Intellectual Property - Legacy St George's

1. Introduction

This policy covers the management and exploitation of St George's, University of London intellectual property. It is a term of employment at St George's that the Intellectual Property Rights (“IP”) in projects which arise from or during employment are owned by St George's subject to the right of the creator to be recognised as the author of the intellectual property and to publish in their own name. Joint Research and Enterprise Services (Joint Research and Enterprise Services) have responsibility for intellectual property protection and management in St George's, specifically the Enterprise and Innovation Team within Joint Research and Enterprise Services. Employees have a continuing duty to inform the Joint Research and Enterprise Services of developments which may have commercial potential at the earliest opportunity.

2. Types of intellectual property and related terms

This policy applies to all intellectual property created through employment at St George's or by students who may contribute to the creation of intellectual property. Relevant terms and types of intellectual property may include but are not limited to the following:

Intellectual Property (IP) means inventions, Copyright Material (as defined below), Patents and patent applications, design rights, trademarks, trade names, service marks, database rights, plant breeders’ rights, topographies, utility models, know-how, confidential information, protected test data and other intellectual property rights, in each case whether registered or unregistered and including applications, the rights granted under licences and licence options and benefit-sharing rights to any of the foregoing and all rights or forms of protection in any jurisdiction.

Copyright Material means copyright intellectual property in all literary, dramatic, musical and artistic works, sound recordings, films or broadcasts and typographic arrangements of published editions such as lecture notes, laboratory note books, research reports, research questionnaires, information on websites, digital teaching tools, including computer generated works and program source codes, smart phone apps, and similar material.

Patents and patent applications: Applications for a patent may be submitted for any new technical concepts or inventions which may qualify for protection if the invention is deemed to be novel, inventive and commercially applicable.

Database rights: these may protect against the extraction and re-utilisation of the content (applies in Europe only).

Trademarks: indicate the source of a product or services and gives the customer assurance of the originating quality and value.

Registered and unregistered design rights: the design of a product or object, including its appearance, form or decoration may be protected and may include either the whole or part of a product or object and may include packaging or parts assembled into a complex product or object.

Know how: this is specialist knowledge. Third parties may pay for access to know-how, as long as it has previously been kept confidential.

Materials: includes blood samples, vectors, bacterial strains, plant varieties, human or animal tissue, etc.

Further information about all types of intellectual property and intellectual property rights can be obtained from the JREO and from the UK Intellectual Property Office website.

3. Other definitions

Assignment is an outright transfer of intellectual property rights.

Associate(s) means individual(s) who are affiliated to St George's, University of London but who are neither employees nor students (for instance honorary staff and visiting academics).

Commercial Revenue means the revenue received from third-party licence fees, royalties, intellectual property assignments, fees for services or any other payments received in respect of commercially exploited intellectual property.

Costs means all of those costs incurred in the creation, development, protection and commercialisation of the intellectual property, which may include payments to third parties and expenses, such as patent prosecution and protection fees, legal and commercial advice and proof-of-concept funding or any funding provided by St George's in direct support of an invention with the express purpose of developing it for commercial exploitation.

Contributor means any member of St George's (including students) or associate who were involved in the development of the intellectual property did not provide an inventive contribution.

Creator means any member of St George's (including students) or associate who creates, devises or invents an item of intellectual property, not merely a person providing assistance in the realisation of an invention.

Cumulative St George's, University of London Net Receipts refers to St George’s Net Receipts received in respect of the specific piece of intellectual property since its first commercialisation.

Faculty staff means all staff of the Faculty of Health, Social Care and Education, whether substantively employed by St George's or by Kingston University and employed pursuant to the terms of the Joint Venture Agreement between St George's and Kingston University.

Joint Research and Enterprise Services is the Joint Research and Enterprise Services, responsible for the commercialisation of intellectual property within St George's.

Inventive contribution means creative effort by an individual that in type and scope qualifies such individual for inventorship status under European patent law.

Licence is a formal agreement granting rights from one party (the Licensor and owner of the intellectual property Rights) to another party (the Licensee), who thereby is able to exploit the intellectual property through the Rights granted under the terms of the Licence.

