Intellectual property exploitation policy

1 Introduction

In the NHS, innovation occurs in the delivery of patient care, in the education and training of employees and in research and development programmes, which can lead to improvements in the delivery of healthcare. Innovation occurs naturally in the normal course of employment. The innovation may be a novel treatment, a device, data, software, training material or a new management system (Department of Health, 2002).

Trust employees may develop ideas and concepts that have practical application and, or commercial potential. These concepts are known as intellectual property (IP) and, as with other forms of property, they can be owned and should be protected.

In line with the NHS strategy for exploitation and commercialisation of IP, the trust encourages its staff to develop and exploit intellectual property in conjunction with the trust and the Medipex Limited. The trust has a responsibility to ensure working practices are widely spread across the organisation. The trust is required to manage IP in accordance with the Intellectual Property Act 2014.

Medipex, established in 2004, is an award winning healthcare innovation hub based in the Yorkshire and Humber region and provides technology transfer services to the National health service helping healthcare providers, commissioners and industry to develop and implement innovations that provide better patient care, improved services and cost savings.

Medipex assists the NHS bodies and their staff in the region to recognise the true value of their ideas. Guidance and practical support are provided from the idea stage through to development and final product launch in the marketplace. This ensures that the innovations and intellectual property within the NHS are identified and developed in the interests of improved patient care and also for the benefit of the NHS and the inventors.

2 Purpose

This policy sets out how the trust can contribute to the development of the NHS as an innovative organisation by capturing innovations and ensuring that those which can make more income available for improving the health service are appropriately developed and exploited.

The policy also sets out the rules of ownership, protection and exploitation of IP arising from employees’ work. It aims to maintain a balance between the legitimate needs of the trust to protect its interests and the provision of a creative working environment for staff.

The policy should be read in conjunction with the Rotherham, Doncaster and South Humber NHS Foundation Trust research governance policy.

3 Scope

This document applies to and is relevant across the following services, departments or care groups, all staff employed by the trust full time and part time, on either a permanent or temporary contract. The policy is intended to advise and support staff that contribute or participate in IP activity.

4 Responsibilities, accountabilities and duties

Exploitation of the trust IP will be the responsibility of the executive medical director who will retain management responsibility for IP generated by trust staff.

All developments of IP should be channelled through Medipex who manage the trust’s intellectual property rights. They will assess the potential of the intellectual property and decide whether or not it is worth protecting and exploiting.

In general, if legal action needs to be taken against an individual or organisation illegally using intellectual property, which the trust has protected, Medipex, to which the trust has assigned the task of commercialising the IP, will pursue this.

4.1 Managers

Managers are responsible for:

all staff they manage being aware of how they can access copies of this policy
if an employee develops an idea or concept, which may have commercial potential, contact the executive medical director at the earliest opportunity and, in any event, before disclosure of the idea to any party outside the trust, either orally or in writing

4.2 All staff

If an employee develops an idea or concept, which may have commercial potential, they must report this to their care group director or line manager, who should contact the executive medical director at the earliest opportunity and, in any event, before disclosure of the idea to any party outside the trust, either orally or in writing. Examples include the development of new techniques, devices, software, pharmaceutical products, formulae and writings.

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

keep it secret and resist pressure to announce or publish details until the matter has been discussed with the executive medical director. Public disclosure (other than under explicit terms of confidentiality) will invalidate any subsequent patent application and severely diminish both potential commercial value and benefits accruing to the trust and the originator. Disclosure without entering into an undertaking of confidentiality (confidentiality agreements) may prejudice negotiations of commercial arrangements with an organisation
confidentiality agreements must be used when discussing intellectual property with external parties. These can be developed and obtained from the trust’s contracts lead or Medipex. All confidentiality agreements must be reviewed by the trust’s contracts lead and signed by an authorised signatory. It must be remembered that confidentiality agreements are difficult to enforce and if a third party has acted in breach of the agreement, then the confidential information will have been broadcast. If in doubt always consult your line manager
avoid giving away or selling samples
do not involve external organisations or companies in testing or prototyping without a written agreement together with confidentiality agreement being in place. Prior to signature these arrangements must be reviewed
do not sign any contracts or agreements or begin any related activities until the contracts lead has reviewed and signed off on them
any trial involving a third-party sponsor must be the subject of due diligence to establish that the third-party organisation is the principal and not an undisclosed agent for another organisation

5 Procedure or implementation

Legal rights such as patents, copyright, trademarks and so on, can protect intellectual property. Acquiring such rights can be costly and is only the initial step. Little or no benefit will accrue from protecting the intellectual property unless they are then developed and commercialised.

