O. Maryukhina. Specifics of Using Intellectual Property Objects for Medical Devices and Disposing of Rights to Them
At every stage of creating and using IP objects, questions arise concerning:
- ensuring effective legal protection of developments,
- protecting confidential information,
- ownership of rights to IP objects,
- building relationships between the authors of developments, right holders and commercial partners,
- and avoiding infringement of the rights of third parties.
Medical devices are often a complex development that combines a whole set of different intellectual property objects, including know-how, software and databases.
Understanding the features of various IP objects and the ways of disposing of rights to them will make it possible to use developments most effectively in Russia and on foreign markets.
Any innovative development may contain various intellectual property (IP) objects.
Besides inventions and trademarks, which the creators of a new product most often use to protect it from competitors, other kinds of results of creative work (results of intellectual activity, RIA) can also be used effectively.
Today, Article 1225 of the Civil Code of the Russian Federation lists 17 intellectual property objects, each of which can protect separate aspects of an innovative product, including medical devices of the most varied types and purposes.
Understanding the features and legal protection mechanisms of each IP object will make it possible to build an effective, comprehensive system for protecting your development
- to use it in commercial activity,
- to fight unscrupulous businesses
- and to reduce the risks of losing the product's image.
Most authors of new products are well aware of how
- it is important to protect the technical part with patents for inventions and utility models,
- the visual design of the product and packaging with a patent for an industrial design,
- the costs of promoting the product with a registered trademark.
However, other protectable IP objects may also appear in a finished product, as well as in the process of creating it, which may have commercial value
and be used both together and each separately.
1. Computer programs, databases and know-how
In the creation and sale of medical devices, patent law objects are widely used to protect innovative developments. However, depending on the essence of the development, the product promotion strategy and the protection against infringement, such IP objects as computer programs, databases and know-how can also help create an effective comprehensive
framework.
Next, we consider their main characteristics and how they can be useful to medical device manufacturers.
1. Computer programs
The concept of "medical devices" covers a very wide range of items and equipment, including equipment that operates using software.
Software itself may be classified as a medical device in accordance with Section III of the Nomenclature Classification of Medical Devices by Type (Appendix to Order of the Ministry of Health of the Russian Federation of 6 June 2012 No. 4n).
In addition, other software products that are not medical devices but are also used in the work of medical professionals and for interaction with patients have become widespread in the medical field
for example, electronic patient records, patient appointment booking services, interactive
training systems and others.
Thus, a software product can be both a valuable component of a comprehensive development and a stand-alone asset. The current legislation makes it possible to protect
rights to computer programs, use them in commercial activity and defend them against infringement.
According to paragraph 1 of Article 1259 of the Civil Code of the Russian Federation, any computer programs, including operating systems
and software packages,
- which may be expressed in any language and in any form, including source text and object code, are protected as literary works.
- State registration is not required for rights to them to arise; the object is recognized as protected at the moment of its creation.
Nevertheless, by virtue of paragraph 4 of Article 1259 of the Civil Code of the Russian Federation, at the wish of the author and/or right holder, a computer program may be registered with Rospatent under the procedure provided for by Article 1262 of the Civil Code of the Russian Federation.
To register a computer program, it is necessary to:
- complete an application in the established form (including an abstract – i.e., a brief description of the program's functionality and purpose)
- attach the deposited materials identifying the program (in effect, a text file with the code or a fragment of it).
All application forms and the documents regulating the procedure for registering computer programs can be found on the FIPS website in the relevant section.
Unlike patent law objects and trademarks, Rospatent does not conduct an examination of an application for registration of a computer program, but in essence deposits the program code and issues a certificate confirming that the right holder and the author hold rights to the object.
Nevertheless, from a practical point of view, registering a computer program can be very useful.
- it makes it simpler and more effective to confirm ownership of rights to it, including for the purposes of entering it in the accounting records
- it can be indicated in agreements on disposal of the right, and the certificate can be used as a reporting document when performing work under a contract; it is equated to a scientific publication.
Indeed, according to Rospatent statistics, the number of applications for registration of computer programs grows every year, and among the applicants are many developers of software used in medicine.
