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DGD18/033

ACT Health Policy Research Contracts and Intellectual Property

Policy Statement

The development and translation of knowledge and expertise is in direct accordance with the ACT Health Directorate (ACT Health) and Canberra Health Services’ (CHS) core values of Care, Excellence, Collaboration and Integrity. Through knowledge transfer there is an important opportunity to create public benefit, achieving better patient and population health outcomes. Wherever possible, ACT Health and CHS will manage its Intellectual Property (IP) to enable the sharing of its knowledge and ideas to encourage further collaboration and re-investment in research and innovation for the benefit of the community.

This Policy is intended to cover the four pillars of health research as defined by the National Health and Medical Research Council (NHMRC), namely biomedical, clinical, public health and health services.

This Policy is underpinned by the guiding principles of ACT Health’s strategic objectives for research: to develop a strong research culture which is focused on patients, families and the community while creating the infrastructure to support high quality research and innovation capabilities.

IP refers to knowledge or intellectual assets, which are often intangible creations of human intellect, and primarily encompasses:

Copyright Patents Designs Trademarks

IP is protected by law, which enables the recognition or financial benefit from the invention or creation of IP. By balancing the interests of ACT Health and CHS, its employees, and the community, this Policy looks to foster an environment in which innovation and research can flourish.

In some instances, IP owned by the Territory (as represented by ACT Health or CHS) may have commercial value. The commercialisation of IP rights should be achieved on an equitable basis which achieves benefit; and appropriate acknowledgement for the transfer of knowledge; and provides an incentive for researchers. Further information on commercialisation is set out later in this Policy.

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The risks that may arise from not adequately managing IP and research contracts, include: Lost opportunities to collaborate with research partners to innovate and achieve

outcomes for the benefit of the community; Potential exposure to legal proceedings; and Failure to receive a return on the investment and contribution of ACT Health and

CHS researchers and patients and to foster quality research.

Purpose

The purpose of this Policy is to: Provide structure for IP management, including its generation, management,

protection and use; Outline a framework in regards to IP ownership and any potential commercialisation

to encourage research in ACT Health and CHS; Outline accountability and governance mechanisms which will function to recognise

and reward innovation by employees; and Provide guidance on measures to protect and enforce IP;

This Policy is also intended to support the efforts of researchers in undertaking future research, innovation and collaborative activity.

In providing a robust support service, it is of vital importance that the IP and Research Contracts Disclosure Form (Attachment 1)is submitted to the Centre for Health and Medical Research via the IP Coordinator prior to engaging in any collaborative research or activity or transferring deliverables to a third party.

Scope

This Policy applies to all ACT Health and CHS employees, visitors and students.

This includes staff who are: Paid for by ACT Health or CHS, but whose work is administered by another entity; Staff employed by ACT Health or CHS and who are using other institutions’ resources

and/ or are located off-site from ACT Health or CHS; Not employed but who are carrying out work using ACT Health or CHS resources or

assets.

This includes students, visitors or independent contractors who are: Visitors and students from research and academic institutions with which ACT Health

or CHS may enter into agreements; Independent contractors.



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A copy of this Policy should be provided to all employees, visitors and students engaged in health research within ACT Health or CHS.

Ownership of Intellectual Property - Staff

This Policy mandates that all IP created by ACT Health or CHS staff in the course of their employment is owned by the Territory, (represented by ACT Health or CHS) consistent with the common law in Australia.

IP which is created by ACT Health or CHS staff through any significant utilisation of resources is taken to be IP created in the course of the employee’s employment with ACT Health or CHS. This Policy will apply unless the employee has the prior written agreement of the Chief Executive Officer of CHS or the Director-General of ACT Health to utilise CHS or ACT Health resources outside the course of their employment to perform the work from which the IP was created.

In the case of scholarly works created by employees, the employee will own the IP, however ACT Health or CHS reserves the right to use those works for the purposes of future research or education.

Should a financial benefit be realised as a result of commercialising any IP owned by the Territory, as a general rule this will be internally allocated as follows:

33% to the Research Team proportional to the contribution of each member of the team; 33% to ACT Health or CHS to be allocated to the Department, Unit or Division which

conducted the research; 33% to the Centre for Health and Medical Research Special Purpose Account to be

held to incentivise or remunerate future research activity.

Further detail on the commercialisation of IP rights is set out later in this Policy.

