Guidance

Intellectual property (IP) guidance for the NHS in England

Published 18 November 2025

Applies to England

Ministerial foreword

For too long, we have heard and seen the challenges faced by innovators, collaborators and partners striving to bring their ideas to reality within the NHS. At the heart of each of these efforts lies a common goal: to enhance patient care and experience, deliver effective solutions to pressing health challenges and strengthen the productivity and sustainability of our health system.

That is why I am excited to launch this updated intellectual property (IP) guidance for the NHS in England, developed by the Department of Health and Social Care (DHSC) and NHS England, with support from the National Institute for Health and Care Research (NIHR).

Innovation is at the heart of this government’s agenda for improving patient care and driving forward healthcare reform. To realise the potential of innovation, ensuring that the NHS has the tools to manage IP effectively is critical. This IP guidance is exactly one of these important tools, providing the practical steps and good practice principles, real-life case studies from the sector and model agreements and templates that will enable the NHS to accelerate the development, adoption and commercialisation of innovations needed to drive forward healthcare reform.

By getting the fundamentals of IP management right, we can drive transformation, commercialise ideas both domestically and internationally and strengthen the UK’s position as a global leader in research and innovation in health and life sciences. Most importantly, it will ensure that the benefits of innovation - whether improved patient care, more efficient services or commercial returns - flow directly back to patients, staff and the NHS.

Dr Zubir Ahmed MP
Parliamentary Under-Secretary of State for Health Innovation and Safety

Introduction

Intellectual property and intellectual property rights

Intellectual property is a collective term referring to creations of the mind. For example:

• acts of innovation
• things you write, make or produce
• the design or look of products
• the names of products or brands
• proprietary knowledge (know-how)

Read an overview of IP from the Intellectual Property Office (IPO) on the web page Intellectual property and your work.

Organisations providing or commissioning NHS services and their staff generate, use and manage IP daily through research, innovation and service provision. This IP includes, but is not limited to:

• the extensive know-how of NHS staff
• training materials
• innovations created with NHS resources (people and infrastructure)
• NHS-generated data, databases and methodologies, including annotated imaging data and outcomes measures

The legal mechanism that provides protection for acts of innovation and creativity is intellectual property protection, giving rise to intellectual property rights (IPRs). These rights formalise the ownership of IP. While some IPRs, such as patents, trade marks and registered designs, are obtained through formal registration, unregistered IP, such as copyright and unregistered designs, receive automatic protection to prevent others from copying them without the owner’s permission. Other examples of unregistered IP, such as know-how, processes and trade secrets, are protected through appropriate confidentiality and contractual mechanisms rather than registration.

IP can be owned, assigned, licensed or shared, under different arrangements. Find more information on licensing at Licensing intellectual property.

The importance of effective IP management

Effective IP management encourages innovation by supporting the development of new products, services and pathways that benefit patients, the public and the organisation’s workforce while also contributing to economic growth. Active IP management is also critical when adapting or co-creating external innovations that involve the use of any NHS resources. Without clear IP management processes, the NHS risks losing valuable opportunities to develop and implement innovations.

Managing public money, issued by HM Treasury, emphasises that effective IP management is essential for safeguarding public assets and maximising value for taxpayers. Public bodies must maintain strategic oversight of IP to protect its value and ensure appropriate licensing or charges to prevent valuable assets from being lost or undervalued (see ‘Annex 4.15: Asset management’ in Managing public money). The guidance also highlights the importance of accountability, transparency and risk management in preventing IP misuse or infringement. Ultimately, it encourages public bodies to treat IP as a valuable and strategic asset that supports innovation, collaboration and long-term public benefit.

The Rose Book: Knowledge asset management in government provides guidance on identifying, protecting and realising the social, economic and financial value of IP. When considering IP in contracts, organisations providing or commissioning NHS services should be mindful of:

• terms and valuation, ensuring that the approach taken is proportional and reasonable
• which party to the contract is best positioned to commercialise the IP developed in the partnership, recognising that this may not necessarily be the organisation providing or commissioning NHS services. Refer to Step 7: IP development and commercialisation for further information

Purpose of this guidance

This IP guidance replaces the 2002 Department of Health document ‘The NHS as an innovative organisation: a framework and guidance on the management of intellectual property in the NHS’. However, it does not replace the 2002 directions within the document. These directions are currently under review.

The objectives of this guidance are to:

• increase awareness of the importance of effective IP management across the NHS
• promote consistent good practices in IP management across the NHS in England
• provide case studies and resources to help organisations providing or commissioning NHS services to apply good practices effectively

The case studies, model agreements and templates are published alongside this guidance.

This guidance is not legal advice. This is non-statutory guidance offering practical steps and good practice principles for organisations providing or commissioning NHS services to manage IP strategically, ensuring innovations benefit the NHS and the public while safeguarding valuable assets.

This guidance does not replace the NHS Identity Guidelines. You must get authorisation from identity@dhsc.gov.uk before allowing use of the NHS Identity by third parties.

Desired outcomes

The good practice principles shared in this guidance have been written to help organisations achieve the following outcomes.

Strategic outcomes are to:

• encourage and empower organisations to develop effective IP policies, commercialise innovations on appropriate terms, both independently and with third parties, and reward staff (‘innovators’) with meaningful incentives
• develop a culture and ecosystem that encourages individuals, teams and organisations to explore their ideas for innovation, improvement and change
• use NHS innovations to improve healthcare, benefit patients and staff and contribute to the growth of the UK economy
• gain recognition by creating an environment and culture that promotes the NHS as a launch pad for innovation, positioning the UK as a global leader in healthcare research and innovation focused on public value and patient benefit

Operational outcomes are to:

• establish a consistent and effective approach to IP management across the NHS, through providing clarity on good practice to help guide operational decisions
• signpost to relevant IP resources and case studies to support organisations
• be ready for IP due diligence and commercial negotiations to accelerate innovation
• where IP is commercialised through third parties, promote conditions that ensure quick and effective commercialisation
• empower the workforce by providing clear guidance and reducing procedural barriers to innovation in the NHS

Scope

This guidance sets out good practice principles covering the assessment of ownership, protection and commercialisation of IP. These principles are relevant for all IP generated by organisations that provide and commission NHS services, including when organisations develop IP in collaboration with external parties.

