This article, which focuses on copyright and database rights, is the third article in a series exploring intellectual property (IP) protection for digital health products in the UK. The first and second articles in this series can be accessed here and here. 

What is a copyright?

Copyright protects original literary and artistic works, as well as other subject matter. A work is original if it is the author's own intellectual creation. This means that it involved the exercise of creative choices and was not copied from a pre-existing work. There is no requirement that the work have aesthetic or other value. Different forms of copyright can subsist in a single product. Copyright can therefore exist in elements such as the software , databases and graphical user interfaces of digital health devices. 

How can copyright protection be obtained in the UK?

There is no system for registering copyright in the UK; provided a work is 'original', copyright resides in the work as soon as it is created and recorded, in writing or otherwise. Ideas are not protected by copyright – only the tangible expression of the idea is protected. Although it is not a legal requirement in the UK, it is good practice to mark products with a copyright notice to put third parties on notice that the owner considers copyright to subsist in the work. Copyright in literary and artistic works lasts for the life of the author plus 70 years from the end of the calendar year in which the author dies. For computer-generated works , copyright lasts for 50 years from the end of the calendar year in which the work was made (see further on computer-generated/AI works below). 

Who owns copyright?

The general rule is that the author of a work (ie the person who creates it) is automatically the first owner of copyright in it. However, it is worth noting that:

• Where a literary or artistic work is made by an employee in the course of their employment, their employer is the first owner of copyright in it. 

• Where a work is commissioned, the author is the first owner of copyright in the work although the commissioner might have an implied licence to use the work for certain purposes. 

• Where a work is computer-generated, the author (and therefore first owner of copyright in it) is the person by whom the arrangements necessary for the creation of the work are undertaken. It might not always be clear who this person is.

These rules can be varied by agreement. Digital health companies should keep records containing evidence of when (and by whom) works are created and ensure that they own (or have the right to use) all copyright that they need (particularly works created by independent contractors, under commission, and computer-generated works).

What rights does copyright confer?

The owner of the copyright in a work has the exclusive right to do certain acts in the UK in relation to that work, including to copy the work, to issue copies of the work to the public, and to make an adaptation of the work. A person infringes copyright if they do (or authorise another to do) any of these acts without the permission of the copyright owner in relation to the whole or a 'substantial part' of the work. 'Substantial part' is assessed qualitatively rather than quantitatively so the taking of a small but important part of a work (if protected by copyright) can infringe. There are also various acts of secondary infringement. Some forms of serious copyright infringement (piracy) constitute a criminal offence.

What impact has Brexit had on copyright protection in the UK?

Brexit has had little practical impact on substantive copyright law. However, it is possible that UK copyright law will gradually diverge from EU copyright law.

What considerations are there in relation to copyright and digital health products?

In recent years, there has been much debate about copyright/IP protection for computer-generated works, including works created by artificial intelligence (AI). In particular, it is unclear whether copyright subsists in such works and – if so – who owns such copyright (see above). The UK Government recently conducted a consultation to consider possible changes to IP legislation in this area. The topics covered included:

• whether copyright should subsist in computer-generated works without a human author and – if so – how; and
• licensing or exceptions to copyright protection of information where that information is used for the purposes of text and data mining (often significant in AI use and development). The consultation sets out the policy options being considered in both areas. Digital health companies with computer-generated/AI-based products should remain alert to future developments in this field and input into any future consultations.

The European Commission published an AI package in April 2021, which included a proposal for an AI regulation setting out harmonised rules for the EU , however this regulation does not comprehensively address the protection of IP rights.

Database rights for digital health products 

What IP rights can be used to protect databases in digital health products in the UK?

Digital health products have resulted in the proliferation of health-related data, much of which is stored in databases. Moreover, many digital health products make use of databases containing medical information to support the decision-making processes that are at the heart of their operating systems. In the UK, there are two forms of IP protection for databases:

• copyright and
• the sui generis database right (database rights). Under both, a database is a "collection of independent works, data or other materials which are arranged in a systematic or methodical way, and are individually accessible by electronic or other means". Database rights are the focus of this section. 