Ownership and Assignment of Intellectual Property – Students and Visitors

ACT Health and CHS does not generally assert ownership of IP created by students or visitors accessing its facilities or resources. Agreements should be implemented in advance of any research activity to determine where IP rights will vest. There may be circumstances where ACT Health or CHS does wish to claim ownership of any IP created, particularly where its resources or background IP have been used intensively in creating any IP, such as where:

The IP has been created using substantial Territory resources; The IP was created as a result of pre-existing IP; The student was part of a team that comprised mostly Territory employees; or The IP was created using funds provided or sourced by the Territory.



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Research collaborations between Visiting Medical Officers or researchers from private institutions and ACT Health or CHS employees will require research agreements which contain terms reflecting IP ownership prior to conducting any research activity.

As a condition of the student or visitor’s access to ACT Health or CHS healthcare and research facilities, equipment or IP, the student/ visitor may be required to sign a Confidentiality Agreement with either entity.

An assessment of the appropriate protection mechanisms will be determined following completion of an IP and Research Disclosure Form and submission to the IP Coordinator.

Joint Appointments and Ownership

Where co-joint appointments (either remunerated or unremunerated) exist between ACT Health or CHS employees and academic partners or other entities, the relevant parties will negotiate in advance the terms of joint ownership appropriately to reach mutual agreement proportional to the contributions and resource contributions of the parties.

Any contract implemented for the purposes of joint-ownership will need to contain provisions specifying in detail the rights and obligations of each party in the management of the jointly owned IP.

As a default position and wherever possible, ACT Health and CHS will share 50 per cent of any IP rights arising from collaborative research work with a third party.

Governance

ACT Health Research Contracts and IP Management

IP and Research Contracts Management is overseen by the Executive Director, Centre for Health and Medical Research. All research activity being undertaken in either ACT Health or CHS should be notified to the Centre for Health and Medical Research in the first instance, in line with the Research Practice Policy.The operational management of IP and research contracts is performed by the IP Coordinator, who reports directly to the Executive Director, Centre for Health and Medical Research.

Essential to sound governance is the assessment of all research contracts in relation IP rights and terms of engagement at inception through lodgement of an IP and Research Contracts Disclosure Form.

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negotiations; at the earliest stage in which researchers become associated with a study; or at the earliest stage of any invention or discovery together with a current Declaration of Private Interest and/or Conflict of Interest Form, if applicable. This documentation will be maintained by the IP Coordinator and will be treated in strict confidence.

From receiving the Disclosure Form, the IP Coordinator will make an assessment of the requirements and triage accordingly. The advice of the ACT Government Solicitor’s Office (ACTGS) may be sought depending on individual requirements.

It is the role of the IP Coordinator to ensure the contract terms are agreed to by all parties and that the contract is appropriately executed and recorded on the ACT Health and CHS IP Register.

ACT Health and CHS IP RegisterThe IP Register identifies and records the details of all IP and research contracts and is maintained by the IP Coordinator.

The Register includes the following information: A description of the IP, its creator and owner, including their contact details; Type of IP protection or contract being negotiated; Renewal date for registered IP (if applicable); Where the IP is licensed, details of any licensor or licensee that is not ACT Health or CHS; Financial aspects of any research contracts such as royalty payments; General details of any commercialisation arrangements

Identification and Protection

ACT Health and CHS IP may be created, assigned to, or acquired in the following ways: Through research or innovation activities; Through the use of ACT Health or CHS resources; Through the provision of health care and health related services; Creation during the course of staff employment with ACT Health or CHS.

ACT Health and CHS will implement appropriate measures to protect its IP rights in accordance with relevant ACT Government policy, the best interests of its researchers and patients and the requirements set out under the service contract or research agreement.

It is essential that researchers contact the IP Coordinator to ensure all research contracts are executed by the required delegate and that the contract documentation contains robust terms and conditions. It is imperative that this occurs prior to any deliverables being transferred to another party, to ensure the Creator/s IP rights are protected and ACT Health or CHS is not potentially exposed to litigation.



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IP rights may require more complex evaluations, particularly in regards to patent applications or potential commercialisation. Such instances will involve the expertise and advice of the ACTGS to ensure ACT Health or CHS rights are protected and relevant legislative obligations are met.

In no circumstances is an employee to take steps to apply for any registration of IP created in the course of their employment in their own name (for example, to file a patent application, or lodge an application for registration of a design) without initially raising this with the IP Coordinator for decision by the Chief Executive Officer or Director-General, or their nominated delegate.

Commercialisation

There may be circumstances where ACT Health or CHS researchers have created IP which will see significant public benefit through its commercialisation. Wherever possible ACT Health or CHS will endeavour to incentivise and reward its researchers by providing a financial return towards future research activity.

