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The Newcastle upon Tyne Hospitals NHS Foundation Trust

Intellectual Property (IP), Revenue Sharing & Equity Policy

Version No.: 3.0

Effective From: 27 June 2017

Review Date: 27 June 2020

Date Ratified: 28 February 2017

Ratified By: Investment Committee & Clinical Policy Group

1. Introduction The Innovation, Health and Wealth Report 2011i and the NHS Five Year Forward View 2014ii state the continuing importance of developing the NHS as an innovative organisation, especially in the current challenging economic environment. This will not only lead to improved health outcomes but also contribute to the wider economy and nation’s wealth. Appropriate management of Intellectual Property (IP) is critical to achieving these goals and this policy sets out the manner in which IP should be managed within The Newcastle upon Tyne Hospitals NHS Foundation Trust (the Trust). The policy supersedes any previous policy held by the Trust and will be effective for any new commercial agreements signed after 1st January 2017. 2. Policy Scope This policy applies to all Trust Directorates, departments and staff including: i. All staff that are full or part time Trust employees, including employees on

honorary contracts1 (paid or not) and/or are self-employed, agency, or locum staff.

ii. Staff with a Trust contract of employment whose payroll costs are partially or wholly funded by another party (e.g. medical charity, government) unless the contract between the Trust and that party assigns ownership of the IP to that party.

iii. Trust staff seconded to another organisation or employees of another

organisation seconded in to the Trust who are under contract. Normally, the IP will be in the ownership of the employees substantiate employer.

iv. Staff who generate IP outside of their normal working hours and/or away from the

workplace, where the IP relates to their specialist area of employment within the Trust, the Trust shall own the IP.

1 The close relationship which the Trust has developed with Newcastle University has led to a number

of jointly employed staff or staff on honorary contracts in either organisation. These include: medical, dental, research and non-medical/non-research honorary contracts. These employees are covered as stipulated in their contract of employment.

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v. Trainee professionals or students hosted by the Trust who generate IP during the course of their training at the Trust.

3. Aim of Policy This policy is in line with and follows the current framework and guidance published by the Department of Healthiii. It relates to additional powers given to “NHS bodies” under section 5 of the Health and Social Care Act 2001iv, which allows them to form or invest in companies and permits NHS organisations to partake in the generation of income. The exploitation of Intellectual Property falls within the Trust’s scope of income generation. It has been recognised that advances in health and social care are sometimes required to be exploited commercially if they are to be made widely availablev. A policy framework for the management of intellectual property arising from R&D in the NHS has been in existence since 1998vi which encourages NHS organisations and their staff to identify, protect and exploit their intellectual property. The current framework and guidanceiii extends the scope to cover the full spectrum of NHS activities (e.g. patient care, education and training, administration and support functions) and not just R&D. This policy aims to outline the importance of intellectual property and its proper management within the Trust and provides guidance by which it can be achieved.

4. Duties (roles and responsibilities)

4.1. Chief Executive / Trust Board

Ultimate responsibility for the implementation of this policy including ensuring that the Trust policies comply with all legal, statutory and good practice requirements.

4.2. Executive Member responsible for business

Responsible for implementing and ensuring compliance with this policy.

Responsible for the management and protection of IP for the Trust

All decision-making authorities and granting of all permissions as described within the policy.

4.3. Trust Secretary

Responsible for ensuring that the Trust has a process in place to verify that all legal documents associated with this policy are legally sound and reflect the Trust’s interests.

4.4. Persons nominated by the Trust’s Executive member responsible for

business

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Responsible for issuing guidance and compliance with this policy, as authorised by the Trust’s Executive Member responsible for business.

4.5. All staff

Responsible for co-operating with the implementation of this policy as part of their normal duties and responsibilities.

5. Definitions None specific to this policy. 6. General Principles

6.1. Intellectual Property Intellectual property is the tangible result of intellectual or creative activity such as novel ideas, knowledge and innovation. Intellectual property can be legally protected (intellectual property rights) through the use of patents, copyrights, design rights, trademarks or non-disclosure agreements (see Appendix 1).

