GENERAL NOTE
NHS Fife acknowledges and agrees with the importance of regular and timely reviews of policy statements and aims to review policies within the timescale set out.
New policies will be subject to a review date of no more than 1 year from the date of the first issue. Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.
If the policy is past its review date, then the content will remain extant until such time as the policy review is complete and the new version published.
1 FUNCTION
1.1 NHS Fife has a responsibility to capitalise on opportunities to exploit Intellectual Property (IP) from any of its core, research, and innovation activities.
1.2 NHS Fife has a mandatory duty to audit, protect and exploit Intellectual Property (IP) generated by all NHS employees in the delivery of health care. Innovations attracting IP can include improved interventions and services for health and social care, and new products including those contributing to the education and training of employees.
1.3 The UK Policy Framework for Health and Social Care Research (2017) also places a duty on NHS Fife to have a mechanism in place for the exploitation of Intellectual Property arising from its employees. Innovation in the NHS can be developed during the delivery of any part of the service, as well as from research and development activity.
1.4 This policy sets out a process for the effective management, including the identification, protection, development, and exploitation, of Intellectual Property within NHS Fife. It is also intended to express the policy as far as possible in non-technical language.
1.5 The policy is to encourage and enable staff to participate in the generation of IP as part of its commitment to delivering the best possible patient care.
1.6 The policy is to maintain a balance between the legitimate needs of NHS Fife to protect its interests, and the provision of a creative working environment for staff. NHS Fife has agreed that revenue generated by successful exploitation of Intellectual Property can be shared with the originators, that is, the members of staff responsible for the innovation.
2. LOCATION AND STAFF COVERED BY POLICY
2.1 Staff
2.1.1 All staff with NHS Fife contracts of employment, whether employed in Research and Development, clinical, managerial, administrative or support roles.
2.1.2 Staff with NHS Fife contracts of employment whose payroll costs are wholly or partially funded by another party (including, but not limited to a commercial sponsor, government department, or medical charity); unless the contract of employment between NHS Fife and that party assigns ownership of IP to that party.
2.1.3 Staff who have a part-time NHS Fife contract.
2.1.4 Agency or consultancy staff employed within NHS Fife.
2.1.5 Non-executive Directors of NHS Fife who generate IP arising from their time spent within NHS Fife.
2.1.6 Members of the public who are representatives on NHS Fife's statutory groups under the Patient Focus Public Involvement Agenda, e.g., the Involving People Team.
2.1.7 Trainees and students hosted by NHS Fife for training purposes are subject to the management arrangements for IP of NHS Fife staff when appropriate agreements are put in place (see 2.2 below).
2.1.8 Staff who generate IP outside normal working hours and/or away from their place of work where the IP relates to their normal course of duties, or specifically assigned duties, where an invention or innovation should be a reasonably expected outcome.
2.1.9 Where NHS Fife staff are seconded to another organisation or are working in partnership with other organisations, NHS Fife will agree an arrangement for sharing IP and revenue, based on the assumption that all IP generated by NHS Fife employees remains the property of the Board.
2.2 Trainees and Students
2.2.1 If they are not otherwise employees, students are not classed as employees simply by undertaking activity on NHS Fife premises. As such they are not covered by the relevant provisions governing IP ownership.
2.2.2 It will be the responsibility of Line Managers who have students engaging in work on behalf of NHS Fife to ensure that they sign a confidentiality and assignation agreement that will require the student to disclose details of any invention and assign the rights to NHS Fife on request. The student will subsequently be treated on a par with NHS Fife staff in consideration of all issues relating to IP.
2.2.3 Other researchers in NHS Fife who are neither staff nor students e.g., Senior Research Fellows and other emeritus staff, will normally be brought within the scope of this agreement.
2.3 Independent Providers of Services (including Independent Contractors)
2.3.1 Reference should be made to HSC 1998/106 and clauses 2.69 – 2.72 Framework & Guidance on the Management of Intellectual Property in the NHS 2002.
2.3.2 Independent Providers of Services who generate IP from NHS Funded R&D are required to share benefits of its commercialisation with the Scottish Executive Health Department.
2.3.3 Independent Providers of Services who generate IP from delivery of their contracted service in the area of patient care can exploit this IP independently, provided no further NHS resources are utilised.
2.3.4 Independent Providers of Service who assign IP generated by them to NHS Fife will be eligible for all benefits under the sharing scheme of that organisation.
3. RESPONSIBILITY
3.1 All staff have the responsibility to ensure that they act in accordance with this policy and under no circumstances, will they disclose, sell, assign, or trade Intellectual Property without NHS Fife agreement. Failure to adhere to 3.1 may lead to an NHS Scotland workforce policies investigation process, which could result in a Conduct hearing and disciplinary sanctions up to dismissal.