Members of St George's, University of London are defined in the St George's statutes and includes all academic staff and students.

Net Receipts are the Commercial Revenues received in respect of the intellectual property minus the direct Costs incurred and minus any payments that St George's, University of London is obliged to pay to any external organisation, other than as a share of the Commercial Revenues.

Normal duties refers to all lawful duties assigned to employees and any other duties arising out of their employment. For the avoidance of doubt employees who are employed to undertake research are expected to create inventive intellectual property.

St George's, University of London’s Net Receipts is the Net Receipt held by St George's which remain after any share is distributed to collaborators outside of St George's, University of London and/or to funding bodies who may be entitled to a share of the Net Receipts.

Spin-out companies are new companies that are formed by individuals (who were and still may be employees of a parent organisation) together with the parent organisation, utilising core intellectual property that originated at the parent organisation and that was then transferred to the new company.

Staff means all employees of St George's, University of London, including all staff who are jointly employed with other employers including but not limited to NHS Trusts (except for clinical academics employed jointly with NHS Trust).

Start-up companies are companies set up by individuals independently of a parent organisation.

Student(s) are defined in the statutes as any person currently registered to receive instruction or supervision in or by St George's, University of London or any other similar arrangements and may apply to any registered student(s) of St George's whether undergraduate, postgraduate (including whilst writing up a thesis or dissertation) or those on an exchange scheme.

4. Exceptions to this policy

4.1. Where intellectual property is generated jointly with St George’s University Hospitals NHS Foundation Trust, each Creator shall be obliged to adhere to the intellectual property policy of his/her own substantive employer. In the case of a Creator employed by both St George's, University of London and St George’s University Hospitals NHS Foundation Trust (“SGFT”), it may be necessary for St George's, University of London and SGFT in consultation with the Creator to identify what work was undertaken on behalf of which organisation and to comply with the intellectual property policy of each organisation in respect of the work done for each. Joint Research and Enterprise Services will support the Creators to facilitate the identification of intellectual property ownership and to establish arrangements for intellectual property exploitation.

4.2. Where intellectual property is generated jointly with other organisations (apart from St George’s University Hospitals NHS Foundation Trust), such as other universities, NHS Trusts or research institutes, the arrangements for exploiting the intellectual property will be negotiated by the Head of Enterprise & Innovation or their nominee within the Joint Research and Enterprise Services on a case-by-case basis with the other organisation, taking into account any pre-existing agreements covering the intellectual property generated.

4.3. Where research which leads to intellectual property generation is funded by external research funders, any intellectual property conditions in the contract which St George's, University of London has with the research funder shall apply to the intellectual property generated.

5. Ownership of intellectual property

5.1. Staff

Section 39 of the Patents Act 1977 (as amended) and the Copyright, Designs and Patents Act 1988 (as amended), with any related intellectual property subordinate legislation, make it clear that all forms of intellectual property generated by an employee, made in the course of the employee’s normal duties, belong to their employer. Hence, as prescribed by law, any intellectual property created by staff in the course of their Normal Duties shall be the property of St George's, whether the intellectual property is developed at St George's or elsewhere.

Notwithstanding the above, to ensure that due-diligence is applied to intellectual property created by staff particularly if it is to be commercially exploited, the Creator will formally assign their intellectual property rights to St George's, University of London, including any ownership rights of others (which may include co-Creators and/or the funders of intellectual property generated under research or other agreements), and provide any details of the intellectual property and its creation that may be reasonably required by St George's, University of London to assist in any future commercial exploitation. Where more than one Creator is involved, the Creators themselves shall determine and agree the appropriate share of the intellectual property that they have jointly created.

In the event of a dispute amongst multiple St George's, University of London Creators as to the division of their percent share, the Vice Chancellor of Research and Enterprise will decide, and their decision will be final and binding on the St George's, University of London Creators. The Creators shall have the right to appeal to the Vice Chancellor. Where some Creators are external to St George's, University of London, Joint Research and Enterprise Services will work with the St George's, University of London Creators to seek an agreement with the external Creators and their employment organisation.

