Out-Law Analysis | 28 Nov 2019 | 3:27 pm | 4 min. read
Digital technology is driving the 'fourth industrial revolution' and changing traditional manufacturing processes, making them faster, more efficient and adaptable. In the dental sector, 3D printing provides an example of the changes made possible by the combination of modern communications technology and digital data flows.
This is part of a series of articles exploring issues in the dental sector. Other topics include a focus on the impact of consolidation in the UK and Irish dental markets, a look at how reforms are impacting private investment in the sector in Germany, and how digital dental care is possible through apps.
Dr. Nils Rauer, MJI
Where data is not subject to protection either under IP rights or data protection law, businesses should consider whether innovative contracting models will provide them with scope to exploit that information.
Being able to use and exploit patents, designs, works of copyright, rights to data and confidential information, including trade secrets, will become increasingly vital to the dental industry as 3D printing and other digital technologies become more prevalent. As such, it is important that businesses in the dentistry sector familiarise themselves with the legal and regulatory framework and understand their licensing options.
The advent of 3D printing and the rights involved in this modern technology has been the subject of dispute and even litigation, with so-called "computer-aided designs" (CADs) in vogue. Ownership of data is an important asset in this respect, as only businesses with the right CAD data available can shape the manufacturing process in the way they desire.
However, there is no such thing as proprietary data ownership. In most jurisdictions, one can own physical property such as a car, a neckless or a house, but not intangible assets such as pure digital data. This is unless the data concerned is subject to specific legal protections, including those that apply to personal data, specially structured information in a wider database, copyright works or trade secrets, or unless further contractual provisions govern its use.
Dealing specifically with CAD data, copyright law offers the widest scope of protection against unauthorised use by competitors and customers. Relying on widely harmonised EU copyright legislation, the digital blueprint any 3D printing process starts with commonly enjoys protection as an intellectual creation. Those protections are enshrined in law and do not require to be registered. The protections apply where there is adequate originality in the CAD data created by its author.
Once established, the copyright work grants its owner a multitude of exploitation rights, notably the right of reproduction, the right of distribution and the right to make publicly available the created work. Third parties can be excluded from any use of the work unless they obtain an adequate license. In other words, the right to use the CAD data and thereby the right to the 3D blueprint are the legal source for everything that comes subsequently in the digital production chain.
There is an overlap in the various legal regimes that apply to data. Trade secrets, for example, can consist of personal data gathered from confidential customer databases. Copyright protected works may also rest on personal data. For example, a dental prosthesis must inevitably be individually shaped on the basis of the biometric data of the patient. However, the manufacture of the prosthesis does not require identification of the person behind the biometric data. The printing process can be carried out on the basis of pure raw data. Accordingly, it is important to get the data flows right and to ensure that only the data actually needed for the next step in the manufacturing process is used to ensure compliance with data protection law.
Software commonly enjoys legal protection as a so-called computer programme, but in many jurisdictions, including within the EU, software as such is not patentable. This is because patent law typically does not extend to protect a digital application that relies on certain algorithms. However, US patent law is somewhat more liberal. In consequence, we see US software patents in the market that furnish the right holders with respective exclusive rights. This is also true for 3D printing equipment.
The legal protection of designs rests on the outer appearance of an item. As such, digital data is not capable of assuming design protection. However, the physical output of a 3D printing process may qualify as a protected design. The core element of such protection is the novelty of the appearance. Designs that are already known to the public cannot be registered or otherwise benefit from unregistered design rights.
Trade mark law is also relevant to 3D printing. Whilst trade marks are traditionally associated with names, logos or labels, 3D images can also be registered as a trade mark. If the output of a 3D printing process was registered as a trade mark, then it may be argued that the blueprint of that output also benefits from the protections provided by that registration.
The digitisation process within the dental sector is closely linked to IP and data rights. There is no one single path to choose. Each business should balance their options and take an informed decision about which IP rights and licenses they should obtain or, as the situation may be, which rights need to be respected to avoid any infringement of third party interests.
Where data is not subject to protection either under IP rights or data protection law, businesses should consider whether innovative contracting models will provide them with scope to exploit that information. Businesses in the dental sector should think about these options at the outset of digitisation projects before data flows and ways of working are set. The process of creating and assembling data is where proprietary rights to that information are generated, so it is vital to set up the right legal framework and infrastructure to operate within.
21 Nov 2019
28 Nov 2019