The FAQs deal with the most common questions from NHS staff

Below is a list of some of the frequently asked questions concerning IP and the NHS. To make it easier to find an answer, the questions are categorised into:

Categories

• General NHS IP issues 
• Specific Issues for Trusts PCTs and independent providers
• Adviser organisations or Innovation Hubs
• Spin Out companies
• Employee(er) issues

General NHS IP issues

• Who can generate IP, is it only those engaged in research?
• Is the NHS changing its position on delivering care?
• Is the NHS planning to make these new products arising from NHS IP?
• I have an idea for an improved device, should I ask my workshop to make it?
• What is technology audit, and who is obliged to carry it out?
• Can income from the successful exploitation of IP be retained by a Trust or PCT?
• Does an inventor share in the benefit derived from successful exploitation of IP
• Is technology exploitation a proper use of NHS resources?
• Is ownership of copyright an important IP issue?
• Will the Trust give me the copyright of an article or book I write?
• Is copyright in things like patient information leaflets important?

General NHS IP issues

• Who can generate IP, is it only those engaged in research?
• No, IP can be generated by all those delivering healthcare: managers, nurses, clinicians, therapists etc. It is those delivering care who have the best opportunity to innovate because they will be aware of what is needed and think about how their job could be done better.

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• Is the NHS changing its position on delivering care?
• The NHS is always aware of improvements which can be made in the delivery of care. Before the NHS Innovation Hubs were established, NHS employees did not have an outlet for their innovative capacity. There have been many examples where innovations made by NHS employees have been developed by others and the NHS has not benefited financially from its own inventions. The Innovation Hubs aim to protect the Intellectual Property (IP) in the innovations that come out of the NHS.

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• Is the NHS planning to make these new products arising from NHS IP?
• Generally, no. It will look to outside organisations, usually through a licence agreement, to bring these products to reality, because that is their expertise.

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• If I have an idea for an improved device, should I ask my workshop to make it?
• If a prototype is made by your workshop, it should be protected preferably through a patent or registered design right. A manufacturer is unlikely to make your device, however good it is, unless the IP is protected. They will need to know that the improvement has not been publicly disclosed, and that the workshop or the design organisation has been working under conditions of confidentiality.

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• What is technology audit, and who is obliged to carry it out?
• Technology audit is the name for the process of identifying IP outputs, and is an essential part of the Research Governance Framework. It is normally the responsibility of the Adviser Organisation appointed by the NHS Trust or the PCT. It is often the case that IP is found in this process which is unrelated to R&D, but which can be treated in the same way as if it had arisen from R&D. Technology audit is only essential for NHS Trusts or PCTs undertaking R&D, but they may wish to set up their own processes and methods to capture IP more widely.

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• Can income from the successful exploitation of IP be retained by a Trust or PCT?
• Yes, IP will only be developed within the Framework Guidance if it can generate income, and this income will be retained by the Trust in line with wider-Government policy. However, this retention of income must be in line with the way that the NHS manages its funding and this is set out in the Framework and Guidance.

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• Does an inventor share in the benefit derived from successful exploitation of IP
• The inventor should always be offered a share in the benefit according to the policy of the NHS Trust or the PCT. The inventor will not be expected to contribute to the costs involved, it is the Trust or the PCT, which takes this risk. It is for this reason that the inventor only takes a portion of the income.

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• Is technology exploitation a proper use of NHS resources?
• The Department of Health fully supports the national policy of capturing and exploiting our innovative capacity for the benefit of the UK economy. Inventions arising from the NHS have the potential not only to improve health care for patients but also to increase industrial activity and generate new jobs. The Department of Health recognises that not all inventions will be able to be translated into practice and that many ideas will not achieve success. It is for this reason that it seeks to set up high quality management systems to give inventions the best chance of success, and to seek external funds to support these systems and minimise use of NHS resources.

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• Is ownership of copyright an important IP issue?
• Yes, it is, because all written work generated by an employee in the course of normal duties will belong to the Trust. This will include learned papers, books, software, training leaflets, patient information leaflets, designs etc.

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• Will the Trust give me the copyright of an article or book I write?
• The Trust will normally assign this IP to you and will waive any benefit, e.g. a share of royalties. However, it will want to be able to use the publication for its own purposes, e.g. training.