As set out earlier in this Policy, should a financial benefit be realised or negotiated through commercialising any IP, as a general rule this will be allocated as follows:

33% to the Research Team proportional to the contribution of each individual member of the team;

33% to ACT Health or CHS to be allocated to the Department, Unit or Division which conducted the research;

33% to the Centre for Health and Medical Research Special Purpose Account to be held to incentivise or remunerate future research activity.

Prior to entering into any commercialisation of research activity or IP, a risk assessment will be conducted by the IP Coordinator and Executive Director, Centre for Health and Medical Research to ensure that ACT Health or CHS is not unduly exposed and that the benefits from commercialisation outweighs risk.

Dispute Process

In the event that an ACT Health or CHS employee becomes aware of a breach of their IP rights, or wishes to challenge a decision in relation to the management of their IP, that employee is required to make a written submission to the Centre for Health and Medical Research. The Centre will review the submission and make a recommendation.

In the event of any legal proceedings or the infringement of IP rights, (such as the unauthorised use or exploitation of IP), the advice of the ACTGS will be sought as soon as possible.



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Roles & Responsibilities

The Director-General, ACT Health and Chief Executive Officer of CHS have equal responsibilities relevant to their respective entities.

When a research contract or IP matter has cross-entity or Territory-wide implications, the Director-General will be made aware of the matter, and where necessary, the Minister for Health and Well Being, Minister for Mental Health and Medical Research.

The Director General of ACT Health is responsible for: Encouraging health research and the acquisition and dissemination of knowledge and

skills across ACT Health; Authorising appropriate delegation in regards to approval of IP and research

contracts within their portfolio, including contracts involving the commercialisation or disposal of ACT Health knowledge or research assets.

The Chief Executive Officer of CHS is responsible for:

Encouraging health research and the acquisition and dissemination of knowledge and skills across CHS;

Authorising appropriate delegation in regards to approval of IP and research contracts within their portfolio, including contracts involving the commercialisation or disposal of CHS knowledge or research assets.

The Deputy Director-General of Health Policy and Strategy is responsible for: Encouraging health research and the acquisition and dissemination of knowledge and

skills; Overseeing the efficient governance of research contracts, including IP management; Recognising ACT Health staff for their contributions to health research and

innovation.

The Executive Director, Centre for Health and Medical Research is responsible for: The direct management of research contracts and IP across ACT Health and CHS; Fostering an environment for IP issues to be identified and developed to promote

research and innovation; The implementation, promotion and monitoring of the IP and Research Contracts

Policy; The facilitation of regular and appropriate educational and training sessions for all

staff in relation to IP and research contracts; Ongoing communication activities and the facilitation of educational sessions for staff

to raise awareness around IP and research contracts; Approving the provision of ACTGS advice as appropriate.



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The IP Coordinator is responsible for: Providing an efficient central triage and coordination service for the execution of

appropriate research contracts and IP agreements; Conducting assessments of IP and Research Contracts Disclosure Forms submitted by

ACT Health and CHS staff and taking appropriate action in consultation with the Executive Director, Research Policy and Innovation and, if required, the ACTGS to ensure appropriate legal requirements are met;

Providing advice to ACT Health and CHS staff on appropriate IP protection and management, including assessing types of agreements to be executed;

Liaising with researchers and partner institutions on IP and research contracts to reach agreed terms of engagement;

The ongoing management and maintenance of the IP Register; Recording and maintenance of any of Declarations of Private Interest and Potential

Conflict of Interest documentation; Determining that obligations and requirements are fulfilled in accordance with the

relevant legislative requirements and the National Health and Medical Research Council’s National Statement on Ethical Conduct in Research.1

ACT Health and CHS Executive staff are responsible for: Ensuring that staff are aware of their responsibilities in relation to the identification

and protection of IP by encouraging their participation in IP educational sessions; Notifying the IP Coordinator when they are aware of an IP right requiring

management; Ensuring a research contract is appropriately executed within the limits of their

delegation.

ACT Health and CHS staff are responsible for: Notifying the IP Coordinator when they become aware of an IP requirement or issue,

particularly in regards to: An invention or innovation created in the course of their employment; Collaborating on a research project which draws on their specialist knowledge

and expertise; Collaborating on a research project which involves use of samples or other

tangible resources Any breach of their IP rights.

Being aware of their responsibilities relating to the identification and protection of ACT Health and CHS IP rights.

Evaluation

Outcome Measures

1



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Employees are aware of ACT Health and CHS’s IP processes and Policy, with IP generated notified to the IP Coordinator for effective management;

Fostering an enhanced culture of innovation through supporting researchers in their work and in attracting and facilitating quality research activity;

The IP Register will be used to measure the volume of activity and the performance of the management system.