Organisations providing or commissioning NHS services vary in the maturity of their innovation work, leading to differences in how they manage idea generation, IP ownership, governance, protection, commercialisation and adoption. This guidance provides support to help organisations at all maturity levels improve their IP management practices.

Strategic alignment and important legal considerations

These good practice principles align with wider government guidance on IP, knowledge asset management and commercialisation, including:

• The Rose Book: Knowledge asset management in government (linked above)
• IPO’s Intellectual Property Rights Guidance Note in the Digital, Data and Technology Playbook, which features information from IPO and others about options to consider when approaching IPRs in contracts
• the Government Office for Technology Transfer (GOTT) guide to Managing intellectual property and confidentiality
• NIHR’s Intellectual Property and Commercialisation Guidance

This guidance on IP is in alignment with legislation and standards such as:

• Patents Act 1977
• Trade Marks Act 1994
• Copyright, Designs and Patents Act 1988
• Copyright and Rights in Databases Regulations 1997
• Registered Designs Act 1949
• Subsidy Control Act 2022
• Competition Act 1998
• National Security Act 2023
• Security policy framework

IP considerations internationally

It is important to note that IP rights are territorial, with different legislation and terminology applying overseas. Organisations providing or commissioning NHS services engaging in international partnerships, research or collaborations should ensure that:

• they have appropriate IP protection
• any agreements align with existing guidance, international standards and legislation, and are adapted for overseas contexts

These arrangements are likely to require additional legal support from an early stage to navigate compliance, ethical considerations and negotiation requirements. Find additional information about IP considerations when operating internationally on the page International IP service.

Audience

This guidance has been written to enable all organisations providing or commissioning NHS services to set up effective IP management processes that support innovation in the NHS to become business as usual. The guidance is directed at those responsible for the management of IP within or on behalf of an organisation providing or commissioning NHS services. Typically, this responsibility sits with an innovation, research or commercial team. In cases where the ownership of IP is unclear, this guidance is directed at executive teams within organisations.

IP decision-making in organisations providing or commissioning NHS services

Effective IP management is a critical foundation for ensuring that innovations are efficiently identified, protected and translated into real-world benefits - thereby maximising public benefit, contributing to economic growth and supporting healthcare advancements.

The step-by-step process and the good practice principles outlined below aim to:

• establish effective and proportionate governance by appointing responsible leaders and implementing clear governance structures
• support transparency and efficiency in IP decision-making and processes
• encourage early, confidential internal identification of new ideas and innovations to the appropriate IP or innovation lead for timely IP assessment and protection
• support innovation and commercialisation through transparent IP pathways
• protect valuable IP assets while avoiding unnecessary costs
• enable a timely pathway for IP management
• position NHS IP as an important contributor to improving health and patient care
• enable the government’s economic growth mission - for example, as set out in Fit for the future: 10 Year Health Plan for England and the Life Sciences Sector Plan

By following these principles, organisations providing or commissioning NHS services can create a structured, fair and innovation-friendly approach to managing IP while ensuring that both the NHS and the wider public benefit from new healthcare innovations.

It is also important to remember that IP can overlap with other issues, such as the appropriate management of personal data, and organisations will still need to comply with the General Data Protection Regulation (GDPR).

Step 1: establish IP governance and decision-making framework

Step 1 good practice principles

Step 1 good practice principles are to:

• appoint a senior responsible officer (SRO) to oversee IP management
• review and update IP policies annually
• make the organisation’s IP policy publicly available (for example, publish on the relevant website)
• develop clear governance structures for IP decision-making. Local IP policies should indicate the ultimate decision maker - who should be able to make informed decisions without causing delays to innovating and contracting
• establish decision-making processes with clearly defined stage gates, metrics and feedback mechanisms
• define innovation pathways to stimulate and support innovation, and clearly explain how IP will be treated within these processes
• communicate IP governance and the decision-making frameworks to ensure transparency with staff and external collaborators

Step 1 resources 

See the case studies published alongside this guidance for:

• case study 1 - NHS IP senior responsible officer (SRO) personas
• case study 2 - the innovation pathway
• case study 3 - IP governance and decision-making

For further guidance on appointing an SRO, see the GOTT page Knowledge Asset Senior Responsible Owner: guide to appointing and the role.

Step 2: clarify IP ownership

Understanding IP ownership, assignment and commercial return

A persistent barrier to progressing innovations in the NHS is a lack of clarity around IP - particularly the assumption that retaining legal ownership of IP is the only way to benefit from it. This misunderstanding often leads to delays, disputes or even abandoned projects.

To support innovation and ensure that ideas can move from concept to reality, it is essential to clarify the following concepts.

Legal ownership of IP

This refers to who legally holds the rights to IP. Clarity of ownership of IP through a clearly defined, documented and available process is important. The owner may be the organisation providing or commissioning NHS services, a staff member (‘innovator’) or a third party. Owning IP does not automatically provide commercial benefit and nor does it necessarily ensure successful development of the idea. The legal position on ownership of IP is decided on a case-by-case basis, taking into account any relevant contractual arrangements and legislation, as appropriate, depending upon the type of IP created and the parties involved.