(see, for example, the data in Rospatent's annual reports https://rospatent.gov.ru/ru/about/reports)
Examples of registered computer programs include:
- Multimedia training program "Diseases of the Hepatobiliary Zone of the Gastrointestinal Tract" (right holder: Pirogov Russian National Research Medical University, Ministry of Health of the Russian Federation, certificate No. 2020612918);
- Module for interfacing diagnostic medical equipment with SMART-PACS (right holder: LLC "TEKHNOMARKET", certificate No. 2015660899);
- "Cardiological Examination" for diagnosing atherosclerosis of the arteries of the extremities (right holder: Voronezh State University, certificate No. 2017618303);
- Software for a mobile fetal monitor (right holder: LLC "Yusontek", certificate No. 2014614812);
- Comprehensive quality assurance system for medical devices at the stages of circulation in medical and pharmaceutical organizations (right holders: F.R. Paigin and E.P. Gladunova, certificate No. 2019666547);
- "Tech-ID Research Control" (right holder: LLC "TEKHNOLOGIYA
- IDENTIFIKATSII", certificate No. 2018612051);
- "EAEU Reg.Meddevice" (right holders: P.I. Popov, A.I. Popov, N.E. Chaikovskaya, A.N. Kazanskaya, certificate No. 2021615531) and others.
2. Databases
Another important aid in protecting developments can be such an IP object as a database.
A database is understood as a set of independent materials (articles, calculations, regulatory acts, court decisions and other similar materials) presented in an objective form and systematized in such a way that these materials can be found and processed using an electronic computer (Art. 1260 of the Civil Code of the Russian Federation).
In the case of a database, what is protected is not the content of its individual elements (rights to them may belong to other persons), but precisely the result of creative activity expressed in the selection and systematization of independent materials.
1. A database is protected as an object of copyright (para. 2 of Art. 1260 of the Civil Code of the Russian Federation),
- if the materials are selected and systematized in an original way
2. A database is protected as an object of related rights
- if creating the database required significant financial, material, organizational or other expenditure,
- if the database contains more than 10 thousand independent elements
The exclusive right to extract materials from the database and to subsequently use them in any form and by any means belongs to the database producer (Art. 1334 of the Civil Code of the Russian Federation).
As with computer programs, rights to databases arise and are valid from the moment of its creation,
but may also be registered with Rospatent at the wish of the right holder or producer. The requirements for the application, the procedure, the amounts of fees and the purposes of registration are similar to those for computer programs described above.
The difference lies in the deposited materials enclosed with the registration application.
The application must be accompanied by:
materials that reflect the objective form of presentation of the set of independent materials contained in it, in the form of examples of actual content and the principles of their systematization (the database structure), making it possible to find
and process these materials using a computer.
- That is, a schematic image (block diagram) of the database structure must be attached, as well as screenshots showing examples of how the materials are arranged.
- If we want to protect a database whose creation involved substantial expenditure, documents confirming this must also be attached.
Examples:
1. Database "Classifier of Medical Devices" (right holder: LLC "OMB", certificate No. 2013620796);
2. Database of compounds of polymer materials used for manufacturing medical tubing by extrusion / coextrusion (right holder: LLC "Konvergent", certificate No. 2018620676);
3. Clinical, functional and laboratory indicators of patients that determine the choice of medical devices for hemodialysis procedures (right holders: E.P. Gladunova, F.R. Paigin, V.V. Timoshchuk, Ya.E. Shirobokov, certificate No. 2019622332);
4. "Bionika" (a database for storing information on auctions held on electronic platforms, and for searching and displaying information by arbitrary parameters on public procurement of medical equipment, medical products, and the provision of services and performance of work) (right holder: JSC "Karta Zdorovya", certificate No. 2017620367);
5. Design of functional rehabilitative garments for persons with health impairments (right holder: Kosygin Russian State University (Technologies. Design. Art), certificate No. 2021622672).
Sometimes applicants for computer programs and databases are concerned about keeping the materials deposited with the applications confidential.
