A. Mustafina, D. Likhaev. What to Know About Trademarks When Registering Medical Devices in the RF and the EAEU
In terms of complexity and possible complications for the subsequent stages of medical device registration, the issue of trademarks (TMs) is the main one when drawing up the schedule of a medical device registration project.
Let us go back to the roots. There is an official position of Roszdravnadzor on this issue on its website: https://www.roszdravnadzor.gov.ru/about/faq/101 (in Russian)
Summary of the regulator's response:
01. The name of the medical device must match in the registration certificate and the registration dossier
(i.e., all documents, including labeling)
02. To add a trademark to the name, it is necessary
to go through the amendment procedure, submitting documents confirming the registration of the trademark
See the letter from Rospatent:
Summary of the Rospatent letter of 31.10.2014 No. 02/21-14928/08
01. The exclusive right to a trademark
is certified by a trademark certificate
02. The exclusive right to an invention, utility model, and industrial design
is certified by a patent for an invention, utility model, and industrial design, respectively
03. The right to use a TM, utility model, or industrial design may be granted on the basis of a license agreement or a commercial concession agreement, and these are subject to mandatory state registration with Rospatent.
04. What is subject to state registration with Rospatent is not the license agreement or the commercial concession agreement,
but the grant of the right to use itself
The last paragraph of the letter raises the most questions among registrars.
The grant of the right to use is registered with Rospatent and is displayed in the register.
Example:
A transfer of rights has a term of validity, so it is important to renew the transfer of the right in time
Analogy:
- The contract between the manufacturer and the production site is attached to the registration dossier
through amendments, with changes to the registration certificate and to the information in the medical device register - Likewise, the contract for the transfer of the right to a TM is registered with Rospatent
and displayed in the FIPS register
Why was such a practice introduced?
- A license agreement or a commercial concession agreement may contain confidential information and therefore it need not be submitted to the regulator; it is enough to provide only the documents on the registration of such a transfer of the right
Liability for violations in the use, registration, and attachment of a TM to the registration dossier:
01. Cancellation of the registration certificate upon a court decision on violation of rights under clause 57 of Government Decree No. 1416:
The registering authority decides to cancel the state registration of a medical device in the following cases:
- a court decision on violation of the rights of a right holder to the results of intellectual activity and the means of individualization equated to them in the circulation of medical devices.
02. Criminal and administrative liability
- Violation of Civil Code Art. 1515, clause 1
Unlawful placement of a TM or a designation confusingly similar to it - Violation of Federal Law No. 323-FZ, Art. 38, parts 16, 17
Criminal liability under Art. 231.1 of the Criminal Code of the Russian Federation.
What to do?
FIRST STEP
- Check for the presence of intellectual property rights
on the medical device - Carefully examine the medical device from all sides, including the inside. For example,
if the housing opens to replace a battery
SECOND STEP
- Check for the presence of intellectual property rights
in the registration dossier set - The presence and conformity of the TM must be reflected not only in the operating documentation and on the labeling of the medical device
(as on the documentation provided to the user of the medical device), but also in all other
documents of the registration dossier.
THIRD STEP
- Discuss with developers / manufacturers / marketers
Questions:
- What do you call the medical device among yourselves?
- How do you plan to advertise/promote the medical device; ask them to provide advertising brochures.
Sometimes manufacturers do not suspect that means of individualization require registration as a trademark
FOURTH STEP
- Inform the responsible persons, against signature, of the consequences of violating intellectual property rights.
- Explain the risks and the advantages of registering
TMs and patents in advance, etc.
If a TM is found on the medical device or in the documentation:
Option 1
- Registration of the TM in the territory of the RF
under the national procedure or adding the country when registering through WIPO
Option 2
- Removal of the protection marks wherever they are found,
if the Manufacturer does not plan to protect IP in the territory of the RF.
This option is less likely, since the Manufacturer will need to produce a parallel medical device with a new set of labeling.
- If a means of individualization of the medical device is found in the name, on the labeling,
in the documentation, or on the medical device – it is necessary to obtain advice from competent persons on whether this name needs to be registered as a TM.
1. Trademark registration
After choosing one option or the other, the authorized representative may face the task of filing an application with FIPS for registration of the TM in the territory of the RF.
To pass the stage of evaluating the documentation during state registration of a medical device
at Roszdravnadzor, it is enough to submit:
- A notice of acceptance of the registration application, with its details.