For the avoidance of doubt, where staff are assigned by St George's, University of London to carry out projects outside of their Normal Duties those staff will also be required to assign their rights (including retrospectively if necessary) to any intellectual property created in the course of such projects to St George's, University of London.

5.2. Associates

All Associates shall be required to assign the rights to any intellectual property they create in the course of their St George's, University of London activities to St George's, University of London. This includes where Associates lead or participate in St George's, University of London research projects.

St George's, University of London may have obligations to organisations which are funding the research in question which it will not be able to honour without such an assignment of rights being in place.

Associates are treated as if they were staff for the purposes of revenue sharing. St George's, University of London recognises that, in a limited number of cases (such as Honorary Academics or Visiting Academics who remain employees of another organisation whilst at St George's, University of London), special arrangements may need to be negotiated regarding the ownership and use of intellectual property which they may generate. Such arrangements will be negotiated on a case-by-case basis, generally by the Head of Enterprise or their nominee on behalf of St George's, University of London and with a duly authorised representative of that individual’s employer. Any individual who believes that he or she falls within such a category should contact the Joint Research and Enterprise Services for advice at the earliest opportunity.

5.3. Students

Where students generate intellectual property in the course of their study or research, they will own that intellectual property in their own right unless one of the following applies:

• they generate intellectual property which is subject to external agreement; or
• they generate intellectual property which builds upon existing intellectual property generated by staff or Associates; or
• they generate intellectual property jointly with staff or Associates or under their direct instruction; or
• they are, or have the status of, staff (in which case they are treated by St George's, University of London and the law as employees), provided that their inventive contribution was made during their time as a staff member.

In the above listed circumstances students will be required to assign intellectual property they have created to St George's, University of London and to comply with, and have the benefits of this policy on the same basis as staff. In the case where a Student may own a share of the intellectual property beforehand and the further development of that intellectual property is required to be assigned to St George's, University of London, agreement will be made between the Student and the Head of Enterprise or their nominee on behalf of St George's, University of London as to the per cent. Generally, ownership will be retained by the Student and St George's, University of London separately.

Students who wish to benefit by using the expertise of, or funding (whether internal or external) administered by the Joint Research and Enterprise Services to protect and commercialise their intellectual property, must agree in consideration for these services to assign such intellectual property to St George's, University of London and to comply with this policy on the same basis as staff.

5.4. Copyright material

St George's, University of London owns copyright of all works created in any form by staff in the course of their employment, or where such works have been specifically commissioned by St George's, University of London, subject to the right of staff to be recognised as its authors and to freely publish and be paid for contributions to learned books, journal articles, conferences, etc.

Notwithstanding the above, where efforts are made by St George's, University of London in relation to the commercialisation of such Copyright Material, especially, for example, exploitable software, smart-phone apps and health-related questionnaires, or where more than incidental use of St George's, University of London’s resources are used for the generation of the intellectual property, it will be necessary for their Creator(s) to assign their intellectual property rights to St George's, University of London and the revenue share terms under 6.5.1 of this Policy shall take effect.

5.5. Teaching material

Teaching material, lecture notes, course summaries, examination and test questions belong to St George's, University of London and staff are not permitted to use these materials outside of St George's, University of London, whether currently employed by St George's, University of London or not. For avoidance of doubt, the revenue share terms under 6.4.1 of this Policy do not apply to Teaching Material.

6. Responsibilities and procedures for protecting intellectual property Rights

St George's, University of London expects staff to take all possible steps to ensure that the University is able to maximise the potential impact of any intellectual property by ensuring early identification, retaining confidentiality, facilitating protection and supporting commercialisation.

6.1. Identification

St George's, University of London expects staff and students to take all possible steps to ensure that the University is able to maximise the impact of any intellectual property by ensuring early identification and confidentiality. It is expected that the Creator brings the intellectual property to the attention of the Joint Research and Enterprise Services as early as possible and cooperates with the Joint Research and Enterprise Services in formalising ownership, registering and commercialising the intellectual property. In order to facilitate protection of the intellectual property, it may be necessary for Joint Research and Enterprise Services to request a delay to any publication or public presentation (Public Disclosure) of the research related to the intellectual property (See 6.2.3 Publication).

