Intellectual Property and Translation is sponsored by Wellcome. Guidance on managing and commercialising Wellcome-funded intellectual property to maximise public health benefit.

## Most recent changes to this policy * This policy combines the Consent and revenue and equity sharing policy with the Intellectual property policy. * No major changes have been made to Wellcome’s approach towards intellectual property, including ownership. ## What this policy covers As a charity, we must ensure that the outputs of the work we fund are applied for the public good.

This principle applies to all funded outputs, including research results, large datasets, software, new research tools, novel healthcare products, commissioned reports, and public exhibitions. It applies equally to outputs from our grant funding to the not-for-profit sector and to our programmatic investments into commercial companies.

We also have an obligation under charity law to ensure that any private benefits arising from our funding, such as intellectual property ownership, and wealth creation where the intellectual property is commercialised, are limited. To meet these obligations, we impose conditions on the ownership and commercialisation of Wellcome-funded intellectual property.

These are intended to drive public health impact, and to establish a proportionate benefit sharing mechanism when Wellcome-funded intellectual property is commercialised.

* how we expect Wellcome-funded intellectual property to be managed * our requirements if Wellcome-funded intellectual property is commercialised * how to report the creation and the commercialisation of Wellcome-funded intellectual property to us * Wellcome’s revenue and equity share when Wellcome-funded intellectual property is commercialised Wellcome-funded intellectual property refers to any of the following which have been created, exemplified or developed, in whole or in part, using Wellcome funding: * patents for inventions, such as for new drugs or medical devices * database rights in large datasets * rights in designs, for example, for new equipment * rights in confidential know-how Commercialisation refers to the process by which Wellcome-funded intellectual property is licensed or assigned for a fee (or other consideration), or where products or services containing, or having been created using, that Wellcome-funded intellectual property are being sold.

This does not include the publication of research under our Open Access policy, making the Wellcome-funded intellectual property freely accessible to partners in research consortia (for research purposes), nor the use of Creative Commons licences (or other royalty-free licensing) to assist with public dissemination.

## Using the outputs of Wellcome-funded research Anyone applying for Wellcome funding must consider what their research outputs are likely to be, and as part of the application, submit a plan for how they will manage and share them in a way that complies with this policy.

Grantholders (being the lead applicant on the relevant grant application) should regularly review how they expect to manage their research outputs and should update their outputs management plans as necessary during their projects. This should be done as intellectual property is created and developed and as new opportunities for commercialisation arise.

We expect researchers to manage their Wellcome-funded outputs in a way that aims to achieve the greatest health benefit, ensuring that outputs are made available, accessible and affordable (or free), and are acceptable to those who need to use them.

This must involve either: * using Wellcome-funded intellectual property as a tool to help protect, incentivise the development of, and ultimately commercialise a discovery, product, technology or intervention; or * making outputs widely available in line with our policy on data, software and materials management and sharing.

Intellectual property arising from Wellcome-funded research must be owned by the organisation that has the main responsibility for administering our award (the administering organisation).

If the administering organisation wants to further develop or commercialise Wellcome-funded intellectual property, this must be done in a way which complies with this policy and with the relevant grant conditions, or in the case of companies, with the conditions under which we funded their programme-related investment.

Wellcome-funded intellectual property must not be used solely to block further research and development by others, either actively or passively. We expect registered intellectual property to be abandoned if there is no credible plan to make it available widely or commercialise it, and if it presents a potential barrier to other researchers.

There may be circumstances in which we will step in to manage the Wellcome-funded intellectual property, for example, if it is not being protected or is no longer being actively commercialised by (or on behalf of) our awardee.

If we exercise step-in rights, our goal will be to achieve public health benefit by making the Wellcome-funded intellectual property available to others, or failing that, to publish the relevant results and abandon any remaining registered intellectual property rights so that they do not inadvertently act as a barrier to other researchers in the field.

Review our guidance on how to comply with our intellectual property policy for further information. ## Intellectual property arising from grant-related activities We fund universities and not-for profit research organisations through charitable grants.

Grantholders can use some of their existing Wellcome project funding to cover the costs of priority filings for patentable inventions and to register designs that arise from the relevant Wellcome-funded project. After this, the administering organisation is responsible for all additional costs of protecting, maintaining and commercialising that Wellcome-funded intellectual property throughout its lifetime.

