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Document name: West Yorkshire Mental Health & Learning Disabilities Research Partnership: Intellectual Property Guidelines

Document type: Guidelines

Staff group to whom it applies:

All staff within the Trust

Distribution: The whole of the Trust

How to access: Intranet

Issue date: March 2011

Version: 4.0

Next review: March 2014

Approved by: Executive Management Team

Developed by: West Yorkshire Mental Health & Learning Disabilities Research Partnership Research Management and Governance Manager

Director leads: Medical Director

Contact for advice: West Yorkshire Mental Health & Learning Disabilities Research Partnership Research Management and Governance Manager

document.doc of 27Document Ref: RD- 0006Date effective from: 13.12.10

Intellectual Property Guidelines

Date effective from: 13.12.10

Review date: 3 years from date effective from

Version number: 4


DOCUMENT SUMMARY SHEET

Document title*: Intellectual Property Guidelines

Document reference number*: RD-0006

Version number: 4

Member of the Executive Team Responsible*:

R&D Director

Document author*: Research Management and Governance Manager

Members of procedural document development group:(Note: please list titles not names of individuals)

Head of R&DLPFT Head of QualitySWPFT Medical Directorate Business Manager

People (please use titles) / committees or groups consulted:

Medipex LPFT and SWYPFT R&D DirectorsLPFT and SWYPFT Finance DepartmentsLPFT and SWYPFT Information Governance LeadsMembership of LPFT R&D CommitteeMembership of SWTPFT R&D Trustwide Action Group

Approved by (group/committee): Joint Research Governance Committee

Date approved: 13.12.10

Ratified by: LPFT Risk Management and Governance CommitteeSWYPFT Medical Director (Exec Responsibility for R&D)

Date ratified:

Date effective from: 13.12.10

Review date: 13.12.13

Frequency of review: 3 years

Responsible for the review: Research Management and Governance Manager

Target audience:(List, by title, the people for whom this procedural document is essential)

All staff

Responsible for dissemination: Research and Development Department

Copies available from: As above


Where are essential paper copies held (include unit addresses):

Research and Development Department North Wing, St Mary’s House, St Mary’s Road, Leeds, LS7 3JXhttp://www.wymhrdconsortium.nhs.uk/

DOCUMENT AMENDMENT SHEET

Version Amendment Reason1 P1 Document Author

P5 Revision of Guidelines aimsP7 Onwards - Significant new sections to bring Consortium Guidelines into line with wording suggested by NHS IP Hub Medipex’s advice and model Guidelines.

Previous document author no longer with the TrustTo explicitly include protection and exploitation.Increased clarity of procedures and resources available for IP protection and exploitation.Increased commonality with other local /National organisations.Inclusion of more appropriate wording, in line with Medipex advice.

4 Format restructuringRewording for new Partnership arrangements

To meet NHSLA requirementsTo reflect the new arrangements between SWYPFT and LPFT following BDCT withdrawal from the Consortium.


http://www.wymhrdconsortium.nhs.uk/

ContentsPage

1 Introduction 5

2 Purpose of Document 5

3 Definitions 6

4 Duties 7

5 Managing IP in the Trust 8

5.1 Overview 8

5.2 Sharing the Benefits 9

5.3 IP Arising From R&D Funded by the NHS 10

5.4 Dealing With IP 10

5.5 Guidelines for Staff 11

5.6 Audit of IP 11

5.7 Disputes 12

6 Development of Procedural Documents 13

7 Dissemination and Implementation 14

8 Monitoring Compliance 14

9 Associated Documentation 15

10 Contacts 15

Appendix A Equality Impact Assessment 16

Appendix B Plan for Dissemination and

Implementation

19

Appendix C Health Service Circular HSC 1998/106 20

Appendix D Categories of IP 23

Appendix E Forms of IP 24


1. INTRODUCTION

Innovation can occur through research and development and in the delivery of patient care. The Intellectual Property (IP) that arises from innovation needs to be properly managed to ensure the benefits for patient 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 Guidelines document provides guidelines for the management of Intellectual Property in Consortium Trusts. It complies with HSC 1998/106 ‘Policy Framework for the Management of Intellectual Property within the NHS arising from Research and Development’1 (See Appendix C). HSC 1998/106 placed a mandatory duty on Trusts to protect and exploit IP arising from Research and Development.