3.2 It is the responsibility of all Line Managers to ensure that their staff have read, and comply with, this policy.
3.3 The Assistant RIK Director, as the Intellectual Property Lead, or their designee (Innovation Manager) has overall responsibility for the management and exploitation of Intellectual Property for NHS Fife. Responsibility includes ensuring that IP awareness training is available to all staff and that identified IP is exploited safely and fully for the good of NHS Fife patients and the organisation.
3.4 The Executive Lead for Research, Innovation and Knowledge is responsible for overall implementation and review of the Policy.
4. OPERATIONAL SYSTEM
4.1 Intellectual Property is the tangible output (new ideas or concepts) of any intellectual or creative activity that is new or not previously described. IP can be owned, and it can be bought, sold, or licensed and must be adequately protected. IP can include inventions, industrial processes, software, data, written work, designs and images. IP Rights are the legally protected rights to the IP which can be exerted through patents, copyright, design rights, trademarks or know-how which allow the owners to exert monopoly control over the exploitation of these rights and prevent others exploiting the IP. Details of the main types of IP and the protection used for each are given in Table 1.
4.2 Once protected, resources can be spent developing results into something useful and investment made in making the results more widely available, with the expectation of recovering that expenditure. However, costs can be considerable so any exploitation should be done in a way which minimises speculative financial investment from public funds, and which does not detract from their primary role in the NHS.
4.3 Generation of Intellectual Property
4.3.1 It is recognised that NHS Fife staff from any discipline or activity can generate new ideas, inventions, innovative solutions, or new ways of working during the normal course of their employment.
4.3.2 If properly managed, these will lead to improvements in the running of hospitals / services or the delivery of healthcare, with improvements for patients and patient care. Innovation is not restricted to those involved in research but occurs throughout the NHS and can involve novel treatments, new diagnostics, devices, new drugs or their new use, data, software, training material, treatment protocols or new management systems.
4.4 Ownership of Intellectual Property
4.4.1 In accordance with UK employment law, the Patents Act (1977) and the Copyright, Designs and Patents Act (1988), the right of ownership to IP created by an NHS Fife employee, carrying out their normal or specifically assigned duties, in the course of their employment will normally reside with NHS Fife and staff must not under any circumstances sell, assign or trade IP without NHS Fife agreement.
4.4.1.1 UK Patents Act (1977), Section 39, specifies an invention made by a member(s) of staff shall be taken to belong to the employer if:
• it was made in the course of the normal duties of the member(s) of staff and the circumstances were such that an invention might reasonably be expected to result from the carrying out of these duties, or
• in the course of duties falling outside their normal duties, but specifically assigned to them, and the circumstances were such that an invention might reasonably be expected to result from the carrying out of these duties, or
• the invention was made in the course of the duties of the member(s) of staff and, at the time of the making the invention, because of the nature of his duties and the particular responsibilities arising from the nature of their duties he had a special obligation to further the interests of the employer’s undertaking.
4.4.1.2 Section 11 of the Copyright, Designs and Patents Act (1988) provides that the employer is the first owner of copyright in an employee’s work, provided that work is done in the course of the employee’s employment.
4.4.2 IP which has been generated by an employee, in their own time, without NHS Fife resources and which is unconnected with their normal contracted course of duties, or specifically assigned duties, will normally be owned by the employee.
4.4.3 There are situations where Intellectual Property will arise as a result of interaction with other institutions, including staff joint or Honorary appointments with other institutions. Specific exceptions regarding ownership may also occur where joint work is undertaken with other organisations such as: other NHS bodies; Universities; other academic institutions; and commercial organisations. In such circumstances, Intellectual Property may be owned by an external sponsor or funding body where ownership of any resulting Intellectual Property has been specifically defined and agreed in the contract to undertake that work.
4.4.4 Responsibility for Exploitation of Intellectual Property
4.4.5 NHS bodies are responsible for the cost-effective exploitation of any IP which they own. However, exploiting IP can be expensive and NHS Fife may bear considerable financial risk in taking a project on. Any exploitation should be done in a way which minimises speculative financial investment from public funds, and which does not detract from their primary role in the NHS. Generally, whenever possible, as much risk as possible should be borne by a private partner.
