Royal Berkshire Ambulance NHS Trust (RBAT) Intellectual Property Management Strategy 2001 – 2006 STRATEGY xxxx D:\533567498.doc Royal Berkshire Ambulance EXECUTIVE SUMMARY NHS Trust Corporate Services Directorate TITLE: Intellectual Property Management Strategy FOR CONSIDERATION BY BOARD DATE: REFERENCE NO: SUMMARY OF STRATEGY: The intent of this strategy is to ensure that intellectual property derived from NHS R&D is owned and exploited in the best interests of the NHS and the country as a whole. The major benefits of the exploitation of intellectual property for the NHS are perceived to be improvement in patient care and generation of income. Implementation of this policy requires development of awareness, understanding and best practice amongst NHS staff, not only amongst those involved in research but also those delivering patient care services, where intellectual property may also be generated. Please note employment contracts on Page 9, or alternative procedure statement on Page 10 – requires changes to employment contracts. REASONS FOR DECISION: The major benefits of the exploitation of intellectual property for the NHS are perceived to be improvement in patient care and generation of income. ALTERNATIVE OPTIONS, IF ANY: To do nothing and risk loss of potential income for the Trust 2 RECOMMENDATIONS: To develop this strategy for enhancing the potential of financial gain for the Trust FINANCIAL IMPLICATIONS Potential gain in resources for the Trust Resources to support the management of Intellectual Property BACKGROUND Research and Development in the Royal Berkshire Ambulance NHS Trust is not a major activity, but does contribute to the culture of the organisation. Supporting R&D within the Trust is beneficial for professional development, contribution to national research and income generation. Participation in such projects ensures that contributions made by patients to research are rewarded with service improvements. There is also evidence that quality of patient care is higher when there is participation in research trials. Support for progress of this document and other R&D activities is freely given by our membership with the East Berkshire R&D Consortium (see RBAT’s R&D Strategy for details) PORTFOLIO REFERENCE MATERIAL Health Service Circular (HSC) 1998/106; "Handling Inventions and other Intellectual Property: A Guide for NHS Researchers", "The Management of Intellectual Property and Related Matters: An Introductory Handbook for R&D Managers and Advisers 3 Contents Section 1: Context 3 National Local 3 4 Section 2: Plan 5 Aim Establish Infrastructure Monitor Assess Manage 5 5 5 6 6 Section 3: Ownership 7 Section 4: Intellectual Property and Technology Transfer Management Arrangements 8 Employment Contracts Distribution of Income Generated from IP Procedures for Employees of RBAT 8 9 9 Key Milestones 10 Appendices: Definitions Brochure: Intellectual Property Awareness Guide 4 11 12 Section 1: Context National The Intellectual Property Strategy for Royal Berkshire Ambulance NHS Trust has been developed in accordance with the NHS Executive Policy Framework for the Management of Intellectual Property outlined in: Health Service Circular (HSC) 1998/106; "Handling Inventions and other Intellectual Property: A Guide for NHS Researchers", "The Management of Intellectual Property and Related Matters: An Introductory Handbook for R&D Managers and Advisers The intent of the framework is to ensure that intellectual property derived from NHS R&D is owned and exploited in the best interests of the NHS and the country as a whole, by those best able to do so. The major benefits of the exploitation of intellectual property for the NHS are perceived to be improvement in patient care and generation of income. Implementation of this policy requires development of awareness, understanding and best practice amongst NHS staff, not only amongst those involved in research but also those delivering patient care services, where intellectual property may also be generated. The Trust is required to implement this policy framework by: Developing its own intellectual property policy. Reviewing its R&D funding arrangements to ensure that any research contracts properly cover the ownership of, and continued access to intellectual property and the arrangements for sharing any income generated by its exploitation. This is being established via the R&D office as part of the implementation of effective research management arrangements. 5 Local Research and Development in the Royal Berkshire Ambulance NHS Trust is not a major activity, but does contribute to the culture of the organisation. Support for progress of this document and other R&D activities is freely given by our membership with the East Berkshire R&D Consortium (see RBAT’s R&D Strategy for details) Last year participation in one non-commercial, externally funded research project was reported to the National Research Register (Sheffield University's 999-prioritisation project). A further 2 ‘own account’ projects were added this year (alternative responses to Category C calls – community nurse and Forestcare projects). These are non-funded research projects. Supporting R&D within the Trust is beneficial for professional development, contribution to national research