This Guidelines document also takes account of the changes introduced by the Framework and Guidance on the Management of Intellectual Property2, which took effect on the 9th September 2002. The framework and guidance extended HSC 1998/106 to include IP generated by NHS employees outside Research and Development activities through the management or delivery of patient care. It also allows Trusts to use companies for exploitation of IP and provides guidance on the management of IP and the handling of any income generated. In addition to the above, the Research Governance Framework for Health and Social Care3 requires employers of researchers to have in place agreements between them and their staff, research funders, and care organisations, relating to the ownership, exploitation, and income from IP arising from research conducted by employees.

2. Purpose of the Document

The aims of the Guidelines 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; To protect and exploit IP (arising from R&D activity).

1 NHS Executive. July 1998. HSC 1998/106. Policy Framework for the Management of Intellectual Property within the NHS arising from Research and Development. 2 Department of Health. 2002. The NHS as an Innovative Organisation. A Framework and Guidance on the Management of Intellectual Property in the NHS.3 Department of Health. 2005. Research Governance Framework for Health and Social Care.


3. Definitions

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 of the HSC1998/106 noted above) and include copyright, design rights, patents, and trade marks (see Appendix 3 ibid). IPR gives the owner of IP the right to stop others exploiting it.

Intellectual property resulting from innovation can occur through the delivery or management of patient care, in education or training, or through a Research and Development project or programme. IP may fall into the following categories (see also Appendix 2 ibid):

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.

Intellectual property can be protected by legal rights such as Patents, Copyright etc. Acquiring such rights can be costly and is only the initial step. Little or no benefit will accrue from protecting the intellectual property unless they are then developed and commercialised. The NHS has set up the IP Hubs to advise Trusts on whether or not the intellectual property has commercial potential and how best to take it forward.

Regional IP Hub – one in a network of organisations mandated to facilitate the identification and exploitation of intellectual property resulting from innovation within the NHS. Locally this organisation is MEDIPEX.


4. Duties

Research and Development Director – it is the responsibility of the each partnership Trust R&D Director to assure themselves of the compliance with the related aspects of this policy. Such assurances should be represented at Trust Board.

In addition they should ensure appropriate approval and ratification of this policy, and its associated procedural documents.

Head of Research and Development – it is the responsibility of the Head of R&D to ensure all relevant staff are aware of the partnership policy, and to facilitate compliance with its contents.

Research and Development Manager – the effective implementation and operation of this procedure. Co-ordinating the approval processes for projects across the Partnership Trusts.

Executive Team – It is the responsibility of all members of the Executive Team to ensure they receive assurance from senior managers that those procedures within their area of responsibility have been reviewed, developed, consulted on, approved, ratified and implemented in line with the ‘Procedure for the Development and Management of Procedural Documents’.

Line Managers –It is the responsibility of all line managers to ensure that staff participating in research within their areas of responsibility are aware of this procedure and that they follow the procedure

All staff – Any member of staff who becomes aware of any practice that is not in accordance with this procedure, or where there are difficulties with implementing this procedure, has a responsibility to report this to their line manager who will assess the problem. If there is a problem specifically with this procedure this should be reported to the Document Author, who will note this for consideration at the next review of the procedure.

Procedural Document Authors – It is the responsibility of procedural document authors to action the ‘Procedure for the Development and Management of Procedural Documents’ and ensure all procedural documents for which they have responsibility are developed, reviewed, authorised, ratified and implemented in accordance with the requirements of the procedure, and that they have been put onto R&D Department website.


5. MANAGING IP IN THE TRUST

5.1 Overview

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 to the input from the Trust.

Where employees have joint contracts with other organisations, for example universities, a partnership agreement on intellectual property issues will need to be developed with each such organisation. Similarly these partnership agreements will need to cover situations in which the NHS would be considered a secondary employer, or where more than one member of staff is involved.

Exploitation of intellectual property involves both costs and risks. Consequently, it will by no means always be appropriate or cost effective to seek to protect and exploit potential intellectual property. In cases where patenting or licensing may be the most appropriate option, the Regional NHS IP Hub will undertake the negotiations on behalf of the Inventor and the Trust. In some instances the intellectual property may be a case of “best practice” which could be shared with other Trust/s and the network of IP Hubs may be used to disseminate these innovations, either through their own network or via other NHS bodies such as the Strategic Health Authority.