Intellectual property rights provide a means for the optimum exploitation of creative activity and can be bought, sold or licensed. Intellectual property must be adequately protected in the interests of both owners and inventors to prevent other parties infringing on their intellectual property rights

6.1.1. Confidentiality

As a condition of employment, all Trust employees or other persons identified in Section 2 should be familiar with the need to preserve the confidentiality of sensitive information which is made available to, or generated by, them during the course of their work. This is critical to maximise the potential benefits of IP as any non-confidential disclosures of IP generated during the course of Trust activities may prejudice future programmes of research, and/or commercial opportunities. If confidential information needs to be shared with another person or organization (e.g. to seek advice or funding), then a confidentiality agreement (CDA) needs to be raised with the other party prior to disclosing such information to them. The Executive Member responsible for business or their nominated person(s) will be able to advise and arrange for a CDA to be raised. All CDAs must be signed by the Trust Secretary, a member of the Executive Board or their nominated person(s).

6.1.2. Disclosure IP cannot normally be protected (especially in the case of filing patents) once prior disclosure has occurred, including through: presenting papers, posters, abstracts, chapters in books and verbal and written communications. Any IP with the potential to be exploited must not be disclosed to anyone outside the

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Trust without prior consent of The Trust’s Executive Member responsible for business, or nominated person(s). Any employee believing they may have potential IP should contact the Innovation Portal via innovation@nuth.nhs.uk prior to any disclosure and the proposition will be assessed. The purposeful disclosure of commercially sensitive material, including ideas which may be protected and exploited in the future contravenes the principles set out in this policy. Please see Appendix 2 for more information on publication.

6.2. Ownership of IP The Patents Act 1977vii and the Copyright, Designs and Patents Act 1988viii state that in the majority of cases the ownership of IP rests with the employing organisation. In accordance with this, the Trust reserves its right to own all intellectual property created by its employees during the course of their normal working duties.

6.2.1. Collaborative Projects The Trust and its employees often work in partnership with external partners or organisations. Where this is the case, an agreement stating the ownership and sharing of any IP generated within the project is required and should be in place before the work commences. The Trust’s Executive Member responsible for business, or nominated person(s), will have the responsibility for developing IP sharing agreements with collaborating institutions. Trust employees should consult with the Trust’s Executive Member responsible for business or their nominated person(s) for advice before entering into a joint project with another organisation which may involve the generation of IP. The Trust and Newcastle University have a long-standing relationship with regard to collaborative projects and realise that collaborative research projects involving staff from both institutions, or staff operating on honorary contracts, may generate intellectual property. The two institutions have therefore aligned their IP policies to give common revenue or equity shares to inventors. Should commercially exploitable IP arise from collaborative projects, employees should inform the Trust’s Executive Member responsible for business or their nominated person(s). 6.2.2. Dispute of Ownership If the ownership of IP is disputed, then any documentation and written records relating to the IP in question will be reviewed to establish the inventor(s) proportionate contributions (see Appendix 2 for the importance of written records). The Trust’s Executive Member responsible for business or their nominated person(s) will make the final decision if an amicable solution cannot be reached, taking professional advice as required.

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6.2.3. Copyright Although by law copyright of any work produced by an employee during the course of their employment belongs to the employer, in common with normal public-sector practice the Trust will generally assign copyright in that work to the author where the work is intended for publication in a professional or academic journal or book. However the Trust reserves the right to reproduce and use this copyright material at no cost for the Trust’s own non-commercial purposes, including for research and training. This assignment of copyright material only relates to publications in professional or academic literature and the Trust will not assign any of its other copyright to the author including, without limitation, copyright in:

Course or training materials

Patient information leaflets

Any software program or database generated by an Trust employee in the normal course of their duties;

Any designs, specification or other works which may be necessary to protect rights in commercially exploitable IP

6.3. IP Management The Trust, on occasion, may utilise the services of external technology transfer organisations or independent patent agents for the exploitation and/or protection of IP. This may involve up-front costs or a share of the eventual revenues being agreed with that organisation.