Where a number of parties are working together to produce innovations, joint IP ownership is extremely complicated (particularly where Crown copyright is also involved) and is unlikely to be the preferred option. Joint IP ownership should not be regarded as fair compromise without legal advice.

Where commercialisation is likely, best practice is for the organisation best placed to commercialise to do so. IP can either be assigned or licensed for this purpose.

Assignment of IP rights

Assigning IP means transferring its ownership to another party. This is often necessary when an external innovator, a spinout company or another commercial partner is better placed to develop and scale the innovation than the organisation providing or commissioning NHS services. Where commercial partners are spinout companies that have yet to establish sufficient funds to fully create the innovation, or there is a risk that licensees could sit on IP to prevent competition, organisations should consider granting a licence with the option to obtain an assignment once financial milestones are met. There are several ways organisations can benefit financially by including terms that provide commercial return, even after assignment. It is important to obtain fair market value and no more for the IP and seek legal advice on competition law and subsidy law.

Licensing of IP rights

Licensing IP means giving permission to a third party to use, share or commercialise IP under agreed conditions, such as for a specific purpose, usually in return for fees or royalties. It does not transfer ownership of the IP and the costs and responsibility for managing the IP stays with the owner. For further guidance on licensing, see IPO’s guidance on Licensing intellectual property. Retaining ownership of IP and granting a licence to use it is often preferable when the IP will remain valuable to organisations providing or commissioning NHS services or it can be made available to a number of different parties for a commercial return. Licences can be one of the following:

• exclusive (only the licensee can use it in a particular field and the licensor cannot use it)
• sole (only one licensee and the licensor can use it)
• non-exclusive (many licensees and the licensor can use it)

Government policy and legislation, such as the Re-use of Public Sector Information Regulations 2015, may also mean that some IP should be made available - for instance, using the Open Government Licence. In addition, organisations should generally avoid granting exclusive licences other than in exceptional circumstances (see, for example, principle 3 of the 5 principles for data partnerships) and organisations should seek legal advice on this point.

Where organisations providing or commissioning NHS services only grant licences to selected groups or on different terms depending on the identity of the licensee or where only a specific company will benefit, rather than many, it is important to seek legal advice on competition law and subsidy control.

Commercial return

This is the financial or strategic benefit gained from the commercialisation of the IP. Consideration should be given to commercial return in the public interest at fair market value and no more as set out in Managing public money, The Rose Book, and subsidy legislation. Crucially, commercial return does not necessarily require ownership. Through licensing or assignment agreements, the organisation providing or commissioning NHS services can secure a share of future revenues, royalties or equity in spinouts - without necessarily bearing the risk or cost of development.

Step 2 good practice principles

Step 2 good practice principles are to:

• include clear statements in your IP policy about the determination of ownership of IP generated by all staff, collaborations and contracts. These include:
  • employees - including but not limited to those employed for clinical services, clinical academics and those employed for non-clinical services such as research, innovation, transformation and change
  • non-employees - including but not limited to individuals on secondments or placements, non-clinical consultants, contractors and students
  • collaborators - including but not limited to university or commercial partners, research partners, funders and hosted bodies such as NIHR Biomedical Research Centres (BRCs)
  • contractual relationships - including but not limited to contracts with large pharmaceutical companies, medical device companies, service providers and start-ups
• clarify the ownership of IP and ensure all parties understand the difference between an assignment of IP rights and a licence of IP rights. All parties should also understand the potential for commercial returns generated from IP, such as by means of licensing

Step 2 resources

See ‘Annex A: IP policy framework’ for more detailed guidance on creating an IP policy for your organisation.

Step 3: raise awareness and provide IP training

Step 3 good practice principles

Step 3 good practice principles are to:

• ensure IP policies are available to all staff (including procedures and decision-making frameworks) and are communicated to relevant staff (for example, commercial, innovation, research and legal teams). All staff should familiarise themselves with IP terms in NHS standard contracts and frequently used terms and conditions to ensure that:
  • they understand the actions they must take when generating or contributing to innovations that may result in IP
  • if engaging with external collaborators or contracting with third parties, they start discussions about IP at the earliest opportunity
• organise regular and up-to-date IP training to make sure staff understand the importance of IP, the identification of IP, their own role in IP management and ensure that staff are aware of the types of operational and research and development outputs that may be protected by IP

Step 3 resources

See the case studies published alongside this guidance for:

• case study 4 - communicating IP policies and processes
• case study 5 - IP training

For IP tools and training see IPO’s online support tools.

Step 4: IP disclosure, collaborations and record keeping

Step 4 good practice principles

Step 4 good practice principles are to:

• clarify and communicate the requirement for all staff to:
  • disclose early-stage innovations or potentially valuable creations at the earliest possible opportunity but only to the appropriate IP or innovation lead and/or team within the organisation
  • ensure there is no external disclosure (for example, publication, presentation or non-confidential discussion with third parties) until an internal IP review has taken place
  • ensure the internal disclosure is appropriately confidential and the process is clearly signposted and accessible to all staff
  • build in IP by design. Think about what IP will be created at the earliest possible opportunity, ideally before work begins. Also think about how it should be protected and managed (see step 6: understanding IP rights and protection strategies) and keep the IP confidential until any decisions about other protection have been made
• clarify and communicate the requirement for all new collaborations and contracts to:
  • report new collaborations or contracts that have the potential to generate IP to the designated team within their organisation (for example, IP, innovation, research, commercial, legal teams) as early as possible
  • make the internal disclosure process accessible to teams involved in setting up or managing collaborations and contracts
  • create an efficient and secure system to record internal IP disclosures, track decision-making and actively manage IP assets on an ongoing basis
• provide clear guidance to the workforce on maintaining IP confidentiality, including:
  • avoiding any informal sharing of IP with external parties
  • using confidentiality agreements, also known as non-disclosure agreements (NDAs), whenever confidential information is likely to be shared with an external party
  • maintaining confidentiality until the initial IP review is completed. Once the initial IP review is completed, the decision may be to keep the innovation confidential, protect it with patents, registered designs or trade marks as applicable, or make it publicly available

Step 4 resources

See the case studies published alongside this guidance for:

• case study 6 - IP disclosure, decision-making and tracking systems
• case study 7 - IP awareness in contracts and early identification

See the ‘Model agreements and templates’ published alongside this guidance for an example mutual NDA template for collaborative projects involving potential IP development.

