With pressures on budgets at an all time high, the drive to seek new revenue streams and to realise unused capital assets in order to release value, is increasing.
When assessing where the value in their organisation lies, trusts should not overlook their intangible assets. However, accurately identifying and effectively managing intellectual property and know-how can be complex and requires a clear and comprehensive strategy.
Intellectual property can be a useful source of extra income for trusts. The first step is for a trust to identify its intellectual property (IP). A due diligence exercise will usually be required to understand where innovation is happening within the organisation and what IP and knowhow has been generated. There will be some obvious areas to investigate, such as in research and teaching arms. These are often hot beds of innovation and creativity which naturally generate traditional health-related IP such as medical devices and new treatments. However, trusts should not underestimate the ability of other areas of their organisation to generate IP that may have commercial value. For example, a finance team may develop a new accounting package or an HR team may devise a new training programme which can be exploited and generate a return, perhaps even outside the health sector. An IP “audit” can allow an IP register to be formulated listing all of the identified assets.
Trusts should not focus on new products and devices alone. The organisation may have written software, developed guidance materials, created new methods of collecting patient data, mapped out new care pathways, or invented distinctive brands to “badge” different service provisions. If an open mind is kept, often something quite unexpected is unearthed. Once an initial list of IP assets has been formulated then investigations can take place to establish which items may have the most commercial value. Trusts will then be able to prioritise which aspects of the identified IP should take precedence when exploitation opportunities are explored.
Trusts should be aware of what intellectual property they hold and how it can be exploited. For each of the agreed IP priorities the trust should then consider:
Does the organisation own the IP?
Are further steps necessary to secure all of the rights? Particular areas to watch are where IP has been generated by those who are not trust employees, through collaborations with third parties or by trust employees acting outside the normal course of their duties. Often action is required in order to “tidy up” ownership issues.
How should the IP be protected?
Protection can secure the value and give effective rights against those who might infringe a trust’s IP. There may be a range of options available including obtaining registered rights such as patents, trade marks and registered designs. Some rights such as copyright, database right and unregistered design rights do not require registration to be effective. However, practical steps may need to be taken in order to ensure that these rights are properly protected and enforceable. If the identified IP is know-how, then
the only way to protect it may be through confidentiality arrangements to prevent it from being disclosed and the value lost. The appropriate protection strategy will be driven by the type of IP created, the potential fields of use, the potential geographic markets and the resources available to support the maintenance and enforcement of the IP.
How can the value be maximised?
Trusts may exploit IP directly, possibly through a special purpose company, or via a third party. To generate revenue the IP may be licensed to a third party in return for a royalty or licence fee. It may also be sold outright for a sum or it may be exploited through a joint venture with a third party. The Trust may also be able to earn additional revenue by providing services alongside the IP, for example, by providing support and maintenance services for proprietary software that it has licensed out.
How do we identify and capture new IP created in the future?
An IP audit can be carried out as a standalone activity, but it will only provide a snap-shot of the IP assets at that point in time. To maximise the benefit of an audit, it can also be used to identify where and when IP is likely to be generated in the future and used as a baseline for the development of a full IP strategy and policy. This should be consistent with the published NHS Framework and Guidance on the Management of Intellectual Property in the NHS. Ownership issues may need to be resolved.
Spotlight on protection – Wearable healthtech
One area that is evolving rapidly is the development of wearable health technologies such as patient monitors, remote testing and diagnostic tools. This is an interesting area from an IP perspective as it often involves:
- A collaboration between a technology provider and a trust, so know-how is shared and potentially jointly owned IP may arise; and
- A blend between fashion, (an item which is designed to be worn easily and comfortably), technology (an item which performs a technical function) and health (an item performing a healthcare related function).
At the start of a project to develop a wearable health technology, a trust looking to derive value from the IP should consider:
- Is the IP ownership position clear in any collaboration arrangement? How is existing IP and new and arising IP to be dealt with?
- How will know-how and confidential information that is shared be protected?
- Are any licences of IP required between the parties and if so, what are the terms?
- What rights will the trust have to independently exploit the resulting technology?
Once the development is underway and as the technology begins to take shape the trust will then need to ascertain:
- Can any aspect of the technology be patented? To be patentable an invention must meet certain criteria, but a patent is a powerful right that can give a monopoly over exploitation for up to 20 years. It is imperative that no disclosure of the invention is made before the patent is filed, so care must be taken in particular with patient and market testing to ensure confidentiality prevails. Innovative mechanical components, novel processes and new products are all potentially patentable.
- If the technology is aesthetically attractive, then design registration may be possible. This protects the appearance of the whole or part of a product.
- Has a brand been developed? If the technology has a distinctive brand then should this be registered as a trade mark? Trade mark registration can give a monopoly over the use of the brand in relation to the same goods and services for an indefinite period.
- Have instruction manuals been developed? If so, copyright protection should be relevant and copyright notices should appear throughout the materials.
- Does the technology involve software? This is commonly the case. In some limited circumstances software may be patentable, but it is more likely that copyright or database rights exist and steps must be taken to ensure that these rights are effectively captured.
- How will the IP generated be exploited to maximum value for the trust? At this point the trust should review the collaboration agreement and ensure the rights it anticipated it would require at the start of the project are still those it requires on completion. New or amended arrangements may be required.
At Hempsons our dedicated IP team advises a broad range of NHS bodies on how best to identify, capture, protect and exploit their IP. The team can help you to formulate effective IP policies and to develop and implement strategic commercialisation plans. Please contact Gill Hall on 0191 230 0669 for more information.
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