intellectual property management sop€¦ · web view1.1this standard operating procedure (sop) and...

DGD15-025

Standard Operating ProcedureIntellectual Property Management1. Purpose

1.1 This standard operating procedure (SOP) and the associated Intellectual Property (IP) policy outlines ACT Health procedures relating to the identification, governance, management, protection, and potential commercialisation of ACT Health’s IP.

2. Scope

2.1 This SOP applies to all:

IP which arises or may arise from health research; health service administration and provision and/or acquisition by ACT Health.

ACT Health staff, including staff:o Employed under contract;o Paid for by ACT Health but whose ‘employment’ is administered by another

entity;o Employed by ACT Health and who are using other institutions’ resources

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

ACT Health resources or assets.

Students, Visitors and/or Independent Contractors, including:o Visiting or contracted medical officers;o Visitors from research and academic institutions with which ACT Health

may enter into agreements;o Independent contractors.

Public health organisations within ACT Health and within the meaning of the Health Act 1993.

Doc Number Issued Review Date Area Responsible PageDGD15-025 May 2015 May 2018 Office of DDG, S&C 1 of 14

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

DGD15-025

3. Establishment and Role of the ACT Health Contracts and Intellectual Property Office (CIPO)

3.1 A Contracts and Intellectual Property Office (CIPO) has been established within ACT Health. The CIPO will assess, govern and manage all IP that is either fully or jointly owned by ACT Health.

3.2 The CIPO will be the central point of contact for advising on IP ownership, dealing with all knowledge contracts, negotiating and managing the contract terms and IP within them.

3.3 The CIPO will use the Guidelines for Determining IP Ownership provided at Attachment A to guide ACT Health employees and the IP Committee on matters pertaining to protection and possible commercialisation of ACT Health IP. If you consider your IP situation is not covered by any of the scenarios included in Attachment A, contact the CIPO for further advice on how to proceed prior to entering into any contractual negotiations or arrangements.

3.4 Where there is more than one creator, the CIPO shall obtain a written agreement as soon as possible from each Creator as to the relative contribution of each of them to the creation of the IP.

3.5 Where protection and/or commercialisation of IP is to proceed, the CIPO will consult with the ACT Health Executive in charge and IP creator regarding appropriate protection and commercialisation strategies.

3.6 All aspects of commercialisation of IP will be managed by the CIPO, including: Providing expertise to commercialise Creations; Identifying and assessing potential value of Creations; Managing new and current patents; Developing and managing research and innovative business propositions; Creating industry-research partnerships to fund research outcomes; Networking and pooling of resources for cost effective commercialisation; and Awareness raising, education and professional development.

3.7 If the CIPO and the ACT Health Executive in charge determine that protection and/or commercialisation of the IP should not proceed, the CIPO will refer the matter to the IP Committee to consider a further recommendation that the:

IP be assigned to the Creator(s) on appropriate terms and conditions (including any retention by the public health organisation of a share of the Net Commercialisation Income appropriately reflecting the effort and risk taken by the creator in such commercialisation); or



DGD15-025

IP be retained by ACT Health, but that the Creator(s) be allowed to act as agent for the public health organisation solely for the purpose of seeking commercial partners, with ACT Health agreeing to participate in negotiations with such commercial partners (if found) regarding commercialisation.

If there is disagreement between the CIPO and the Creator(s) on whether to commercialise or not, or as to the assignment of IP rights between contributors the final decision on whether to commercialise will rest with the Director General.

3.8 The appropriate recommendation will depend upon the circumstances of the case and the creator(s) should be consulted in this regard.

4. Procedure - Notifications and Reporting of IP to the CIPO

4.1 ACT Health employees must notify the CIPO as early as possible of the anticipated creation of any work, product or process undertaken in the course of their employment, which may have commercial application.

4.2 Contact Information for the CIPO is:

ACT Health Contracts and Intellectual Property OfficeEmail: [email protected]: 0418 726 622Web: www.intellectualpropertyoffice.org.au

4.3 Notification must be made in writing, in the first instance, marked as ‘confidential’ and must identify: the work, product or process in detail each person involved in the creation of the work, product or process the period in which the work, product or process was created the research project or program in the course of which the work, product or

process was created, and any known details as to the likely commercial significance of the work, product or

process.