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• Is copyright in things like patient information leaflets important?
• Yes, it is. The Trust may want to sell the information, perhaps, or make it available freely across the NHS. The Trust will probably need to make provisions against copying, and this can only be done if it owns the copyright. Assertion of copyright in material used across the NHS will raise the profile of the Trust even if the material is not intended to be sold. But aside from raising the profile it is always important to assert ownership of copyright before making it available outside the Trust.

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Specific Issues for Trusts PCTs and Independent Providers

• What responsibility do we have as a NHS Trust or a PCT to capture IP?
• Can a NHS Trust or a PCT without NHS R&D Funding ignore IP?
• How can a NHS Trust or a PCT assist in exploiting IP unrelated to R&D?
• What level of IP knowledge will a Trust IP Lead require?
• Does a PCT have the same responsibilities as a NHS Trust for the management of IP?
• Will the nature of IP differ between a PCT and a NHS Trust?
• What is the position regarding IP of a GP or dental practice within a PCT?
• Are independent provider e.g. GPs given any help to manage their IP?
• If an independent provider is intent on exploiting IP independently, can NHS resources be used to develop a product?
• Are there restrictions on the use of income generated by a NHS Trust or a PCT?
• If a Trust supports an invention which fails to whom is it accountable?
• How can a Trust ensure the arrangements for IP be made known to its employees?

Specific Issues for Trusts PCTs and Independent Providers

• What responsibility do we have as a NHS Trust or a PCT to capture IP?
• Your only explicit responsibility relates to capturing IP arising from the R&D you carry out using your NHS R&D budget. This must then be managed according to the Research Governance Framework for Health and Social Care.

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• Can a NHS Trust or a PCT without NHS R&D Funding ignore IP?
• There is no formal responsibility on a NHS Trust or a PCT to capture IP arising from other work carried out by NHS employees. However, the delivery of patient care will have a bigger potential than R&D to generate IP, and Trusts will need to assist their employees to realise their invention when it can generate income for use by the Trust to improve the health service.

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• How can a NHS Trust or a PCT assist in exploiting IP unrelated to R&D?
• Very few if any Trusts have in-house expertise to exploit IP, it is a specialist business. It is recommended that a Trust appoints an Adviser Organisation to carry out the work on its behalf. What trusts should do is appoint a person, a Trust IP lead, who will act as the focal point for all IP generated by its employees. This lead person will be the conduit to the Adviser Organisation.

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• What level of IP knowledge will a Trust IP Lead require?
• The Department of Health has published a Handbook which goes into detail on what the person will need to know.

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• Does a PCT have the same responsibilities as a NHS Trust for the management of IP?
• Yes, exactly the same.

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• Will the nature of IP differ between a PCT and a NHS Trust?
• Yes, there will be differences but similar principles will apply. A PCT is likely to have more outputs protected by copyright rather than by patent, where the confidentiality requirements are less severe. Nevertheless copyright will need to be registered to protect the position of the PCT or the NHS Trust.

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• What is the position regarding IP of a GP or dental practice within a PCT?
• If such a practice is operating as an independent provider of NHS services then it will own the IP generated by its work even if it is carrying out R&D funded by the NHS.

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• Are independent provider e.g. GPs given any help to manage their IP?
• Because the exploitation of IP is a difficult task, the Guidance encourages the independent providers to assign its IP to the PCT, which would then assume responsibility for the management and treat the practice employee as if he or she was a PCT employee. The employee would share benefit derived through successful exploitation according to the scheme of the PCT.

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• If an independent provider is intent on exploiting IP independently, can NHS resources be used to develop a product?
• If the IP comes out of an NHS R&D programme, then there is an obligation on the provider to share benefit with the Department of Health on terms to be agreed. The split would depend, amongst other things, on the extent to which NHS resources were used in the development. If the IP does not arise from R&D then the provider will need to obtain permission to use NHS resources to realise IP, and the permission will be dependent on the provider of the resources (normally the PCT) being satisfied that the IP will be managed effectively. Use of NHS resources will mean that any resulting benefit will need to be shared with the provider.

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• Are there restrictions on the use of income generated by a NHS Trust or a PCT?
• The statutory purpose of exploiting IP is to make more income available to the health service. It can be used to improve services, to do more R&D or to pay further IP costs, but not for things unconnected with improved delivery of care e.g. the building of car parks.

