Introduction
This guide provides information on how the National Institute for Health and Care Research (NIHR) ensures intellectual property (IP), resulting from funding through the NIHR research contract, is protected appropriately. It offers advice to researchers on important issues to consider during the funding application process, the research period, and when funded research generates commercial interest. Please note, this guide does not replace the need to review the NIHR research contract with your organisation’s contracts office (or similar) or the NIHR Programme Management team or IP Unit.
The NIHR funds research through contracts with organisations, such as higher education institutions and NHS Trusts, to conduct research projects, develop specialist healthcare infrastructure units, and improve the workforce.
The mission of the NIHR is to improve the health and wellbeing of the nation through research. NIHR is responsible for public funds and therefore aims to ensure that the research funded leads to improvements in treatments, technologies, services, and expertise that can be used by the healthcare system and other related organisations to deliver patient benefit.
IP is a crucial tool for delivering patient and public benefit, therefore, it is vital that intellectual assets generated from NIHR funding are protected appropriately. The NIHR research contract is designed to ensure that IP is protected within an appropriate legal and contractual framework to achieve this goal.
IP resulting from NIHR-funded research
The majority of NIHR funding leads to the creation of various forms of IP, highlighted in the table below. Contractors are expected to be able to identify intellectual assets, protect them, and exploit them appropriately to enhance healthcare systems in the UK and abroad.
| Intellectual Property | Likelihood | Protection |
|---|---|---|
| New local guidelines | Very likely | Copyright |
| Improved checklists or questionnaires | Very likely | Copyright |
| New clinical data | Very likely | Database rights |
| New national guidelines | Likely | Copyright |
| New software tool | Likely | Copyright |
| New or improved medical device | Less likely | Design Rights, Patent, Trademark |
| New or improved pharmaceutical drug | Less likely | Patent, Trademark |
Most NIHR-funded IP will provide benefit by supporting or changing current practice. Some NIHR awards result in the creation of novel treatments or devices that may be patentable which may attract commercial interest and require licensing them to a third party or forming a spin out company. In such cases, Contractors must obtain consent to make any commercial use of or permit any third party to make commercial use of IP assets that were developed using NIHR funding. Where IP arising from NIHR-funded research may be of interest to third parties, care needs to be taken to ensure that appropriate legal mechanisms are put in place to prevent inappropriate use (e.g. management of copyright or data by way of a licensing programme). IP assets must be carefully managed to ensure that publicly funded research is utilised in a way that produces benefits for patients and the public.
Considerations
There are a number of factors that researchers must consider during the contracting process, such as:
- Does the research involve collaborators and/or subcontractors?
- What is the Background IP position?
- What are the proposed ownership arrangements for Foreground IP?
Does the research involve collaborators?
The NIHR wants to make sure that the research funding is carried out in a way that promotes maximum dissemination and if appropriate, exploitation of any results. The NIHR acknowledges that Contractors may need to involve collaborators and therefore requires information regarding the parties involved in the research and how that relationship is governed. NIHR expects there to be a formal collaboration agreement in place between the Contractor and all collaborators either before the project starts, or within an appropriate time frame to be agreed. Any collaboration agreements must be disclosed to the NIHR prior to signing to ensure there is no conflict with the terms of the NIHR award contract. It is important to note that while NIHR can advise on these agreements, it is the organisation's responsibility to make sure they follow the NIHR funding terms.
What is the Background IP position?
Background IP can play an important role in creating Foreground IP. Often the creation of the Foreground IP cannot be produced or used without Background IP. Therefore, the NIHR research contract contains specific provisions on Background IP that are intended to ensure that the research can be conducted and research outcomes funded by NIHR may eventually be translated into patient and public benefit. For example, clause 23.1.5 requires the Contractor to confirm that they have the appropriate authorisation to use Background IP introduced to the Research.
Sometimes, Background IP used in the research has certain restricted uses, such as exploitation. If researchers have limited rights to use Background IP and are unable to make the warranty at clause 23.1.5 the Contractor should include a list of the restricted use IP in Schedule B. This will clarify ownership and rights relating to Background IP needed for generating patient and public benefit.