6.1.1. Record keeping

Members of St George's, University of London who are carrying out research are required to keep good records of their work in a bound notebook where pages are numbered, and work is dated in accordance with Good Laboratory Practice (GLP). These records can be called upon to show the date of conception of the invention, which may be required to validate a patent or to confirm the rights and ownership in the intellectual property for licensing.

6.1.2. Material Transfer Agreements (MTAs)

Material Transfer Agreements (MTAs), (available from the Joint Research and Enterprise Services) should always be used when transferring material to third parties. All MTAs (including those provided by other institutions and companies) must be agreed (and negotiated if necessary) by the Joint Research and Enterprise Services before being formally signed by Joint Research and Enterprise Services. When receiving material from another institution or providing material, Members of St George's, University of London should be aware of the implications of the clauses covering intellectual property.

6.1.3. Consultancy agreements

All consultancy agreements, whether St George's-managed or Institutional, should be reviewed by the Joint Research and Enterprise Services. The Joint Research and Enterprise Services will negotiate the contract on behalf of the member of staff. In the case of private consultancy arrangements, the Joint Research and Enterprise Services must agree the contract to ensure that there is no leakage of institutional intellectual property or obligations on the institution. Consultancy is managed as per the Consultancy Policy 2018.

6.1.4. Research and development contracts

Research and development contracts usually contain a clause which covers intellectual property ownership. All research and development contracts must be agreed by the Joint Research and Enterprise Services before being officially signed by Joint Research and Enterprise Services. Where possible, St George's, University of London will retain the ownership of any foreground intellectual property developed by St George's, University of London staff resulting from the contract and may agree commercial terms to a commercial partner for exploitation, consistent with the terms of the underlying contract. The negotiation of such commercial agreements is conducted by the Joint Research and Enterprise Services in co-operation with the Principal Investigator and the Creator of the intellectual property.

6.2. Public disclosure

St George's, University of London encourages publication and dissemination of research by Members of St George's, University of London. However, Members of St George's, University of London wishing to publish or present in a public forum should first consider if any of the work may be patentable or otherwise protectable and if any other intellectual property rights are impacted. For avoidance of doubt, Public Disclosure includes, but is not limited to, academic publications, abstract submissions, poster presentations, conference presentations, PhD Thesis (unless under embargo). If there is doubt as to the commercial value or potential of the research the Members of St George's, University of London involved are expected to discuss with Joint Research and Enterprise Services prior to any Public Disclosure. Public Disclosure prior to filing a patent application in most cases will prohibit the protection of the intellectual property and prevent successful commercialisation. Therefore, the timing of any publication related to intellectual property must be agreed by the Joint Research and Enterprise Services prior to the submission.

6.2.1 Confidentiality

Any new intellectual property, inventions and associated information should be kept confidential until after a full evaluation by the Joint Research and Enterprise Services for its exploitation potential and, if appropriate, protection. Standard form Confidentiality Agreements (CDAs) (available from the Joint Research and Enterprise Services) should be put in place as soon as possible after initial contact with third parties, and before any intellectual property is disclosed. All CDAs (including those provided by other institutions and companies) must be agreed (and negotiated if necessary) by the Joint Research and Enterprise Services before being formally signed by Joint Research and Enterprise Services.

6.2.2 Publication

It is important to recognise that filing a patent application and publishing are not mutually exclusive. However, once a patent application has been filed it is usually safe to publish. Publishing prior to filing a patent application in most cases will render the patent application invalid. However, secrecy may be desirable for commercial reasons; therefore, the timing of any publication related to intellectual property must be agreed by the Joint Research and Enterprise Services prior to the submission.

6.3. Conflict of interest

Creator(s) shall notify the Joint Research and Enterprise Services of any actual or potential Conflict of Interest relating to any intellectual property either in their own circumstances or in connection with any other third party and to ensure compliance with St George's, University of London’s Conflict of Interest policy.

