Intellectual propertyPatentability and inventorship
What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?
Digital health inventions are often connected to the creation of software, an algorithm or a database that companies will seek to protect. While, as a general rule, EU and Spanish regulations do not allow for the patentability of software, algorithms or databases, when claimed as such (see article 52(2)(c) and (3) of the European Patent Convention), an inventor could seek protection whenever the computer-implemented health invention (or computer program) produces a further technical effect going beyond the interaction between the software and the hardware on which it is run.
By way of example, under the European Patent Convention algorithms, claimed as such, would be considered mathematical methods that do not provide a solution against a technical problem, and therefore are not considered patentable. Nevertheless, when the role of the algorithm within a computer-implemented invention goes beyond the mere technical characteristics of the same, the technical items or process could be patented (eg, providing a medical diagnosis by an automated system processing physiological measurements).
Although there is a certain degree of harmonisation at the EU level, most provisions governing the ownership of employee inventions tend to be specific for each IP right and further developed under local legislation that, often, leads to divergences between EU member states.Patent prosecution
What is the patent application and registration procedure for digital health technologies in your jurisdiction?
First, patentable inventions shall meet three key requirements:
- novelty: it must be an innovation not included in the state of the art;
- inventive step: it must be the result of an inventive activity; and
- industrial applicability: it must apply to industry.
Should the relevant digital health technology be patentable, application and registration procedures would be the same as for any other patentable invention. In this context, there are mainly three alternatives to have the patent registered:
- file an application before the Spanish Patent and Trademark Office, which shall initiate a national granting procedure;
- file an international or Patent Cooperation Treaty application, which shall trigger an international granting procedure; and
- file an application before the European Patent Office, which shall trigger a regional granting procedure.
The most convenient alternative shall depend on, inter alia, countries where the applicant seeks protection, the existence of prior inventions in the field of application or business concerns has any impact on the intangible asset.
In practice, as a general rule, the inventor must file an application form, pay a mandatory fee and provide specific documentation (applicant’s details, description of the invention, claims) to the relevant receiving office. The patent application is normally published by the relevant Patent Office 18 months after the date of its filing, which triggers further procedure implications that shall depend on the selected filing strategy and the designated office of the state where patent protection is sought.Other IP rights
Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?
Different technical aspects of digital health inventions can be, under certain circumstances, also protected through other IP rights such as:
- utility models;
- the protection of software source code under copyright law;
- databases under a specific sui generis right;
- algorithms as trade secrets;
- trademark protection of distinctive signs within the digital health offering; or
- design protection over digital user interfaces.
Nevertheless, the compatibility among them and requirements for their protection shall depend on the specific technical characteristics, business implications and the nature of the IP rights.
As a general rule, the source code of a computer program can be protected through copyright without the necessity to apply or register any right. In such case, employers shall be the exclusive owners of the right to exploit the software created by employees in the course of their assigned duties or following the employer’s instructions, unless agreed otherwise.
Should any aspect, such as algorithms, have actual or potential business value, they may be protected as trade secrets provided that it constitutes secret information, has a commercial value connected to its secrecy and has been subject to reasonable measures to be secret. As such, secrecy of the algorithm becomes a key concern: owners shall adopt proactive measures to ensure effective confidentiality and avoid the disclosure of the algorithm to benefit from such protection. The ownership of trade secrets will correspond to ‘any natural or legal person who legitimately exercises control over the trade secret’.
Database sui generis right
Databases are mainly protected through copyright sui generis right where the right holder shall have, inter alia, an exclusive right to access and exploit the database, as provided by the Spanish Intellectual Property Law. This right aims at protecting material investments made by owners for the collection, verification or display of database content. Thus, companies must be able to prove the relevance of the investments made (financial, technical or human) to create and maintain such databases. Unless agreed otherwise, the rights to exploit databases created by employees in the course of their labour duties are presumed to have been assigned to the employers.Licensing
What practical considerations are relevant when licensing IP rights in digital health technologies?
In Spain, relevant practical considerations are not specific of digital health technologies and will depend on the IP rights in question and the characteristics of the technology at hand.
The licensing of copyrights and sui generis rights applicable to databases is regulated under Title V of the Spanish Law on Intellectual Property. Considerations to take into account include:
- a formalisation in writing is compulsory;
- unless stated otherwise, licensing is limited in time to five years and geographically to Spanish territory; and
- exclusivity must be expressly provided to be valid.
With regard to trade secrets, it is vital that proprietary companies take measures to ensure the confidentiality of trade secrets. Consequently, the inclusion of adequate confidentiality and non-disclosure provisions shall be a key concern in the drafting of licence agreements. In addition, provisions of the Spanish Law on Trade Secrets offer other main practical considerations to have in mind:
- licences are considered non-exclusive unless provided otherwise; and
- limitations to the licensing rights conferred to the licensee shall be expressly included in the agreement (namely, temporary, territorial, material and objective limitations).
The licensing of patents is also regulated under the Spanish Patents Act, and subject to the same considerations. In particular, it should be noted that the registration of patent licensing is not compulsory, but highly advisable to promote legal certainty through publicity and encourage business activities. The registration of the licence is also advised if the licensee intends to bring actions against third-party infringers.
In addition to the compliance with the legal requirements for the validity of the IP licence, it is advisable to evaluate, depending on the IP right at hand, whether any additional provisions are needed such as the insertion of software escrow provisions, fallback provisions or additional technology transfer-related obligations.
The contractual relationship between parties and the role of IP within the latter is also of paramount concern. The latter considering the differences between, for instance, a mere IP licence or an IP licence included in the context of the provision of software as a service, platform as a service or X (everything) as a service.
Moreover, there are relevant aspects such as the implications of the use of open-source software (or parts thereof) and open libraries to develop and produce digital health technologies, which may have an implication in the ability, not only to licence, but also to protect and enforce potential rights over such technologies. Finally, another key aspect to consider is the relevance of data, its potential protectability under earlier-mentioned IP legislation and proper regulation of licensing aspects involved in the provision and processing of data.Enforcement
What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?
Spanish law does not regulate specific procedures for the enforcement of IP rights in digital health technologies. Therefore, said rights shall be enforced according to the provisions governing the enforcement of IP rights and, complementary, the general applicable regime applicable.
Depending on the infringement or crime at stake, legal action may be brought before civil or criminal courts. However, there is a relevant set of IP-related procedural law provisions in terms of preliminary injunctions and IP disclosure having an impact on both IP right holders and infringers.
In general, it is relevant to note the exclusive competence of some courts with regards to the infringement or invalidity of certain IP rights (eg, patents, trademarks or trade secrets).