By the end of 2015, it is predicted that more than 13million users in the UK alone will have a wearable health and fitness devices. In the future, however, medical applications for invasive technology will increase massively.
Even now implants have been developed that sit inside the human body to monitor a patient's well-being. 'Smart dust' is being developed, which is an array of microscopic computers with antennas, each smaller than a grain of sand. These computers, controlled by a doctor, arrange themselves inside the body to power a range of complex internal processes. It is envisaged that these nano-devices will attack early cancer or bring pain relief to an open wound.
Outside the medical arena, implantable technology is also being developed to replace externally worn technology. A company called Dangerous Things has developed a Near Field Communication (NFC) chip that is embedded in a finger through a tattoo-like process, allowing devices to be unlocked and payment for goods being carried out by simply pointing.
Whilst sensors, nano-devices and chips should be capable of patent protection in their own right, in Europe there are exclusions in the field of medical diagnosis and surgery which may impact on a company's ability to maximise their IP protection for these new and useful products.
European patents will not be granted for:
- a method of treatment of the human or animal body by surgery;
- a method of treatment of the human or animal body by therapy;
- or diagnostic methods practised on the human or animal body.
Whether a method involves 'treatment by surgery' depends on the nature of the treatment, rather than its purpose. It must involve a substantial physical intervention which requires professional medical expertise and which entails a substantial health risk. Other criteria to consider are the degree of invasiveness or the complexity of the intervention performed. An example might be the injection of a contrast agent into the heart, catheterisation and endoscopy. Invasive techniques which are performed on uncritical body parts and which are generally carried out in a non-medical, commercial environment are not affected by this exclusion, for example tattooing and piercing.
A method of implanting or imbedding a nano-device (for example, smart dust) into a subject is therefore likely to fall within this exclusion. In contrast, the method of implanting an NFC chip into a user's finger through a tattoo-like process should be protectable.
Whether a method involves ' treatment by therapy' depends on if a disease or malfunction of the human or animal body is cured or prevented. For the wearable technology discussed above, this exclusion is therefore most relevant to the use of nano-devices (smart dust) for treatment or prevention of a condition in a human or animal body. For instance a method of treating early-stage cancer or providing pain relief to an open wound using nano-devices is likely to fall within this exclusion.
Whether a method is an excluded 'diagnostic method', depends on the inclusion of the following four steps, all of which must be performed on the human or animal body:
- Collection of data.
- Comparison of data with standard values.
- Finding any significant deviation.
- Attribution of this deviation to a particular medical or veterinary medical condition.
The exclusion does not therefore apply to X-ray methods, MRI studies and blood pressure measurements. The latter means that the use of bionic sensors to monitor certain aspects of a patient's well-being should be protectable.
We note, however, that products for use in any of these methods are not excluded. As well as being protectable in their own right, the medical use of wearable technology such as an implantable nano-device should therefore be protectable.
By moving technology into the human body, companies face a possible challenge to the breadth of IP protection available to them by falling under exclusions intended to ensure that medical and veterinary practitioners can practice freely without worrying about patent infringement.
It may be possible to obtain protection for the use of the technology, as well as the actual technology itself. This clearly is advantageous in maximising patent protection.
This is a complex area where the technology may evolve faster than the law. Companies should seek professional advice on how best to protect their innovations.