The trust has a contract with Medipex healthcare innovation hub to advise it on whether or not the intellectual property has commercial potential and how best to take it forward.

As a general rule, intellectual property created by an individual during the course of his or her employment, or training arising out of his or her employment, belongs to their employer.

In certain circumstances however, the trust may decide not to take up its rights to the intellectual property, subject to the agreement of fair and reasonable terms, in which case the intellectual property rights of ownership may be assigned to the employee.

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

In general, the organisation with the main contract will be responsible for protecting the property rights and for any commercialisation.
Agreement will need to be reached as to the way the costs and benefits will be apportioned between the two organisations. These working arrangements may differ with each particular organisation.
Exploitation of intellectual property involves both costs and risks. Consequently, it will by no means always be appropriate or cost effective to seek to protect and exploit potential intellectual property.
In cases where patenting or licensing may be the most appropriate option, Medipex will undertake the negotiations on behalf of the inventor and the trust. In some instances, the intellectual property may be a case of best practice which could be shared with other trusts and the network of Healthcare Innovation Hubs may be used to disseminate these innovations, either through their own network or via other NHS bodies.

If the trust chooses to commercially exploit and protect intellectual property rights, then it may be appropriate that members of staff who have created or developed the intellectual property have a share in any benefits for example, through a royalty income or other recognition. Agreement to share benefits will be considered on a case-by-case basis and a contract drawn up to reflect the agreement.

Medipex will only undertake work on behalf of the trust. If a trust employee wishes Medipex to advise or undertake commercialisation of IP for which they are the inventor, it is done on the understanding that Medipex is acting on behalf of trust, in line with the trust’s policy and any benefits accrued from such work will belong to the trust who will split them with the inventor as outlined above.

In the event of any dispute about the interpretation of this policy, trust employees have recourse to the trust grievance procedure to resolve the dispute.

6 Training implications

There are no specific training needs in relation to this policy, but the following staff will need to be familiar with its contents, and any other individual or group with a responsibility for implementing the contents of this policy).

As a trust policy, all staff need to be aware of the key points that the policy covers. Staff can be made aware through a variety of means such as:

one to one meetings or supervision
group supervision
intranet
local induction
team meetings

7 Monitoring arrangements

7.1 IP register

How: Upkeep of register.
Who by: Executive medical director or director of research.
Reported to: Clinical leadership executive.
Frequency: Annually.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act 2005

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure for that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005) (section 1).

9 Links to any other associated documents

10 References

11 Appendices

11.1 Appendix A Definitions or explanation of terms used

Definitions or explanation of terms used
Term	Explanation of term
Intellectual property (IP)	Results from knowledge, creative ideas, or expressions of human mind that have commercial value. Intellectual property is something unique that you physically create – an idea alone is not intellectual property. In this policy IP will refer to any form of original creation. It is any patent, copyright, database right, registered design, unregistered design rights, design specifications, drawings, software or any other IP protection or right and any application for such protection and all rights in any discovery, improvement process, secret process, know-how or other confidential information
Confidentiality agreements	A legal agreement made between at least two parties to protect confidential information, material or knowledge that the parties wish to share with one another for certain purposes
Medipex healthcare innovation hub	Healthcare innovation hubs offer legal and commercial support to NHS staff that has a pre-market product that are of interest to patients or society as a whole. The trust has a contract with Medipex to provide this support. More information on intellectual property rights (IPR) can be found on the Medipex website (opens in new window). Contact details for Medipex are: Medipex Ltd Pure Offices Ltd 4100 Park Approach Thorpe Park Leeds LS15 8GB Telephone: 01133970830 Email: enquiries@medipex.co.uk
Due diligence	Appraisal of IP to evaluate its commercial potential in the process of collecting and understanding risks associated
Best practice	Professional procedures that are accepted or prescribed as being correct or most effective
Patenting or licensing	Patenting is a process to protect new inventions and covers how things work, what they do, how they do it, what they are made of and how they are made. Licensing is a legal agreement to allow a third-party certain rights to use your intellectual property for a defined purpose and under defined conditions
Copyright	Copyright protects literary works including software, apps, websites, printed material, photographs or images and recordings. Copyright is automatic, does not require registration and is fee free. It is highly recommended that any trust documents should bear a copyright statement. for example, Copyright © Trust Name (in full), 20XX [year of creation], All Rights Reserved

Document control

Version: 6.1.
Unique reference number: 334.
Approved by: Corporate assurance approval group.
Date approved: 29 January 2024.
Name of originator or author: Research governance manager.
Name of responsible individual: Executive medical director.
Date issued: 9 February 2024.
Review date: December 2025.
Target audience: All staff.

Page last reviewed: April 30, 2024
Next review due: April 30, 2025

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