IP protection for invasive technology innovation
The expansion of the wearable technology sector has been meteoric. In 2010, the sector was worth around $6 million, whilst it is estimated that by 2018 the sector will be worth over $12 billion. This 2000-fold increase in value over just eight years shows that many technological companies are investing huge resources in this area to secure market share.
Protecting innovation with IP
One of the best ways of securing market share is by monopolising the innovation using IP. Traditionally, electronics companies have focused on protecting how their technology functioned using patents. However, with wearable technology, design is also vitally important; no one will wear technology if it does not look good. The design aspect can of course be separately protected.
For watches, fitness bands and other more traditional wearable technology, the IP system is quite predictable; if the innovation relates to how a product operates, protect it with a patent, if it relates to how the product looks, protect it with a design.
Companies are looking at ever more disruptive technology. One area of interest to companies is so-called 'invasive' or 'embedded' technology. Will the IP system be as predictable for this future technology?
By the end of 2015 it is predicted that more than 13.1 million users will have a wearable health and fitness device in the UK alone. In the future, however, medical applications for invasive technology will increase massively.
Even now implants have been developed that sit inside the human body which monitor certain aspects of a patient's well-being. For example, scientists at Boston University are developing a 'bionic pancreas'. This device has a sensor in it which communicates with a smartphone app informing the user of their blood sugar levels.
Similarly, so-called 'smart dust' is being developed. Smart dust 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 influence a whole range of complex internal processes. It is envisaged that these nano-devices will attack early?stage cancer or bring pain relief to an open wound. In other words, rather than a surgeon performing traditional surgery on a patient, the doctor will instead control these nano-devices to treat the patient from the inside.
Outside the medical arena implantable technology is also being developed which replaces technology traditionally positioned on the exterior of a user.
A company called Dangerous Things has developed a near field communication (NFC) chip that can be embedded in a finger through a tattoo-like process. This allows you to unlock devices and pay for goods simply by pointing.
IP rights for invasive technology
Whilst the above 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 its IP protection for these new and useful products. According to Article 53(c) EPC, a European patent 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. The treatment must involve a substantial physical intervention which requires professional medical expertise to be carried out and which entails a substantial health risk. Other criteria to consider are the degree of invasiveness or the complexity of the intervention performed.
Examples of treatment by surgery include 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, for example tattooing and piercing, are rarely affected by this exclusion.
A method of implanting or embedding a nano-device (eg smart dust) into a subject is more likely to fall within this exclusion: it is an invasive method which requires professional medical expertise and entails a substantial health risk. 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. This exclusion is therefore most relevant to the use of nano-devices (eg smart dust) for treatment or prevention of a condition in a human or animal body. 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.
To fall within the diagnostic method exclusion, the claimed method must include the following 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; and
- Attribution of this deviation to a particular medical or veterinary medical condition.
As a result the exclusion rareley applies to X-ray methods, MRI studies and blood pressure measurements. The example suggests that the use of bionic sensors to monitor certain aspects of a patient's well-being should be protectable.
Article 53(c) EPC also states, however, that products for use in any of these methods are not excluded. This means that although the medical use of wearable technology such as an implantable nano-device will be decided on a case by case basis, generally the device itself should be protectable.
In order to move wearable technology into the body of the user, companies will be making huge investments in R&D. To maximise protection for this investment, companies need to consider the IP landscape and obtain appropriate IP protection. It may be possible to obtain protection for the use of a device as well as the actual device itself. This clearly is advantageous in maximising patent protection.
However, by moving the technology into the human body, companies face a possible challenge to the breadth of protection by falling under exclusions intended to ensure that medical and veterinary practitioners can practice freely without worrying about patent infringement.
In some instances, such as with smart dust, the surgical method exclusion is likely to be particularly relevant.
This is a complex subject where technology is very likely to evolve faster than the law. We look forward to discussing and advising on the protection of innovations in this area.