trials and income generation. Participation in such projects ensures that contributions made by patients to research are rewarded with service improvements. There is also evidence that quality of patient care is higher when there is participation in research trials. Due to the Trust’s role in research and development, the generation of intellectual property within the organisation does not occur on a regular basis. To date intellectual property has not been managed on a pro-active basis within the trust and the Director of the Finance Department has dealt with any queries on an ad hoc basis. In September 1999 Moran & Co conducted a project review of IP management within Trusts in the Anglia and Oxford Region. The report recommended that: the research proposal form should include a question on IP; the R&D database should include IP information; organisations should assess IP before research is published; information on IP should be made available to investigators. These recommendations will be implemented in the Trust via the Clinical Effectiveness department. The Royal Berkshire Ambulance NHS Trust is a member of the East Berkshire Research and Development Consortium, together with Heatherwood & Wexham Park Hospitals NHS Trust and East Berkshire Community Health NHS Trust ( now WAM PCT ). In April 2002, the Consortium received £84,509 from the R&D Levy fund. The policy on Intellectual Property was reviewed by all members of the R&D Consortium during a meeting on the 28 th February 2002. 6 Section 2: Plan Aim Royal Berkshire Ambulance NHS Trust aims to meet statutory requirements in monitoring, assessing and managing Intellectual Property for the benefit of our patients and the Trust. Establish Infrastructure The first requirement is to establish an infrastructure covering employment contracts, disclosure contracts and information sources. Support services will be developed through the Consortium with external organisations specialising in IP management. The research team will remain up to date with Regional and National R&D developments. Monitor It is an essential part of the policy for intellectual property management that regular technology audits are carried out. This will increase staff awareness of the issues surrounding IP and ensure that a basic understanding of intellectual property principles is widespread. Monitoring process The proposed monitoring process will involve a quarterly review of all areas to include: Emergency Services Estates IT Non-emergency Patient Transport Services (NEPTS) Medical Devices This will meet the dual aim of assessing IP and raising awareness by developing, for example: Computer Programs Medical Devices Management Processes 7 Assess Assessment of any intellectual property is in 2 stages, internal and external where necessary. This process should include an assessment of the ownership of IP. As described below the basic principle is as follows; if the cost of the research is shared between the NHS and the investigator the benefits should be shared in the same ratio. In this context ‘costs’ include use of resources and equipment, time and skills. Manage The management of intellectual property is not within the expertise base of the Trust and should be handled externally in association with a technology transfer unit, which may identify commercial partners for further exploitation of the IP. The unit that will fulfil this role will be identified in the near future, following guidance from the DHSC for the South. 8 Section 3: Ownership The Trust owns intellectual property arising from research and development projects undertaken by its employees in the course of their work for the Trust and/or using Trust facilities, unless such intellectual property is subject to a formal agreement between the Trust and an external funding organisation. The ownership of intellectual property arising from research undertaken jointly with another organisation, e.g. Reading University, will be assigned to either of the employing organisations by agreement, unless subject to prior agreement with an external third party organisation. The proportion of intellectual property contributed by each party will be agreed by discussion between the parties at the earliest stage of the process. In specific instances the Trust may decide not to pursue its intellectual property rights and may assign ownership of the intellectual property to the relevant inventor(s), the costs of such assignment to be borne by the assignee. In such cases, employees may pursue and exploit the relevant intellectual property in their own time and without utilising Trust facilities and resources. 