6.4 Protection

6.4.1 Patents and other forms of intellectual property requiring registration

Following discussions with the Joint Research and Enterprise Services, the Creator must complete a technology disclosure form. The Joint Research and Enterprise Services will then review the information provided in discussion with the Creator to ensure that St George's, University of London is the owner of the intellectual property, that the invention is novel and that there is a suitable market for the invention.The Joint Research and Enterprise Services will then look at the avenues available for commercial exploitation. Following this review, the Joint Research and Enterprise Services will decide whether to:

• protect the intellectual property and exploit it, or
• where St George's, University of London does not wish to take the invention forward the intellectual property may be assigned to the Creator for the Creator to exploit at his/her own risk and cost and subject to certain terms and conditions to be agreed with the Joint Research and Enterprise Services.

Once the initial application has been filed, the appointed patent agent and the Joint Research and Enterprise Services will hold a copy in their files. The Joint Research and Enterprise Services will keep a record of the status of each Patent application and granted Patent. This will include:

• the title of the Patent
• the date of the priority filing, the dates of the International filing, the National Phase filings and the dates of any related divisional applications, examination deadlines, etc.
• the full names and contact details of all individuals with a financial interest in the Patent or having an inventive contribution
• the names of all organisations that have a financial interest in the Patent and documents which confer these rights
• details of who the intellectual property has been assigned or licensed to or who may have been granted option rights or other access to the intellectual property.

6.4.2 Copyright

The Copyright legend (© St George’s, University of London, date) should be used on the bottom of all copyright material owned by St George's, University of London, including databases and websites.

6.4.3 Agreements

Authority to enter into agreements, including the licensing of intellectual property or other commitments with third parties, or accept obligations on behalf of St George's, University of London is set out in the Financial Regulations and accompanying Schedules of Delegation as varied from time to time. Creators must not enter into agreements or licences which have not been approved in advance by the Head of Enterprise or their nominee. For guidance, advice may be sought from the Joint Research and Enterprise Services.

6.4.4 Portfolio Management

Each item of intellectual property will be reviewed by the Joint Research and Enterprise Services at regular intervals. If it is considered that the intellectual property is unlikely to bring any significant return, then the protection may be allowed to lapse. Before the lapse occurs the Creator(s) will be informed in writing by the Head of Enterprise or their nominee. If the Creator(s) decide that they wish to support the ongoing protection of the intellectual property at their own risk and expense, St George's, University of London may formally assign its interest to the Creator(s) by prior written agreement of the Head of Enterprise or their nominee. The standard terms of such an assignment will be that once Commercial Revenues are received by the assignee, the assignee shall first pay back to St George's, University of London St George's, University of London’s Costs (up to the value of the Commercial Revenues) and then 5% of any remaining or future Commercial Revenues.

6.5 Commercialisation

Joint Research and Enterprise Services is committed to generating impact from research undertaken at St George's, University of London. This may be achieved through licensing intellectual property or supporting the set-up of a spin-out company. After reviewing the commercial value of any intellectual property, Joint Research and Enterprise Services will engage the Creator in determining the correct route to market. Joint Research and Enterprise Services will manage the commercialisation process, including seeking potential licensors and negotiating contracts. However, projects are likely to be more successful if the Creators remain engaged in the process.

6.5.1 Revenue share and rewards

Payments received for the successful commercialisation of intellectual property through licensing or assignments are treated as commercial revenue They may take a number of forms, including one-off lump-sum payments, up-front payments, option fees, milestone payments, royalties or other forms. St George's, University of London may on occasion receive shares or other assets instead of money. On the occasions where such gross revenues are received, St George's, University of London will distribute any income/capital receipts in the proportions defined in the table in clause 8.3 below and may hold non-monetary receipts in its own name.St George's, University of London’s Net Receipts will be shared amongst the Creator(s) and St George's, University of London up to £200,000 as follows:

* St George's, University of London will have complete discretion in respect of any sum over £200,000 and will not necessarily repatriate any funds to the Creator(s) Institute(s).

