As more neural prosthetics devices become viable at commercially accessible prices, demand will increase and more businesses will be attracted to the field. This raises the more mundane, but necessary, questions about law and regulation – both to protect patients and the investment of further innovation.
Regulation of medical devices
Implantable devices and devices serving therapeutic purpose or use in medical treatment, (such as the neural prosthetic devices discussed in this article), are regulated as "medical devices". Medical devices are regulated by a system of European and national legislation. In particular, the European Parliament adopted proposals for two new EU regulations on medical devices on 5 April 2017 – one for medical devices and the other for in vitro diagnostic medical devices. These are currently in a transition period of application, replacing three European Directives, before coming into full force from 26 May 2020 and 2022, respectively (see our article for more).
The reason provided in the recitals to the new Regulations as to why the three Directives required a significant overhaul, was the need to "establish a robust, transparent, predicable and sustainable regulatory framework for [medical devices and in vitro diagnostic medical devices] which ensures a high level of safety and health whilst supporting innovation". This need for change was particularly highlighted by the highly publicised PIP breast implant scandal and the unexpected early failure of certain metal-on-metal hip implants, which flagged the need for greater scrutiny of medical devices and patient safety. Significant technological and scientific advancements, of which the above technologies are just examples, were also cited as reasons for the regulations.
The Regulations state in their recitals that "key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety".
An example of this reinforcement for implants specifically, is the introduction of an implant card which must be provided to the patient and contain information allowing the identification of the device, including: the device name, serial number, lot number, the UDI, the device model, together with name, address and the manufacturer's website. Updates of the information on the implant card must be made available to the patient through the manufacturer's website. Additional information must also be provided on the manufacturer's website such as certain warnings and precautions to be taken by the patient or a healthcare professional, expected lifetime of the device and safe use of the device.
Certain products with only an aesthetic or other non-medical purpose that were not previously regulated as medical devices may also be subject to the new legislation if their functioning and risk profile is similar to medical devices. This has implications for implants and prosthetics used purely for body enhancement as well as therapeutic purposes.
Patent protection
Novel and inventive devices and systems – innovative prosthetics and their means of operation – are more usually the subjects of patent protection. Patents are registered rights, protecting everything expressly recorded in their claims.
Patents currently protect on a country-by-country basis, although a new 'unitary patent' right that protects a large part of the EU is awaiting ratification by Germany. A national patent may be obtained, through a national office (for the UK this is through the UK Intellectual Property Office (UKIPO)); or, a European patent designating several European countries may be obtained, through the European Patent Office (EPO).
A UK or European patent (and when it is available, a unitary patent) may be enforced against infringement by a third party doing certain acts in the territory protected without the patent owner's (or their licensee's) consent, these being:
- Making, disposing of, offering to dispose of, using, importing or keeping a patented product or a product obtained directly by means of a patented process.
- Using, offering for use in the territory a patented process.
- Supplying or offering to supply in the territory a person other than a licensee with any of the means relating to an essential element of the patented invention for putting the invention into effect – in order to infringe, the supplier must also know, or have reason to believe, that such means will be used to put the patented invention into effect in the territory.
As well as protecting against the direct copying of the invention, patents cannot be avoided by reverse-engineering and they protect against the production of the same invention completely independently.
As regards computer implemented inventions (technical apparatus operated or assisted by computer programs) is that the law governing patents in Europe, European Patent Convention (EPC), contains a provision that excludes programs for computers from protection. This is implemented in the national laws of the contracting states to the EPC. The effect of this exclusion is that a pure computer program is not patentable – pure programs therefore remain the preserve of copyright and confidentiality.
However, the EPC does say that the exclusion only applies to computer programs "as such". This means that inventions which do not consist purely of computer software, but instead implement the software in a device or a system, are potentially patentable. This suggests that many neural prosthetic systems, in which software is an adjunct to the technical apparatus, are potentially patentable.
Design protection
In some cases, objects will be protected by design rights. Commercial reproduction of certain objects used in neural prosthetics could amount to infringement of a design right. There are four different types of design right and the law governing their application is complicated. Where an object is protected by these rights, the rights will be infringed where an unauthorised third party makes a copy. It will not be an infringement for a third party to copy any features of a protected design that enables their own design to be connected to or matched with the protected design. Design features enabling one product to be functionally fitted or aesthetically matched to another are specifically excluded from protection.
Copyright
Copyright gives a bundle of rights to creators to prevent other people from copying, using or exploiting their original works without their consent. It is the most pervasive of all intellectual property rights, subsisting in anything from menial pieces of text to great works of art, literature and music. Computer programs also attract copyright protection.
Copyright only protects "original works". Would-be copyright owners have to show two things:
- That their creation is original – ie that it originates from the creator and has required some intellectual creation in creating it. This is normally easy to show.
- That the creation fits into one of the categories of work that copyright protects.
Although copyright may protect the underlying software in a neural prosthetic system, this form of protection is limited. For example, copyright law cannot prevent the independent development of rival products, it can be hard to prove and it is generally inadequate to stop reverse engineering. For this reason, patent protection is preferable if it is available (see above).
Confidential information and trade secrets
The law of confidential information is an ancillary right used to protect commercially sensitive, valuable and private information which is not afforded protection under more usual intellectual property rights such as copyright and patents. This protection is generally owed to the person who created the information (or paid for it to be created), but the rule is not absolute and is largely dependent on the circumstances in each case. An obligation of confidence can also apply to third parties who receive information by accident or through any other means, even if they don't know at first that it is confidential.
Brexit
At the time of writing, the UK is poised to leave the EU which means the regulatory regime in the UK is uncertain and liable to change. Specific advice should be taken.
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