Worcestershire Mental Health Partnership NHS Trust Intellectual Property & Property Rights Policy. This policy should be read in conjunction with Research Governance Key words Unique identifier: Intellectual Property Adopted by: Governance Committee Property Rights Issue date: 4 th May 2007 Patent Invention Version update: July 2009 Innovation Review interval: 3 Years Copyright Review date: July 2012 Responsible Director: Document type: Director of Medical Development Policy If printed, copied or otherwise transferred from its originating electronic file this document must be considered to be an uncontrolled copy. When documents are updated notification will be circulated throughout the organisation. Policy amendments may occur at any time and you should consult the principle electronic file if in doubt.
Ownership of Intellectual Property Intellectual Property (IP) is used to describe the output of all creative or innovative human activity, which might be used for commercial purposes. The inventor holds the Intellectual Property rights even if they are developed as part of the individual s contract of employment unless the employer (the Trust) has specifically reserved the rights. It is important that the Trust owns the Intellectual Property it generates to maintain the ability to exploit the invention and any financial return. All staff are required to notify the Trust of technology which may have potential for commercial exploitation. The following detail will be required in the first instance; this may be followed by an independent assessment of its commercial potential. 1. Description of invention. 2. Names of inventors. 3. Relative contributions of inventors. 4. Other interested parties. 5. Whether or not there has been any public disclosure of the invention. The following is the Worcestershire Mental Health Partnership Trust s Intellectual Property & Property Rights Policy. 2
CONTENTS Introduction 4 1 Aims of the Policy 4 2 What is Intellectual Property? 4 3 Managing Intellectual Property in the Trust 6 4 Scope 7 5 Intellectual Property arising from Research and Development funded by the NHS 7 6 Dealing with Intellectual Property 8 Appendix 1 Health Service Circular HSC 1998/106 - Policy Framework for Managing Intellectual Property in the NHS 8 Appendix 2 12 Categories of intellectual property Appendix 3 12 Different Forms of Intellectual Property Appendix 4 13 Bibliography 3
Introduction Innovation can occur through Research and Development and in the delivery of service user and carer care. The Intellectual Property (IP) that arises from innovation needs to be properly managed to ensure the benefits for service user and carer care are maximised. IP can also generate income for the Trust. Research findings, training materials, new developments in patient treatment, or other inventions by NHS employees can have a commercial value. This could be of financial benefit to the Trust and can also be an effective way of implementing Research findings to improve health care. This Policy provides guidelines for the Management of Intellectual Property in the Trust. It complies with HSC 1998/106 Policy Framework for the Management of Intellectual Property within the NHS arising from Research and Development (See Appendix 1). HSC 1998/106 placed a mandatory duty on Trusts to protect and exploit IP arising from Research and Development. This Policy takes account of the changes introduced by the Framework and Guidance on the Management of Intellectual Property which took effect on the 9 th September 2002. The framework extended HSC 1998/106 to include IP generated by NHS employees outside Research and Development activities through the management or delivery of care to service users and carers. It also allows Trusts to use companies for exploitation of IP, and provides guidance on the management and handling of any income generated. In addition to the above, the Research Governance Framework for Health and Social Care requires employers of researchers to have in place agreements between them, their staff, research funders, and care organisations, relating to the ownership, exploitation, and income from IP arising from research conducted by employees. 1. Aims of the Policy The aims of the Policy are to: Increase awareness and understanding of IP issues by Trust staff; Encourage innovation by staff; Encourage innovation by staff with regard to Research and Publication; Maximise the sharing of good practice and appropriate exploitation of Trust IP; 2. What is Intellectual Property? Intellectual Property is the novel or previously undescribed, tangible output of any intellectual activity. It has an owner and can be bought, sold or licensed and must be adequately protected. Intellectual Property means products of creativity or innovation which can be given legal recognition of ownership as Intellectual Property Rights through for example Patents, Trademarks or Copyright (HSC 1998/106). Intellectual Property Rights (IPR) define the legally protected rights that enable owners of IP to have control over the exploitation of those rights and protect their IP. Different rights apply to different forms of IP (see Appendix 2) and include Copyright, Design Rights, Patents, and Trade Marks (see Appendix 3). IPR gives the owner of IP the right to stop others exploiting it. Innovation can occur through the Delivery or Management of Service User and Carer care, in Education and/or Training, or through a Research and Development Project or Programme. IP may fall into the following categories (see also Appendix 2): 4