Indeed, Rospatent stores the application materials and deposited materials in its own archive and does not publish them in the public domain. The registers contain only information about authors and right holders, the abstract, and technical data on the operating systems, programming language and DBMS involved.
3. Know-how (trade secret)
A trade secret (know-how)
is any information of any nature (production, technical, economic, organizational and other) on the results of intellectual activity in the scientific and technical field and on the methods of carrying out professional activity,
that has actual or potential commercial value due to being unknown to third parties, provided that third parties have no free access to such information on a legal basis and the holder of such information takes reasonable measures to keep it confidential, including by introducing a commercial secrecy regime (Art. 1465 of the Civil Code of the Russian Federation).
Generally known information cannot be recognized as a trade secret, nor can information whose disclosure is mandatory or access to which may not be restricted under the law or another legal act.
- No registration is required for the exclusive right to know-how to arise; it arises at the moment measures are taken to keep the information confidential and remains in effect until the information is disclosed.
- Moreover, a very wide range of business-valuable information can be protected under the know-how regime, including information that cannot be protected under any other IP object regime.
- For example, a trade secret may be:
- product manufacturing technologies
- research methods
- a customer database
- Document templates and agreement terms
- local regulations (internal company rules)
- the design of a retail outlet
- Moreover, when preparing applications for inventions and utility models, patent specialists can effectively combine, to protect a development, the patent form of protection (thereby allowing certain information to be published) and know-how (keeping the most valuable information about the technological process secret), thereby making it as hard as possible for competitors to "work around" the patent, create a similar product and infringe the legitimate interests of the original manufacturer.
- As stated above, for information to become a protected trade secret
it is sufficient to take reasonable measures to keep it confidential.
The law does not contain a specific list of such measures.
In practice, the commercial secrecy regime is very often used for this purpose – a set of measures for protecting confidential information listed in a special law –
Federal Law "On Commercial Secrets" of 29.07.2004 No. 98-FZ:
- Define a list of confidential information;
- Introduce a procedure for handling the information and measures for monitoring compliance with the procedure;
- Keep records of persons who have been given access to the information;
- Include commercial secrecy conditions in contracts: employment and civil-law contracts;
- Use the "Commercial Secret" stamp, indicating the holder;
- Familiarize employees with the list of information, the commercial secrecy regime, the rules for handling confidential information, and liability for disclosure;
- Create conditions for employees to comply with the commercial secrecy regime.
To ensure the introduction of these measures, the following set of documents may need to be developed:
- Regulation on commercial secrecy;
- Instruction on working with commercial secrets;
- Employee familiarization log;
- Access log for commercial secrets;
- NDA (non-disclosure agreement) with employees and counterparties.
In addition, it is important to:
- provide technical equipment for access to confidential data and for transferring it to third parties,
- constantly monitor compliance with the commercial secrecy regime,
- train employees in handling this information and tell them about the importance of keeping it secret.
An exclusive right arises to a trade secret (know-how), which the right holder may use personally,
- and the right holder is also entitled to transfer it under an alienation agreement
- or grant the right to use it to third parties under a license agreement or a commercial concession agreement,
- it may be the subject of a pledge.
At the same time, since this IP object is not subject to state registration, acts of disposing of the exclusive right likewise do not require registration.
For infringement of the exclusive right to a trade secret (including for disclosure of confidential information), liability is provided under labor law (up to dismissal of the employee), civil, administrative and criminal law.
2. Contracts for creating RIA and disposing of rights to them
An exclusive right to an RIA enables the right holder to use
the object in any way that does not contradict the law and the nature of the IP object, and to dispose of it.
The main ways of disposing of an exclusive right named in the Civil Code of the Russian Federation are:
- alienation of the right to another person under a contract (under which, in essence, the exclusive right is sold in full) (Art. 1234 of the Civil Code of the Russian Federation);
- granting another person the right to use the IP object within the limits established by the contract (on the basis of a license agreement or a commercial concession agreement) (Art. 1235 of the Civil Code of the Russian Federation, Chapter 54 of the Civil Code of the Russian Federation).