Exploitation of the Trust’s IP will be the responsibility of the Trust R&D Director/Head of Consortium R&D who will retain management responsibility for IP generated by Trust staff. All developments of IP should be channelled through the IP Hub managing the Trust’s intellectual property rights. They will assess the potential of the intellectual property and decide whether or not it is worth protecting and exploiting.

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;

In general, the organisation with the main contract will be responsible for protecting the property rights and for any commercialisation. Agreement will need to be reached as to the way the costs and benefits will be apportioned between the two organisations. These working arrangements may differ with each particular organisation.

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 these Guidelines 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 INSERT NAME Trust, INSERT YEAR OF CREATION’. 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.

5.2 SHARING THE BENEFITS

If the Trust chooses to protect intellectual property rights then it is considered appropriate that members of staff who have developed the intellectual property should have a share in any benefits e.g. through a royalty income.

It is suggested that the net benefits to the Trust should be split 40% for the inventor and 60% for the Trust (after deductions of the costs due to The Regional NHS IP Hub associated with protection and commercialisation). Half of the Trust’s 60% would be retained by the relevant Clinical Management Team or Corporate Function, and half would go to R&D.

If IP arose from research which was funded by an external, non-NHS or University agency, whose Guidelines on the commercialisation of IP was different from the Trust and which formed part of the research contract, then the distribution of financial benefit would be negotiated by the Regional NHS IP Hub on behalf of the Trust with the funding body.

If the Trust does not wish to own a certain piece of Intellectual Property then it may be assigned to the member of staff who would then assume ownership. The member of staff would then take up responsibility for protection and commercialisation. In this case the Trust would retain a residual share of the financial benefits, for example 20%.

The Regional NHS IP Hub will only undertake work on behalf of the Trust. If a Trust employee wishes the Regional NHS IP Hub to advise or undertake


commercialisation of IP for which they are the inventor, it is done on the understanding that the Regional NHS IP Hub is acting on behalf of Trust, in line with the Trusts policy and any benefits accrued from such work will belong to the Trust who will split them with the inventor as outlined above.

5.3 INTELLECTUAL PROPERTY ARISING FROM RESEARCH AND DEVELOPMENT FUNDED BY THE NHSAppendix C contains the policy framework for managing intellectual property that 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 R&D Policy and Procedures and submit all research proposals to the Trust’s R&D Department. Advice on compliance with the NHS Executive Policy Framework and the Trust’s R&D Policy and Procedures can be obtained from the Trust’s Director of R&D or Head of R & D.

Researchers must also ensure compliance with the ‘Research Governance Framework for Health and Social Care’4. This states that researchers must consider the appropriate exploitation of intellectual property rights.

5.4 DEALING WITH INTELLECTUAL PROPERTY

Employees who think they may be undertaking work that might generate IP, particularly those involved in research and development, 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 lead for IP (the R&D Director or the Head of R&D). The IP lead, the inventor, and any partner organisations will liaise with Medipex, the local NHS Intellectual Property Hub5, and make an assessment of whether the innovation has any significant commercial value or potential. The IP lead will make a decision about how to proceed. The role of the IP Hub, Medipex is to:

Identify and register any IP, Provide advice on the exploitation, patenting and licensing of any IP, Undertake any negotiations on behalf of the inventor or the Trust,

4 Department of Health. 2005. Research Governance Framework for Health and Social Care.5 Regional Innovation Hubs are funded to manage the commercialisation of innovations arising from the NHS. The Innovation Hub in the Yorkshire and Humberside region is Medipex, www.medipex.co.uk or [email protected].


mailto:[email protected]

http://www.medipex.co.uk/

http://www.open.gov.uk/doh/coinh.htm

http://www.open.gov.uk/doh/nhsexec/ipr.htm

Assist with any legal matters that may arise as a result of the use or misuse of IP.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) cannot be obtained. The employee should seek a Director’s approval to submit for publication and ensure that the Trust’s contribution is acknowledged.