Copyright in databases 

The law in relation to copyright in databases is much the same as that applicable to other types of copyright (see above). A database is original if, by means of the selection or arrangement of the contents of the database, the database constitutes "the author's own intellectual creation". 

Database rights 

Database rights protect databases for which there has been a "substantial investment" in "obtaining, verifying or presenting the contents of the database". Unlike copyright, there is no requirement for originality/creativity. "Investment" can mean "any investment whether in financial, human or technical resources." "Substantial" means substantial in terms of quantity or quality or both. The investment must relate to the construction of the database itself not the creation of the underlying contents which make up the database. Database rights protect the collection of data, not its constituent elements (which may or may not be separately protected by copyright).  

Database rights are infringed when a person extracts or re-utilises all or a substantial part of the contents of a protected database without the consent of the owner of the database right. Substantial part must be assessed qualitatively as well as quantitatively. Extraction occurs regardless of whether the extracted data is eventually discarded, and includes the retyping or copying of some or all of the contents of a database into another medium which can then be used. Re-utilisation means making the contents available to the public by any means. Repeated and systematic extraction or re-utilisation of insubstantial parts of the contents of a database may amount to the extraction or re-utilisation of a substantial part. Mere consultation of a publicly available database does not amount to infringement, nor does the extraction or re-utilisation of insubstantial parts of such a database by a lawful user.  

How can database rights be obtained in the UK?

Like copyright, database rights are an automatic right that exist as soon as the database is fixed in recorded form. The maker of a database (and the first owner of database rights in it) is the person who takes the initiative in obtaining, verifying or presenting the contents of the database and assumes the risk of investing in that obtaining, verification or presentation. In some circumstances, this could be the commissioner of a database. Where a database is made by an employee in the course of their employment, their employer is regarded as the maker of the database and the first owner of database right in it. This is subject to any agreement to the contrary. Database rights last (i) for 15 years from the end of the calendar year in which the database was completed ; or (ii) if the database is made available to the public prior to the end of this period, for 15 years from the end of the calendar year in which the database was first publicly disclosed. Substantial changes which result in the database being considered a substantial new investment qualify the database resulting from that investment for its own term of protection. In other words, updating a database regularly could extend the term of protection.

What has been the impact of Brexit on database rights in the UK?

Prior to the UK's departure from the EU, eligible databases received protection in all EEA member states (including the UK) under the EU Database Directive. Eligible databases are those made by EEA nationals, residents or businesses. Now that the UK has left the EU, UK nationals, residents and businesses are no longer eligible to receive or hold database rights in the EEA for databases made after 31 December 2020 (the end of the Brexit transition period). Likewise, only UK nationals, residents and businesses are able to receive or hold UK database rights for databases made after 31 December 2020. However, database rights that existed in the UK or EEA on or prior to 31 December 2020 will continue to exist in the UK and the EEA for the remainder of their term of protection. 

Digital health companies that own databases made after 31 December 2020 should consider whether there are alternatives such as copyright (or licensing arrangements) that will protect the database in the EEA. 

What considerations are there for digital health products in relation to database rights?

Digital health companies should be aware that database rights only arise when the maker of the database has invested substantially in obtaining, verifying or presenting the data from independent sources. Where a contractor or other third party is the maker of a database, they might be the first owner of database rights in it and digital health companies should therefore ensure that service agreements include an assignment of all rights in databases. Given the importance of data in this field, digital health companies should also pay attention to licence terms relating to the control of the information exchanged to ensure that they account for the loss of database rights for UK companies in the EEA.

Summary

Protection of IP is of increasing importance to digital health companies due to the rapid expansion of this field. This series of articles has outlined the practical steps that digital health companies can take to protect their products using the key IP rights. Whilst the interdisciplinary nature of the field gives rise to unique IP challenges, digital companies can enhance their competitiveness through a well-considered IP strategy.