Step 5: IP initial evaluation and feedback

Step 5 good practice principles

Step 5 good practice principles are to:

• review all internally identified IP, recognising that most will not generate significant commercial returns and focus assessment on identifying those ideas with genuine potential for adoption, scaling and commercialisation. Detailed valuation should be reserved for promising opportunities to avoid unnecessary delays or overvaluation
• conduct market assessments and horizon scanning to inform next steps
• seek early advice from relevant legal, innovation and commercial teams to support IP protection and arrange appropriate returns from the outset
• where appropriate, propose options for development, adoption or commercialisation pathways, ensuring they:
  • are regularly reviewed and adapted as the project develops and new insights emerge
  • include consideration of the end point for real-world use, outcomes and the IP protection strategy
• where relevant, consider opportunities to work with university partners, enabling opportunities to jointly develop IP
• provide timely feedback to staff (‘innovators’), collaborators and third parties

Step 5 resources

See the case studies published alongside this guidance for:

• case study 8 - IP triage and evaluation frameworks
• case study 9 - jointly developed IP through university or academic partner collaboration

See the ‘Model agreements and templates’ published alongside this guidance for an example collaboration agreement to use when working with the NHS, academia and/or industry partners on IP matters.

Step 6: understanding IP rights and protection strategies

Not all IP needs to be formally protected by registration to be valuable or useful. In some cases, the costs of obtaining and maintaining registered protection may outweigh the potential benefits, particularly where the IP has limited commercial potential or a short lifecycle.

Additionally, some IP may be better safeguarded through confidentiality and good information management. The decision to apply for registered protection of IP should always be strategic and guided by:

• its potential value
• its relevance to the innovation’s development path
• the organisation’s broader goals

Step 6 good practice principles

Step 6 good practice principles are to:

• understand that different types of IP require different protection processes and strategies. Protection should be aligned with the intended development and commercialisation pathways
• understand that artificial intelligence (AI) generated innovations present unique challenges, such as authorship, data ownership and protection. Find information on using AI safely, effectively and securely in the Government Digital Service’s AI Playbook for the UK Government. Check regularly for updates, as this is a rapidly developing area
• seek advice from legal, innovation and commercial experts to assess whether and how to protect IP in line with the chosen strategy, including consideration of whether protection is needed in international markets
• take a balanced approach to IP protection, weighing the potential value of IPRs against the cost of protection
• conduct regular reviews of NHS-registered IP assets to maintain value for money and actively manage IP portfolios in line with these good practice principles and to:
  • avoid spending money and resources on protection unless a development plan exists and unless there is an intention that the IP will be actively supported and developed towards adoption and/or commercialisation
  • use standardised templates for evaluating the cost-effectiveness of maintaining IP rights, ensuring resources are directed toward assets with the highest potential benefit
• manage IP in collaborations by:
  • establishing clear agreements on the ownership, use and management of jointly developed IP, as well as background IP (pre-existing IP brought into the project), ensuring alignment between partners and alignment with funders’ terms
  • defining who is responsible for assessing and documenting background IP at the outset of collaborations to prevent disputes and to clarify ownership
  • implementing structured methods to track and measure foreground IP (IP created during the project) within collaborations, ensuring fair attribution and appropriate commercialisation strategies

Step 6 resources

See the case studies published alongside this guidance for:

• case study 10 - IP protection compared with open source-open licensing for wider benefit
• case study 11 - using expert legal advice to shape IP protection strategy

See IPO’s online support tools for people learning how to manage or use IP

For further information on IP rights, see GOTT’s guide to Managing intellectual property and confidentiality.

Step 7: IP development and commercialisation

Not all innovations should, or need to, lead to commercial returns. Some innovations are essential for improving NHS services or patient care without a commercial pathway, while others may offer opportunities for licensing, spinouts or other commercial models. Both types, however, create value by improving care, enabling adoption or generating returns. Organisations providing or commissioning NHS services should encourage environments where innovation thrives to meet healthcare challenges.

To maximise the benefit of innovations, organisations providing or commissioning NHS services should adopt a clear framework to assess which route for commercialisation is the most appropriate on a case-by-case basis and take appropriate legal advice.

Step 7 good practice principles

To determine the most appropriate route, organisations should consider the following factors:

• the intended use and benefit - what is the end goal, what is its intended use and where will it have value?
• NHS contributions to date and planned support - including access to data, staff time, infrastructure or funding
• internal capacity - does the organisation providing or commissioning NHS services have the skills, resources or mandate to lead development?
• partner capability - is the organisation providing or commissioning NHS services, the staff member (‘innovator’) or a third party best positioned to carry out development and commercialisation?
• contractual context - are there pre-existing obligations to partners, funders or regulators?
• fair return - what level and form of return is proportionate (for example, royalties or equity)? Consideration should be given to understanding or applying fair market value, with the aim of enabling timely adoption and scaling of innovation, recognising that overvaluation can inhibit progress
• feasibility and market potential - have feasibility assessments, market analysis and IP due diligence been conducted to evaluate the innovation’s commercial viability and strategic alignment?

An assessment against these principles will help organisations to select the most suitable IP development and commercialisation route (see below).

IP development and commercialisation routes

Below are 3 primary routes, supported by good practice principles. While these are unlikely to cover every scenario, they provide a useful framework for decision-making.

