Intellectual Property Policy

1. Purpose 

SEA DREAM works to ensure that the results of the research SEA DREAM funds are applied for the public good. This includes creating an environment that enables and incentivises researchers to develop innovative products and technologies that lead to health improvements.

SEA DREAM recognises that certain research outputs may involve intellectual property (IP) with potential for commercialisation. This policy is intended to provide guidance on how grantees should manage such IP to maximise public health benefits and assist further research. It also sets out best practices for engaging with commercial actors along with the reporting requirements to SEA DREAM.

2. Our Position

SEA DREAM expects our researchers to manage their research outputs in whatever way will achieve the greatest health benefit. This may involve either:

• Using intellectual property (IP) as a tool to help protect and commercialise a discovery, original idea, product or technology, or
• Making outputs widely available in line with our Data, Software and Materials Management and Sharing Policy.

SEA DREAM does not seek to directly own or co-own IP arising from our research funding. IP created by SEA DREAM-funded researchers will generally be owned by their employing organisations. However, SEA DREAM reserves the right to step in to protect, manage and commercialise SEA DREAM-funded IP on the grantee's behalf by giving six-months' written notice if the grantee does not protect, manage or commercialise any IP to the reasonable satisfaction of SEA DREAM.

3. Our Policy

1. This policy applies to all forms of IP, including:
   • patents for inventions, such as new drugs or medical devices
   • copyright, such as in books, software, or in reports, artworks or audiovisual works
   • database rights in large datasets
   • rights in designs, for example, for new equipment
   • rights in confidential knowhow
   • trademarks
      
2. SEA DREAM recognises and values a range of research outputs – including inventions, datasets, software and materials, as well as publications – in assessing researchers’ track records. The guidance SEA DREAM gives to our committees, reviewers and staff emphasises that our funding decisions should take account of the:
   • full and diverse range of outputs that result from research
   • efforts made by researchers to use outputs to deliver health benefits or assist further research
      
3.  SEA DREAM asks anyone applying for the funding to consider their approach to managing and sharing anticipated outputs at the research proposal stage. In cases where these outputs are significant – for example, patentable inventions, large databases, substantial pieces of software, or new research materials, such as antibodies, cell lines or animal models – applicants will need to include an outputs management plan explaining their planned approach. SEA DREAM will review this plan as part of our funding decision.
    
4. Researchers (and their employing organisations) should take a dynamic approach to outputs management. Outputs management plans should be reviewed throughout the research life cycle – as IP is created and developed, and as new opportunities for commercialisation arise.
    
5. Researchers can use part of the SEA DREAM funding to cover the initial costs of protecting patents and registering designs arising from their SEA DREAM-funded research. However, researchers must first obtain SEA DREAM’s approval regarding the maximum amount of funding that may be used for this purpose, which SEA DREAM will determine at its sole discretion on a case-by-case basis. After this, their employers are responsible for all additional costs of protecting, maintaining and commercialising that IP throughout its lifetime.
    
6. Where appropriate, SEA DREAM asks our award holders to make special provisions in their commercialisation agreements for access in low- and middle-income countries. As SEA DREAM receives core funding from Wellcome, we are also committed to Wellcome’s equitable access to healthcare interventions statement.
    
7. SEA DREAM-funded IP must not be used solely to block further research and development by others, either actively or passively. SEA DREAM expects registered IP to be abandoned if there is no credible plan to commercialise it and if it presents a barrier to other researchers.
    
8. Funded organisations will need to complete and submit the Annual Consolidated IP and Commercialisation Report to SEA DREAM once a year during the funding period, and until SEA DREAM-funded IP has expired if the IP is commercialised, unless other bespoke reporting conditions have been agreed.
    
9. Where SEA DREAM supports public engagement activities (rather than research activities), they may also lead to the generation of IP. Examples include creating public exhibitions, publishing books, digitising archives, and commissioning reports, films, broadcasts, games and artworks. Depending on the scale of SEA DREAM’s involvement, SEA DREAM will either own the arising IP, so that SEA DREAM can ensure open access to it, or, where the IP is owned by others, exercise sufficient control over it to ensure that our public engagement aims are met.

4. Reporting Your IP to SEA DREAM

Your organisation is responsible for reporting IP creation and its subsequent sharing (open access) or its commercialisation to SEA DREAM. SEA DREAM expects 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 the annual Consolidated IP and Commercialisation Report by the end of Quarter 1 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. 

In the last Quarter of each calendar year, SEA DREAM will send a unique link or template to each organisation's technology transfer team or nominated focal point to SEA DREAM so they can complete the report. 

The report:

• should cover all IP-related activity for the previous calendar year and must detail SEA DREAM 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. SEA DREAM grantees are responsible for ensuring they account for any relevant taxes in the country in which their organisation is based. SEA DREAM is not responsible for any such taxes. You should seek specialist advice if you have any questions.