4.4 The CIPO may request further information if information provided in the initial notification is insufficient to manage potential IP.

4.5 Notifications are to occur whether employees are carrying out the work alone or with other ACT Health employees, or as part of a collaborative project with visitors or persons from other organisations.



http://www.intellectualpropertyoffice.org.au/

mailto:[email protected]

DGD15-025

4.6 In no circumstance are employees to take steps to apply for any registration of IP created in the course of their employment in their own name, the name of a company or any other person (e.g. file a patent application, or lodge an application for registration of a design etc.), unless the IP has been assigned to them by ACT Health.

5. IP Protection and Commercialisation Assessment

5.1 Where a particular item of IP is identified as being potentially worthwhile for protection or commercialising, the following assessment will inform the decision whether to commercialise:

What are ACT Health’s rights in relation to the IP? Have these rights been protected appropriately? Is commercialisation of the IP consistent with the operational activities of ACT

Health? Is the commercialisation for the benefit of the Territory? What would be the cost of commercialisation? Is there sufficient funding to develop the IP to a level of commercial viability? Are there any investors who may be willing to inject venture capital? How is future IP to be managed and exploited if non-Territory parties are involved

in commercialising the IP? What are the risks of commercialising the IP? What would be the estimated return from commercialisation? Would the commercialisation return come to ACT Health? How is the IP to be commercialised?

Commercialisation 5.2 ACT Health may contract an organisation or individual (not being an ACT Health

employee) to commercialise ACT Health IP on the Territory’s behalf. Arrangements of this kind will vary in their terms and conditions, and may or may not involve the following aspects: Assignment of the IP to the commercialising entity; Provisions for profit sharing with Creators (rather than relying on the royalty

model described in the IP policy of the public health organisation).

5.3 Where such arrangements are entered into, the CIPO will ensure that the return to the organisation is equitable, and that any profit sharing arrangements with employees do not disadvantage employees by providing a lesser entitlement than that envisaged by this policy. The advice of the Committee may be sought in relation to such arrangements.

5.4 In many ‘two or more-party arrangements’ the parties concerned must negotiate IP rights, usually by reference to their varying levels of contribution on a case-by-case basis and following legal advice as required.

6. Establishment of an IP Facility Loading for all knowledge contacts/agreements



DGD15-025

6.1 When an agreement is required to define the terms under which ACT Health materials, facilities and resources will be utilised, these agreements will include an IP Facility Loading of up to 35%, where the CIPO deems it appropriate to do so, to be paid by the partner organisation.

6.2 The CIPO will determine on an individual basis whether it is appropriate to include the IP Facility Loading into an agreement, in consultation with the Director-General, following discussion with the relevant ACT Health staff member and the partner organisation.

6.3 The CIPO will take into consideration a number of factors in determining whether a Facility Loading will be appropriate, including whether a concessional rate is more appropriate.

6.4 Funds received through the Facility Loading will be held in a separate special purpose and access account, to be managed from the Office of the Deputy Director-General, Strategy and Corporate.

7. Approval and development

7.1 Following assessment and recommendation by the CIPO, all the relevant documentation will be sent to the Director General for approval and sign off.

8. Moral Rights

8.1 Prior to the decision to commercialise, it should also be considered whether the Creator of the work has moral rights in the work. This may occur where the work contains a significant degree of creativity, for example an important journal article written by a researcher. Creators have the right:

to be attributed (or credited) for their work; not to have their work falsely attributed; and not to have their work treated in a derogatory way.



DGD15-025

9. Assignment of Intellectual Property and Distribution of Income

9.1 Where ACT Health determines that IP will not be developed and commercialised, and the IP is clear of any encumbrance, the IP Creators will be given the opportunity to have the IP personally assigned to them. In instances where IP is not taken up for commercialisation either by ACT Health or the creators it is can be offered up to any other party providing they maintain the protection costs and an agreed royalty payment on successful commercialisation.

9.2 Where the IP is assigned, all Protection Costs incurred will be reimbursed from any royalty or commercialisation income generated after assignment in the following order or priority:

1. The Creators Protection Costs will be reimbursed first;2. ACT Health’s Protection Costs will be reimbursed second; and lastly3. A share distribution to ACT Health of the remaining revenue stream will

be agreed upon.