4.5 Staff Obligations
4.5.1 Members of staff identifying or creating Intellectual Property thought suitable for protection and / or commercial exploitation whilst acting in the course of their employment, or at any other time using NHS Fife resources, are obliged to inform their Manager and the RIK Office (fife.innovation@nhs.scot) at their earliest opportunity. Ownership of the Intellectual Property and prospects for its commercialisation will then be discussed. IP brought to the RIK Office will be recorded by the innovator in an Invention Record Form (Appendix 2) available from the RIK Office.
4.6 Dissemination
4.6.1 A natural reaction is often to publish findings as soon as possible in order to contribute to new knowledge and improvements in healthcare. However, early public disclosure can be counter-productive, especially when results could have led to a new treatment or drug. If details are published before the IP is protected it is unlikely that the product will be made, or the process developed since exclusive rights to the IP would normally be a prerequisite. By avoiding disclosure and undertaking proper protection, new treatments will be developed and become available, with substantial royalties being paid for the new invention.
4.6.2 If you think you have made an innovation, whether potentially patentable or any other type of IP, do not tell anyone until you have taken advice from the RIK Office.
4.6.3 There will rarely be a conflict between the exploitation of IP and the appropriate dissemination and take-up of new knowledge to help improve the service which the NHS provides. Should a conflict arise, the best interests of the NHS and the country will prevail.
4.7 Safeguarding Intellectual Property – Confidentiality
4.7.1 The public disclosure of any IP with potential to be exploited, to anyone outside NHS Fife, will jeopardise the future potential for protection. Disclosure includes presenting papers or posters at conferences, abstracts, chapters in books, and any other written communication or even conversation. An invention needs to remain secret prior to any patent application and know-how must remain confidential if it is to be exploited. IP cannot normally be protected once prior disclosure has occurred, no matter how informal. Publication of any work relating to an invention or know-how must be avoided until advice has been sought from the RIK Office.
4.7.2 Confidentiality is generally protected by using written agreements and an NHS Fife Non-Disclosure Agreement (Appendix 1) can be used to safeguard unprotected IP. Agreements are available from the RIK Office which, when completed, will enable staff to then discuss their IP with external parties.
4.8 Record Keeping
4.8.1 An NHS Fife Invention Record (Appendix 2), available from the RIK Office, should be used to register your invention/idea. Once completed, this should be submitted to the RIK Office for assessment on how best to proceed and will ensure ideas for patenting are processed as quickly as possible. After assessment it may be possible to make public the nature of the idea by publishing an article, giving a talk or poster presentation, or disclosing to any outside organisation.
4.8.2 The RIK Office will maintain a register of all Intellectual Property owned by NHS Fife where a member of the organisation’s staff is a named inventor or originator. A record will be kept of the date on which a member of staff reports to the RIK Office that they are the Inventor/Author of a creative product. Details will also be kept of arrangements entered into by NHS Fife for the protection and subsequent use of the Intellectual Property.
4.9 Decisions on Exploitation
4.9.1 IP will be assessed by the Assistant RIK Director and NHS Fife Innovation Manager who will discuss details of the IP with InnoScot Health. If it is decided to explore the potential further, a meeting will be arranged with the RIK Department, the inventor and InnoScot Health to advise whether or not the NHS should exploit the IP, and if so, to discuss the routes for exploitation. Recommended outcomes will be reported to the Executive Lead for RIK, for final decision regarding NHS Fife selecting the IP for exploitation.
4.9.2 If NHS Fife chooses not to take up its rights to the Intellectual Property, the Intellectual Property rights of ownership (IPR) may be assigned to the employee.
4.10 Financial Arrangements - Revenue Sharing with Inventors / Distribution of Residual Income
4.10.1 NHS Fife will negotiate financial arrangements for sharing the proceeds of IP in association with the Service Level Agreement in place between NHS Fife and a Technology Transfer Office, InnoScot Health which provides the necessary support and advice in managing Intellectual Property for NHS Scotland.
4.10.2 Although there is no legal requirement to share income from IP exploitation with employees who created it in the normal course of their duties, NHS Fife wishes to encourage full participation of employees in innovation and the commercial exploitation of IP.
4.10.3 NHS Fife takes every step to recognise staff who have contributed substantially to the generation of the IP. Such individuals will be named as the Inventor on a patent or Author on copyright material and will also be due a share of any net revenue received from the commercialisation of the Intellectual Property Rights. Shared revenue will be net of all costs involved in the protection and exploitation of the IP (e.g., patent costs, fees due to InnoScot Health for their role in IP exploitation).
4.10.4 Income will generally be allocated between NHS Fife and the Inventor/Author according to the revenue sharing formula given below in Table 2.