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• If a Trust supports an invention which fails to whom is it accountable?
• A Trust is always accountable for its expenditure, and the Audit Commission has powers to investigate expenditure. The Audit Commission will take a supportive position to well thought through risk taking in the exploitation of NHS IP. If you haven't failed you haven't tried!

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• How can a Trust ensure the arrangements for IP be made known to its employees?
• Dissemination of this information is an important task for a Trust, because employees need to be aware of the opportunities to support innovation, which are now available. The Framework and Guidance suggests that a Staff Handbook is an important tool to achieve this, and a model entry is given. It will, however, be up to the Trust to make the content known in whatever way is appropriate, including for example newsletters and at induction for new employees.

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Adviser organisations or Innovation Hubs

• What is a NHS Innovation Hub?
• Who can be an Adviser Organisation to a Trust for the management of its IP?
• Do Innovation Hubs cover all of England?
• Will a Trust pay a fee to use a Hub?
• Is the fee the only contribution a Trust will make to obtain IP services from a Hub?
• Will a NHS Innovation Hub be able to provide IP services to everybody?

Adviser organisations or Innovation Hubs

• What is a NHS Innovation Hub?
• A NHS Hub is a specialist organisation with the sole purpose of providing an NHS IP service. It provides these services to Trusts in a geographical area. A NHS Hub is currently supported by DTI, the Department of Health, through its R & D budget, and by others. The services it provides are given in para 2.23 of the Framework and Guidance.

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• Who can be an Adviser Organisation to a Trust for the management of its IP?
• A university technology transfer office, a technology transfer company or an NHS Hub could provide IP management services. A NHS Hub would normally be able to provide its services without tender and value-for-money considerations will be important in making the choice.

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• Do Innovation Hubs cover all of England?
• Yes. The Hub contact details can be found on NHS Innovation Hubs.

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• Will a Trust pay a fee to use a Hub?
• Yes, this will be negotiated with the Hub and will reflect the fact that currently a Hub is subsidised with public funding to provide its services.

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• Is the fee the only contribution a Trust will make to obtain IP services from a Hub?
• The Framework and Guidance states that Trusts will be expected to meet initial patent costs and costs for IP training for their employees. Each Hub will have its own policy for establishing the financial arrangement with Trusts for whom it supplies services.

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• Will a NHS Innovation Hub be able to provide IP services to all NHS bodies?
• The intention is that this will be the case but it will take time to deliver all services to every Trust. You are advised to indicate to your local Hub your intention to take up these services as soon as you have made this decision.

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Spin Out Companies

• What will a NHS shareholding in a spin out company cost?
• Is a Trust expected to contribute to the running costs of a spin out company?
• What is the purpose of taking a shareholding?
• Will the Trust be asked to support the company in various ways?
• Can the inventor of the IP have a shareholding?
• Can the inventor of the IP be a Director of the spin out and an employee of the Trust?
• How does a Trust ensure that it minimises its risk?
• Can the Trust just go ahead and approve a shareholding in a spin out company?
• What is the purpose of submitting a business case for approval.
• How do I submit the business case?
• Does the Department of Health have interest in the activity of the spin out?
• Can an independent provider of NHS Services set up a spin out?
• Is approval of a business case by the Private Finance Unit necessary for jointly held IP? 

Spin Out Companies

• What will a NHS shareholding in a spin out company cost?
• The shareholding is obtained in recognition of its past work, including the IP, and this shareholding will normally be obtained without further investment.

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• Is a Trust expected to contribute to the running costs of a spin out company?
• No. It would take no management role in running the company, but it would normally want a Director or Observer on the Board. Funding for the company would come from external sources.

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• What is the purpose of taking a shareholding?
• The shareholding is intended to grow in value as the company grows. The Trust could sell its shares in due course with the income treated by the Trust in the same way as any other IP income.

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• Will the Trust be asked to support the company in various ways?
• It is in the Trust's interests that the company grows, and it is likely that it could be asked to provide, for example, laboratory space, access to equipment, access and possibly secondment of staff. If this is agreed the cost and conditions should be agreed formally. It will be necessary to ensure that access to resources does not impede provision of patient care.

