Intellectual Property Management Strategy

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Royal Berkshire Ambulance NHS Trust (RBAT)
Intellectual Property
Management Strategy
2001 – 2006
STRATEGY
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D:\533567498.doc
Royal Berkshire Ambulance
EXECUTIVE
SUMMARY
NHS Trust
Corporate Services Directorate
TITLE: Intellectual Property Management Strategy
FOR CONSIDERATION BY BOARD
DATE:
REFERENCE NO:
SUMMARY OF STRATEGY:
The intent of this strategy is to ensure that intellectual property derived from NHS R&D is owned
and exploited in the best interests of the NHS and the country as a whole. The major benefits of
the exploitation of intellectual property for the NHS are perceived to be improvement in patient
care and generation of income.
Implementation of this policy requires development of awareness, understanding and best
practice amongst NHS staff, not only amongst those involved in research but also those delivering
patient care services, where intellectual property may also be generated.
Please note employment contracts on Page 9, or alternative procedure statement on Page 10 –
requires changes to employment contracts.
REASONS FOR DECISION:
The major benefits of the exploitation of intellectual property for the NHS are perceived to be
improvement in patient care and generation of income.
ALTERNATIVE OPTIONS, IF ANY:
To do nothing and risk loss of potential income for the Trust
2
RECOMMENDATIONS:
To develop this strategy for enhancing the potential of financial gain for the Trust
FINANCIAL IMPLICATIONS


Potential gain in resources for the Trust
Resources to support the management of Intellectual Property
BACKGROUND
Research and Development in the Royal Berkshire Ambulance NHS Trust is not a major
activity, but does contribute to the culture of the organisation.
Supporting R&D within the Trust is beneficial for professional development, contribution to
national research and income generation. Participation in such projects ensures that
contributions made by patients to research are rewarded with service improvements. There is
also evidence that quality of patient care is higher when there is participation in research
trials.
Support for progress of this document and other R&D activities is freely given by our
membership with the East Berkshire R&D Consortium (see RBAT’s R&D Strategy for details)
PORTFOLIO REFERENCE MATERIAL

Health Service Circular (HSC) 1998/106;

"Handling Inventions and other Intellectual Property: A Guide for NHS Researchers",

"The Management of Intellectual Property and Related Matters: An Introductory Handbook for
R&D Managers and Advisers
3
Contents
Section 1: Context
3
National
Local
3
4
Section 2: Plan
5
Aim
Establish Infrastructure
Monitor
Assess
Manage
5
5
5
6
6
Section 3: Ownership
7
Section 4: Intellectual Property and Technology
Transfer Management Arrangements
8
Employment Contracts
Distribution of Income Generated from IP
Procedures for Employees of RBAT
8
9
9
Key Milestones
10
Appendices:
Definitions
Brochure: Intellectual Property Awareness Guide
4
11
12
Section 1: Context
National
The Intellectual Property Strategy for Royal Berkshire Ambulance NHS Trust has been developed in
accordance with the NHS Executive Policy Framework for the Management of Intellectual Property
outlined in:

Health Service Circular (HSC) 1998/106;

"Handling Inventions and other Intellectual Property: A Guide for NHS Researchers",

"The Management of Intellectual Property and Related Matters: An Introductory Handbook for
R&D Managers and Advisers
The intent of the framework is to ensure that intellectual property derived from NHS R&D is owned
and exploited in the best interests of the NHS and the country as a whole, by those best able to do so.
The major benefits of the exploitation of intellectual property for the NHS are perceived to be
improvement in patient care and generation of income.
Implementation of this policy requires development of awareness, understanding and best practice
amongst NHS staff, not only amongst those involved in research but also those delivering patient care
services, where intellectual property may also be generated.
The Trust is required to implement this policy framework by:

Developing its own intellectual property policy.