Please see Appendix 3 for the Trust’s IP commercialisation pathway

6.3.1. Staff Obligations Employees have an obligation to inform the Trust Management (through their directorate manager or by informing the Trust Secretary or the Executive Member responsible for business) regarding identified or potential IP resulting from their activities and must not, under any circumstances, sell, assign, license, give or otherwise trade IP without the Trust’s formal written agreement. Any employee found to be involved in the unauthorised exploitation of IP on the Trust’s behalf, or for their personal gain, may face disciplinary action.

See Appendix 2 and 3 for further guidance on staff procedures. 6.3.2. Decisions on Exploitation The decision whether to progress the commercialisation of an idea/invention will be taken at the joint Opportunities Meeting between Newcastle University’s Faculty of Medical Sciences (FMS) and the Trust. Following a positive recommendation from the Joint Opportunities Meeting, approval for

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expenditure for filing patents or other similar investment must be gained from the Trust Innovation Committee. The decision on the final exploitation step for such opportunities, in particular to take the opportunity to market (e.g. through licence or spin out) will be made by the Trust Investment Committee or the Joint Business Executive (JBE) for joint projects with Newcastle University and/or Northumberland Tyne and Wear NHS Foundation Trust. Decisions on whether to exploit IP will be based on factors such as the ability to demonstrate market potential, the likelihood of success of the venture, patient benefit and potential financial return. Where or when the Trust chooses not to exploit IP, exploitation rights may be granted to the inventor, or other party, at the Trust’s discretion. In the event that the Trust grants exploitation rights to the inventor, or other party, it retains the right to use the IPR for its own purposes royalty-free and in perpetuity. 6.3.3. Contract Negotiations Any IP that is licensed, sold or otherwise transferred to another organisation will be negotiated in the best interests of the Trust by the Trust’s nominated officer. Such nomination will be made by the Executive Member responsible for business for the Trust. Employees will not under any circumstance, being the inventor or otherwise, enter into commercial negotiations regarding the Trust’s IP with external organisations without the prior consent and authority of the Executive Member of the Trust responsible for business.

6.4. Revenue & Equity Sharing The Trust believes that it is important to actively encourage employee innovation in the work place, especially where it significantly enhances patient care and contributes to the overall productivity of the Trust. The Trust’s policy will be to reward staff [lead inventor(s)2] and departments who have had the initial original idea that results in commercially valuable intellectual property being generated and subsequently exploited. Members of staff include former members of staff, i.e. where revenue or equity is received after employment has ended. The Trust does not expect to share revenues or equity with those individuals employed by the Trust whose everyday role it is to generate ideas and develop those or other ideas into products. The activity of new product development is expected to be rewarded at the departmental level, not the individual level. Any dispute regarding who may be considered an inventor or developer will be settled in accordance with Section 6.2.2

6.4.1. Revenue Sharing

2 A lead inventor is defined as the person(s) who had the original novel idea. A lead inventor is not

somebody who then goes on to make that idea a reality (i.e. a developer).

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Where the Trust Investment Committee, or Joint Business Executive (JBE) for joint projects with Newcastle University and/or Northumberland Tyne and Wear NHS Foundation Trust, decide that the best route to commercialising IP generated within (or in partnership with) the Trust is through licensing, then the below revenue sharing formula shall be applied. Revenue Sharing with External Partners

The Trust recognises that it does not, and should not hold all of the resources or capabilities necessary to take an initial idea all the way from initial concept to market. In order to achieve this it is likely that external organisations will play a part in the development and commercialisation of intellectual property and that these organisations may be eligible for a share of revenues generated from product sales. The main external partners who might be entitled to a share of revenues generated from the exploitation of IP would be:

Commercial Partner i.e. the organisation that the IP is sold, licensed or assigned to for commercial exploitation

Co-Developer i.e. organisations that aid in the development of intellectual property

Funding Body i.e. government grants, charitable bodies, financial institutions or private finance

Technology Transfer Body – a function or organisation that aids the commercialisation process and transfers intellectual property from the Trust to the commercial partner for further development and exploitation.

