Modified medical devices and tech-savvy patients

12.01.2016

This article was first published by LexisNexis on 8 Jan 2016/7 Dec 2015. Click for a free trial of Lexis®PSL
IP & IT analysis: It was recently reported that a man suffering from diabetes–described as a ‘citizen hacker’–
bought a continuous glucose monitor and modified it so that it delivers a readout of his blood glucose level to
his mobile phone. Matthew Warren, a partner at Bristows, considers the legal implication of modifying medical
devices.

What is fuelling this medical revolution?

Multiple factors, but fundamental to all is the availability of information on the web which previously was much harder to access or simply not available. There’s also a new ‘Kickstarter’ mindset which promotes the idea that, instead of relying on big corporations or government, you can get together a group of like-minded people and solve even quite ambitious problems. There are also some technically skilled patients who are frustrated with the slow development of new products and services in relation to their conditions and who decide to experiment for themselves.
What is the position around intellectual property if a citizen hacker or amateur designer builds upon or adapts an existing medical technology?

First of all, I think ‘hacker’ is an unhelpful term in this context because it tends to imply that the activity is in some way unlawful. Here, I think we are talking about people who take existing products and software and adapt them to their own requirements or improve them. That kind of activity is not necessarily unlawful. But to answer this question, we first need to understand that intellectual property ownership often builds in layers and is
interrelated. To illustrate this, I would use the hypothetical example of a first inventor in the dawn of time who creates the wheel and obtains a general patent on the concept of the wheel. Later on, a second inventor develops a wheel with spokes (which is a big improvement on the previous solid wheels) and obtains a patent covering the concept of wheels with spokes. How would these two patents interrelate? The first inventor owns the patent on the general concept of the wheel and can assert their patent to prevent the second inventor from selling wheels with spokes because a wheel with spokes is still a wheel. However, the second inventor can assert their patent to prevent anyone else (including the first inventor) from selling wheels with spokes. As a consequence, neither the first inventor nor the second inventor can sell wheels with spokes unless they get together and one agrees to licence the other. In relation to a medical device that has been adapted by an amateur designer, the company that developed the original device would continue to own their intellectual property in the original medical device and in the adapted device, but the amateur designer would own any intellectual property in their adaptations. So neither the amateur designer nor the company that developed the original device can manufacture and sell the adapted device without getting the consent of the other.

Could medical tech/pharma companies take action against these amateur designers? Is this likely?

If a physical off-the-shelf product is purchased by an individual and adapted for their own personal use, almost certainly not. However, in the case of software, the amateur designer may be bound by licensing terms that govern the use of the software and those terms may prohibit any adaptation of that software.
f the amateur designer manufactures and sells a product based upon the designs of another company, it is likely that they will infringe that company’s intellectual property. However, if the amateur designer purchases an off-the-shelf component device, incorporates it into their own product and then sells the product, this may be OK under English law, as long as they do not in any way imply that the manufacturer of the component device sanctioned or approved the resulting product.
If found to be cheaper and more effective than existing technologies from mainstream companies, could health care providers opt to use the creations of these amateur inventors/programmers?

This would be difficult in a healthcare setting due to the regulatory environment and issues of liability. The rules
surrounding medical devices are becoming more stringent in order to safeguard patients–partly also as a result of previous issues in relation to the safety of medical devices. The idea of the NHS taking a product which had been produced by an amateur and supplying it to patients without any further development, testing or regulatory approval is quite fanciful.
One should consider that the cost of discovering a pharmaceutical products is a rather small proportion of the overall cost of development–the majority of the cost is in demonstrating to regulators that the product is safe and effective for patients with the relevant condition.

In the case of an adapted medical device, it’s also necessary to consider the potential differences in usage between a skilled (ie technically competent) user and a non-skilled user. The adapted device might work very well for the person that developed it as they understand how it works and what its limitations are. It is a very different matter giving the same device to another patient who may have very little technical or medical knowledge and may also have a different or more complicated medical history.
Could the creators of these technologies be opening themselves up to legal action if the technology is found to be ineffectual or if it malfunctions and harm is caused to the user?

If they just use it on themselves and simply report how they developed the device and their experiences using it, this may be OK (in the UK).

Legal issues might arise if they promote or sell adapted products, or encourage (expressly or impliedly) others to do the same or even start to advise others about how to develop their own adaptations.

Are NHS Hack Days a thing of the future as medical innovation seeks to utilise the pool of talent existing in its user base along the lines of the Wikipedia model?

Although more people may come together online to exchange ideas and discuss the use of medical devices, the
regulatory environment means that actually manufacturing and supplying an improved medical device to the public is a much more complex and costly venture.

Matthew Warren advises on transactions involving the development, exploitation and transfer of intellectual property rights. He has experience working in many sectors including the IT, pharmaceuticals, biotechnology, telecommunications and digital media sectors. His scientific background is of particular assistance when advising organisations that are negotiating transactions involving new technologies. He has advised on a number of successful licensing programmes for the exploitation of new technologies on a world-wide basis.