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• Can the inventor of the IP have a shareholding?
• Yes. If the inventor wishes to remain an employee of the Trust then the shareholding would normally be treated as any other item of IP according to the Trust reward structure. If the inventor, or another Trust employee, wishes to move into the Company, he or she would still be entitled to a shareholding, but the terms and conditions will depend on the particular circumstances.

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• Can the inventor of the IP be a Director of the spin out and an employee of the Trust?
• Yes, but there would need to be a formal agreement. The first duty of the Director would be to the company, not to the Trust.

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• How does a Trust ensure that it minimises its risk?
• The Framework and Guidance sets out, in detail, the procedures for minimising risk. The Adviser Organisation will play a key role in setting up the company, but the Trust will also need to take its own independent advice to ensure that its position is protected. The Trust Board will need to approve the legal documents around the setting up and running of the company. It will need to take its own legal advice.

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• Can the Trust just go ahead and approve a shareholding in a spin out company?
• No, it needs approval of a business case by the Private Finance Unit of the Department of Health. The business case will include legal documentation, e.g. shareholders agreement, Memorandum and Articles of Association.

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• What is the purpose of submitting a business case for approval.
• The purpose is to develop best practice and to provide constructive advice, not to slow things down. It is intended that the Private Finance Unit will provide an efficient and helpful service.

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• How do I submit the business case?
• A Hub will be the vehicle for channelling business cases to the Private Finance Unit. If a Hub is not yet operational you can still contact the Hub Lead in your geographical area. (See contacts).

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• Does the Department of Health have interest in the activity of the spin out?
• The Secretary of State wishes to receive published accounts, reports and changes to the Memorandum and Article Association annually, on all companies in which Trusts have shareholdings. The Hub organisations or IP Leads will be the conduit for this information.

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• Can an independent provider of NHS Services set up a spin out?
• If the intended company arises from IP developed by an independent provider as part of an R & D project, or through the use of NHS resources, then the Private Finance Unit will need to approve the business case. If the IP arises outside R & D, or no NHS resources are used to develop the IP, then the independent provider does not have to refer to the Private Finance Unit and assumes all responsibility and the risk.

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• Is approval of a business case by the Private Finance Unit necessary for jointly held IP?
• Approval of a business case is required in all cases in which the Trust wants to take a shareholding, even if the project is led by a University.

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Employee(er) Issues

• Why is it important for me to have provisions for IP in my NHS employment contract?
• Why is it important for a Trust or PCT to deal with IP in an employment contract?
• Isn’t changing employment contracts a difficult and time-consuming process?
• Will the changes involve negotiation with the unions and consultation with professional bodies?
• Does the Trust employer own by law the IP a NHS employee generates?
• If I think I am the IP owner, can I go ahead and exploit the IP myself?
• Are the model employment conditions intended to be used in all contracts?
• Who owns the copyright when work is written by employees from different organisations?
• Who owns the IP generated when employment costs are paid wholly or in part by another body?
• Is the IP always owned by the organisation holding the employment contract?
• When IP is generated jointly by employees in a Trust and a University, who owns the IP?
• My payroll costs are funded by a Trust but I hold a University appointment. Who owns the IP I generate?
• I hold an honorary contract with a University and have an NHS appointment. Who owns the IP I generate.
• I am an independent consultant commissioned by the NHS to do a piece of work. Who owns the IP?
• I have been seconded from a Trust to carry out work in a University. Who owns the IP?
• I am a Trust employee and had an idea at home, which I want to patent. Do I own it?
• I am an NHS consultant but I do some private practice. Do I need to tell anybody in my Trust about my innovation which occurred during my private practice?

Employee(er) Issues

• Why is it important for me to have provisions for IP in my NHS employment contract?
• You need to know where you stand legally regarding the ownership of any IP you generate, how it will be managed by the Trust and how you would be rewarded in the event that it is successfully made and sold.

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• Why is it important for a Trust or PCT to deal with IP in an employment contract?
• It protects the position of the Trust, asserting its ownership of the IP where this is appropriate. It also shows the commitment of the Trust to developing the NHS as an innovative organisation, as detailed in the Framework and Guidance.

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• Isn’t changing employment contracts a difficult and time-consuming process?
• Yes it is, but without effecting this change much unnecessary effort will be required to deal with IP on an individual basis. The Employment Guidance simply reflects the law and its interpretation in situations, which affect the NHS.