Who will own the new IP arising from NIHR-funded research?
The NIHR position prefers that the research institution that receives the funding owns all Foreground IP resulting from the NIHR-funded research. However, due to the complex nature of research and the importance of partnerships in its success this is not always appropriate. Therefore the research contract contains provisions that recognise collaborations and the need to accommodate flexible IP ownership.
The purpose of Schedule C of the research contract is for researchers to indicate where the ownership of Foreground IP may differ from NIHR’s preferred position. This gives NIHR comfort that the new IP can be used to generate public and patient benefit. Alternative ownership of new IP may be necessary due to pre-existing agreements or to simplify the route to patient benefit. If alternative IP ownership arrangements are proposed , researchers must give a strong justification during contract negotiation to show how it will maximise public and patient benefit over the preferred arrangement. In rare cases where not all Foreground IP is owned by the Contractor, for example where a third party’s Background IP is being used to deliver research, improvements may be made as part of the research. In that case the third party may want to own the rights to any improvements which are developed. Whether this is acceptable will vary from case to case and depend on the context.
Joint ownership of Foreground IP may appear to be the simplest option, but NIHR has found that it can make it more challenging to exploit and disseminate Foreground IP for patient and public benefit. Therefore, NIHR will only agree to joint ownership in exceptional circumstances. If researchers believe that joint ownership is appropriate for their project, this should be justified in their application.
Commercialising new IP arising from NIHR-funded research
As a custodian of taxpayer funds, NIHR has a duty to handle public finances with care so that patients and the public can reap the benefits. If a Contractor believes that commercialising research provides the maximum benefit to patients and the public, NIHR requires them to obtain consent before proceeding to market. By having this mechanism in place, NIHR can monitor how its funding is used, while also ensuring that all parties involved are informed of the potential commercialisation, have the opportunity to give their input, and reach an agreement on any financial returns.
NIHR aims to agree a fair and proportionate return that acknowledges its funding contribution with Contractors, however, the primary objective is not to receive a direct financial return from the commercialisation of NIHR-funded research outcomes. Therefore, whilst revenue sharing is one option, there are other ways to demonstrate a return on public funding, and the top priority of the NIHR is to ensure that patients and the public receive the maximum benefit.
This method provides that IP arising from NIHR funding is used in accordance with NIHR's goals and objectives, without causing any undue burden, and at the same time maintaining equal treatment with other major research funders in the UK.
Licensing or assigning arising IP to the NIHR
NIHR requires Contractors to provide access to any Background IP that is necessary or useful for the research and for the protection, dissemination or exploitation of the Foreground IP. If Contractors fail to comply, NIHR has the right, but not the obligation, to take over responsibility for relevant Background IP to ensure the appropriate dissemination or exploitation of the Foreground IP. The NIHR expects this right to be rarely exercised, and only under limited circumstances. These provisions are to ensure that NIHR-funded IP can be exploited or disseminated without any hindrance.
The standard research contract also includes the right, but not the obligation, for the Authority to obtain a licence to use and publish Foreground IP, Research Data, Arising Know How, Reports and any information or conclusion arising from the Research that the Contractor does not reasonably protect, manage or exploit. As with the provisions concerning Contractor Background IP, this right is one that is expected to be rarely exercised.
The NIHR seeks to ensure that arising Foreground IP is exploited where possible and appropriate to achieve public and patient benefit. Therefore there are two conditions for possible transfer of ownership to the Authority:
- First, if the Contractor elects not to protect the Foreground IP, then the Authority reserves the right (but not the obligation) to take ownership
- Second, if reasonable steps are not being taken to exploit or manage Foreground IP then, subject to any third party rights the same right for the Authority applies.
Licence to use the Reports
The research contract gives the NIHR licence to use the copyright in the Reports provided by the Contractor, (including reports, executive summaries, papers, abstracts, or other documents) and publish under a CC-BY licence. However, this licence does not extend to any Arising Know How, Research Data, Foreground IP or other Intellectual Property contained within the report. The purpose of this licence is to enable NIHR to publish information about the research for the purposes of demonstrating patient and public benefit.