5. SEA DREAM's Guidance on IP Commercialisation Agreements

5.1. Key issues

SEA DREAM expects to see the following key issues (where relevant) addressed by grantees in entering into commercialisation agreements with commercial partners. It is not intended to be an exhaustive list, and it will depend very much on the circumstances of the particular IP and the chosen commercialisation route. We will consider these points when assessing consent applications.  

i. Resources and expertise of the proposed commercialisation partner

The proposed commercialisation partner should have the necessary expertise and adequate resources to exploit SEA DREAM-funded IP. For example, to be able to take a new drug through the necessary regulatory process to the market place. This does not mean that the proposed partner has to have all necessary expertise and resources for all stages of commercialisation at the date of consent, but the commercialisation plan must be realistic. 

For example, it may be prudent to:

• set a deadline within which a new spin-out company has to raise additional funds or enter into a further. commercialisation deal, without which the IP reverts to the institution
• provide for IP to revert on insolvency to the extent that is legally possible 

ii. Diligence obligations

The terms of an agreement commercialising SEA DREAM-funded IP should place appropriately-worded diligence obligations on the commercialisation partner to make sure:

• suitable resources are devoted to commercialising the IP
• development is not sidelined or shelved if commercial priorities change

For example, the IP may revert to the institution that created it (i.e., the SEA DREAM-funded grantee)  if diligence obligations are not complied with.

iii. Step-in rights on IP

If the institution gives responsibility to the commercialisation partner for filing, prosecuting and maintaining SEA DREAM-funded IP and the partner fails to do so adequately, or decides to abandon a piece of registered IP, the institution should retain the right to take back that responsibility at its own cost. This may be considered particularly important for early spin-out companies where financial resources are tight, or where there is a potential application in low- and middle-income countries, but the partner may not wish to maintain patents in these countries.

iv. Appropriate financial return

While we do not give specific guidance for the amount of return that an institution should get from commercialisation, we will check that the return is not obviously disproportionate (in either direction) to the institution’s contribution. This is to ensure that the private benefit to the commercialisation partner is no more than incidental to the public health benefit arising from the commercialisation of SEA DREAM-funded IP through the improvement of human health.

v. Research licence reserved for the institution and researchers

We generally expect that the institution will reserve the right to continue using SEA DREAM-funded IP for academic research and teaching so that its researchers’ careers are not restricted. This should hold true regardless of the funding period and should also be sub-licensable/transferable if the researcher changes institution.

vi. Publications

Any delays on publications by the institution or its researchers should be limited to a reasonable time period (typically three months, maximum six months) and only to:

• allow for filing of new IP, or
• remove information that is genuinely confidential to the commercial party

vii. Appropriate exclusivity

Where an institution wishes to grant an exclusive licence to a commercial third party, we expect it to evaluate whether exclusivity is the most appropriate way of achieving the maximum public health benefit. We recognise that exclusivity is often required to attract the investment necessary to successfully commercialise SEA DREAM-funded IP. However, in cases where SEA DREAM-funded IP underlies a new research field or could act as a fundamental platform for further important work, the public health benefit may be best achieved by a series of non-exclusive or co-exclusive licences to avoid giving one party a blocking position.

viii. Provisions to address commercialisation agreements in low- and middle-income countries

We encourage institutions to consider including provisions in commercialisation agreements for low- and middle-income countries where appropriate. These will need to be negotiated on a case-by-case basis, but examples include:

• dividing up territories between a commercial and a not-for-profit partner
• providing for territories to revert to the institution if not commercialised by the commercial partner
• requirements for products to be supplied to low- and middle-income countries at or close to cost

ix. Pipeline arrangements

Pipeline arrangements are where a company receives or pays for the right of first refusal to research outputs from a university lab, department, or even an entire institution. This may have the positive impact of bringing in funding to an institution, but it essentially forward-sells the IP. This conflicts with our approach to IP, which is that the institution focuses (on a case-by-case basis) on maximising the potential public health impact when it commercialises SEA DREAM-funded IP. As a result, the institution should not enter such an arrangement unless:

• it is appropriately limited in time and scope
• the third party is clearly the most suitable commercialisation partner
• the institution receives an appropriate return

5.2. Consent to commercialise SEA DREAM-funded IP

We require our grantees to seek prior approval from us in writing before entering into any commercialisation agreements. We will review details of the proposed transactions of SEA DREAM-funded IP by such institutions on a rolling basis. We will then provide consent for those commercialisation agreements and associated transactions as part of our revenue and equity sharing agreement with the institution.  

SEA DREAM is currently developing a standard template on Revenue and Equity Sharing Agreement to be used between SEA DREAM and concerned grantee(s) that will commercialise SEA DREAM-funded IP. Meanwhile, you can check a reference template of Wellcome (Annex I) to understand possible provisions in the agreement template. While a grantee is preparing a commercialisation agreement with a commercial entity, we may, upon request, provide guidance on certain terms of a particular transaction. However, our formal consent will only be given based on the final commercialisation agreement.

6. Annexes

Annex I. Wellcome’s Revenue and Equity Sharing Agreement Template

Annex II. More information

If you need more information related to intellectual property, check out the following sources from Wellcome:

• Wellcome's approach to intellectual property and translation
• Transforming UK translation: our commitments to developing the system over the next 10 years [PDF 99KB]
• Wellcome's approach to equitable access to healthcare interventions