9 Section 4: Intellectual Property and Technology Transfer Management Arrangements The former South East Regional Office was unsuccessful in its bid to the Public Sector Research Enterprise Fund for an Intellectual Property Management Structure, or Hub. In response to this disappointing outcome an IP Working Group was established with representation from several Trusts across the South East. In the absence of funding, at least in the short term, the aim of the group is to access and develop ways to introduce IP management as an additional responsibility of Trusts in the region. A pilot study was conducted to assess the IP management needs of SERO Trusts and to recommend ways in which an interim IP capacity could be developed until future funding is obtained. The main focus of the study was to look at IP auditing, raising awareness of IP amongst NHS staff and identifying skill and resource gaps. The following recommendations were made from the study: The appointment of an IP Advisor, based at the DHSC for the South – to take lead responsibility for moving the proposed programme forward. The development of IP nodes – R&D offices in key Trusts that are a focal point for IP advice and practice development for a surrounding catchment area. Collectively they will provide lead responsibility for a Regional IP infrastructure. The establishment of increased links with potential professional advisers and exploitation partners The development of NHS IP management capacity along side potential sources of external funds ‘Intellectual Property Management in the NHS South East Region: Recommendations arising from the South East Region IP Management Working Group pilot study to assess ways forward in the absence of support for an IP hub’ by Graham H. Farrar on the behalf of the SERO, April 2002. The exercise highlighted the importance of the participation of Trust senior management in supporting IP and found that Trusts where senior management are IP Champions, are always active innovative working environments. Incorporating responsibility for IP into Trusts will not be the entire solution to IP Management in the South; however, it will form one stage in a complex process that will develop with time. Once identified, the exploration of IP will have to involve partners with expertise in this area. The Trust wishes to encourage the interest and involvement of researchers in the pursuit and exploitation of their inventions. However, centralised co-ordination of these processes is essential to avoid confusion, ensure adherence to the policy of the Trust and to maximise the return from IP. The Clinical Effectiveness Department will remain up to date with the progress made by the IP Working Group through the East Berks R&D Consortium. Links have already been made with the IP Adviser for the new DHSC for the South and the Clinical Effectiveness Department will use this resource to establish an IP auditing capacity for the Trust. Researchers who anticipate that intellectual property will arise from a project should identify this on the RBAT project register form. The R&D Regional Office will also aim to identify potential intellectual property from the R&D projects database and from discussions with R&D leads and individual researchers. 10 Employment contracts The Trust owns all intellectual property arising from research and development projects undertaken by its employees in the normal course of their work for the Trust, unless such intellectual property is subject to a formal agreement with an external funding organisation. Such ownership remains with the Trust upon the departure of the employee. The Trust will be amending and updating employment contracts to cover issues relating to the ownership of intellectual property and obligations of the employee and employer respectively. 11 Distribution of Income Generated from Intellectual Property The intellectual property protection and exploitation costs that are incurred will be met, in the first instance, from the R&D Levy. The decision to incur such costs for any item of intellectual property will be taken by the researcher(s) and the R&D Office after due consideration of the protection and exploitation potential of the intellectual property. Inventions may generate income in three ways: lump-sum payments for transfer of ownership of intellectual property; lump-sum payments for licensing agreements; royalties paid per unit of relevant product sold. The East Berkshire R&D Consortium will have first call on the income generated by intellectual property to enable full recovery of the costs incurred by the R&D office during the protection and exploitation processes. After recovery of such costs, the net income generated by IP will be shared amongst inventors, the directorate and the Trust as follows: Total Net Income Researcher(s) Trust Up to £50k 90% 10% From £50k to £500k 45% 55% 22.5% 77.5% Over £500k The inventor’s share of the net income is a discretionary gift by the Trust, which is intended to continue for the inventor’s lifetime or the term of the licence agreement. Procedures for Employees of the Royal Berkshire Ambulance NHS Trust Employees of the Trust are reminded that the Trust owns all intellectual property arising from research and development projects undertaken by its employees in the normal course of work for the Trust, unless such intellectual property is subject to a formal agreement with an external funding organisation or agreed otherwise. Researchers, their collaborators and staff should not make potential intellectual property public, e.g. via publications, abstracts, presentations at meetings etc, until such time as a patent application is filed. They should also maintain absolute confidentiality until this time. 12 Researchers who believe that their research will generate a patentable (or protectable) invention should notify the Clinical Effectiveness Department at the earliest