5.5 GUIDELINES FOR STAFF

If an employee develops an idea or concept, which may have commercial potential, they must report this to their Director or Senior Manager, who should contact R&D at the earliest opportunity and, in any event, before disclosure of the idea to any party outside the Trust, either orally or in writing.

Examples include the development of new techniques, devices, software, pharmaceutical products, formulae and writings.

It is often difficult to protect IP and advice is needed at the earliest stages. If an employee thinks they have an item of intellectual property there are a few simple guidelines which will help maximise the chances of being able to protect it:-

Keep it secret and resist pressure to announce or publish details until the matter has been discussed with either R&D or the Regional NHS IP Hub. Public disclosure (other than under explicit terms of confidentiality) will invalidate any subsequent patent application and severely diminish both potential commercial value and benefits accruing to the Trust and the originator. Disclosure without entering into an undertaking of confidentiality may prejudice negotiations of commercial arrangements with a company.

Confidentiality Agreements must be used when discussing intellectual property with external parties. These can be obtained from R&D or the Regional NHS IP Hub.

Avoid giving away or selling samples. Don’t involve external organisations or companies in testing or prototyping

without a written agreement together with confidentiality agreement being in place. These agreements must be reviewed by R&D prior to signature.

Do not sign any contracts or agreements until they have been reviewed by R&D.

5.6 AUDIT of IP

R&D, with the assistance of The Regional NHS IP Hub will, from time to time, arrange for an audit of Trust activity to identify intellectual property of potential commercial value. Staff are required to co-operate fully with this activity.


A Register of intellectual property will be maintained centrally and this will be made available to the auditors, as required.

5.7 DISPUTES

In the event of any dispute about the interpretation of these Guidelines, Trust employees have recourse to the Trust’s grievance procedure to resolve the dispute.


6 THE DEVELOPMENT OF PROCEDURAL DOCUMENTSThe development, consultation, approval and ratification of this procedure is listed in the Document Summary Sheet

6.1 Prioritisation of WorkThis procedure has been developed to ensure LPFT and SWYPFT can participate in research and development that is compliant with national guidance and legislation.This procedure will be reviewed in three years unless national guidance or legislation requires an earlier review. This policy will be reviewed by consultation with stakeholders along with the results of any monitoring of the compliance and effectiveness of this procedure.

6.2 Identification of Stakeholders

Stakeholder Level of involvementHead of Research & DevelopmentLPFT Medical Directorate Business ManagerSWPFT Medical Directorate Business ManagerResearch Management and Governance Manager

Development

LPFT and SWYPFT R&D DirectorsLPFT and SWYPFT Finance DepartmentsLPFT and SWYPFT Information Governance LeadsMembership of LPFT R&D CommitteeMembership of SWYPFT R&D Trustwide Action Group

Consultation

Joint Research Governance Committee

Approval

Risk Management & Governance Committee (LPFT)Clinical Risk and Clinical Governance Committee (SWYPFT)

Ratification

6.3 Equality Impact AssessmentThe completed equality impact assessment is in Appendix A.


7. DISSEMINATION AND IMPLEMENTATION

The plan for dissemination and implementation is attached as Appendix B.

7.1 Dissemination

The Procedure will be disseminated in accordance with the plan detailed in Appendix A.

7.2 Training and support for the implementation of the procedural document

This procedure provides guidance which someone not familiar with the process can follow.

Specific training for guidance enquiries will be provided to all new Research and Development Team members and Medipex representatives.

8. MONITORING COMPLIANCE WITH AND THE EFFECTIVENESS OF PROCEDURAL DOCUMENTS

8.1.Process for Monitoring Compliance

Confirmation of compliance as part of the annual R&D audit. periodic audit by MEDIPEX of Trust IP

8.2.Process for Monitoring Effectiveness

Confirmation of compliance by annual paper based monitoring process and in the randomly selected sample of projects in the R&D audit. Receipt of MEDIPEX Audit report

8.3.Standards/Key Performance Indicators

The standard and key performance indicators for the Project Management Procedure are as follows:-

any IP generated is identified by R&D/MEDIPEX Exploitable IP is used by MEDIPEX to generate appropriate

income.