Method The Executive Director, Centre for Health and Medical Research will review

management processes on a yearly basis and provide a report to the appropriate governance agency on the performance of IP and research contract functions.

Related Policies, Procedures, Guidelines and Legislation

Legislation Copyright Act 1968 Designs Act 2003 Financial Management Act 1996 Government Procurement Act 2001 Patents Act 1990 Public Sector Management Act 1994 Trademarks Act 1995 Human Rights Act 2004

Policies and Guidelines ACT Health Research Practice Policy National Health and Medical Research Council’s National Statement on Ethical

Conduct in Human Research 2007 (updated 2018) Responsible Investment Policy 2018

Definition of Terms

These definitions are contained within the Australian Government Intellectual Property Manual.

Background IPRefers to IP which exists prior to performance of the contract or is developed independently by a party in the contract. Background IP may be used as a tool for, or a platform within, the project.

Copyright



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A form of IP that protects the creative expression of an idea – not the idea itself. Copyright protection is provided by the Copyright Act, which grants exclusive rights to the copyright owner for a limited time for particularly types of works in a particular platform. If the work is original, Copyright protection is automatic and does not require to be registered.

Licence AgreementA contract in which the licensor gives another person or company (the licensee) the right to use something. It can provide a high degree of flexibility in meeting the relevant parties’ needs and requirements.

LicenceA grant of certain specified IP rights allowing another entity to exercise those rights. A licence enables the owner of the IP to retain ownership of those rights and exercise a varying degree of control over its use. It can be highly flexible, requiring contracts to be clearly worded to ensure certainty and adequate rights.

Material Transfer AgreementAn agreement which governs the transfer of tangible research materials between two organisations.

Moral RightsMoral rights are personal rights granted to the individual creator of a copyright work. They are the right:

Of attribution: the right of a creator to be identified with his or her work (i.e. be named as the creator);

Against false attribution: the right of a creator not to have authorship of a work falsely attributed to another person; and

Of integrity: the right not to have a work subjected to derogatory treatment (e.g. substantially editing/ altering reports – which are prejudicial to the creator’s honour or reputation.)

As moral rights are personal rights, they cannot be assigned or licenced. Even if ACT Health owns the copyright in a work, the creator will still retain moral rights in relation to it for the term of copyright in the work. However, a creator can agree to the use of the work by providing a written consent, in which as it will not infringe their moral rights.

Ensuring that the moral rights of a contributor are not infringed can be mitigated by communicating the proposed use of the work, seeking consent and attributing authorship.

PatentA patent is a right granted in respect of a method, process, device or substance that is new, inventive and useful. Patents are regulated under the Patents Act 1990 and confer on the owner (the patentee), for a limited time, exclusive rights to exploit the invention claimed in the patent and to authorise a third party to exploit that invention.



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Research ContractsRefers to contracts in the following forms:

Licence Agreements Material Transfer Agreements Confidentiality Agreements Research Collaboration Agreements Contract Agreements

RoyaltyA fee paid to the IP owner by another party for the use of the IP, particularly through a Licence Agreement.

Service Level AgreementAn output based contract between a service provider and the end user that defines the level of service expected.

Trade MarkAny sign or mark capable of distinguishing one trader’s goods or services from another, e.g. a tag, shape, colour, picture or logo, word or number, scent, sound, pattern, configuration or ornamentation.



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References

IP Australia. Australian Government intellectual property manual [Internet]. 2018 June [cited 2018 Oct 4]. Available from: https://www.communications.gov.au/policy/policy-listing/australian-government-intellectual-property-rules

The National Health and Medical Research Council, the Australian Research Council and Universities Australia. National Statement on Ethical Conduct in Research [Internet]. Canberra (ACT): NHMRC; 2007 [updated 2018; cited 2018 Oct 4]. Available from: https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1

Search Terms

Research, Intellectual Property, Research Contracts

Attachments

Attachment A - Intellectual Property and Research Contracts Disclosure Form

Disclaimer: This document has been developed by ACT Health specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 17 Dec 2018 Whole document ED Research Policy Advisory

Committee

This document supersedes the following: Document Number Document NameDGD15-025 ACT Health Intellectual Property Policy



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https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1

https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1

https://www.communications.gov.au/policy/policy-listing/australian-government-intellectual-property-rules

https://www.communications.gov.au/policy/policy-listing/australian-government-intellectual-property-rules

DGD18/033

Attachment A - Intellectual Property and Research Contracts Disclosure Form

IP Coordinator Use OnlyID No.Date received

ACT Health Directorate and Canberra Health ServicesIntellectual Property and Research Contracts Disclosure Form

1. About this form

This form is to be completed by ACT Health or Canberra Health Services employees who may create Intellectual Property in the course of their employment, either through independent or collaborative research activity.