Before commercialising any Wellcome-funded intellectual property, grantholders must review the relevant award letter to determine whether any project specific commercialisation requirements were made when the grant was issued. Administering organisations must submit an intellectual property and commercialisation report to Wellcome each year, unless other bespoke reporting conditions have been agreed.

### Consent to commercialise Unless we have waived our prior consent right, administering organisations must obtain our written consent **before** entering into transactions to commercialise Wellcome-funded intellectual property. We may refuse consent at our discretion or grant it subject to certain conditions being met.

We waive this prior consent right for awards made under our standard grant conditions to most universities and not-for-profit organisations. Instead, we confirm consent retrospectively when the commercialisation is reported to us. We can modify or withdraw this organisational consent waiver at any time.

For it to continue, an organisation must comply fully with this intellectual property policy and ensure that all commercialisation of Wellcome-funded intellectual property is carried out in line with our guidance on commercialisation and in accordance with any project related conditions set out in the relevant award letter(s).

We may reimpose the prior consent right for specific projects, in which case this will be set out in the relevant award letter. We review each organisation’s consent waiver annually when we review their intellectual property and commercialisation report.

If we have any concerns about how an organisation has dealt with Wellcome-funded intellectual property, we will raise those concerns and provide feedback for how future commercialisation should be improved. Organisations that fail to take such feedback on board (or who do not provide adequate details of commercialisation through their intellectual property and commercialisation reports) will have their consent waiver removed.

### Revenue and equity share We will usually take a share of the revenue and equity received by administering organisations from the development or commercialisation of Wellcome-funded intellectual property, to ensure there is limited private benefit under charity law. Our standard share for grants is 25%.

We may agree later to reduce this in specific circumstances, for example where the goal of all the parties involved in commercialisation is to support equitable access to a new healthcare product and where Wellcome reducing or dropping its revenue share would further support that collective effort. If this is of interest, please contact us as early as possible to discuss the details of your proposed transaction.

### Applying to keep Wellcome’s share of money (revenue retention) Eligible organisations can request annually to keep some or all of Wellcome’s share of revenue to put towards activities aligned with our charitable mission. Organisations can apply when submitting their annual intellectual property and commercialisation report.

This revenue retention is, except under exceptional circumstances, limited to a maximum of £1 million per year (excluding VAT) per organisation. For more information about applying, review our guidance on how to complete the intellectual property and commercialisation report. We will consider applications on a case-by-case basis, and any money kept will be subject to terms and conditions.

If your organisation does not report to us through the annual intellectual property and commercialisation report and we have agreed other reporting arrangements with you, contact IPcommercialisation@wellcome. org if you wish to apply to keep Wellcome’s share of revenue.

## Intellectual property in product development awards to companies Product development activities carried out by commercial companies will usually be funded through a programme-related investment, rather than a charitable grant. Terms applied to the award, including reporting requirements, will be detailed in the project-specific funding agreement.

Companies must always obtain our written consent before entering into transactions to commercialise Wellcome-funded intellectual property. Diligence requirements, aimed at ensuring that the project delivers public health benefit, are standard.

Our charitable obligations in relation to excessive private benefit will be satisfied through either a convertible loan mechanism or through a revenue sharing mechanism, depending on the type of award made. Reporting will be managed separately to the annual intellectual property and commercialisation report for grants. Check the specific award terms and conditions for details.

## Intellectual property in non-grant related activities Where we carry out or commission non-research related activities to further our charitable mission, they may also generate intellectual property.

Examples include: * creating public exhibitions * commissioning artworks, reports, films, broadcasts and games We typically own the intellectual property arising from non-research related activities which we commission, so we can make the outputs available openly to achieve the maximum public benefit.

If Wellcome does not own such intellectual property, we must be able to exercise sufficient control over the Wellcome-funded intellectual property to ensure that the outputs arising out of our charitable funding deliver public benefit with limited private benefit, as required under charity law.

* Conflicts of interest policy: Wellcome-funded researchers and commercial organisations * How to complete your Intellectual Property and Commercialisation report * How to comply with our intellectual property policy * Intellectual property guidance