Alienation agreements and license agreements may be paid or free of charge. A license agreement must also specify:
- its type (exclusive or non-exclusive),
- the term for which the right of use is granted,
- the territory of validity,
- the methods of using the IP object,
- the possibility of granting a sublicense and other terms at the parties' discretion.
The law contains no rigid requirements for the terms of such contracts, so the parties themselves are free to determine the terms of use of the exclusive right to an RIA in line with their own interests.
A feature of disposing of an exclusive right to an RIA is that most
IP objects are subject to state registration, and consequently the fact of disposing of the right is also subject to state registration in the manner established by law (Art. 1232 of the Civil Code of the Russian Federation).
Thus, if the right holder of a patent law object or trademark wishes to
transfer their right or grant it for temporary use to a third party
- they need to formalize this relationship with an appropriate contract and file an application for registration of the disposal of the right with Rospatent.
- If such an application is not filed and registered, the disposal of the right is deemed not to have taken place.
The general requirements for the application and the enclosed documents are set out in paragraph 3 of Article 1232 of the Civil Code of the Russian Federation, and more detailed information and the registration procedure for the disposal of an exclusive right are contained in the Rules of State Registration of the Disposal of an Exclusive Right
to an invention, utility model, industrial design, trademark, service mark, registered integrated circuit topology, computer program,
or database under a contract, and of the transfer of an exclusive right to them without a contract (approved by Decree of the Government of the Russian Federation of 24 December 2015 No. 1416).
An application for registration of the disposal of an exclusive right may be signed by both parties to the contract, in which case no enclosures are required.
If the application is signed by one of the parties to the contract or its representative, then it is necessary to:
- attach the original contract (sign three copies in advance, since Rospatent does not return documents enclosed with the application),
- or a notification of the disposal of the right that has taken place (this is a brief extract from the contract),
- or a notarized extract from the contract.
A notification and an extract are convenient in that you will not have to submit the entire contract to Rospatent, especially if the contract contains information you would not wish to disclose (for example, the terms on the amount and procedure for payment of remuneration under the contract).
It is important to bear in mind that the procedure for registering the disposal of an exclusive right at Rospatent takes about two months,
- and if all the documents are drawn up correctly, information about the registration will appear in the Open Registers in the "card" of the relevant IP object.
- If the examination reveals any inconsistencies of the documents with the requirements of the legislation, it will send you a request and propose that you correct the deficiencies.
As for contracts for creating an RIA, the current legislation also provides for several types of them:
- copyright commission agreement – if an individual creates a copyright object for you on commission (Art. 1288 of the Civil Code of the Russian Federation);)
- commission agreement for creating an RIA (Arts. 1296, 1372 of the Civil Code of the Russian Federation) – if the contractor, a legal entity, organizes the creation of an RIA under the contract;
- contract for work and R&D contracts (Arts. 1297, 1371, 1471 of the Civil Code of the Russian Federation) – if IP objects are created in the course of performing the work;
- state and municipal contracts (Arts. 1298, 1373, 1471 of the Civil Code of the Russian Federation) – if IP objects are created in the course of work performed in the interests of a state or municipal customer;
- employment contracts (Arts. 1295, 1370, 1470 of the Civil Code of the Russian Federation) if an IP object is created by an employee of an organization in the course of performing job duties (on a regular basis or on the employee's own initiative).
Whatever the format and on the basis of whatever contract an RIA is created, one of the key terms must be an indication of
- who will own the exclusive right to the IP object created,
- and who will be granted the right to use it, within what limits and on what terms.
Example
If you hire an organization to develop a utility model, you can provide in the contract
- that the exclusive right will belong to you as the Customer
- while the Contractor acquires the right to use the utility model it created for its own needs on the terms of a free simple (non-exclusive) license for the entire term of the patent, unless you agree otherwise.
With regard to employee RIAs created by an organization's employees in the course of their employment, it is important to remember
that as a general rule the exclusive right to such RIAs passes to the employer,
but the law also establishes a procedure for formalizing rights and an obligation of the employer to take
certain actions after receiving a notification from the employee about the creation of an RIA.