opportunity. When the invention is sufficiently advanced, the Clinical Effectiveness Department will arrange for a consultation with an expert Project Manager from the technology transfer unit to assess its patentability and commercial potential. A decision to apply for intellectual property protection, e.g. a patent, will signal the need to contract the services of a patent agent and the R&D Office, and to start seeking a commercial partner. Such discussions should only take place after a confidentiality agreement is signed with a prospective commercial partner. A decision not to apply for intellectual property protection and exploitation of the invention will require that Trust management determine if the Trust wishes to retain ownership of the intellectual property. If not, the inventor(s) will be invited to meet the cost of a legal transfer of ownership to the inventor(s), after which they can pursue the intellectual property at their own expense and in their own time. The NHS Executive has produced a useful guide for researchers entitled “Handling Inventions and other Intellectual Property” which is available from the Clinical Effectiveness Department on request. Key Milestones Strategy July 2002 Initial Technology Audit November 2002 Rolling monitoring established March 2003 Employment contracts To be determined in the light of national guidance Develop expertise Ongoing, demonstrate attendance at appropriate meetings, maintain and develop contacts externally Develop information package Accomplished with East Berks R&D Consortium December 2001 Technology transfer unit Act in accordance with regional arrangements 13 Section 4: Document Control Royal Berkshire Ambulance Trust References J:\Clinical Effectiveness\RandD\RBAT Intellectual Property Management Strategy.doc Controlled document: CEf 46 September 2002 Review due: September 2003 Acknowledgements Written by: C Breen Clinical Effectiveness Officer Approved by: S Brown Medical Director TBA Accepted by: Debbie Dunning Emergency Services Director TBA Accepted by: Sarah Peth Director of Customer Services (date) Comments from: Operations Committee Meeting TBA Comments from: At Risk and Clinical Governance Meeting TBA Approved by: People and Organisation Committee TBA Ratified by: Keith Nuttall Chief Executive At Board Meeting: TBA 14 Appendix 1 Definitions: Intellectual property: Represented by new knowledge such as in technologies, drugs, devices, diagnostics, treatments, software, new applications and skills which are not in the public domain and can be protected. Patent: This is a form of IP protection that describes an invention that is new, involves an inventive step and is capable of commercial application. It confers a monopoly right to the inventor(s) for twenty years from the date of patent filing. Copyright: This arises automatically in original literary, dramatic, musical and artistic works. Within the context of the NHS this will largely be applicable to software. No registration is required and rights exist for the life of the originator plus fifty years. Registered design and design rights: The outward shape or configuration of products of all kinds is protectable by either a registered design, giving stronger protection, or by the (unregistered) design right which gives weaker but automatic protection without the need for registration. Trademark: Trademarks are signs, such as a distinctive name, emblem or logo that distinguish the goods and services of one organisation from those of another. It provides protection for the goodwill and reputation of an organisation in its products and services. Registration confers greater protection and there is no time limit. Goodwill or know-how: Intangible assets of an organisation which may not be protected by one or other of the above means but which, nonetheless, may also be of value to a third party. Technology transfer: This covers the transfer of ownership of IP or allows a third party to develop and exploit the IP whilst ownership is retained. It is often more broadly defined as the management arrangements under which IP is identified, protected and exploited. Licensing agreement: An agreement whereby ownership of IP is retained while a third party is given rights by the IP owner to development and marketing. Such an agreement usually involves payment of an initial lump sum to the owner of the IP, dependent on the commercial potential of the IP, plus royalties as products from the invention are sold. Ownership: IP generated by an employee in the normal course of duties belongs legally to the employer. The employer may decide on some kind of income sharing arrangement with the inventor(s) and his department upon the successful exploitation of the IP. The employer may decide to waive their rights in some cases e.g. copyright on books. In the event of the departure of the inventor(s) from the employing organisation, all IP rights remain with the employing organisation and cannot be transferred with the employee to the new organisation unless by prior agreement. Confidentiality: It cannot be stressed too strongly that if there is IP that has potential for exploitation, then it should neither be discussed nor shown to any third party who is not under a legal obligation to keep it confidential. 15