日期: 14 May 2018
By Dr. Fiona Kellas
Digital health is rapidly changing the healthcare industry by transforming the way that patients interact with doctors and making healthcare services accessible to more people.
One of the significant drivers of change is the use of data to assist in identifying and diagnosing disease, as well as detection of factors that may assist in predicting, managing and potentially preventing disease. In addition, the development of digital health may lead to lower health care costs and achieve better patient outcomes.
Digital health products include wearables, mobile health, health and wellness applications and electronic medical records. Thus, digital health falls at the intersection between healthcare IT, medical devices and pharmaceutical products. Wearables encompass a variety of devices available for monitoring aspects of a patient’s health such as heart rate, blood pressure, asthma, diabetes and tracking sleep patterns. These wearable devices often have the capacity to feed back to medical professionals on a real time basis, such that any abnormal changes can be readily detected and acted upon quickly.
In contrast to some other healthcare industries (e.g. pharmaceuticals) which are typically developed over a slower period of time, in the digital health industry product life cycles are typically much shorter. Thus, digital health businesses need to develop and regularly revise their IP strategy. In addition, businesses should ensure that procedures and contracts are put in place when working with any third parties, to establish ownership of any IP that may arise during development of the digital health product.
Various aspects of the digital health product may be protected using IP, such as the hardware, the software and any data analytics that may be involved. An example of a digital health product that is typical of those being developed in this area is as follows:
A research team in a medtech company have developed a non-invasive wearable sensor that can measure blood glucose levels over programmed time intervals. The sensor will transmit high or low blood glucose alerts to the sensor wearer or to an individual identified by the wearer. The sensor also stores the collected data in a database that is accessible by the sensor wearer and medical professionals via a web based application on either a mobile device or a computer. Additional data such as prescription medication, weight, daily exercise and diet can be added and stored in the database.
In the above example, the areas of IP that may be used to provide protection are patents (for example, to protect the mechanical aspects of the device), designs (to protect the appearance of the device), copyright (for example, to protect the programs and algorithms that are used by the device), database right (to protect the data stored in the database). These forms of protection are discussed in greater details below:
Digital health products often comprise mechanical, chemical and/or electrical components which may be patentable if they are novel and inventive. In addition, further aspects of the device, methods and protocols associated with using the device may be patentable. However, digital health products often comprise a software and/or a computer-based element which may be difficult to protect using patents. Therefore, developing a meaningful patent portfolio around these innovations can be challenging.
In Europe, in order for a patent to be granted for a computer implemented invention, a technical problem needs to be solved in a new and inventive manner. Thus, when considering patent protection in Europe, it is necessary to demonstrate that the software component of the digital health product has a technical effect.
In the US, developments over recent years have increased the difficulty associated with protecting innovations where the underlying software or technology is built on abstract ideas or laws of nature. This is due to the finding of the US Supreme Court case Alice v CLS Bank International 134 S. Ct. 2347 (2014) which found that a patent is invalid if the claims relate to an abstract idea, since such abstract ideas are excluded from patentability. Following Alice, it is important for digital health companies to think more strategically about how to acquire patent protection.
Although there may be challenges associated with protection IP within this area, many successful digital health companies have been able to secure patent protection for their inventions and in some cases are pursuing enforcement of these patents.
2. Registered and Unregistered Design Protection
Due to the competitive nature of the digital health industry, it may be important to protect aspects of the appearance of the digital health device. For example, it is possible that the customer may be drawn to the product due to its size, colour, or a feature of the design of the user interface of the device. If there are aspects of the appearance of the digital health device that may be important in driving sales of the device, design protection should be considered.
The use of trademarks may be important in protecting the brand of the product, for example, where the user associates the product with its name. This can be seen with brands such as Fitbit ® where the product is associated with the name of the device.
4. Copyright and Database Right
Digital health devices often collect and store data which may be transmitted to a healthcare professional or a hospital. Data is one of the grey areas of IP and establishing the ownership of the data may be complex. Patients often own their own data and medical records. However, consolidated and anonymised data often belongs to the NHS. In addition, data sets that are licensed from third parties will be subject to the terms of those licenses and the restrictions of any copyright that may apply.
Digital health devices may be linked to a database in which the data is collected and stored. Database Rights are defined in Directive 96/9/EC. A database is defined as “a collection of independent works, data or other materials which are arranged in a systematic or methodical way and are individually accessible by electronic or other means”.
The data stored in a database may be protected: (1) under the law of copyright and the rules that apply in relation to databases; and (2) under the UK Copyright and Rights in Databases Regulations 1997.
Databases are treated as a class of literary works and may have copyright protection for the selection and/or arrangement of the contents provided that they were recorded in a medium and that they were the author’s own intellectual creation. Since the copyright owner is the creator of the database, digital health companies need to be careful when using a contractor to create a database. This is because the contractor is likely to be the owner of the copyright in the database. Therefore, if a company wants to own the copyright, it must enter into an agreement with the contractor which contains an assignment of the copyright.
If a set of data comes within the definition of a database and there has been a “substantial investment” in obtaining, verifying or presenting the contents of the database, it will qualify for protection under the Database Regulations. In contrast to copyright, the maker of the database is the first owner. Database right lasts for 15 years from the end of the calendar year in which the production of the database was completed. However, updating the database may extend this term.
Copyright may also exist in the programs and algorithms used by the digital health device.
5. Contracts and Licensing
As in other sectors, the development of digital health products and services may involve a number of parties. It is therefore important to assess any contracts and licences that may apply and to be clear about the ownership of any IP that may arise.
The digital health sector is rapidly growing and many medtech companies are moving into this area. Thus, the use of IP to protect innovations in this sector is increasingly important. Whilst there may be challenges associated with IP protection of digital health innovation, many companies are successfully navigating these challenges.