.

The following cannot be registered as TMs

• Terms related to a particular activity carried out in the production of goods, performance of work and provision of services
• Designations consisting only of elements that are generally accepted terms

EXAMPLES

• the image of a bowl with a snake is generally accepted in the field of medicine and pharmaceuticals

• the image of a red cross, which is the symbol of the International Red Cross Movement, is also a generally accepted designation in the field of medicine

Elements that characterize goods include

• simple names of goods
• designations of the quality category of goods
• indications of the material or composition of the raw materials
• indications of the weight, volume, price of goods
• indication of the properties of goods (including those of a laudatory nature)
  date of manufacture of goods
• data on the history of the creation of production
• generic names of enterprises
• addresses of manufacturers of goods and of intermediary companies
• designations consisting partly or entirely of geographical names that may be perceived as an indication of the place where the manufacturer of the goods is located

*the said elements may be included in a trademark as unprotected elements if they do not occupy a dominant position

The key point is to determine whether this designation or its elements may be perceived by consumers as an indication of the type, quality, quantity, property, purpose, value, as well as the time, place and method of production or sale of the goods.

Designations consisting only of elements that characterize goods are not granted legal protection, because any person may need to use in civil circulation designations that characterize a product or service – this is logical.

When registering the claimed designation, you should make sure that it does not include an official state symbol or distinguishing mark, the name of an international or intergovernmental organization, its official symbol or mark, or recognizable parts of such symbols, names or marks, and that the designation is not a reproduction or imitation of them.

When registering the claimed designation, you should make sure that it does not include an official state symbol or distinguishing mark, the name of an international or intergovernmental organization, its official symbol or mark, or recognizable parts of such symbols, names or marks, and that the designation is not a reproduction or imitation of them.

• State symbols and marks (flags, coats of arms, orders, banknotes and the like)
• Abbreviated or full names of international and intergovernmental organizations, their flags, coats of arms, other symbols and marks
• Official control, guarantee or hallmark stamps, seals, awards and other distinctions

How a medical device manufacturer can independently check whether competing manufacturers or authorized representatives have a registered trademark

Publicly available resources can be used to search for someone else's trademark or application.

Open Rospatent registers and other private sites with an open database: Linkark, Znakoved.

The search can be conducted by name, by application or trademark number, or by the name of the right holder.

Important. If registration is refused, the fee paid is not refunded.

What to bear in mind

• Publicly available resources most often show only
  already registered trademarks, but do not show filed registration applications. Such applications may become grounds for refusing registration on your application, since they are taken into account during examination.
• Publicly available resources show only identical designations, whereas trademarks and applications must also be analyzed for confusing similarity.
• Before filing an application, the designation must be assessed not only for similarity to other trademarks and applications, but also in terms of other grounds for refusing registration

How to overcome a preliminary refusal to register a TM

What a response to a notification means, and how to prepare it to obtain a positive decision from Rospatent

Examination at Rospatent consists of the following stages

• Formal examination (the presence of the necessary documents and the correctness of their completion are checked)
• Examination of the claimed designation (substantive examination; the designation is assessed against the requirements of the legislation)

The examination may send

A request. To ask the applicant for additional materials without which the examination cannot be carried out.

A notification. A preliminary refusal with a proposal to present one's arguments regarding the grounds given in the notification

Notification = preliminary refusal

If the examination of the claimed designation establishes that the claimed designation does not comply with the requirements of the legislation of the Russian Federation for the purposes of trademark registration, the applicant is sent a notification of the results of checking the compliance of the claimed designation with the requirements of the legislation of the Russian Federation.

In the notification, the applicant is invited to present, within 6 months from the date the notification was sent, their arguments regarding the grounds given in the notification.

A notification is sent if the check establishes that state registration of the trademark cannot be carried out in full, or only in respect of part of the goods contained in the list of goods submitted by the applicant.
Thus, upon receiving a notification, you must respond to Rospatent within 6 months from the date it was sent. You need to analyze carefully the arguments given by the expert – this same expert will make the final decision.

You must substantiate the arguments in favor of registering your designation as a trademark: refer to the provisions of the law and the recommendations of Rospatent, and set out the facts thoroughly, supporting your arguments with documents (of any kind).

After you send your response to the notification, the expert makes
the final decision within 2 months

Either a decision to register.

• It may be issued in respect of part of the goods / services
  
• The examination is carried out in respect of each ICGS class

Or a decision to refuse registration

• The second part of the fee is not paid
• The first fee paid is not refunded
• It may be challenged in full or in part

Drafting a letter of consent

How to increase the chances of a positive Rospatent decision in practice

Registration as a trademark, in respect of homogeneous goods, of a designation confusingly similar to any of the trademarks specified in paragraph 6 of Article 1483 of the Civil Code of the Russian Federation is permitted only with the consent of the right holder.