Inventions Literary and artistic works Designs and design drawings Engineering components, architectural drawings Product brand names, logos Trade secrets IP may be a novel treatment, a new diagnostic tool, new drug or new use of a drug or treatment, Training material, or a new system of Management. For an innovation to be developed commercially IP needs to be professionally managed. Generally, IP produced by employees in the course of their employment belongs to the employer. The owner of IP can control its use and be rewarded for it. 2.1 The generic term Intellectual Property (IP) is used to describe the output of all creative or innovative human activity, which might be used for commercial purposes. It can include written works, images, designs, software, data, plant varieties, industrial processes and inventions. 2.2 Legal advice from the Trusts Solicitors is that the normal rule is that any inventor/author of work holds the intellectual property rights in that work even if it is developed as part of the individual s contract of employment unless the employer (the Trust) has specifically reserved the right. The position in many Organisations, including this Trust, is that the rights in intellectual property are reserved by the employer although there are varying arrangements as to the share of benefits. However, The Patents Act 1977 states that: (1) an invention made by an employee shall be taken to belong to the employer if (a) it was made in the course of the normal duties of the employee and the circumstances were such that an invention might reasonably be expected to result from the carrying out of his duties, or (b) the invention was made in the course of the duties of the employee and because of the nature of the duties he had a special obligation to further the interests of the employer s undertaking. (2) Any other invention made by an employee shall be taken to belong to the employee. The Copyright, Designs and Patents Act 1988 adopts the same stance on ownership for all classes of intellectual property it covers, namely that intellectual property produced by employees in the course of their normal duties belongs to the employer. Finally, The Health Service Circular HSC 1998/106 states that The NHS should benefit from the profits of any commercial exploitation of Intellectual Property derived from R&D that it is funded or for which it has been funded, even where the Intellectual Property itself is to be owned by people or organisations outside the NHS. 5
3. Managing IP in the Trust The Trust has the right of ownership to all IP produced by its employees in the course of their normal duties. It does not claim any right to an individual s personal knowledge or expertise. The Trust should receive income and ownership rights equivalent to the proportion of time and money invested by the Trust. These guidelines only apply to work undertaken by Trust employees during working hours. It is recognised that IP might arise as a result of work with other organisations for example where: Staff have joint or honorary contracts with other organisations or academic institutions; There are collaborations with other organisations relating to research projects or programmes; The Trust has provided facilities for employees of other organisations; Where possible i.e. in the case of long standing collaborations, the Trust will seek to establish agreements to deal with any IP that may arise. In other cases, the Trust should negotiate the appropriate share of the ownership of the IP that has been developed. Where a number of Trusts and organisations are collaborating as part of a research programme, a common agreement on the handling of IP may exist as part of the collaborative agreement. Honorary contracts will not normally affect the ownership of IP; it will continue to belong to the organisation that holds the substantive employment contract. Where activity identified in this Policy is undertaken, and external income is available, agreement should be reached in advance as to the ownership of the findings and the apportionment of any income from the work. Training manuals and packages, whether for use by staff, users of services, or other consumers, produced with resources from the Trust, should be clearly marked, copyright of Worcestershire Mental Health Partnership NHS Trust. Where other Organisations seek to use such material a decision regarding the appropriateness of a charge should be made by a Senior Manager of the Trust, including the apportionment and use of such income. The Worcestershire Mental Health Partnership NHS Trust reserves right of ownership of all intellectual property created by an employee if: a) it arises from them carrying out their normal duties or b) is directly related to their duties or c) it arises from research and development activity supported by the trust. 3.1 The Trust does not reserve right of ownership of I.P. created by an employee for which the employee can demonstrate: a) it has been created in their own time, and b) is unrelated to their normal duties, and c) has not been supported by the trust in any way. 3.2 The trust recognises that in order to exploit intellectual property it may be necessary to involve an external organisation, and in some cases assign I.P. rights to a third party. The trust delegates responsibility for decisions on how best to manage I.P. to the Audit & Research group as defined in Section 4. 6
3.3 The trust further recognises that in some cases it may be appropriate to share the benefits arising from exploitation of I.P. with an individual and/or partner organisation (e.g. a University). This will be decided by the Audit & Research Group, taking into account the individual s or partner organisation investment in the discovery or development of the I.P. 3.4 It is not always essential that a new technology be fully developed before it can be commercially exploited. However, it is essential that its potential applications are identified. A company will often carry out further development work, whatever the status of the new product or process. With this in mind it is important that researchers keep the Trust informed of emerging technologies. All staff are required to notify the Trust of exploitable technology as under Appendix 1. On being notified the Trust will record the date of notification and discuss with inventors the following points: - - Description of the invention - Names of inventors - Relative contributions of inventors - Other interested parties - Whether or not there has been any public disclosure of the invention. 