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• Will the changes involve negotiation with the unions and consultation with professional bodies?
• Yes, but the changes are important and there are examples where Trusts have already achieved this change. The message is that the provisions contained in the Employment Guidance are intended to create an environment seen to be fair to employees and employers. Without this balance, a balance which has been shown to work across public sector bodies in many countries, there will be no partnership and little, if anything, will be achieved.

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• Does the Trust employer own by law the IP a NHS employee generates?
• Unless there is an existing agreement, if the employee generates IP in the course of duties or normal employment then by law the IP belongs to the Trust. However, for IP, which is patentable, that IP must have been expected to arise for the Trust to own it automatically. IP would be expected to arise from R & D and would therefore be owned by the Trust, but when it arises from the delivery of patient care it may not be expected and the Trust may not have a legal claim. However, patenting requires a full disclosure of an invention in a patent application, and its development would normally use NHS resources and would give the Trust a strong claim to ownership of the IP. To remove argument, the Employment Guidance proposes that employees formally assign their rights in IP to the Trust and then share in any benefit derived from its exploitation as any other employee.

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• If I think I am the IP owner, can I go ahead and exploit the IP myself?
• You should always discuss the IP with the Trust IP Lead and the Adviser Organisation. They can inform you, and a legal adviser, of your rights. If development of your invention requires NHS resources these are likely to be refused unless you assign the IP. You should be advised that trying to exploit IP yourself so that it provides maximum benefit to you and the NHS is extremely hard.

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• Are the model employment conditions intended to be used in all contracts?
• They are, as the name implies, a model, which can be adapted by Trusts in the way they consider most appropriate to their situation.

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• Who owns the copyright when work is written by employees from different organisations?
• This needs to be agreed at the outset. If a particular Trust wishes to produce, e.g. an information booklet and to invite authors from different organisations to contribute it should agree with these other organisations for the copyright to be assigned so that it is owned by one organisation. The moral rights of these and other authors should be acknowledged by naming them.

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• Who owns the IP generated when employment costs are paid wholly or in part by another body?
• This is a difficult question to answer if there is no contract. IP ownership should always be decided before the appointment begins and inserted in to a contract of employment.

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• Is the IP always owned by the organisation holding the employment contract?
• Not always, because it may be a contract of convenience or the costs of the employment could be wholly met by another organisation. Ownership should be agreed jointly by the organisations.

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• When IP is generated jointly by employees in a Trust and a University, who owns the IP?
• If there are inventors from both organisations then both need to be named and the IP will be owned by their employers, the Trust and the University. Jointly owned IP is possible and agreeing this at an early stage removes any later debate. If there is joint IP, however, one of the organisations should take responsibility, with the agreement of the other, for managing the IP. A potential industrial licensee will need to be sure that the organisation with whom it is negotiating has the necessary authority.

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• My payroll costs are funded by a Trust but I hold a University appointment. Who owns the IP I generate?
• Your contract of employment should include IP provisions to avoid any uncertainty later. Both organisations need to agree up front what would be the position on ownership and sharing any benefit.

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• I hold an honorary contract with a University and have an NHS appointment. Who owns the IP I generate.
• If the IP is generated by you, the Trust holding the appointment would own the IP. However, it is very likely that the University contributed to the development of the IP and would be entitled to a share in benefits due to your organisation. It should not affect the benefit due to you.

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• I am an independent consultant commissioned by the NHS to do a piece of work. Who owns the IP?
• Unless the contract of engagement specified otherwise then you do.

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• I have been seconded from a Trust to carry out work in a University. Who owns the IP?
• It will depend on what the contract says, but if it is silent on IP then IP resulting from your work is owned by the Trust.

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• I am a Trust employee and had an idea at home, which I want to patent. Do I own it?
• If the idea (which has to be more than an idea to patent) results directly from your work as an employee of the Trust then it is likely that it is owned by the Trust. You should discuss it with the Trust IP Lead.

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• I am an NHS consultant but I do some private practice. Do I need to tell anybody in my Trust about my innovation which occurred during my private practice?
• Yes, you do. If the invention is unconnected with your normal business then you will own it and this will be confirmed by your Trust IP Lead. If it is connected with your main employment in that it arose because of the work you do for the NHS then the situation needs discussion with the Trust.

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