9. Associated Documentation

LPFT Intellectual Property Policy

SWYPFT Intellectual Property Policy

Partnership Project Monitoring and Audit Procedure

Partnership Project Approvals Procedure

‘Handling Inventions and other Intellectual Property: A Guide for NHS Researchers’. NHS Executive. 1998. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4008102

10.Contacts

MEDIPEXLyndon Judd [email protected]

Tel: 0113 397 0837

Medipex Ltdicon Business Centres (Leeds) Ltd4100 Park ApproachThorpe ParkLeeds, LS15 8GB


mailto:[email protected]

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4008102

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4008102

Appendix A – Equality Impact Assessment Form

Equality Impact AssessmentInitial Impact Screening Form

1 Name of procedural document/function/service development being

assessed?

Intellectual Property Guidelines

2 Describe the main aims, objectives and intended outcomes of the procedural document/function/service development?

Aim: 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;

Objective:

Intended Outcomes: good research governance and high quality research, appropriate exploitation of intellectual property derived from Trust activity

3 Who is affected by this policy?

Staff x Service Users

Other Stakeholders □ (please specify)…University partners………………


4 Are there differences in outcomes for different groups? Yes □ No xWhich equality groups may be disadvantaged/experience negative

impact?

Race Yes □ No x

Disability Yes □ No x

Gender Yes □ No x

Age Yes □ No x

Sexual Orientation Yes □ No x

Religion/Belief Yes □ No x

Mental ill health Yes □ No x

Other (e.g., refugees, gypsies and travellers)……............Yes □ No □

Equality Impact AssessmentInitial Impact Screening Form (cont...)

5 Is there an adverse impact? Can you please rate on a scale of 1-5. (none = 0, low = 1-2, medium = 3-4, high = 5)

Rating = 0

How have you arrived at the above rating?

What evidence do you have and how has this been collected? (personal knowledge, feedback, research, etc)

Consultation and feedback from stakeholders.


6 Relevance to General Duties – is the procedural document or practice directly or indirectly discriminatory? Is there any differential and/or adverse impact contrary to key service objectives and/or Respect – Our Single Equality Scheme and our Respect Strategy? Can you please rate on a scale of 1-5. (none = 0, low = 1-2, medium = 3-4, high = 5)

Rating = 0

How have you arrive at the above rating?

Consultation and feedback from stakeholders.

7 Overall Rating - please add the two ratings and divide by two to give the over all rating. 0

Please note that all policies where an adverse impact has been identified (even low) will need to have a full impact assessment.

8 Have you explained your procedural document/function/service development to people who might be affected by it?

Yes x No □

If yes, please give details of those involvedBriefings at relevant committees and advisory groups.


Appendix B – Plan for Dissemination and implementation of Procedural Documents

SECTION 1 – DETAILS OF DOCUMENT TO BE DISSEMINATED

Title of Document Intellectual Property Guidelines

Date Ratified Insert date when ratified

Dissemination lead name

John HileyResearch Management and Governance Manager

Contact details 0113 2954462

SECTION 2 – DETAILS OF PREVIOUS DOCUMENT TO BE RETRIEVED

Previous document already in use (Y/N) Y Version No &

Date 3.0 June 2009

Name of document if different from Section 1In what format (paper/electronic) E Where is this

filed locallyPartnership Web-site

Proposed action to retrieve out-of date copies of the document

Deletion form web-site

SECTION 3 – DETAILS OF DISSEMINATION

Date put on R&D Website Insert

Who is the document to be disseminated to

Research and Development CommitteesResearch active staff

Disseminated to (either

directly or via meetings, etc)

Format Date

disseminatedNo of

copies sent

Contact details/comments

Research and Development Committees

Electronic


Appendix C

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.

1.1Intellectual 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.

1.2There 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.

2.1When 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.

2.2Ownership 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.

2.3NHS 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.


2.4Exceptionally, 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 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.

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.

4.1NHS 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.

4.2Ownership 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.

4.3Exploiting 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.

4.4Few 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.

4.5Before 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.

5.1This 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.

5.2To 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.


Appendix D – Categories of intellectual property6

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

Registereddesign rights

Engineering components, architectural drawings, etc. Unregistered design rights

Product brand names, company logos, etc. Trade marks

Trade secrets, background techniques Know-how

6 NHS Executive. July 1998. ‘Handling Inventions and other Intellectual Property. A Guide for NHS Researchers’.


Appendix E – 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.