Route 1: development, adoption and spread with no commercialisation

Some innovations designed to improve services within the NHS may have no clear commercial opportunity. However, organisations may still benefit through development and scaling within an NHS setting or through open dissemination to share knowledge. In these cases:

• the emphasis should be on effective dissemination of non-commercial NHS outputs or innovation through publication under appropriate licences. Registered IP protection may still be needed to ensure quality control and consistency or to safeguard future development options
• organisations should:
  • support adoption, sharing through collaboration, education or digital infrastructure
  • consider open access or permissive licensing where appropriate
  • track and evaluate the effect on patient outcomes and service quality
  • avoid unnecessary costs of seeking registered IP protection if it does not serve a practical purpose
  • encourage staff (‘innovators’) by recognising their contribution, even when no commercialisation occurs
  • consider whether IP that is no longer being used in an organisation could be sold to a third party for fair market value or, where appropriate, made available

Route 2: staff (‘innovator’) or third-party development with no further NHS involvement

Where the organisation providing or commissioning NHS services decides it is not best placed to develop the IP due to limited internal capability or strategic alignment, it should act decisively to transfer the innovation for development elsewhere. However, even where IP is to be assigned, any agreement should contain a licence back to the organisation for the purposes of patient care, teaching and research.

Organisations should seek to maximise the success of innovation while meeting their own legal obligations by:

• licensing or assigning (if merited) the IP to the staff (‘innovators’) or third party in a timely and transparent way
• securing a fair commercial return (consideration should be given to fair market value and no more) that reflects the organisation’s contribution to date
• establishing a fair, transparent and benchmarked reward structure that motivates staff (‘innovators’) or third parties to develop the IP
• clearly defining the terms under which staff (‘innovators’) or third parties may continue to access NHS resources (for example, clinical input or data) after licensing or assignment of the IP to them
• where IP is to be assigned to a third party, including a licence back to the NHS for continued use, limited to a healthcare setting, teaching or research
• ensuring obligations to funders, investors and collaborators are upheld
• providing timely feedback to all parties to maintain momentum and trust

Route 3: strategic co-development for commercialisation

Where the NHS brings significant added value, such as access to data, infrastructure, expertise or resources, it may be appropriate to co-develop the innovation and share future returns. This approach should be underpinned by strong collaboration and clear and early agreements, particularly where the parties need to comply with applicable legislation, such as GDPR.

Organisations should:

• clearly define their support proposal, including:
  • access to data, software, technology, infrastructure, expertise or patients
  • clinical validation or research capabilities
  • support for regulatory or real-world testing
• establish and record upfront agreements on:
  • contributions from all parties to date
  • planned roles and inputs
  • the planned ownership of IP outputs, noting that joint ownership is rarely an appropriate or effective option
  • responsibility for registering IP outputs (if applicable)
  • what should happen to the IPR on termination and whether anyone can continue to use it
  • commercial model options based on each party’s contributions (for example, licensing, equity or joint ventures)
• ensure no development proceeds without a clear, shared understanding of expectations and upfront agreements in writing
• use flexible commercial models that:
  • encourage innovation from the NHS workforce
  • fairly reflect the contribution of the organisations involved
  • prioritise accelerating innovation over financial returns
  • enable clear, transparent and efficient negotiations
• ensure funder, investor and collaborator needs are reflected in agreements, where appropriate

Characteristics of effective IP commercialisation models include:

• clarifying the nature and value of NHS contributions to an innovation, such as clinical insight, infrastructure, data access or funding and how these are recognised in any future IP or commercial discussions
• turning the attention from retaining IP ownership to fair value realisation and effective commercialisation, emphasising that ownership is not the only route to securing returns. NHS contributions can be protected and recognised through licensing, equity or revenue-sharing agreements
• any proposed assignment of IP should entail full consideration of the maturity and stability of the entity taking control of publicly funded innovations to ensure it is appropriately placed to commercialise them
• outlining expected commercial returns early in the process, ensuring fairness, transparency and trust between partners
• rewarding all parties appropriately - negotiation should emphasise long-term innovation partnerships rather than maximising short-term income or control
• in cases of international collaboration, ensuring IP is addressed in a way that supports international adoption sharing while providing returns to the NHS

Step 7 resources

See the case studies published alongside this guidance for:

• case study 12 - IP agreement involving NHS data
• case study 13 - fair NHS commercial returns - licensing and spinout models

See the ‘Model agreements and templates’ published alongside this guidance for:

• an example collaboration agreement to use when working with the NHS, academia, and/or industry partners on IP matters
• an example ‘hand back’ agreement to use when a decision is made for IPRs to be formally assigned to an innovator or third party, also known as IP being ‘handed back’

See the Value Sharing Framework for NHS data partnerships, published by the Centre for Improving Data Collaboration in the NHS Transformation Directorate, for guiding principles to help organisations providing or commissioning NHS services negotiate fair terms for NHS data partnerships.

Also see GOTT’s Knowledge Asset Spinouts Guide and the Knowledge Asset Commercialisation Guide.

Step 8: IP asset management and tracking returns

Step 8 good practice principles

Step 8 good practice principles are to:

• implement a system to actively manage IP assets, ensuring that:
  • IP agreements are properly entered into and managed for the life of the agreement
  • revenue, licensing fees or other returns are accurately recorded
• ensure financial returns to staff are handled in accordance with IP policies of the organisation providing or commissioning NHS services
• direct NHS-generated returns towards supporting future innovation and continuous improvement in IP management within organisations
• implement structured frameworks for reviewing IP portfolios, ensuring that NHS-registered IP assets are actively managed and aligned with strategic priorities
• consider the ongoing usefulness of any registered IP assets and where these are no longer in use and it is appropriate to do so, sell to a third party for fair market value or allow the registered rights to lapse

Step 8 resources

See the case studies published alongside this guidance for case study 14 - managing and reinvesting NHS IP returns for future innovation.

