Intellectual property and translation - our approach

Research outputs generated by Wellcome-funded science should be translated into practical applications as quickly and effectively as possible.

This is in line with our Constitution [PDF 153KB], which states that when funding research, 'it is expected that a large part of such research may lead to results that will benefit the life, health and well-being of humankind'.

We define research outputs broadly. They include patentable inventions, software, datasets, designs, materials (such as reagents and cell lines) and know-how.

The guidance on this page applies to awards made on our standard grant conditions. It does not apply to:

• awards made to companies
• other legacy schemes or awards which were made on bespoke terms by our Innovations team, usually done in the form of a funding agreement rather than a standard award letter.

In these cases, review the 'Legacy awards agreed with our Innovations team' section.

We expect you to manage your research outputs in a way that will achieve the greatest health benefit, while complying with our grant conditions and the policies we refer to on this page. This might involve:

• translating inventions into new drugs or medical devices which benefit patients directly
• developing and disseminating new research tools, software and materials, to help the research or translational efforts of others.

The methods used to generate impact from research outputs may also vary, but the chosen method must be based on an assessment that will lead to the greatest health benefit.

Researchers and their organisations must:

• make their outputs freely available to others (open access), or
• use intellectual property (IP) as a tool to protect and commercialise them.

When we assess grant applications, we look at the steps you've taken to benefit health through your previous research. This is as important to us as your publication history.

All applicants and organisations must read our:

• Grant conditions – section 8 (as well as condition 4.8 'Management of the Grant and reporting' for our annual consolidated IP and Commercialisation reporting requirements)
• IP policy
• Consent and revenue and equity sharing policy.

If your research is likely to generate significant research outputs that will be of value to other researchers and users, you must complete the outputs management plan section of your grant application. Learn how to complete an outputs management plan.

Collaborating with others on your research project

If you plan to collaborate with others on your research project, you must make sure that you comply with grant condition 8.1 in relation to the ownership and protection of IP.

The organisation administering your grant is expected to own all Wellcome-funded IP (apart from copyright in research articles which may be retained by the authors). This is important to avoid delaying the delivery of any public health impact. This can happen if various parties can’t reach agreement over the ownership of IP and how the IP in question will be later commercialised. Limited exceptions are allowed under grant condition 8.2, which enables access to proprietary materials and the background IP of others. In these cases, when dealing with others, your organisation must ensure that the funded research project can still deliver the anticipated public health impact. This is not an issue if no Wellcome-funded IP arises from the award.

This exception does not apply to ownership of IP by individual inventors because under charity law, public health impact must be prioritised and any private benefit must not be excessive.

Working with others outside academia

We encourage researchers to engage with people outside of academia to increase the impact of their research outputs. However, if this creates a potential conflict of interest, it will need to be managed appropriately.

If you have relationships with industrial partners, you should assess if you have a conflict that will need to be disclosed and managed, in line with our Conflicts of interest policy: Wellcome-funded researchers and commercial organisations. Examples include other (commercially funded) research collaborations or positions as consultants, scientific advisors or directors.

Researchers should immediately tell their research office/technology transfer office about the creation of any significant research outputs (for example, potentially patentable inventions, new software or new materials such as antibodies or cell lines).

Researchers should work closely with their organisation to determine whether to use IP as a tool to commercialise such outputs, or whether to instead make them freely available through open access.

If a significant research output has been created, and you have determined that the best way to achieve health benefit is by commercialising the IP, you must comply with our:

• Grant conditions (condition 8.3), and
• Consent and revenue and equity sharing policy.

You can use your Wellcome grant to pay for the initial costs of protecting patents and registering designs. After this, your employer is responsible for all additional costs of protecting, maintaining and commercialising that IP throughout its lifetime.

Details of significant research outputs and IP creation must be included in your organisation's annual consolidated IP and Commercialisation report to Wellcome. Review the 'Reporting your IP to Wellcome' section for more information.

Getting consent

In most cases, you no longer need our consent before commercialisation. This applies to grants awarded under our standard grant conditions. We want to make it quicker and easier for organisations to translate promising scientific discoveries.

Where we still need to consent to commercialisation beforehand, this will be stated in your award letter/funding agreement. Before you enter into any commercialisation agreement, we recommend you check the specific terms under which Wellcome funded the project. This will help you determine if you need to get our written consent first.

We can also withdraw this waiver of consent under our standard grant conditions if an organisation fails to meet our requirements (including failing to submit their annual IP and Commercialisation report). We check this each year when we review each organisation's annual consolidated IP and Commercialisation report. If we withdraw the waiver, all future IP transactions by that organisation will need our prior written consent, until we feel comfortable enough with their activities to reintroduce the waiver.

Transactions

Any IP transactions, such as licences, options, assignments, material transfer or evaluation agreements, must be consistent with our guidance on commercialisation agreements. The driving factor when negotiating these agreements should be maximising public benefit to achieve the maximum health impact, not generating revenue.