Please note that not all IP might require funding from external sources, engagement with a co-developer and/or utilisation of an external technology transfer organisation to aid in the commercialisation of IP. It is asked that employees give due consideration to the income dilution effects of engaging with external organisations for the development and commercial exploitation of intellectual property.

Approaches to commercial partners and external technology transfer bodies will be made by the Executive Member responsible for Trust business or their nominated person(s). Employees should not negotiate with commercial partners without express permission from the Executive Member of the Trust responsible for business or their nominated person(s) (see section 6.3.3).

Revenue Sharing from IP Exploitation The share of revenues will be allocated to the lead inventor(s), the directorate(s) involved in the concept and development of the IP and the Trust Innovation Fund (which is used to re-invest in innovation within the Trust). This will be in accordance with the following formula and net of any protection and exploitation costs (e.g. patent protection costs) and amounts distributed

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to external partners involved in the development and commercialisation of the IP. The amounts distributed to external partners will be governed by agreements made on a case-by-case basis.

% Revenue Share Cumulative Net

Income Trust Innovation

Fund Directorate Lead Inventor(s)

< £5,000 n/a n/a 100% £5000 - £200,000 25% 25% 50% > £200,000 40% 20% 40%

Due to close working arrangements often found between Hospital Trusts and University medical schools, the adoption of a similar or identical revenue sharing schemes to that of University partners is generally recommended. This avoids co-inventors in separate institutions being rewarded differently. The Trust and Newcastle University have therefore decided to align their internal revenue sharing agreements for the avoidance of confusion and/or doubt. The Trust will always be willing to consider arrangements to reinvest lead inventor(s) shares in further departmental research should the lead inventor(s) wish to do so. 6.4.2. Equity Sharing As an alternative to licensing IP, it may be decided by the Trust Investment Committee, or Joint Business Executive (JBE), that the best way to exploit IP might be to form a spin out organisation. This would involve sharing equity between the lead inventor(s), institution(s) and any external partners, i.e. management, involved in the company formation. The Trust Investment Committee (or JBE) will review projects on a case by case basis to agree the appropriate equity sharing arrangements between inventors and the other organisations involved, taking into account the relative contributions made by each party. The agreed common framework for initial (pre-dilution, pre-investment) equity allocation is as follows: Institution: 40% Founding staff (to be allocated between them on a case-by-case basis): 40% Founding management: 20%

6.5. Open Source Software

The designation of software developed by, or on behalf of Trust staff, as open source and the release of an ‘app’ requires the formal approval of both the Chief Information Officer and the Trust’s Executive Member responsible for business or their nominated person(s).

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7. Training This document does not form part of the mandatory training content although it is advisable that all staff should have an awareness of the importance of intellectual property and its proper management as outlined in the policy. The Business & Development department regularly provides training initiatives on IP and innovation support to help spread awareness – further details can be obtained from the Trust’s Executive Member responsible for business or their nominated person(s). 8. Equality and Diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This document has been properly assessed.

9. Monitoring Compliance

Standard / Process / Issue

Monitoring and Audit

Method By Committee Frequency

Raise confidentiality agreement prior to disclosure of sensitive information

Maintenance of Business & Innovation legal agreement register

Persons nominated by Trust’s Executive member responsible for business

N/A Monthly

Decision to progress the commercialisation of an idea

Submission and approval of paper to Opportunities Meeting

Persons nominated by Trust’s Executive member responsible for business

Joint Trust-FMS Opportunities meeting

Fortnightly

Approval for expenditure on filing patents or other IP

Agenda item for Trust Innovation Committee

Executive Member responsible for business

Trust Innovation Committee

As required

Decision to exploit an idea/invention

Preparation and submission of position paper

Executive Member responsible for business

Trust Investment Committee or Joint Business Executive

Two-monthly

Ideas processed in accordance with IP Commercialisation Pathway

Innovation pathway tracking system

Persons nominated by Trust’s Executive member responsible for business

Business & Innovation team meetings

Monthly

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10. Consultation and Review This policy has been reviewed and ratified by the Trust Investment Committee, with input and feedback also being sought from the Chief Executive Directorate. 11. Implementation (including raising awareness) A summary of the key changes will be notified to managers following implementation. Further advice and guidance will be available from the Business & Development Department. 12. References