Step 9: access to IP expertise and technology transfer capabilities

To implement an efficient and effective IP management process, all organisations providing or commissioning NHS services require access to IP expertise and technology transfer capabilities (TTCs). TTCs provide the skills, support and ability to execute the commercialisation of IP.

Currently, organisations providing or commissioning NHS services access TTCs through the following models:

• working with university TTCs and business accelerators
• using regional TTCs through integrated care boards or health innovation networks and innovation hubs
• building in-house TTCs
• working with private sector providers of TTC services

Step 9 good practice principles

If not already in place, organisations providing or commissioning NHS services should:

• evaluate the necessity of accessing TTCs and explore available TTC support
• make sure their TTC partnerships reflect good practice principles
• ensure that any fees are proportionate to the work undertaken by the TTC
• make IP policies and TTC arrangements publicly available (for example, publish on website)
• provide appropriate training in IP and commercialisation for SROs and NHS staff involved in technology transfer activities.
• ensure training aligns with good practice principles and equips staff (‘innovators’) and supporting teams (for example, commercial, legal, innovation) with the necessary skills to manage and commercialise NHS-generated IP effectively

Step 9 resources

See the case studies published alongside this guidance for:

• case study 15 - in-house TTC models
• case study 16 - support with IP expertise from regional or innovation hubs
• case study 17 - using university TTC

See ‘Annex B - considerations for organisations providing or commissioning NHS services when entering into technology transfer agreements’.

Actions for organisations to take

In summary, organisations providing or commissioning NHS services should:

• assign an SRO for IP management and set up effective IP decision-making processes
• review and update their IP policies in line with the good practice principles
• explore and evaluate accessing TTCs
• make IP policies and TTC arrangements publicly available (for example, publish on their website)
• provide rolling training to staff on the importance of effective IP management

In due course, there will be an expectation for organisations to provide an annual return to DHSC and NHS England summarising how they have complied with the actions on good practice and explain any variation from this guidance with appropriate mitigations.

Continuous improvement in IP management

Publishing updated guidance is only one step towards improving the management of IP across the NHS. To ensure that IP management is continuously improved we welcome feedback on this guidance to ip@dhsc.gov.uk.

This guidance aims to bring clarity on good practice and improve IP management across the NHS. It will be reviewed and updated on an annual basis and organisations should review their IP policies annually to ensure continued alignment with good practice.

Annex A: IP policy framework

This framework is intended to support organisations providing or commissioning NHS services (‘organisations’) to develop their own IP policy. It is designed to help organisations to draft an IP policy for their organisation that both reflects local priorities and practices and follows the principles and expectations set out in the IP guidance for the NHS in England.

This annex should be considered as a framework that sets out suggested important provisions to include in an IP policy, arranged by subject heading. This framework is non-exhaustive and organisations are encouraged to adapt, expand and tailor the content to reflect their specific operational context, legal obligations, level of innovation maturity and strategic goals.

1. What intellectual property is

Organisations should consider providing a working definition of IP, what IP rights are, and how they arise. Organisations may also wish to explain that some IP rights, such as copyright, arise automatically on creation of an innovation, while others, such as patents and trade marks, are only obtained through registration at official bodies such as the UK IPO.

Organisations may wish to include examples of how IP may be used or created within the organisation. The table below sets out information on important IP rights as they apply to organisations.

Table 1: example IP rights in organisations providing or commissioning NHS services

Nature of IP	Relevant IP right	Examples
New invention	Patent	A new medical device devised as a result of a research project (can include software).
Literary works	Copyright	The source code for computer software, the text from a patient leaflet and research papers produced for medical journals.
Artistic works	Copyright	Photographs and other images appearing on the internet are likely to be protected by copyright.
Designs	Design rights	The design for a new medical device.
Brand names	Trade marks	The NHS logo or the brand name of a particular drug.
Know-how	Confidentiality	Specific equipment set-up or methods of working that are not patentable but which have been kept confidential and are not generally known.

2. Purpose and aim 

Organisations may wish to begin their IP policy by explaining its purpose in identifying, managing, protecting and commercialising IP generated through its activities, with a clause such as:

“This policy outlines how [insert name of organisation] identifies, manages, protects and commercialises intellectual property (‘IP’) generated through its activities, to ensure that:

• current and new innovations are identified, developed, protected and disseminated appropriately
• unauthorised use of third-party IP is prevented
• good practice guidance and legal frameworks relating to IP are complied with”

3. Scope

Organisations should consider who the IP policy applies to. This may include:

• employees (whether employed in clinical, non-clinical or research and development roles)
• contractors
• consultants
• students and trainees
• seconded staff
• collaborators (for example, universities or commercial partners)

The section on scope may also explain that IP policy will be subject to updates and that the organisation is able to modify the IP policy at any time.

4. IP ownership

Organisations should consider clarifying IP ownership rules relating to different categories of persons or contributors. This may include:

Employees

The Patents Act 1977 and the Copyright, Designs and Patents Act 1988 provide that IP created by employees in the course of their employment belongs to the employer. Accordingly, the organisation will normally be the first owner of any IP that is created by its employees in the course of carrying out their normal duties or the duties assigned to them. Organisations may wish to confirm whether these provisions also extend to research postgraduate students and trainees at the organisation.

Students

The term ‘students’ can encompass a variety of roles within the NHS. The following general principles typically apply but note that this is not exhaustive and judgement will be required.

Undergraduate students

Undergraduate students will retain ownership of any IP they create, as they are not employees of the organisation. While apprentices are usually employed and subject to an employment contract, their academic work may be subject to the IP policy of an academic organisation and therefore owned by the apprentice.

