Result card

  • LEG2: Does Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?
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Does Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Internal reviewers: Ingrid Rosian

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts. The document was searched for „property right“ and „intellectual“, articles includig these terms are listed.

A Search was done within the EPO – European Patents registration using the keywords „telemedicine“ and „telemonitoring“

Agreement on Trade-Related Aspects of Intellectual Property Rights The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

According to the Directive 2004/18/EC {2} there are some aspects where the property rights regulation cannot be sufficiently precise, these areas have to be solved using the rules for governing open or restricted procedures.

Within the patent database EPO – European Patents registration {5} one document was found about Telemedical expert service provision for „telemedicine“ / „telemonitoring“, which seems to be an ongoing negotiation, and several other documents about disease management systems, telemedicine systems, interfaces, corresponding methods, etc. This as a result of the legal aspects means, that a provider is on the saver side when checking for patents before implementing STS as telemonitoring. There might be some features not allowed to be copied.

There are some companies providing a full package of telemonitoring including structured telephone interview. If STS is planned to be implemented, the provider has to be aware of possible patents, especially for a certain structure and/or the implemented questionnaire and the risk-calculation-model.

The use of a patent-binded source (or parts out of it) without permission could result in penal costs.

A search within the patent database can help to find out existing patents.

For the implementation of telemonitoring one has to look at least for existing property rights on the used system, the implemented software, existing patents, and to secure/regulate the permission for use, and be in line with the Directive 2004/18/EC.

 

  1. Patents (search in EPO {5}. A list of possible relevant patents is provided in appendix 1. This list is not exhaustive! (links checked on 13th May 2015)

General provisions

 

  • Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts {2}

This applies to public contracts concluded by a contracting authority in sectors for: supplies services; and public work contracts. It depends on the context of the provision of structured telephone support for patients with chronic heart failure whether this directive has to be taken into account.

 

Art 30 (c) ”...in the case of services, inter alia services within category 6 of Annex II A, and intellectual services such as services involving the design of works, insofar as the nature of the services to be provided is such that contract specifications cannot be established with sufficient precision to permit the award of the contract by selection of the best tender according to the rules governing open or restricted procedures“

 

  • The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. {4}

TRIPS in connection to telemonitoring/ telemedicine could be relevant for the definitions and interventions listed in TEC_5 (out of the studies from the basic search) (selected narratively):

Part II Article 9 (2)

”Copyright protection shall extend to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such.”

Part II Article 10 (1)

”Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971).”

Part II Article 10 (2)

”Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself.”

Part II Article 27

According to Article 27 1. patents shall be available for any interventions, products and processes. But there is an option to exclude patentibility in 2.:

” 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

”3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

Part II Article 31

”Where the law of a Member allows for other use (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:”

”(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;”

 

 

Important
Wilbacher I, Rupel V Result Card LEG2 In: Wilbacher I, Rupel V Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

References