i Department of Health (2011) Innovation Health and Wealth; Accelerating Adoption and Diffusion in the NHS (available from http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_131299) ii Department of Health (2014) NHS Five Year Forward View October 2014, (available from https://www.england.nhs.uk/ourwork/futurenhs/) iii Department of Health (2002) The NHS as an Innovative Organisation: A Framework and Guidance on the Management of Intellectual Property in the NHS (available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4002660) iv Health and Social Care Act 2001(available from: http://www.legislation.gov.uk/ukpga/2001/15/contents) v Department of Health (2005) Research Governance Framework for Health and Social Care (available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962) vi HSC 1998/106 (1998) Policy Framework for the Management of Intellectual Property within the NHS Arising from Research and Development, (available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004971) vii Patents Act 1997 (available from: http://www.ipo.gov.uk/patentsact1977.pdf) viii Copyright, Designs and Patents Act 1988 (available from: http://www.legislation.gov.uk/ukpga/1988/48/contents)

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Appendix 1: Forms of Intellectual Property This appendix describes certain areas of intellectual property and how it can be protected. Intellectual property law is very complex and members of staff are advised to contact the Trust Secretary or the Executive Member responsible for business or their nominated person(s) to discuss IP protection at their earliest convenience. Employees are required not to disclose their inventions or ideas in any way (i.e. publication, presentation, word of mouth) to third parties before seeking advice. This can seriously diminish the potential value of the invention or idea. Category

Protection Examples How to protect

Inventions Patents Medical devices, novel processes, methods of operation

Filing of a patent application. The invention should not be made public anywhere in the world (e.g. journals, presentations, posters) prior to the filing of a patent application

Literary works

Copyright Leaflets, articles, assessment tools, training packs, databases, computer software

Automatic. Should include a statement e.g. "Copyright © [year] The Newcastle upon Tyne Hospitals NHS Foundation Trust. All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner."

Designs Registered and Unregistered Design Rights

Engineering components, architectural drawings, medical illustrations, unique appearance of commercial objects

Automatic or registration. Where registered design protection is required, the design should not be made public prior to filing of registration

Branding Trademarks Trust logo, slogans, labelling

Registration – can be filed at any time

Trade Secrets

Know-how Surgical techniques, chemical processes, client lists

Non-Disclosure Agreement or total secrecy

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Appendix 2: Staff Procedures and Expectations

Publications Whilst the Trust realises that employees may, from time to time, publish their work and be named as the author of the copyright material which may be shared with colleagues, it urges employees to consider that the best and most efficient way to develop and distribute concepts and ideas might not always be through publication but to protect that intellectual property and exploit it. If this route is to be taken then employees should be aware that all work needs to be kept confidential until it is correctly protected before publication. The employee should seek advice from Executive Member responsible for business or their nominated person(s) before publicly disclosing work which they believe may have potential for commercial exploitation. Confidentiality All work must be kept strictly confidential prior to seeking the correct intellectual property protection. If it is necessary to disclose commercially sensitive information advice should be sought from the Executive Member responsible for business or their nominated person(s). Record Keeping It is important for staff working on projects which generate IP to keep written, dated records of their activities and results. It is important that all correspondence, including e-mails, telephone conversations and meeting are logged and documented to provide a detailed account of any discussions relating to the IP. Supporting Technology Transfer From time to time it may be necessary for the lead inventor(s) to support the technology transfer of the intellectual property rights from the Trust to the commercial partner and aid in the commercialisation of that intellectual property. This may involve:

The translation of the intellectual property rights and know-how relating to the intellectual property either through written instruction or otherwise; and/or,

Reasonable support in commercialisation of the intellectual property through sharing of industry knowledge, hosting reference site visits, conducting further commercial research and development and presenting research at conferences, seminars and workshops.