4. Scope An employee for the purposes of this policy will be regarded as: a) An individual holding a contract of employment directly with the trust, including those holding a joint contract with another organisation (e.g. a University). b) An individual holding a contract with another organisation but holding an honorary contract with the trust. c) Students of a university working on Trust property. d) Academic staff from a university on sabbatical working on Trust property. Where the individual is not solely employed by the Trust ownership of the I.P. will be managed as under Section 2.4 of this policy. 5. Intellectual Property arising from Research and Development funded by the NHS Appendix 1 contains the Policy framework for Managing Intellectual Property which arises from Research and Development, funded by the NHS. In order to comply with this framework it is essential that all members of Trust staff, undertaking Research, comply fully with the Trust s Research Governance and submit all Research proposals to the Trust s Audit & Research Group. Advice on compliance with the NHS Executive Policy Framework and the Trust s Policy can be obtained from the Audit, Research & Clinical Effectiveness Manager. 7
Researchers must also ensure compliance with the Research Governance Framework for Health and Social Care 1. This states that Researchers must consider the appropriate exploitation of intellectual property rights. 6. Dealing with Intellectual Property Employees who think they may be undertaking work which might generate IP are advised to read the following: Handling Inventions and other Intellectual Property: A Guide for NHS Researchers. NHS Executive. 1998. http://www.open.gov.uk/doh/nhsexec/ipr.htm or http://www.open.gov.uk/doh/coinh.htm Employees who think they have produced any IP should notify the Trust Audit, Research & Clinical Effectiveness Manager. The A,R&CE Manager, the inventor, and any Partner Organisations will make an assessment of whether the innovation has any significant commercial value or potential. The A,R&CE Manager will make a decision about how to proceed. The Trust will not seek to cause any unnecessary delay in the publication of an article or publication relating to the work carried out, but the employee should not publish any details of the invention before taking advice as once inventions or research results are publicised in any form legal protection (IPR) can not be obtained. The employee should seek approval to submit for publication and ensure that the Trust s contribution is acknowledged. 1 Department of Health. 2001. Research Governance Framework for Health and Social Care. 8
Appendix 1 Health Service Circular HSC 1998/106 Policy Framework for Managing Intellectual Property in the NHS 1. The Intellectual Property which arises from Research and Development (R&D) funded by the NHS is a potentially valuable resource both for the NHS and for the country as a whole. The NHS has a responsibility to help ensure that this Intellectual Property can be appropriately exploited either within the NHS or by others, although this remains a subsidiary objective to securing the proper dissemination and take up of new knowledge. 1.1 Intellectual Property means products of creativity or innovation which can be given legal recognition of ownership as Intellectual Property Rights through for example patents, trademarks or copyright. 1.2 There will rarely be a conflict between the exploitation of Intellectual Property and the appropriate dissemination and take up of new knowledge to help improve the service which the NHS provides. However, should such a conflict arise, the best interests of the NHS and the country as a whole should prevail. 2. Intellectual Property arising from R&D funded by the NSH R&D Levy should normally be owned by those people best able to exploit it. This will generally be the organisation carrying out the R&D. It is the responsibility of NHS bodies to ensure that the question of ownership is properly dealt with in any contracts they issue for R&D. 2.1 When an NHS body (for these purposes an NHS Trust or a Primary Care Independent Contractor) commissions R&D it should make sure that the contract for the work contains, wherever appropriate, explicit agreement about the ownership of any resulting Intellectual Property. 2.2 Ownership of Intellectual Property should normally rest with those best able to exploit it. In general this will be the organisation contracted to carry out the R&D, whether that is a University, a commercial organisation or another NHS body. The contractor organisation is, almost certainly, most familiar with the work and best placed to assess and act on any opportunities for exploitation. 2.3 NHS bodies commissioning R&D should normally only seek to retain ownership of Intellectual Property where they believe that the contractor is not in a position adequately to manage the Intellectual Property, or where there are good grounds for thinking that the NHS body itself, or some other party, is better placed to exploit it. 2.4 Exceptionally, there may be other cases where NHS bodies should retain Intellectual Property, despite the potential that exists elsewhere for exploitation, if there is an overriding public interest. 3. The NHS should benefit from the profits of any commercial exploitation of Intellectual Property derived from R&D that it has funded or for which it 9
has been funded, even where the Intellectual Property itself is to be owned by people or organisations outside the NHS. 3.1 NHS bodies should ensure, wherever appropriate, that an agreement to this effect is included in the contracts they issue for R&D or they enter into to undertake R&D funded by others. 3.2 This will generally be in the form of a requirement on the parties to take reasonable steps to ensure identification and exploitation of Intellectual Property, and an agreement that the NHS body concerned will be entitled to an appropriate share of any subsequent profits. 3.3 The size of such share will vary from case to case according to the relative contribution of the NHS body, the owner of the Intellectual Property and other interested parties. (The Department of Health advises that income should be shared in the following way: 33% to the Inventor; 33% to the Clinical Department in which the Inventor works; 33% to the Trust Management.) 