The information you provide in this form will assist in the evaluation and prioritisation of the appropriate action required to protect, use, manage and potentially commercialise ACT Health or Canberra Health Service’s interests in Intellectual Property and research contracts. The information provided in this form may be disclosed to the ACTGS to assist in providing comprehensive advice.

Following completion of this form, you will be contacted by the Intellectual Property Coordinator to discuss your requirements further.

2. How to use this form

This form consists of Part A, which requests a brief outline of the innovation, and Part B which requests more detailed information relevant to the ownership, protection and commercial potential of the innovation or research project.

You may complete both Part A and B in submitting the form. Alternatively, if you prefer, you may complete Part A only, and the Intellectual Property Coordinator will contact you to arrange a meeting to assist you in completing Part B.

Please email your form to [email protected].



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3. Confidentiality

Please note that if you publicly disclose the innovation or research results, the opportunity to patent it or apply for design registration may be lost.

The contents of this form (once details are provided) should not be disclosed to anyone other than ACT Health or Canberra Health Services staff closely associated with the research project, the Executive Director, Research Policy and Innovation, the Intellectual Property Coordinator and the ACTGS. You should discuss it with others only on a strictly confidential basis, preferably following execution of a confidentiality agreement.



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Part A

1. Primary contact details (person completing this form)

Name Position

Centre / Unit Division

District Telephone

Email Signature of primary ContactDate this form

is completed

2. Brief description of the Research Project

a. Project title

b. Short description in lay terms including the problem potentially solved by this work

c. Please indicate at what stage of development is at by marking the relevant box with an ‘x.’

Idea Preliminary resultsClinical Trials Animal or laboratory modelsProduct Other (please specify)

Research Collaboration with external party



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3. Confidentiality

Is a publication or oral disclosure descriptive of the innovation, invention or research project planned within the next three months? If yes, give date (if unknown, please estimate).

Note: This Form should be completed well before presenting the discovery through any public communications. In order to protect ACT Health and Canberra Health Services’ interests, (including potential patenting of the innovation) information about an innovation must not be disclosed except as indicated in section 2 of this Form or with the written approval of the Executive Director, Research Policy and Innovation. Once publicly disclosed, the Intellectual Property will have more limited options for any patent protection.



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Part B

If preferred, submit only Part A and the Intellectual Property Coordinator will contact you and assist you to complete Part B.

4. Details of Innovation/ research project

a. Have you completed a patent or literature search for similar or related technologies? Please include those results, if available.

b. What is the closest existing or known technology?

c. Does the Innovation/ research project include any background intellectual property owned by others? If so, please email the contributors to notify them of this disclosure and to ensure they are satisfied with the content of the submission.

d. What do you see are the possible applications for the Innovation/ research project? Are you seeking a financial return? Are you looking to share your research for free?



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e. Was the effort that led to this Innovation/ research project undertaken as part of a funded research project, i.e. an NHMRC Grant? If yes, please provide details.

f. Are you aware of any contracts that might relate to aspects of the Innovation/ research project (e.g. Materials Transfer Agreements, Linkage Grant contract, etc.)?

g. Does the Innovation/ research project have or require approval from the ACT Health Human Research Ethics Committee? If so, at what stage is this at in the approvals process?

5. Disclosure

a. Has the Innovation/ research project been described in a publication, abstract, public presentation, conference, poster, etc.? If so, please provide details, including dates.

b. Has the Innovation/ research project been discussed or any written material given to any colleagues or collaborators outside ACT Health? If yes, please give details.



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6. Contributors to the Innovation/ research project

The person completing this form should include their own details if they are a contributor to the Innovation or research project.

a. Contributor 1 (Principal Investigator)

Name

Position

Organisation

External Affiliations/ academic appointments (please list all)

Contact details

Description of contribution, including dates

b. Contributor 2

Name

Position

Organisation

External Affiliations/ academic appointments (please list all)

Contact details

Description of contribution, including dates

Please copy and paste more tables if required.

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For assistance and to submit this form, please contact:

Intellectual Property CoordinatorResearch Policy and InnovationPhone: 6205 1123Email: [email protected]

8. Associated Documents ACT Health Intellectual Property Policy ACT Health Research Practice Policy



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