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Appendix 3: Trust IP Commercialisation Pathway

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The Newcastle upon Tyne Hospitals NHS Foundation Trust Equality Analysis Form A

This form must be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. PART 1 1. Assessment Date: 12th January 2017 2. Name of policy / guidance/ strategy / service development / Investment plan/Board Paper:

Intellectual Property (IP), Revenue Sharing & Equity Policy

3. Name and designation of author:

Tony McCormack and Finn Willingham, Business Development Managers, Business and Development Department

4. Names & Designations of those involved in the impact analysis screening process:

Tony McCormack (Business Development Manager) and Lucy Hall (Equality & Diversity Lead, Patient Services Directorate)

5. Is this a: Policy x Strategy Service Board Paper

Is this: New Revised x

Who is affected: Employees x Service Users Wider Community 6. What are the main aims, objectives of the document you are reviewing and what are the intended outcomes? (These can

be cut and pasted from your policy)

The policy aims to outline the importance of intellectual property and its proper management within the Trust. It provides

guidance by which this can be achieved and gives a framework by which the Trust can identify, protect and exploit intellectual

property arising from all members of staff across the full spectrum of the Trust’s activities. The policy also provides information on

how members of staff who have original ideas that result in the generation and commercial exploitation of valuable intellectual

property should be rewarded.

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7. Does this policy, strategy, or service have any equality implications? Yes x – These have been taken into consideration within the final policy

If No, state reasons and the information used to make this decision, please refer to paragraph 2.3 of the Equality Analysis Guidance before providing reasons:

8. Summary of evidence related to protected characteristics Protected Characteristic

Evidence What evidence do you have that the Trust is meeting the needs of people in all protected Groups related to the document you are reviewing– please refer to the Equality Evidence within the resources section at the link below: http://nuth-vintranet1:8080/cms/SupportServices/EqualityDiversityHumanRights.aspx

Does evidence/engagement highlight areas of direct or indirect discrimination? For example differences in access or outcomes for people with protected characteristics

Are there any opportunities to advance equality of opportunity or foster good relations? If yes what steps will be taken? (by whom, completion date and review date)

Race / Ethnic origin (including gypsies and travellers)

The policy is being disseminated through presentations and discussion at Directorate level. Mangers are encouraged to let staff know what to do when they have a good idea and what support is available in the Trust to help them. Mandatory EDHR Training Each idea is assessed on its merit not on who submitted the idea

No Add equality issues into the flow chart so that new ideas take equality issues into account Tony McCormack Jan 2017

Sex (male/ female)

As above No As above

Religion and Belief

As above No As above

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Sexual orientation including lesbian, gay and bisexual people

As above No As above

Age

As above

No As above

Disability – learning difficulties, physical disability, sensory impairment and mental health. Consider the needs of carers in this section

As above Some staff with disabilities such as dyslexia may find it more difficult to submit ideas. This has been taken into account in the dissemination of the policy.

As above

Gender Re-assignment

As above No As above

Marriage and Civil Partnership

As above No As above

Maternity / Pregnancy

As above No As above

9. Are there any gaps in the evidence outlined above. If ‘yes’ how will these be rectified ?

No

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10. Engagement has taken place with people who have protected characteristics and will continue through the Equality Delivery System and the Equality Diversity and Human Rights Group. Please note you may require further engagement in respect of any significant changes to policies, new developments and or changes to service delivery. In such circumstances please contact the Equality and Diversity Lead or the Involvement and Equalities Officer. Do you require further engagement No

11. Could the policy, strategy or service have a negative impact on human rights? (E.g. the right to respect for private and

family life, the right to a fair hearing and the right to education?

No

PART 2 Signature of Author

Print name

A D McCORMACK

Date of completion

12th January 2017

(If any reader of this procedural document identifies a potential discriminatory impact that has not been identified, please refer to the Policy Author identified above, together with any suggestions for action required to avoid/reduce the impact.)