Reviewing its R&D funding arrangements to ensure that any research contracts properly cover the
ownership of, and continued access to intellectual property and the arrangements for sharing any
income generated by its exploitation. This is being established via the R&D office as part of the
implementation of effective research management arrangements.
5
Local
Research and Development in the Royal Berkshire Ambulance NHS Trust is not a major activity, but
does contribute to the culture of the organisation. Support for progress of this document and other
R&D activities is freely given by our membership with the East Berkshire R&D Consortium (see
RBAT’s R&D Strategy for details)
Last year participation in one non-commercial, externally funded research project was reported to the
National Research Register (Sheffield University's 999-prioritisation project). A further 2 ‘own
account’ projects were added this year (alternative responses to Category C calls – community nurse
and Forestcare projects). These are non-funded research projects.
Supporting R&D within the Trust is beneficial for professional development, contribution to national
research trials and income generation. Participation in such projects ensures that contributions made by
patients to research are rewarded with service improvements. There is also evidence that quality of
patient care is higher when there is participation in research trials.
Due to the Trust’s role in research and development, the generation of intellectual property within the
organisation does not occur on a regular basis. To date intellectual property has not been managed on
a pro-active basis within the trust and the Director of the Finance Department has dealt with any
queries on an ad hoc basis.
In September 1999 Moran & Co conducted a project review of IP management within Trusts in the
Anglia and Oxford Region. The report recommended that:

the research proposal form should include a question on IP;

the R&D database should include IP information;

organisations should assess IP before research is published;

information on IP should be made available to investigators.
These recommendations will be implemented in the Trust via the Clinical Effectiveness department.
The Royal Berkshire Ambulance NHS Trust is a member of the East Berkshire Research and
Development Consortium, together with Heatherwood & Wexham Park Hospitals NHS Trust and East
Berkshire Community Health NHS Trust ( now WAM PCT ). In April 2002, the Consortium received
£84,509 from the R&D Levy fund. The policy on Intellectual Property was reviewed by all members
of the R&D Consortium during a meeting on the 28 th February 2002.
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Section 2: Plan
Aim
Royal Berkshire Ambulance NHS Trust aims to meet statutory requirements in monitoring, assessing
and managing Intellectual Property for the benefit of our patients and the Trust.
Establish Infrastructure
The first requirement is to establish an infrastructure covering employment contracts, disclosure
contracts and information sources. Support services will be developed through the Consortium with
external organisations specialising in IP management. The research team will remain up to date with
Regional and National R&D developments.
Monitor
It is an essential part of the policy for intellectual property management that regular technology audits
are carried out. This will increase staff awareness of the issues surrounding IP and ensure that a basic
understanding of intellectual property principles is widespread.
Monitoring process
The proposed monitoring process will involve a quarterly review of all areas to include:

Emergency Services

Estates

IT

Non-emergency Patient Transport Services (NEPTS)

Medical Devices
This will meet the dual aim of assessing IP and raising awareness by developing, for example:

Computer Programs

Medical Devices

Management Processes
7
Assess
Assessment of any intellectual property is in 2 stages, internal and external where necessary. This
process should include an assessment of the ownership of IP.
As described below the basic principle is as follows; if the cost of the research is shared between the
NHS and the investigator the benefits should be shared in the same ratio. In this context ‘costs’ include
use of resources and equipment, time and skills.
Manage
The management of intellectual property is not within the expertise base of the Trust and should be
handled externally in association with a technology transfer unit, which may identify commercial
partners for further exploitation of the IP. The unit that will fulfil this role will be identified in the near
future, following guidance from the DHSC for the South.
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Section 3: Ownership
The Trust owns intellectual property arising from research and development projects undertaken by its
employees in the course of their work for the Trust and/or using Trust facilities, unless such intellectual
property is subject to a formal agreement between the Trust and an external funding organisation.
The ownership of intellectual property arising from research undertaken jointly with another
organisation, e.g. Reading University, will be assigned to either of the employing organisations by
agreement, unless subject to prior agreement with an external third party organisation. The proportion
of intellectual property contributed by each party will be agreed by discussion between the parties at
the earliest stage of the process.
In specific instances the Trust may decide not to pursue its intellectual property rights and may assign
ownership of the intellectual property to the relevant inventor(s), the costs of such assignment to be
borne by the assignee. In such cases, employees may pursue and exploit the relevant intellectual
property in their own time and without utilising Trust facilities and resources.
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Section 4: Intellectual Property and Technology
Transfer Management Arrangements
The former South East Regional Office was unsuccessful in its bid to the Public Sector Research
Enterprise Fund for an Intellectual Property Management Structure, or Hub. In response to this
disappointing outcome an IP Working Group was established with representation from several Trusts
across the South East. In the absence of funding, at least in the short term, the aim of the group is to
access and develop ways to introduce IP management as an additional responsibility of Trusts in the
region. A pilot study was conducted to assess the IP management needs of SERO Trusts and to
recommend ways in which an interim IP capacity could be developed until future funding is obtained.
The main focus of the study was to look at IP auditing, raising awareness of IP amongst NHS staff and
identifying skill and resource gaps. The following recommendations were made from the study:

The appointment of an IP Advisor, based at the DHSC for the South – to take lead
responsibility for moving the proposed programme forward.