Where more than one Creator is involved, the distribution of their share of the income amongst themselves shall be in accordance with their agreed share of the intellectual property, as described in clause 5.1

If a Creator leaves St George's, University of London’s employment there shall be no consequential change to the share which the Creator receives. When a Creator leaves St George's, University of London’s employment, he/she shall have an obligation to leave any physical embodiments of the intellectual property, including data, notebooks, prototypes and equipment in the safe custody of St George's, University of London and shall not make or retain any copies of such material whether physical or digital nor allow any other person to do so.

In the event of the Creator’s death, entitlement to royalties shall transfer to the Creator’s estate.

6.5.2 Calculation of amounts available for distribution

The first claim on the gross Commercial Revenue received will be the Costs incurred. The amount distributable within St George's, University of London will then be reduced by any share which is distributed to Creator(s) outside of St George's, University of London and/or to funding bodies who may be entitled to a share of the Net Receipts. The remaining St George's, University of London’s Net Receipts will then be distributed in accordance with the scheme described in 6.5.1.

6.5.3 Staff/Student Start-up Formation

It is permissible for St George's, University of London staff/students to establish a start-up without St George's, University of London becoming a partner. These companies differ from spin-outs in that no access to university intellectual property is required, the company does not rely on any University resources or facilities (for the avoidance of doubt including staff), and the University will not take any shareholding in the company. However, any staff/Student that intend to set up a start-up are required to engage with Joint Research and Enterprise Services early on in order to ensure that any formal contractual relationships with the University are put in place. Founders of staff/Student start-ups must refer to and comply with the Conflict of Interest and Financial Dealing Policy 2018.

6.5.4 Spin-out Formation

The Creator(s), in partnership with the University, may wish to found a company to commercialise the intellectual property. Start-up companies founded by employees/students in which the University has a shareholding are known as ‘spin-outs’. The shareholding is given to the University in return for access to University- owned intellectual property, and/or access to University equipment and facilities.

6.5.5 Arrangements for setting up Spin-out companies

The ‘St George’s Spin-Out Guidelines’ document sets out guidance for the formation of Spin-out companies. In all cases, the shareholdings for the Creators and St George's, University of London will be negotiated according to the circumstances and in line with the Guidelines. Approval of Spin-out arrangements require approval from the Research and Enterprise Committee.

The agreed future arrangements regarding the ownership of the company’s shares will be formalised in the Shareholders’ Agreement for the Spin-out company which shall be entered into by and between the Head of Enterprise or their nominee on behalf of St George's, University of London and other parties as applicable including the Creator.

Both St George's, University of London and the founder(s) will be represented on the company’s board of directors as either a Non-Executive Director or with observer roles (subject to the requirements of any third-party investor or collaborator) for so long as they hold shares in the company.

The arrangements above will also apply to joint ventures where a number of parties other than St George's, University of London and the founders may be involved.

Through the process of setting up a Spin-out, the Joint Research and Enterprise Services and Founders will collect a document package that will (at a minimum) contain:

• a memorandum of understanding (MOU) detailing the proposed equity split between institution and founders, what services are required from the TTO and a description of the Company and a summary of its planned activities
• company formation documents including articles of association and shareholders agreements based on St George's, University of London approved templates
• intellectual property holding letter (if applicable)
• licence or intellectual property Assignment term sheet by which intellectual property is transferred to the Spin-out
• information on HMRC academic researcher’s tax safe harbour arrangements, as appropriate.

7. Implementation

This policy shall apply to all intellectual property with effect from the date of its adoption at which date this policy shall replace the previous intellectual property Policy dated 18 October 2016.

8. Related Polices

• St George’s, University of London, Policies and Procedures, Conflicts of Interest and Business Dealings
• St George’s, University of London, Policies and Procedures, Private Earnings including Consultancy and Private Clinical Practice
• St George’s, University of London, Policies and Procedures, Public Interest Disclosure
• St George’s University of London, Consultancy Policy 2018
• St George’s University of London, Financial Regulations.

Download the full policy

Date approved: 13 November 2023

Document owner: Head of Enterprise and Innovation

Document approved by: Research and Enterprise Committee