4.10.5 In cases where several staff have been involved in generating the IP, the proportion of the income allocated to inventors will be divided amongst them by agreement on the basis of their relative inventive contributions. Discussions if required to be managed by Assistant RIK Director who will facilitate any disputes.
4.11 Intellectual Property Management Structure
4.11.1 It is the role of the appointed IP Lead or their designee to assume overall responsibility for the management and exploitation of IP for NHS Fife, reporting to the Executive Lead for Research, Innovation and Knowledge, who reports to the NHS Fife Chief Executive. The appointed IP Lead for NHS Fife is the Assistant RIK Director. The RIK office should be the first point of contact for staff seeking information and advice on IP issues.
4.11.2 A wide range of specialist skills are required to undertake the protection and exploitation of IP and external expert advice will be sought as required from a variety of sources including patent agents, local enterprise companies, and solicitors. A Service Level Agreement is in place between NHS Fife and InnoScot Health (formerly called Scottish Health Innovations Ltd or SHIL), who provide the necessary support and advice in managing IP for NHS Scotland.
4.12 Agreements with Partner Bodies
4.12.1 Where learning institutions present agreements for entry into by NHS Fife, any clause relating to IP needs to be tested against NHS Fife policy. Agreements on IP will be included as appropriate within individual partnership agreements (e.g., Memoranda of Understanding (MOUs) with Universities).
4.13 Awareness Raising
4.13.1 It is crucial that all staff are aware of the issues arising from the management of IP and to this end raising awareness will be covered in the following ways. Whilst arrangements will be made to include information on IP in the NHS Fife Corporate Induction Programme for new employees, it is the responsibility of the local manager to ensure that this issue is also covered within the local departmental induction process. Information will be contained within the NHS Fife website, RIK newsletter and Staff Handbook on an ongoing basis. IP will be included in the Induction Training with regular ongoing seminars and training events provided by the RIK Office to raise awareness across the organisation of the importance of identification, record keeping, protection and exploitation of IP. Internal communication mechanisms e.g., NHS Fife Newsletter and other routes will also be used to raise awareness around IP. InnoScot Health also provide IP advice clinics within the RIK Department or on request to discuss notional IP.
4.14 Intellectual Property Audits
4.14.1 Technology Audits (Opportunity Surveys) will be carried out from time to time by the RIK Office in order to identify any potential IP arising from staff activities and assess any commercial possibilities. Such audits will involve questionnaires and meetings with staff to discuss the technology transfer process and undertake a preliminary assessment of potential innovations suitable for exploitation. Identification of potential IP at an early stage is essential to ensure that correct action is taken to protect any IP which might later be developed.
4.15 Contracts of Employment
4.15.1 As part of their employment contract or honorary contract, staff will be made aware of the IP Policy. NHS Fife will include a statement referring to IP within the contract issued to all new staff. For existing staff, the policy will be incorporated into their terms and conditions of employment via the normal national and local collective bargaining arrangements and by the adoption of this policy. A statement will be included in the Licence to Operate agreement for those working on a Licence to Operate basis.
5. RISK MANAGEMENT
5.1 The adoption and implementation of this policy will ensure a robust, fair, and transparent process which will significantly reduce risks due to the unregulated development of Intellectual Property within NHS Fife.
5.2 The risk around unwise investment by NHS Fife resulting from the implementation of this policy is mitigated by an ongoing process of consultation and collaboration with InnoScot Health in all IP development and selection. InnoScot Health is recognised throughout the NHS as an organisation trained in IP protection and development and has a Service Level Agreement with NHS Fife.
5.3 This policy will be regularly reviewed as part of the implementation process.
6. RELATED DOCUMENTS
• Appendix 1: NHS Fife Non-Disclosure Agreement
• Appendix 2: NHS Fife Invention Record/Disclosure Form
7. REFERENCES
• Handling Inventions and Other Intellectual Property. A Guide for NHS Researchers. NHS Executive. 1998
• The Management of Intellectual Property and Related Matters. An Introductory Handbook for R&D Managers and Advisers in NHS Trusts and Independent providers of NHS Services. NHS Executive. 1998
• Policy Framework for the Management of Intellectual Property within the NHS Arising from Research & Development. NHS MEL (1998) 23
• Patent Protection. The Patent Office. 1998
• The Patents Act. 1977
• The Copyright, Designs and Patents Act. 1988
• Baker Report. ‘Creating Knowledge Creating Wealth’ - Realising the Economic Potential of Public Sector Research Establishments. 1999
• Policy Framework for Health and Social Care Research. 2017.
• Guidance for NHS Scotland is set out in “A Framework and Guidance on the Management of Intellectual Property in the NHS Scotland” (HDL(2004)9)
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