The development of IP nodes – R&D offices in key Trusts that are a focal point for IP advice
and practice development for a surrounding catchment area. Collectively they will provide
lead responsibility for a Regional IP infrastructure.

The establishment of increased links with potential professional advisers and exploitation
partners

The development of NHS IP management capacity along side potential sources of external
funds
‘Intellectual Property Management in the NHS South East Region: Recommendations arising from the
South East Region IP Management Working Group pilot study to assess ways forward in the absence of
support for an IP hub’ by Graham H. Farrar on the behalf of the SERO, April 2002.
The exercise highlighted the importance of the participation of Trust senior management in supporting
IP and found that Trusts where senior management are IP Champions, are always active innovative
working environments.
Incorporating responsibility for IP into Trusts will not be the entire solution to IP Management in the
South; however, it will form one stage in a complex process that will develop with time. Once
identified, the exploration of IP will have to involve partners with expertise in this area.
The Trust wishes to encourage the interest and involvement of researchers in the pursuit and
exploitation of their inventions. However, centralised co-ordination of these processes is essential to
avoid confusion, ensure adherence to the policy of the Trust and to maximise the return from IP. The
Clinical Effectiveness Department will remain up to date with the progress made by the IP Working
Group through the East Berks R&D Consortium. Links have already been made with the IP Adviser
for the new DHSC for the South and the Clinical Effectiveness Department will use this resource to
establish an IP auditing capacity for the Trust.
Researchers who anticipate that intellectual property will arise from a project should identify this on
the RBAT project register form.
The R&D Regional Office will also aim to identify potential intellectual property from the R&D
projects database and from discussions with R&D leads and individual researchers.
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Employment contracts
The Trust owns all intellectual property arising from research and development projects undertaken by
its employees in the normal course of their work for the Trust, unless such intellectual property is
subject to a formal agreement with an external funding organisation. Such ownership remains with the
Trust upon the departure of the employee.
The Trust will be amending and updating employment contracts to cover issues relating to the
ownership of intellectual property and obligations of the employee and employer respectively.
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Distribution of Income Generated from Intellectual Property
The intellectual property protection and exploitation costs that are incurred will be met, in the first
instance, from the R&D Levy. The decision to incur such costs for any item of intellectual property
will be taken by the researcher(s) and the R&D Office after due consideration of the protection and
exploitation potential of the intellectual property.
Inventions may generate income in three ways: lump-sum payments for transfer of ownership of
intellectual property; lump-sum payments for licensing agreements; royalties paid per unit of relevant
product sold.
The East Berkshire R&D Consortium will have first call on the income generated by intellectual
property to enable full recovery of the costs incurred by the R&D office during the protection and
exploitation processes.
After recovery of such costs, the net income generated by IP will be shared amongst inventors, the
directorate and the Trust as follows:
Total Net Income
Researcher(s)
Trust
Up to £50k
90%
10%
From £50k to £500k
45%
55%
22.5%
77.5%
Over £500k
The inventor’s share of the net income is a discretionary gift by the Trust, which is intended to continue
for the inventor’s lifetime or the term of the licence agreement.
Procedures for Employees of the Royal Berkshire Ambulance NHS Trust
Employees of the Trust are reminded that the Trust owns all intellectual property arising from research
and development projects undertaken by its employees in the normal course of work for the Trust,
unless such intellectual property is subject to a formal agreement with an external funding organisation
or agreed otherwise.
Researchers, their collaborators and staff should not make potential intellectual property public, e.g. via
publications, abstracts, presentations at meetings etc, until such time as a patent application is filed.
They should also maintain absolute confidentiality until this time.
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Researchers who believe that their research will generate a patentable (or protectable) invention should
notify the Clinical Effectiveness Department at the earliest opportunity.
When the invention is sufficiently advanced, the Clinical Effectiveness Department will arrange for a
consultation with an expert Project Manager from the technology transfer unit to assess its patentability
and commercial potential.
A decision to apply for intellectual property protection, e.g. a patent, will signal the need to contract the
services of a patent agent and the R&D Office, and to start seeking a commercial partner. Such
discussions should only take place after a confidentiality agreement is signed with a prospective
commercial partner.
A decision not to apply for intellectual property protection and exploitation of the invention will
require that Trust management determine if the Trust wishes to retain ownership of the intellectual
property. If not, the inventor(s) will be invited to meet the cost of a legal transfer of ownership to the
inventor(s), after which they can pursue the intellectual property at their own expense and in their own
time.
The NHS Executive has produced a useful guide for researchers entitled “Handling Inventions and
other Intellectual Property” which is available from the Clinical Effectiveness Department on request.
Key Milestones
Strategy
July 2002
Initial Technology Audit
November 2002
Rolling monitoring established
March 2003
Employment contracts
To be determined in the light of national guidance
Develop expertise
Ongoing, demonstrate attendance at appropriate
meetings, maintain and develop contacts externally
Develop information package
Accomplished with East Berks R&D Consortium
December 2001
Technology transfer unit
Act in accordance with regional arrangements
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Section 4: Document Control
Royal Berkshire Ambulance Trust References
J:\Clinical Effectiveness\RandD\RBAT Intellectual Property Management Strategy.doc
Controlled document: CEf 46
September 2002
Review due: September 2003
Acknowledgements
Written by:
C Breen
Clinical Effectiveness Officer
Approved by:
S Brown
Medical Director
TBA
Accepted by:
Debbie Dunning
Emergency Services Director
TBA
Accepted by:
Sarah Peth
Director of Customer Services
(date)
Comments from: Operations Committee Meeting
TBA
Comments from: At Risk and Clinical Governance Meeting
TBA
Approved by:
People and Organisation Committee
TBA
Ratified by:
Keith Nuttall
Chief Executive
At Board Meeting: TBA
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Appendix 1
Definitions:

Intellectual property: Represented by new knowledge such as in technologies, drugs, devices,
diagnostics, treatments, software, new applications and skills which are not in the public domain
and can be protected.

Patent: This is a form of IP protection that describes an invention that is new, involves an inventive
step and is capable of commercial application. It confers a monopoly right to the inventor(s) for
twenty years from the date of patent filing.

Copyright: This arises automatically in original literary, dramatic, musical and artistic works.
Within the context of the NHS this will largely be applicable to software. No registration is
required and rights exist for the life of the originator plus fifty years.

Registered design and design rights: The outward shape or configuration of products of all kinds is
protectable by either a registered design, giving stronger protection, or by the (unregistered) design
right which gives weaker but automatic protection without the need for registration.

Trademark: Trademarks are signs, such as a distinctive name, emblem or logo that distinguish the
goods and services of one organisation from those of another. It provides protection for the
goodwill and reputation of an organisation in its products and services. Registration confers greater
protection and there is no time limit.

Goodwill or know-how: Intangible assets of an organisation which may not be protected by one or
other of the above means but which, nonetheless, may also be of value to a third party.

Technology transfer: This covers the transfer of ownership of IP or allows a third party to develop
and exploit the IP whilst ownership is retained. It is often more broadly defined as the management
arrangements under which IP is identified, protected and exploited.

Licensing agreement: An agreement whereby ownership of IP is retained while a third party is
given rights by the IP owner to development and marketing. Such an agreement usually involves
payment of an initial lump sum to the owner of the IP, dependent on the commercial potential of
the IP, plus royalties as products from the invention are sold.

Ownership: IP generated by an employee in the normal course of duties belongs legally to the
employer. The employer may decide on some kind of income sharing arrangement with the
inventor(s) and his department upon the successful exploitation of the IP. The employer may
decide to waive their rights in some cases e.g. copyright on books. In the event of the departure of
the inventor(s) from the employing organisation, all IP rights remain with the employing
organisation and cannot be transferred with the employee to the new organisation unless by prior
agreement.

Confidentiality: It cannot be stressed too strongly that if there is IP that has potential for
exploitation, then it should neither be discussed nor shown to any third party who is not under a
legal obligation to keep it confidential.
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