Important. When designations are registered as trademarks with the consent of the right holder of a confusingly similar trademark, the issues examined relate not only to the similarity of the trademarks but also to the homogeneity of the goods.

How to increase the chances of a positive Rospatent decision in practice

The right holder's consent to the registration of a confusingly similar trademark may be taken into account when granting legal protection in a situation where the question of the homogeneity of the goods is debatable and the right holder believes that the possibility of confusion when the trademarks are used for the respective goods is excluded.

A letter of consent will not help in registering an identical designation for homogeneous goods.

Registration as a trademark, in respect of homogeneous goods, of a designation confusingly similar to any of the trademarks specified in paragraph 6 of Article 1483 of the Civil Code of the Russian Federation is permitted only with the consent of the right holder.

Important. Taking a letter of consent into account in the examination is a right, not an obligation, of the expert.

But a letter of consent must in any case be drawn up in accordance with the requirements of the law.

If the question of the homogeneity of goods is not debatable and the homogeneity is obvious, the owner of the cited trademark, in order to exclude the possibility of confusion between the trademarks, may give consent to the registration of the confusingly similar designation for only part of the homogeneous goods.
In this case the restriction may be made either by excluding part of the goods from the list, or by replacing general terms with specific ones falling within the same generic group of goods.

Real practice of TM registration

• Under Decree of the Government of the Russian Federation of 30.06.2021 No. 1066, state control over the circulation of medical devices is exercised by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
• Under Article 38 of Federal Law of 21.11.2011 No. 323-FZ*, the import into the territory of the Russian Federation and the sale of falsified, substandard and counterfeit medical devices, as well as unregistered medical devices, are prohibited.

A counterfeit medical device is
a medical device in circulation in violation of civil legislation.

• Roszdravnadzor Order of 06.05.2019 No. 337** establishes an exhaustive list of data required to obtain a registration certificate, which does not mention a document on the lawfulness of the use of a TM.
• The list of reasons for which registration of a medical device may be refused contains no sanction for failing to provide a document confirming the lawfulness of the use of a TM.

*Federal Law of 21.11.2011 No. 323-FZ "On the Fundamentals of Health Protection of Citizens in the Russian Federation"
** Roszdravnadzor Order of 06.05.2019 No. 337 "On Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for the Provision of the State Service for State Registration of Medical Devices"

Discussing the real practice of TM registration for medical devices

At the beginning of May 2019, a collective appeal was filed by medical device distributors, who asked the Ministry of Health of the Russian Federation to clarify the meaning of Roszdravnadzor's requirement to provide, with an application for medical device registration, documents confirming the lawfulness of the use of a trademark.

The Ministry of Health of the Russian Federation responded to the appeal

Roszdravnadzor has no right to require documents for the designation applied to a medical device – these documents are not among the documents that must be submitted when registering a medical device.
But Roszdravnadzor itself has the right to check the designation applied to the medical device being registered against the trademarks in the Register of Trademarks under the procedure of "interdepartmental information exchange".
This means that Roszdravnadzor can itself check whether the trademark on the medical device for which registration is requested belongs to another person – that is, not the applicant. If the trademark does not belong to the applicant, registration of the medical device will be refused – this helps to stop counterfeit goods from reaching the market.

Decision of the Intellectual Property Court of 19.11.2020 in case No. SIP-721/2020

рус-фарм
rus-farm

TM application 2019734790

Rospatent considers unfounded the applicant's argument that the word elements "рус" and "фарм" and their transliterations "rus" and "farm" possess distinctive character because they are inseparable word combinations written with a hyphen. Since the said word elements do not form a stable word combination or a compound word with a meaning different from the words that make it up, the examination must be carried out for each word separately.

The entrepreneur objected to Rospatent's conclusion that the claimed designation, for goods in ICGS classes 03, 05 and 10 that do not belong to the category of pharmaceutical goods, is capable of misleading the consumer as to
their properties and purpose.

TM registration practice in the medical device field

Decision of the Intellectual Property Court of 19.11.2020 in case No. SIP-721/2020

Having determined the meanings of the words

• "pharmaceutics" (the set of applied disciplines concerning the obtaining, processing, storage and dispensing of medicines)
• "pharmacology" (the science of the action of medicinal substances on a living organism)

Rospatent concluded that the claimed designation can be interpreted as follows – "Russian science of medicinal products", "Russian science of the action of medicinal substances on the body".

On this basis, Rospatent recognized that

• In respect of the claimed goods belonging to goods for pharmaceutical purposes, the claimed designation lacks distinctive character, since it will indicate the place of manufacture, properties and purpose of the goods, which does not meet the requirements of paragraph 1 of Article 1483 of the Civil Code of the Russian Federation.
• In respect of other goods not connected with the manufacture of medicinal products, the claimed designation, in Rospatent's opinion, is capable of misleading the consumer as to the properties and purpose of the goods, which contradicts paragraph 3 of Article 1483 of the Civil Code of the Russian Federation.