4. NHS bodies are responsible for the cost-effective exploitation of any Intellectual Property which they own. They should do this in a way which minimises speculative financial investment from public funds and which does not detract from their primary role in the NHS. In general, as much as possible of the financial risk of exploitation should be assumed by a partner outside the NHS. 4.1 NHS bodies will own Intellectual Property arising directly from their use of funds from the R&D Levy and they may also own Intellectual Property because they themselves have been contracted by another body to carry out R&D. They may occasionally retain Intellectual Property arising from R&D they commission from others. 4.2 Ownership of Intellectual Property may require explicit recognition in contracts of employment of their staff by NHS bodies. Where staff hold joint appointments with Universities, or where staff are engaged in R&D away from their place of employment, a Policy on ownership of Intellectual Property arising from their work will need to be agreed locally between the parties. 4.3 Exploiting Intellectual Property involves both costs and risk, either directly or indirectly (for example through the identification of the Intellectual Property and the maintenance of patents). It will by no means always be appropriate or cost effective to seek to protect and exploit potential Intellectual Property. The resources that NHS bodies devote should be commensurate with the likely benefits and with other calls on their funds. This can only be determined locally in the light of relevant circumstances. 4.4 Few NHS bodies have the expertise themselves actively to exploit Intellectual Property in a commercial way, and for the vast majority it will be inappropriate for them to develop such capacity. As a general rule, NHS bodies should seek to minimise the risk they take on, by assigning or licensing Intellectual Property to commercial or other organisations able and willing to meet all or most of the costs of exploitation in return for a greater share of any subsequent income. 10
4.5 Before using their powers to generate income by exploiting Intellectual Property NHS bodies will carry out any consultation with other interested parties required by statute. 5. To provide an incentive for the appropriate and cost effective exploitation of Intellectual Property, NHS bodies will in general be able to retain any income they generate. 5.1 This general approach is subject to normal NHS financial disciplines, such as those relating to trading surpluses. It will also be subject, in exceptional cases, to the use by the Secretary of State of powers to expropriate excessive balances from NHS Trusts. 5.2 To provide a similar incentive within their own organisation, it is permissible for NHS bodies, in appropriate circumstances, to establish schemes for giving their employees reasonable financial rewards, linked to the commercial success of Intellectual Property. 6. The NHS Executive will be responsible for ensuring that Intellectual Property within the NHS is managed in accordance with this Policy Framework. 6.1 In line with this Policy Framework, when the NHS Executive commissions R&D from another NHS body under the NHS R&D Programme it will generally agree that any Intellectual Property is owned by that other body. 6.2 It will be a condition of R&D Support Funding for NHS Providers that they act in accordance with this Policy Framework when using that funding. The NHS Executive will not require a share of profits from Intellectual Property developed as a result of R&D funded by NHS Trusts using their NHS R&D Support Funding. Such revenue sharing will, however, be a condition of R&D Support Funding contracts with Primary Care Independent Contractors and voluntary or private sector healthcare providers. 6.3 The NHS Executive will monitor the implementation of this Policy Framework within the NHS. 11
Appendix 2 Categories of intellectual property Categories Protected by Inventions, each embodying a new idea capable of being made or used by industry and involving a non-obvious inventive step. (exclusions to this include mathematical algorithms, methods of treatment of the human or animal body by surgery or therapy, or methods of diagnosis) Patent Literary and artistic works, films, videos, records, broadcasts and typographical arrangements, including computer software Copyright Designs and design drawings, mainly of aesthetic objects Engineering components, architectural drawings, etc. Registered design rights Unregistered design rights Product brand names, company logos, etc. Trade marks Trade secrets, background techniques Know-how 12
Appendix 3 Different Forms of Intellectual Property There are several forms of protection for Intellectual Property. They are as follows: Patents Patents cover products or processes that have new aspects to them. A patent means the owner has a monopoly right that prevents others using their invention. Patents are published. Copyright Copyright provides legal protection for original literary, musical, artistic work. It protects against copying. Copyright happens automatically when work is produced and doesn t need to be registered, but it is advisable for the owner to attach a statement to their work to establish ownership. Trademarks A trademark is a sign which distinguishes one trader from another e.g. a logo, picture, word or phrase. It can be used as a marketing tool. Registered Design Registered design protects the visual appearance of an object. Design Rights Design rights are applied to original designs and provide protection against copying. 13
Appendix 4 Bibliography HSC 1998/106 Policy Framework for the Management of Intellectual Property within the NHS arising from Research and Development. Department of Health, Leeds 1998. NHS Executive, 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, Department of Health 1998. Department of Health. 2002. The NHS as an Innovative Organisation. A Framework and Guidance on the Management of Intellectual Property in the NHS. Department of Health. 2001. Research Governance Framework for Health and Social Care. UK Intellectual Property Office www.ipo.gov.uk 14