Intellectual property and translation - our approach

We want to make sure that research outputs generated by Wellcome-funded science are translated into practical applications as quickly and effectively as possible.

This is 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 following overview applies when our standard grant conditions apply. 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, in compliance 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
• the development and dissemination of 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 of which one 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 IP reporting requirements)
• Intellectual property (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 in your grant application. Review how to complete an outputs management plan for advice on what we're looking for and what factors to consider.

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 so that the delivery of any public health impact is not delayed in the absence of an agreement between various parties 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 extend to allowing ownership of IP by individual inventors because under charity law, public health impact must be prioritised and any private benefit must not be excessive.

Example:

If you're using a proprietary research tool provided by a company for other research purposes, it is acceptable to:

• share research data that you generate using that tool and which relates to the performance of that tool, and
• allow that company to own any incidental improvements to the tool which happen to be made while using it.

However, all other results and IP generated from the use of the tool should be retained by the funded organisation, so that they can be published and/or commercialised in line with Wellcome’s policies.

Collaborators should not be able to veto conditions conditions relating to the commercialisation of Wellcome-funded IP, but there is an expectation that they should be treated fairly, given their contribution to the project. Below are examples of some aspects that we would expect collaborators to agree within a collaboration agreement:

• access to arising datasets (for non-commercial research purposes) by collaborators is fair and reasonable;
• financial returns from any commercialisation (after deduction of our standard 25% revenue share) are distributed in an equitable way between collaborating institutions who contributed to the creation of the IP in question; and
• the lead organisation (as the commercialising party) should discuss the commercialisation plan with collaborators and update them on progress.

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 commercialisation of IP is the optimal route to deliver health benefit from it, 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 report to Wellcome. Review the 'Reporting your IP to Wellcome' section for more information.

Getting consent

In most cases, you no longer need to get 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 get on with translating promising scientific discoveries.

Where our prior consent to commercialisation is still necessary, this will be stated in your award letter/funding agreement. Before you enter into any commercialisation agreement, we recommend that 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 consolidated IP 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 must be consistent with our guidance on commercialisation agreements. In particular, the driving factor in the negotiation of any such agreement should be maximising public benefit toward the potential for health impact, not revenue generation.

Wellcome is increasingly focusing on equitable access to ensure the maximum public health benefit 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.

All new transactions related to Wellcome-funded IP must be included in the organisation's annual consolidated IP 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 simple flat rate of 25% revenue and equity share for commercialisation of outputs resulting from our standard grants.

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

Wellcome supports science to improve health, not to generate a financial return. However, we have a legal obligation to make sure that our funding is used for charitable purposes, not to financially benefit individuals or companies.

In the past, we met this obligation by taking our share of any revenue or equity generated when Wellcome-funded IP was commercialised, and then reinvested it for the public good. But we want to provide greater support to the translation of IP, and to recognise and reward those organisations that do so. Under our new arrangements, any university that generates revenue from translation can apply to keep our share to support new translational activities in their organisation, or to improve equitable access. Organisations can do this when they submit their annual IP report to Wellcome

Information on the revenue that has been retained by organisations to date:

Your organisation is responsible for reporting IP creation and its subsequent sharing (open access) or its commercialisation to Wellcome, not individual researchers (Grant Condition 4.8). However, we expect researchers to work with their organisations to do so by keeping them updated on the creation of significant research outputs and their plans for using them.

Consolidated 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 the commercialisation agreements that you have entered into which relate to the activity set out in your report. This is a condition of our funding, as set out in our Grant Conditions.

The reports are submitted in electronic format. Each November, we will send a customised link for the electronic form to each organisation's technology transfer team. 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 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 only to report that there has not 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.

Failure to submit copies of agreements (in unredacted form) may result in your organisation’s prior consent waiver being revoked. This would mean your organisation seeking our prior written consent for each proposed transaction before finalising, which is likely to result in delays to contracting. Some organisations have begun inserting provisions into their contracts to clarify that Wellcome will review copies of such licences as a condition to its funding, for this purpose.

Organisations can only apply to retain Wellcome’s share of revenue received in the year covered by the report. If your organisation wishes 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.

If your application to retain revenue is successful, the retained revenue can be spent on any projects as long as they 1) focus on new translational activity or 2) 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. 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 should inform us as soon as possible before doing so.

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.

If you are expecting large revenue amounts, especially those which are unusual in your organisation’s history of translational activities, please bring this to our attention as soon as possible during the year, and before submitting a revenue retention request. This will help shape your application to retain revenue and reduce the risk of an unsuccessful application.

Early discussion of unusually large transactions may also allow us to consider whether an extended spend period is required for the amount in question. Retained revenue must usually be at least committed within one year of the revenue retention request being approved. Organisations are usually informed about the outcome of their revenue retention requests annually around June. The spend report is then due at the end of the following reporting period in December. In practice, this results in around 18 months to spend any retained revenue. Wellcome will notify organisations when spend reports are due.

Depending on the proposal, we may grant a longer spend period. This is at our complete discretion and would be an exception. We reserve the right to:

• enforce limits on retained amounts and spend periods, for example, if we have concerns about an organisation’s ability to use the revenues effectively; and
• reject exceptionally large amounts (this will depend on what is unusually large for the organisation in question, based on their history of translational activity).

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.

Where our Innovations team funded R&D 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 or equitable access.

General housekeeping

You should ensure your organisation’s contact details are kept up to date, including the appropriate person(s) to submit the annual IP and commercialisation report(s). Failure to review your contact details regularly may result in your prior consent waiver being revoked, if you fail to submit your annual IP and commercialisation report as a result. You can add more than one contact email address. Update your contact details.

Overseas organisations are responsible for ensuring that 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.

We produced a set of collective commitments to translation with the Royal Society, the Academy of Medical Sciences and the Royal Academy of Engineering in 2017. Following this initiative, we revised our policies, grant conditions and supporting documents relating to IP and translation, to help Wellcome funded researchers and organisations, and to support and reward translation.