Roszdravnadzor is aware that the registration of a TM, like the registration of a medical device, takes a long time,
so it is not required to wait for the registration of the TM in order to begin the procedure for registering the medical device.
It is important to confirm that the applicant has initiated the registration of the TM.
However, the Roszdravnadzor website clearly states that, where a registration certificate already exists and a TM needs to be added to the name of the medical device,
it is required to submit documents confirming the registration of the TM, i.e., it is necessary to wait for the registration of the TM.
After the trademark certificate is obtained, it is recommended to attach it to the registration dossier (for example, together with the documents on the results of clinical studies).
If the manufacturer plans to use the Madrid system for TM registration,
the proof of TM registration will be a screenshot from the WIPO register, WITH THE RF OR THE EAEU COUNTRIES (when registering under EAEU rules) MANDATORILY INDICATED as the country of TM registration
accompanied by a letter from the Right Holder stating that the attached screenshot is correct,
duly certified.
The Manufacturer and the Right Holder may be different companies. In that case, the following options are possible when preparing the documents on TM registration:
1. The TM Right Holder is one company, and the Manufacturer is another, and both companies belong to a single group of companies, being subsidiaries of some third company.
- in this case a letter from the parent company listing the subsidiaries
that belong to the single group of companies is sufficient; - as well as a letter from the Right Holder addressed to the Manufacturer consenting to the use of
the TM in the territory of the RF.
Interestingly, if such a letter is issued, the grant of the right of use
need not be registered with Rospatent.
🛈 At the same time, in practice many simply resort to issuing letters of consent to the use of a trademark, thereby bypassing the need for registration with Rospatent.
Such letters of consent are, rather, a confirmation on the part of the right holder
that it has no claims regarding the use of the trademark,
- and they can also be used as evidence of the right to put goods into circulation in the territory of the RF (the customs authorities accept such letters of consent),
- But it must be borne in mind that, in the absence of registration of the grant of the right of use with Rospatent, information on the rights of use of the trademark by a specific person is not freely available to third parties.
- and they are also accepted by Roszdravnadzor
as confirmation of the right of use.
If the parties so wish, where they have not concluded a license agreement but have simply issued a letter of consent:
- they may file an application with Rospatent for registration of the grant of the right of use on the basis of a bilateral application,
without attaching a copy of the license agreement - if the application is signed by only one of the parties, a copy of the license agreement must be submitted to Rospatent,
copies of letters of consent or other unilateral documents are not accepted
The grant of the right of use of an international trademark at WIPO is not subject to registration at all.
Even in the absence of such registration of the grant of the right of use of the trademark with Rospatent, these unilateral letters of consent, with the required degree of legalization, must be submitted to Roszdravnadzor together with the confirmation of TM registration attached.
2. The TM Right Holder is one company, and the Manufacturer is another,
and they are separate legal entities.
- The Manufacturer and the Right Holder must have a license agreement
that specifies the subject matter (the specific TM) - And the territory in which the Manufacturer
has the right to use the TM. - If the territory does not include the RF, the agreement must be amended,
and an application must also be filed on behalf of the Right Holder with FIPS for registration of the grant of the right to use the TM.
Thus, a copy of the license agreement and the application to FIPS
(or the attached confirmation of TM registration) will have to be submitted to Roszdravnadzor.
The same plan of action must be followed in the case where the TM is already registered in the RF.
🛈 As a result, already at the stage of preparing the dossier documents, many problems can be eliminated
with the absence of TM registration or in the case of a complex chain of transfer of rights.
2. Labeling of the medical device after TM registration
According to Article 1485 of the Civil Code
- The right holder, to give notice of its exclusive right to a trademark,
has the right to use the protection mark R or ®.4 - I.e., there is no direct obligation to indicate the protection mark R or ® on the labeling.
- It is possible to indicate the fact of protection of a given trademark
in the documentation for the medical device
Rules for using the TM sign
1. The TM sign confirms that the application has been filed,
but not that the TM has been registered.
2. This means that, after successful registration of the TM,
it is necessary to go through the amendment procedure to remove or replace the TM sign with the R or ® sign.
3. For this reason, it is not recommended to use the TM sign in the procedure for registering a medical device.
since this would entail additional costs and actions in the form of making amendments to the registration dossier.
Issues of protecting intellectual property and issues of the circulation of medical devices are interrelated.
🛈 Only the right approach can protect the applicant from additional unnecessary,
and often costly, actions.
Authors of the article: Alina Mustafina, Dmitry Likhaev