Formula for distributing Income

9.3 ACT Health shall deduct all establishment costs and protection costs expended by ACT Health as a first call on all gross commercialisation income.

9.4 Where ACT Health owns 100 per cent of the IP, the standard expectation is that any net commercialisation income will be distributed as follows: One third to the Creator(s) of the IP; One third to the department(s) or section(s) of ACT Health which originated the

IP; and One third to ACT Health.

9.5 ACT Health shall divide the one third share of net commercialisation income payable to the creators amongst the individual Creators in accordance with the contributions identified by them. If Creators have not identified contributions, ACT Health shall distribute the one third share in accordance with its own reasonable estimate of the relative contributions of each Creator. In making such an estimate, consideration should be given to the role of any Creators who have left the employ of ACT Health.

9.6 Monies paid to staff under this policy shall be paid as income. Eligibility for income is conditional upon staff having acted in good faith in accordance with the ACT Health Intellectual Property policy.



DGD15-025

9.7 In the event that commercialisation income is received by ACT Health in one lump sum payment, all sub-division payments will be made out to Creators within three (3) months of ACT Health receiving the commercialisation income and after all commercialisation costs including future envisaged costs have been deducted, providing there is certainty around these costs. In the event that commercialisation Income are made as gradual payments (eg. milestone or royalty based or gradual income), all sub-division payments will be made quarterly if the net amount to be paid out exceeds AUD$3,000 or annually if the net amount to be paid out is less than AUD$3,000.

9.8 Where the student of a University with which ACT Health has an arrangement, ACT Health and the University may come to an agreement on how to equitably deal with the IP of students, bearing in mind any claims the students may have under this Policy and the IP Policy of the University.

10. Dispute Resolution

10.1 Any dispute must be brought to the attention of the Director General or their nominee. The Director General has responsibility to: be fully aware of the dispute circumstances; and ensure relevant parties have the opportunity to resolve the identified conflict.

10.2 The Director General must consider the dispute and may call for a recommendation from the IP Committee. The Director-General has absolute discretion to take any appropriate course of action subject to the terms of any agreement.

11. Evaluation

11.1 Outcome Measures All IP generated is notified to the CIPO and reviewed to determine and manage

ownership and commercialisation where appropriate; IP with a potential commercial value is managed to benefit the public health

system.

11.2 Method The CIPO will review notifications and management processes and provide

ongoing compliance monitoring; ACT Health IP and any revenue generated by associated commercialisation will be

reported annually to the Director-General.



DGD15-025

12. Related Legislation, Policies and Standards

12.1 LegislationCopyright Act 1968 Crimes Act 1900 Designs Act 2003 Financial Management Act 1996 Patents Act 1990 Public Sector Management Act 1994 Trademarks Act 1995

12.2 PoliciesACT Health Intellectual Property Policy

12.3 Standards N/A

13. References

www.ipaustralia.gov.au - IP Australia is the Australian Government agency responsible for administering patents, trademarks, designs and plant breeder’s rights.

Earlier republicationsSince 1 November 2014 every authorised republication has been published in electronic pdf format on the ACT Health policy register.

Republication No and date

Effective Last amended to

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.



http://www.ipaustralia.gov.au/

DGD15-025

ATTACHMENT A

Guidelines for Determining IP Ownership

Generally under copyright law ACT Health (on behalf of the ACT) will own the IP rights in anY works created by an employee in the ordinary course of performing his or her duties as an employee. This will include documents, applications or any other works developed under instruction by an employee’s manager, and is usually also the case with material created by an employee after hours, if it relates to tasks performed or projects undertaken in order to perform the employee’s duties.

IP can be created in the course of employment through utilisation of ACT Health resources, for example:

use of ACT Health’s laboratory facilities or equipment through modifying or updating any existing ACT Health IP in preparing material for presentation at conferences – this may be particularly

significant where the conference organiser purports to gain future commercial advantage from content submitted by presenters.

ACT Health employees:

need to be aware that someone other than ACT Health may own some of the material that the employees work with during the course of their employment. For example, ACT Health might only have use of documents, software or other works because of licences from universities, contracted consultants or others;

must only use a licensed work on the same conditions on which the licence has been given; and

must safeguard ACT Health’s IP from misuse by other employees and by individuals who are not employees, but who access ACT Health’s systems, documents and any other materials or media that contain ACT Health’s IP.