Wellcome expects a heavy focus on equitable access to ensure the maximum health impact is achieved. We expect organisations to include provisions in commercialisation agreements for equitable access for low- and middle-income countries where appropriate. The GHIAA MAPGuide may be a good starting point for institutions to review various equitable access clauses and strategies that may be suitable for them to use. Working with patent pools (such as the Medicines Patent Pool) to licence Wellcome-funded IP can be an effective method of facilitating equitable access.

All new transactions related to Wellcome-funded IP must be included in your organisation's annual consolidated IP and Commercialisation report to Wellcome. Review the 'Reporting your IP to Wellcome' section for more information.

Our revenue and equity share

In most cases, we apply a flat rate of 25% revenue and equity share where outputs of our standard grants are commercialised.

Our equity share is typically held by the relevant organisation on trust for us, and then treated as revenue when the organisation sells our shares along with its own.

Although we support science to improve health, we have a legal obligation to make sure that our funding is used for charitable purposes – not to financially benefit individuals or companies.

We want to provide greater support to translation. We are doing this by rewarding organisations that translate Wellcome-funded IP to achieve a health benefit.

Any university that generates revenue from translation can apply to keep our share to support new translational activities. These activities should be underpinned by a focus on improving equitable access. Organisations can do this when they submit their annual consolidated IP and Commercialisation report to Wellcome.

Revenue that has been retained by organisations to date:

Types of report received:

Your organisation is responsible for reporting IP creation and its subsequent sharing (open access) or its commercialisation to Wellcome (Grant Condition 4.8). We expect researchers to work with their organisations to support this by keeping them updated on the creation of significant research outputs and their plans for using them.

IP and Commercialisation report

Your organisation must complete and submit a consolidated IP and Commercialisation report by the end of February each year. This includes providing unredacted copies of commercialisation agreements that you have entered into, which relate to the activity set out in your report. This is a condition of our funding and maintains your institution’s prior consent waiver (see Grant Condition 8.3(b)).

Each November, we will send a unique link to each organisation's technology transfer team so they can complete the electronic form. If the technology transfer team at your organisation has not received this link by 1 December, contact IPCommercialisation@wellcome.org. Please use this short form to ensure your organisation’s contact details are kept up to date, particularly if key contacts for the reporting process leave your organisation.

Guidance on how to complete the electronic form is available in our IP and Commercialisation Quick Start Guide.

The report:

• should cover all IP-related activity for the previous calendar year and must detail Wellcome grant numbers, where known
• must include copies of the commercialisation agreements relevant to all IP-related activity
• must be submitted, even if you’re only saying there hasn’t been any IP-related activity.

It is your organisation’s responsibility to ensure that all information contained in your report is accurate to the best of your knowledge.

If you do not provide full, unredacted copies of agreements in future cycles, your institution's prior consent waiver will be revoked. You would then need to obtain our written consent to each proposed transaction before it can be finalised. This will likely lead to contracting delays.

Overseas organisations are responsible for ensuring they account for any relevant taxes in country in which their organisation is based. Wellcome is not responsible for any such taxes. You should seek specialist advice if you have any questions.

Organisations can only apply to retain Wellcome’s share of revenue received in the year covered by the report. If your organisation wants to retain Wellcome’s revenue share, you must:

• include a revenue retention request in the report
• submit your report form to Wellcome by the February deadline. Forms submitted after this date may result in your request being refused.

We are keen for institutions to retain our share of revenue that they generate. If your application to retain revenue is successful, the retained revenue can be spent on any projects as long as they focus on new translational activity and are underpinned by considerations to improve equitable access to healthcare interventions, particularly in low- and middle-income countries. The project does not need to be Wellcome-funded or linked to the original project that generated the revenue. While we would prefer for retained revenue to be used towards areas that align with Wellcome’s strategic goals, even if that work was originally funded elsewhere, this is not a requirement.

You should provide as much detail as possible on the proposed use of the retained funds in your application. If you would like to change the proposed use at any point following a successful application, you must inform us beforehand.

Your organisation must also complete Appendix 2 of the report – Our Revenue and Equity Sharing Agreement – if they entered into one or more commercialisation agreements related to Wellcome-funded IP in the year covered by the report.

Retained revenue can be added to an institutional fund for IP and patent costs but should not replace or substitute the core funds available at that institution.

Wellcome’s IP and revenue sharing policies will not typically apply to activities funded indirectly through retained revenue, however we retain the right to request that our conditions flow down in certain circumstances (for example, depending on the value retained and the proposed work).

Where our Innovations team funded Research and Development projects – through either a bespoke funding agreement or a convertible loan (rather than on Wellcome’s standard grant conditions) – the specific provisions negotiated for that project will apply.

The protection and management of Wellcome-funded IP may be overseen by an IP management group and Wellcome’s prior consent to the commercialisation may be required. The revenue share may be different to the default 25%, but your organisation can still apply to retain it to support future translational activities with a view to improving equitable access.