Postgraduate students

If a postgraduate student is employed by the organisation, IP rights are typically governed by the terms of their employment contract. If they are self-funded, ownership arrangements may vary. Consideration should be given to the nature of the work and whether it would be more appropriate for the IP to vest with the organisation or remain with the student.

Secondees and honorary contracts

IP created by secondees or people working on honorary contracts will not automatically be owned by the organisation unless this has been specifically agreed with the secondee’s or honorary’s employer or institution. The agreements between organisations in these cases should specify who owns the IP created in which circumstances.

Funded research

Where IP arises from activities funded by another organisation, the organisation may be required to assign such IP to the funding organisation under the terms of the relevant funding agreement.

Collaborations

Where IP arises from activities undertaken jointly with another organisation, the parties must be clear which party owns such arising IP and has the responsibility to protect it under the terms of the collaboration agreement. The non-owning party can in return receive a share of any revenue derived from commercialisation.

Suppliers and contractors

Unless a contract for services states otherwise, IP created by contractors will be owned by them, not the organisation. In some cases, where the organisation is paying for IP to be developed (sometimes called foreground IP) it will be appropriate for the contract to assign ownership in that IP to the organisation. However, it is reasonable for the contractor to retain ownership of anything it created prior to or unrelated to the contract (background IP). If the organisation needs to use IP owned by the contractor that is not assigned to the organisation it should be licensed to the organisation in the contract.

Procedure and governance processes

Organisations may also wish to consider a procedure and governance process to attempt to resolve any potential IP disputes between the organisation and its employees and to describe that in the IP policy.

5. Duties and/or responsibilities

Organisations may wish to include a section to describe the important decision makers for their organisation. This section could cover:

• who has overall responsibility and financial accountability for ensuring that IP generated by your organisation is managed appropriately
• who is responsible for developing IP policy, managing policy updates and supporting compliance and compatibility with policy for your organisation
• who ensures that systems are in place to audit and monitor such compliance
• who advises your organisation on issues arising from IP and this policy
• who ensures that your organisation has an effective due diligence process in place to identify and manage all IP projects
• which managers within your organisation are responsible for regarding IP (for example, are they responsible for ensuring that the policy is brought to the attention of staff and there is adequate training in place)
• what the IP responsibilities of staff members are within your organisation (for example, they read and comply with the policy, they report the creation and development of new IP to the relevant person, and so on)

This is not an exhaustive list and duties and responsibilities may differ from organisation to organisation.

6. Procedures of organisation employees

The NHS is a naturally innovative organisation that generates IP that, if managed properly, can lead to significant improvements in patient benefit and in the provision of healthcare. The organisation may, through the IP policy, encourage users to take appropriate steps to ensure that new ideas are identified, IP rights are protected and avenues are opened for commercialisation and dissemination as applicable.

To make the IP policy as practical as possible for its users, organisations may wish to:

• confirm the individual or team to act as the first point of contact for information and advice on any matters regarding the IP
• remind staff that they should notify the relevant point of contact in the organisation of any new innovation that they create as soon as possible and, in any event, always prior to disclosing them externally
• emphasise the importance of record-keeping relating to IP
• remind staff that they must not sell, assign, license, give or otherwise commercialise IP without the organisation’s formal written agreement and following the processes advised by the organisation
• emphasise the importance of any confidentiality agreements, NDAs, data sharing agreements or material transfer agreements that have been provided, negotiated and signed by the organisation

7. Protection and commercialisation of innovations

Organisations may choose to highlight in their IP policy that:

• not all IP needs formal protection by registration to be valuable or useful and in some cases the costs of protection may outweigh the potential benefits
• not all innovations will lead to commercial returns. Some innovations are essential for improving NHS services or patient care or reducing cost without a commercial pathway. Other innovations may offer opportunities for revenue through licensing, spinouts or other commercial models
• decisions on whether to protect or commercialise IP will be based on factors such as the ability to demonstrate market potential, the likelihood of success of the venture, patient and public benefit and potential financial return
• each innovation should be assessed to see what route is appropriate on a case-by-case basis and appropriate legal advice should be taken

8. Process to support commercialisation

Organisations may wish to provide commentary on how they intend to assess IP innovations. Such an assessment may consider whether innovations need protection or are appropriate for commercialisation and, if so, the process that will be followed. This section may include:

• important points of contact for employees who have created IP that they believe is capable of commercialisation and/or needs protection
• the important decision makers in this process
• the criteria to consider when assessing innovations
• any due diligence that needs to take place to assess legal and financial risks and benefits
• potential routes for commercialisation such as (not exhaustive):
  • licensing
  • assignment
  • spinout company formations
  • direct distribution by organisation (for example, apps)
• the process for when the organisation decides to pursue exploitation of an innovation (for example, informing the employees responsible for its creation, affording them the opportunity to commercialise the innovation themselves independently from the organisation, assignment and/or licensing of the IP to the employee)

Organisations may also find it helpful to include a transparent formula or guiding principles addressing, for example, percentage splits and recognition of contributions.

9. IP remuneration

Organisations may wish to document how revenue may be shared following commercialisation of IP. This may include, where relevant:

• who receives revenue share and in what circumstances
• how revenue share is calculated
• spinout equity arrangements

10. Use of IP owned or controlled by a third party

Organisations may wish to address the use of third-party IP, in particular:

• reminding staff that employees are not entitled to use IP belonging to another NHS organisation without the express permission of that organisation. As such all agreements for the organisation to use third party-owed IP should be documented by a written contract that includes a clause dealing with the ownership of IP
• use or copying of any materials for which the IP is owned or controlled by a third party without permission may be an infringement of that third party’s rights. The unauthorised use of IP creates legal, financial and reputational risks
• staff who become aware of any infringement or alleged infringement of any IP should report it to the necessary point of contact within the organisation

11. Dispute resolution

Organisations may wish to include information on the process for resolving any disputes relating to IP.