To build an effective system of interaction with employee-authors, it is strongly recommended to:
- set out provisions in the employment contract
- and approve local regulations governing the creation of IP objects (setting tasks, acceptance of the result of work), the decision on legal protection of the development created, and its use.
It is also important to bear in mind that for employee IP objects the employer is obliged to pay the employee remuneration, separately from salary.
1. The amount, procedure and timing of payment of such remuneration are determined by agreement between the employee and the employer.
2. In the absence of such an agreement, remuneration issues may be resolved by a court
In addition, for patent law objects the Rules for Payment of Remuneration for Employee Inventions, Employee Utility Models and Employee Industrial Designs apply (approved by Decree of the Government of the Russian Federation of 16 November 2020 No. 1848).
These Rules establish the amounts and procedure for payment of author's remuneration both for creating an RIA and for its subsequent use.
The employer is obliged to pay remuneration to the employee even after the employee's dismissal.
3. Protection of IP abroad
IP objects are protected and defended only in the country where they are granted legal protection under the law, including after passing an examination procedure and the issuance of a patent or certificate.
There is no "international" patent or trademark that would be automatically protected worldwide.
Therefore, if the developer of an innovative product plans to enter foreign markets, they need to ensure protection of the IP objects embodied in this product in all the countries of interest.
The legal basis for protecting intellectual property objects abroad
was laid by the Paris Convention for the Protection of Industrial Property of 1883.
Besides general issues governing the concept of intellectual property objects and unfair competition,
- the Convention contains a number of important provisions aimed at making it easier for authors to obtain protection for the results of their creative work in foreign states.
- Thus, under the Paris Convention, the principle of territoriality of intellectual
property lies not only in the fact that legal protection is valid only in the country where the right to the object is recognized and/or registered, and is therefore defended against infringement in accordance with national legislation. - But also, recognition of legal protection of an intellectual property object in each country occurs independently of the others, i.e., if in one state registration of an invention or trademark did not take place for some reason, this does not mean an automatic refusal of registration in another country.
Moreover, the Paris Convention introduces the concept of convention priority (Article 4) – an important rule that applicants use successfully and frequently to this day.
Convention priority means the following:
- If you have filed an application for an invention, utility model, industrial design or trademark in any country party to the Paris Convention, then on its basis, within a certain period (12 months for inventions and utility models, 6 months for industrial designs and marks), you may seek protection in any of the other member states of the Convention.
- Such subsequent applications are deemed filed on the same date as the first application and take priority over applications filed during that period for the same invention, utility model, mark or industrial design by other persons.
In practice this gives a very important advantage: applicants who wish to obtain protection in several countries are not obliged to file all their applications simultaneously,
but have a period of 6 or 12 months at their disposal to decide in which countries they wish to obtain protection, and to properly prepare their actions and the financial resources needed to obtain protection.
Despite some advantages that the Paris Convention gives applicants, filing applications with foreign patent offices requires:
- significant expense, organizational effort and time;
- in this case we need to file separate applications with the patent office of each country where we want to register our RIA;
- as a rule with the help of a local specialist – a patent attorney;
- all document flow will be conducted in the local language (which will entail additional translation costs).
In addition, as a rule, in order to exercise the right of priority, it will be necessary to obtain a certified copy of the first application from the patent office where it was filed and send it to the foreign offices.
And, finally, the examination procedure will be conducted in each country under its national laws and at different times, which makes this whole process rather unpredictable.
There are currently several international and regional systems for registering IP objects in the world,
which make it possible, under a single procedure, to file applications in different countries and significantly reduce the cost of patenting and registration abroad, and to unify examination times.
The following global systems of international IP protection operate within the World Intellectual Property Organization (WIPO):
1. The Madrid Agreement Concerning the International Registration of Marks of 1891 and the Protocol Relating to the Madrid Agreement of 1989 (Madrid System) – allows registering trademarks in 130 countries of the world;
2. The Patent Cooperation Treaty of 1970 (PCT system) – helps applicants patent their inventions in 157 countries of the world, assists patent offices in making decisions on granting patents, and facilitates public access to technical information relating to inventions;
3. The Hague Agreement Concerning the International Registration of Industrial Designs of 1925 (Hague System) – makes it possible to obtain legal protection for industrial designs in 96 countries of the world.