The decision to refuse registration was upheld in court.

TM registration practice in the medical device field

Decision of the Intellectual Property Court of 12.08.2022 in case No. SIP-275/2022

Дезэнда
Dezenda

TM application 2020731793

The designation was filed for disinfectants in respect of ICGS class 05.

Even though the trademark is fanciful in nature, the Rospatent examination refused registration.

The ground for refusal was the existence of similar trademarks registered earlier by other right holders:

• "Дезентис" No. 813869 with priority (filing date)
  of 23.04.2020, right holder – LLC "Naro-Fominsk Combine of Household Chemicals and Perfumery and Cosmetic Products"
• "Tisenta", international registration No. 934672
  with priority of 26.07.2007, right holder – Merz Pharma GmbH & Co. KGaA Eckenheimer Landstr.

In the first case, a similarity of more than three letters was noted. Transliteration in different languages is irrelevant here.
In the second case, there is phonetic similarity, and the first letters are paired consonants.

The applicant tried to challenge Rospatent's decision, but the lawfulness of the refusal of registration was confirmed.

TM registration practice in the medical device field

РИКТА (RIKTA)

TM 182014

Product. Magnetic infrared laser therapeutic devices

ICGS classes and list of goods and/or services. 10 – medical apparatus and instruments; lasers for medical purposes.

Right holder. LLC "RIKTAMED"

Medical device manufacturer. JSC "MILTA-PKP GIT"

Information on the medical device

FSR 2011/10170 Magnetic infrared laser therapeutic devices RIKTA with a set of optical attachments according to TU (technical specifications) 9444-002-18537172-01
RZN 2013/1003 Portable electro-light-magnetic-infrared laser therapy device with optical attachments RIKTA-ESMIL according to TU 9444-007-18537172-2003
FSR 2011/12214 Magnetic infrared laser therapeutic device RIKTA-05 according to TU 9444-003-18537172
29/06060699/0432-00 Magnetic infrared laser therapeutic device RIKTA-01

TM registration practice in the medical device field

CANDELA

TM 1249919

Product. Dermatological laser devices with accessories

ICGS classes and list of goods and/or services.

09 – Scientific lasers, capacitive charging power supplies and parts thereof.
10 – Medical lasers, capacitive-charge medical lasers, power supplies and parts thereof.

Right holder. Candela Corporation

Medical device manufacturer. Candela Corporation

Medical device applicant. LLC "INLZ"

Information on the medical device.

RZN 2017/5599 Dermatological laser devices CANDELA with accessories

TM registration practice in the medical device field

FLOWFLEX

TM 1587464

Product. Immunochromatographic rapid test kit
for the qualitative detection of the SARS-CoV-2 coronavirus nucleocapsid protein antigen

ICGS classes and list of goods and/or services.

05 – Medical diagnostic immunoassays for the examination of biological fluids

Right holder. LEADWAY (HK) LIMITED

Medical device manufacturer. "Acon Biotech (Hangzhou) Co., Ltd"

Medical device applicant. LLC "Company "BiVi""

Information on the medical device

RZN 2022/19067 Immunochromatographic rapid test kit for the qualitative detection of the SARS-CoV-2 coronavirus nucleocapsid protein antigen in a nasal swab, for in vitro diagnostics (Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal)), Lots COV2045033, C
RZN 2022/18753 Immunochromatographic rapid test kit for the qualitative detection of the SARS-CoV-2 coronavirus nucleocapsid protein antigen in a nasal swab, for in vitro diagnostics for self-testing (Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test))
RZN 2022/16861 Immunochromatographic rapid test kit for the qualitative detection of the SARS-CoV-2 coronavirus nucleocapsid protein antigen in a nasal swab, for in vitro diagnostics for self-testing (Flowflex ARS-CoV-2 Antigen Rapid Test), Lots COV108

TM registration practice in the medical device field

TM 721186

Product. Thin-walled guiding catheter

ICGS classes and list of goods and/or services 07, 09, 11, 16, 35, 38, 41, 42

Right holder. LLC "X10"

Medical device manufacturer. "Clearstream Technologies Ltd"

Medical device applicant. LLC "Becton Dickinson Vostok"

Information on the medical device

RZN 2022/18107 Thin-walled guiding catheter Halo One

Author of the article

My knowledge has been tested many times in practice

• I have worked as an in-house lawyer
  at an international corporation
• I worked as a lawyer at an intellectual property legal consulting firm
• I am currently in private practice

Other articles · Issue No. 1, 2023