12. Implementation and monitoring arrangements

Organisation should include details of how the policy will be implemented and how compliance will be monitored. This might include:

• who will be responsible for implementation and where the policy can be accessed from
• who is responsible for monitoring compliance
• what the monitoring process is
• what aspect of compliance is being monitored
• what the frequency of such monitoring is
• who will review the findings and monitor completion of any resulting action plan arising from such findings

Annex B: considerations for organisations providing or commissioning NHS services when entering into technology transfer agreements

Technology transfer capabilities (TTCs), also referred to as technology transfer offices (TTOs), can provide a useful service to organisations providing or commissioning NHS services by providing development and exploitation support. TTCs can provide:

• IP evaluation
• IP protection
• market analysis
• licensing
• spinout support

These services have to date been developed with organisations providing or commissioning NHS services that do not have their own commercialisation function, or supporting those that do on specific projects.

This annex outlines important considerations, governance principles and operational steps to ensure alignment with NHS values, legal compliance and commercial success. It provides guidance on good practice to assist organisations providing or commissioning NHS services to understand the opportunities provided by collaborating with TTCs and how to negotiate reasonable terms.

Understanding the role of the TTC

TTCs act as intermediaries between organisations and external parties (for example, industry or academia) to commercialise innovations developed within the organisations. From a legal perspective, they will usually be agents for the organisation so that the organisation is responsible for managing its IP and concluding contracts, but the TTC manages the opportunities and financial elements and helps facilitate the relationship with the other parties.

TTC responsibilities typically include:

• IP assessment and protection (for example, patents or trade marks)
• market analysis and partner identification
• negotiation and execution of licensing agreements
• revenue management and royalty collection

It is important for the contract with a TTC to clearly define the scope of the TTC’s role and the boundaries of their authority. Organisations will need to consider how IP is identified and selected to be included in a contract with a TTC. They should prioritise the most important, promising and highest value IP. Organisations will need to define clearly that a TTC cannot commit the organisation to a contract with a third party without final review and approval by the organisation.

Occasionally, TTCs play a direct role in IP commercialisation. In these cases, the IP is licensed to the TTC, which then is responsible for developing it into a commercial product and further licensing it to commercial parties. In these cases the organisation providing or commissioning NHS services will need much clearer reporting and controls on the TTC’s activities to ensure it maintains an appropriate degree of oversight.

Important contractual elements to manage

Appointment

TTCs are often appointed as agents to provide services (such as marketing and managing innovations) to the organisation. This may be on an exclusive basis so it is important to consider the best TTC for the organisation in a procurement process.

Set clear strategic objectives in the contract with the TTC, including the following:

• align with NHS values: public benefit, affordability and accessibility
• define success metrics: for example, licences executed, revenue, time-to-market and health impact

IP ownership and rights

The organisation needs to ensure that the innovations included in the TTC agreement are actually owned by the organisation. This means these arrangements are less suitable for IP developed through multi-party collaborations unless all the parties agree or the organisation engaging the TTC has clear rights to exploit the IP.

It is important to verify the organisation’s ownership of IP before the TTC starts work as withdrawing innovations from the process at a later stage could result in the organisation having to pay the TTC additional costs.

The organisation and the TTC need to agree the type of IP licences the TTC can negotiate. Typically, licences the TTC can negotiate will:

• define the type of licence (exclusive, non-exclusive or field-limited - note that non-exclusive licences will be the normal approach and exclusive licenses will need to be justified and only agreed after legal advice)
• ensure terms reflect DHSC’s IP guidance for the NHS in England
• include performance milestones and termination clauses for underperformance by the licensee

Fees and revenue sharing

The TTC business model is likely to include some inclusive services (which are paid for under an annual fee and revenue share for IP which is later licensed) and service charges for additional services.

Organisations should:

• establish a transparent revenue-sharing model (for example, net revenue split between the organisation (and any other parties, inventors and so on) and the TTC)
• assess and negotiate the level of fees and revenue sharing (this should be done by the organisation providing or commissioning NHS services). This should be carefully considered in the context of the IP being developed and commercialised to assess proportionality. In addition, the ability for the TTC to receive payment before another (‘top slicing’) needs to be considered by reference to the commercial risk taken by each party and negotiated against a balanced model where each party receives the agreed share of the revenue at the same time
• consider other benefits such as discounts, priority access and provision of devices, facilities and other equipment
• clearly define how revenue is calculated and exactly which costs can be deducted prior to calculating the share of net revenue
• include audit rights to verify financial reporting

Exit and renewal strategy

An exit and renewal strategy should:

• include clear exit provisions (for example, breach, insolvency or conflict of interest)
• plan for contract renewal, transition or re-tendering based on performance and market conditions. Understand that obligations to continue to pay the TTC a revenue share are likely to continue after contract termination (consider whether this is appropriate if the contract has been terminated for breach by the TTC)

Governance and reporting - managing TTCs

Agreements with TTCs are most likely to be successful where there is active engagement by all interested parties. Parties should:

• involve clinical and operational leads, research and development, commercial, legal and innovation teams early in the process
• ensure inventors understand their rights and obligations
• set up a joint steering committee or review board for oversight
• require regular reporting on licensing activities, deal pipeline and financials
• carefully review due diligence on potential licensees (for example financial stability or ethical alignment)
• use key performance indicators (KPIs) such as time to agree licence, revenue generated and number of active licences
• review TTC performance quarterly with a more formal review annually
• require detailed financial reporting and conduct cost-benefit reviews
• encourage knowledge sharing from the TTC to the organisation