All these global systems operate on the "one-stop" principle
- a single international application is filed in one language
- uniform fees are paid and applications are sent to the national patent offices in which the applicant wishes to obtain legal protection for the IP object
- Then the application is examined in each national patent office in accordance with national legislation, but within regulated time limits.
- If the examiner finds no grounds for refusal, the examiner sends a decision to register, and from that moment the intellectual rights to your RIA are deemed granted in that country.
If the examiner finds any inconsistencies between your application and national requirements, the examiner's preliminary refusal to grant legal protection will need to be overcome with the help of a local IP specialist.
You can find them yourself or, as a rule, Russian patent attorneys who have their own partner network abroad will be able to help you find such specialists and prepare a response to the examination's preliminary refusal.
- In order for a Russian applicant to use the international trademark registration system and patenting under the PCT system, it is necessary that a Russian application has already been filed with Rospatent, on the basis of which the international applications can be made.
- And for international patenting of industrial designs under the Hague System an international application can be filed directly with WIPO.
Another important advantage of filing through international systems is the ease of subsequently managing your registration
renewal of the term of the IP object and disposal of the exclusive right also take place through the "one-stop" system, fairly accessibly, quickly and efficiently.
Detailed information on the procedures for filing applications under the international systems can be obtained:
- on the Rospatent website (https://rospatent.gov.ru/ru/international-cooperation)
- on the WIPO website (https://www.wipo.int/services/ru/).
Besides the global systems for protecting IP objects, there are several regional systems, created to help applicants from the member countries of a regional integration association patent or register their RIA in several countries of the region at once.
The following regional systems are currently in operation:
1. Benelux Office for Intellectual Property, www.boip.int – where
a single trademark and industrial design can be registered, valid in the territory of three countries at once – Belgium, the Netherlands and Luxembourg.
At the same time, patents for inventions and utility models must be obtained from the patent office of each of these countries.
2. European Union Intellectual Property Office (EUIPO, formerly OHIM), www.euipo.europa.eu – makes it possible to register a single trademark and a single industrial design, valid in all EU member states. This regional system operates in parallel with national protection of trademarks and industrial designs, i.e., national applications can be filed in each EU country separately if registration is of interest not in the whole EU but in individual states.
3. European Patent Organisation, www.epo.org – as a "one-stop" system, it helps protect inventions and utility models in European countries; the application is examined
and a European patent is granted, which then needs to be validated in the chosen countries where the development is to be protected.
Russia is not a member of this organization, but Russian applicants actively use this system to obtain protection in European countries.
4. African Intellectual Property Organization (OAPI), www.oapi.int – under which single protection documents are issued for inventions
and utility models, industrial designs and trademarks, valid in 17 member states, but national applications cannot be filed in each country separately.
5. Eurasian Patent Office, www.eapo.org/ru – makes it possible to obtain legal protection for inventions and industrial designs that will be valid in the territory of 8 member states (CIS countries). In addition, an initiative to introduce a Eurasian trademark system is currently under discussion.
Thus, today there are several ways to obtain legal protection for IP objects in foreign countries:
- filing applications through national patent offices;
- filing international applications under global and regional systems.
Each method has its own features, advantages and disadvantages.
- The choice of the route for international protection of an IP object should be based on the business development strategy and the market potential,
- take into account the costs of fees and the services of local patent attorneys, the possibilities of optimizing them, the time frames and the specifics of the examination procedure
- and also the potential for expanding the types and geography of activity in the future.
Author of the article: Olga Maryukhina
Specialization and experience
- Consultant on registration and patenting of IP objects in the Russian Federation and abroad.
- IP lawyer, Master of Laws in IP and IT Law (Magister Lvcentinvs master's program, University of Alicante, Spain).
- Eurasian patent attorney No. 39 specializing in "industrial designs" and No. 550 specializing in "inventions".
- Patent attorney of the Russian Federation No. 1998, all specializations
