Pete Sadler, partner, and Zack Mummery, senior associate at Reddie & Grose, explain the implications of classifying as a medical device and how to patent technological solutions, by focussing on their output rather than the software itself.
Technologies such as Artificial Intelligence (AI), Augmented Reality (AR), Robotics and Machine Learning (ML), are increasingly being leveraged across society to enhance the way people live their everyday lives. In recent years, healthcare has become an area of particular focus, with innovative technologies being adopted to monitor health, assist in diagnosis, and manage and treat disease.
From the perspective of European patent law, these new digital health technologies present no new patentability challenges in themselves compared to traditional medical device technology or software in general. However, the coming together of medical device technology and software combines two traditionally separate areas of patent practice which have their own separate issues. On the one hand, under European law, additional hurdles are placed in the way of obtaining patents for software. On the other hand, inventions relating to healthcare technology, pharmaceuticals and medical devices must navigate various medical exclusions. The combination of these two traditionally separate areas of technology means that applicants are often presented with a unique set of challenges. That said, with the right team of experienced patent attorneys working collaboratively, many of these challenges can be overcome at an early stage by the careful drafting of patent applications.
Medical challenges
Under European patent law, methods for treatment of the human or animal body by surgery or therapy are excluded from patentability. Diagnostic methods practiced on the human or animal body are also excluded. The rationale behind these exclusions is to avoid the situation where a medical professional is prevented from treating or diagnosing a patient due to the existence of a patent right.
In the case of a method of treatment or diagnosis involving a pharmaceutical product, these exclusions can easily be overcome by reformulating the patent specification to refer to a medical use as opposed to a method of treatment. For example, under European law it is possible to protect a compound for use in treating a disease. However, this reformulation is not available in the same way for medical devices, so care must be taken not to fall foul of these exclusions.
Let’s take a wearable device as an example. Let’s imagine a wearable device is able to measure a particular characteristic of blood flow, process the collected data, use the processed data to diagnose certain cardiovascular conditions and send a report to the patient’s GP.
The device clearly relates to diagnostics, but this does not mean that patent protection is not available. While certain methods of diagnosis are not patentable, the device used to carry out the diagnosis is potentially patentable. The wearable device is going to include multiple potentially patentable products. For example, the sensor may be potentially patentable. Similarly, the combination of the sensor together with a processor and output might represent a patentable device or system. However, care must be taken when seeking protection for the software and methods which underlie the device.
A method of diagnosing a cardiovascular condition by measuring the value of a blood flow parameter using a wearable device, comparing the value to a threshold and then determining whether the patient has the cardiovascular condition based on the comparison is likely to be excluded from patentability in Europe. However, if the clever part of the invention is the way in which the data is analysed and processed, then the method could focus on that aspect and avoid the diagnostic method exclusion. Similarly, if the method relates to the collection of the data but stops short of diagnosing a disease, then the method is unlikely to be excluded. In short, careful drafting of the patent specification can help to avoid this exclusion.
Digital healthcare is also being utilised to help treat diseases and is a key tool in personalised medicine. For example, a device might measure the level of a particular biomarker and then administer a tailored dose of a drug based on the biomarker level. In this case, care would need to be taken to avoid the method of treatment exclusion, but the device itself would potentially be patentable, and the method of measuring the biomarker may also potentially be patentable. Just because the device relates to treating a disease, does not mean that patent protection is not available.
Software challenges
There is a misconception that computer programs cannot be protected by patents in Europe. Although it is true that the European Patent Convention includes an exclusion to computer programs, it is limited to the extent that the invention relates to the computer program itself rather than what it does or how it does it. Software implemented inventions are patented all the time in Europe, you just need to know what to look for.
The key is whether the software, when executed, exhibits a “technical effect”. Although there is no legal definition of what this means, case law at the European Patent Office (EPO) has been built up over decades to establish where the boundaries lie. Software controlling a real-world device, such as a dialysis machine, is likely to meet the requirement. Likewise, software processing data derived from sensors to produce a tangible result may also be patentable.
Taking the above wearable device example, software would be needed to analyse the blood flow sensor data. Merely transforming data from one form to another is unlikely to meet the technical effect requirement unless the transformation is motivated by, and addresses a problem with, the underlying system in which the software executes. For example, if the sensor data arrives at unpredictable time intervals, adapting the software to take this into account may be patentable. Similarly, if the software is specifically adapted for the hardware it operates on to take into account the limited system resources of a wearable device then this aspect of the software might be patentable.
It is also worth noting that modern healthcare is becoming all about connectivity. Data is being produced and shared between systems at ever increasing rates. Software involved in such connected systems might be patentable but it is important to take into account what the software is doing. Software with an administrative or organisational purpose is less likely to exhibit the required technical effect because the EPO considers administrative matters to be non-technical. In the example above, software that sends a report to the patent’s GP would likely fall within this category, so this aspect of the software would not be patentable. Likewise, software that addresses privacy and regulatory issues will often not be considered technical where the issue being addressed by the software stems from legal obligations rather than underlying technical problems with the system.
Conclusion
Patent protection is an important tool to protect innovations and help secure or maintain a strong position in the market. As digital healthcare technology continues to grow and become ever more important in our modern lives, companies operating in this space should remain confident that European patent protection remains available to protect their key innovations. Many of the challenges in this sector can be overcome by careful drafting and management of patent applications at an early stage, so it is highly recommended to engage with a firm of patent attorneys with expertise spanning software and life sciences before seeking patent protection in this sector.
