With the vast amount of information generated by new medical technologies, IP legal specialist Elizabeth Ward looks at the often complex issue of who owns the information and how to be proactive about protecting your ideas

 One of the main drivers of change in the global healthcare industry for 2016 is the clever use of data to monitor such things as disease trends and patient outcomes. Take wearables, for example. A whole variety of devices are available for monitoring heart rate, asthma and diabetes, and for tracking sleep. These devices currently feed back information to doctors on a real-time basis, ensuring that abnormal changes can be readily detected and acted on.

Healthcare IP and the data dilemma

However, the real value created here is the vast amount of data these devices yield. And therein lies the conundrum – who owns that information and what are they going to do with it?

Data is one of the grey areas of intellectual property. In fact, patients usually own their own data and medical records. However, consolidated and anonymised compiled information often belongs to the NHS; such data is of huge value and can be used to model all aspects of patient care.

Ownership matters

It is an interesting area and highlights one of the healthcare industries’ main problems, namely, identifying the intangible assets in a company and who owns them. Where internal research teams create technology and brands, then the company will own all the intellectual property created by its employees. However, increasing reliance on subcontractors or technology that is bought or ‘licensed’ in can create a problem.

Software in medical devices is a case in point. It is often commissioned in and so unless express provisions over the assignment of the software or a formal licence are put in place, problems can arise.

The same applies when two or more companies work together to improve a device. It is always important to set out contractually who owns the improvements and who does what with the resulting IP. Disputes often arise over ‘improvements’, and it pays to anticipate the situation before people fall out.

How proactivity can prevent future problems

As the biggest improvements in healthcare now rely on treatments such as combination therapies, or the increasing use of data and software to improve existing technology, the opportunities for problems to arise are increasing. So what can a company do to be proactive in this area and avoid future healthcare IP problems? Here are a few tips.

• Ensure that all externally sourced research or software is commissioned properly, and that the ownership and direction of all IP is clearly laid out from the start.
• Always be clear about the ownership of copyright material, such as test results, and the creation of data; test results can have significant value in the commercial life of products. It is also important to keep such information confidential so that it doesn’t fall into competitors’ hands.
• The healthcare industry already has numerous arrangements where information is shared, and collaboration yields up results and useful data for everyone. Check before joining any collectives of this kind that your share of any results can be used commercially for the benefit of your company.
• If you contract with institutions and universities, then again make sure that any intellectual property is owned by the company paying for the research.
• Academics often wish to publish results of experimental work. Ensure your agreements with them allow them to publish but only with your express permission. Allowing publication can compromise things such as patent filings and mandatory approvals under the Medicines Directive.

With contractual situations, it is all about anticipating the problems before they arise. An ounce of protection is worth a pound of cure. Curing companies’ healthcare IP issues can be very costly indeed.

10 useful IP resources

1. The UK government’s IP Health Check – an interactive general resource not targeted for health IP but useful nevertheless.
2. IP non-disclosure agreements – if you’re not quite ready to go the whole hog, make sure nobody’s sharing your ideas by using a NDA.
3. The World Intellectual Property Organization – find out all about international provisions for public health and patenting.
4. The European IPR Helpdesk’s factsheet – IP considerations for medical devices.
5. A useful guide to IP rights in the new and often complex world of 3D printing.
6. How to get a patent in Europe from the European Patent Office.
7. Background reading on the importance of patenting in medtech, worldwide.
8. How Internet of Things and changing physical boundaries may affect IP in the near future.
9. An analysis of the patent landscape in wearables.

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