In many instances, IP created within ACT Health is not created through 100% ACT Health-owned contributions. However, ACT Health will most likely have some ownership of the IP that is produced. If full ownership is attributable to another institution or if joint ownership with ACT Health results, the other institutions will be contacted by the CIPO to discuss the way forward to register, protect and develop the IP.

ACT Health acknowledges that many employees privately engage in study, research, writing books and articles, and undertaking other activities that involve the creation of works by those employees outside of their employment. ACT Health encourages those endeavours and will not assert rights over works created in the private capacity of employees, unless the academic or other work has been commissioned by ACT Health or uses or draws on the resources of ACT Health. However, ACT Health may enter into agreements with employees for the right to use academic works or subject matter generated by employees.



DGD15-025

Students visiting ACT Health FacilitiesThere are various arrangements under which students may attend ACT Health facilities (for example, work experience, research or to fulfil requirements for tertiary education and other training purposes).

Students to be given access to ACT Health facilities, including any systems, data, patient and other records or documents, will be required to sign confidentiality undertakings.

Unless otherwise agreed in advance with a student, ACT Health retains all IP rights in any document, application or any other work created by the student, or in which the student has been involved in creating, when that is within the ordinary course of ACT Health’s operations and in other instances. For example, it will be appropriate for ACT Health to retain or assert IP rights over works created by students, if a work is created:

utilising ACT Health resources as a result of pre-existing IP owned by ACT Health by a team of ACT Health Creators of which the student is a member for the period of

time of his or her visit to ACT Health’s facilities, or is created as a result of funding provided by, or obtained by, ACT Health.

Generally, if a student is visiting ACT Health facilities to conduct independent research or to fulfil education or training, ACT Health will not claim ownership over IP created by the student. However, this will depend on the terms of the agreement on which a student is given access and any arrangement between ACT Health and their institution.

Supervisors and Heads of Research Departments should be mindful of any students undertaking health research or other activities that may lead to the creation of a work by students and consider the IP status of the work. In those circumstances contact should be made with the CIPO to discuss whether any form of written agreements should be considered.

Where the student of a University has an arrangement with ACT Health, ACT Health and the University may come to an agreement on how to deal with the IP in any work created by students, having regard to this Policy and the IP Policy of the University.

Visitors and Independent Contractors From time to time, ACT Health facilities and knowledge will be used by visitors and independent contractors. The ownership of IP created by visitors, will depend upon the terms of any agreements between the visitor (or the visitor’s employer) and ACT Health. It is the responsibility of the host department to ensure that a CIPO-approved agreement is in place prior to the visitor commencing works.

Appropriate agreements may include an assignment of IP by the visitor to ACT Health on certain terms and conditions, or may include terms under which ACT Health receives a share of the income of commercialisation of the IP. Whether such terms are appropriate will depend upon a number of factors, including the:



DGD15-025

Extent and nature of the work; Use of ACT Health resources; Source of funding of the research; Involvement of other ACT Health staff; and Any other relevant factors.

In the absence of an agreement between ACT Health and the visitor, the project IP created by the visitor will be shared with ACT Health calculated through a resources input model.

Clinical academics and joint teaching hospital / university facilitiesSignificant issues may arise in relation to IP created by clinical academics who work in both the university sector and ACT Health. In many situations, both the relevant university and ACT Health are likely to have contributed significantly to the remuneration of the clinical academic, as well as providing the clinical academic with resources, support and infrastructure. It will not always be possible to determine which resources were utilised in the creation of IP by clinical academics.

Similar issues arise in relation to joint teaching hospital/university facilities, where health research may be undertaken jointly by a mixture of university and hospital staff.

It is in the interests of both universities and ACT Health that issues regarding IP created by clinical academics and at joint facilities be clarified as early as possible in the identification, protection and commercialisation processes.

ACT Health will negotiate fair and equitable agreements as to the rights of respective parties to the IP created in joint facilities or by clinical academics. For example, ACT Health has negotiated an agreement with the ANU in relation to the operation of the Medical School, which also includes arrangements for handling IP. In general, the organisation that pays for the resources used to create the IP, owns the IP or their portion of financial input.

Independent Contractors Where ACT Health engages a third party contractor to provide goods or services, there must be an agreement in place with appropriate terms in the contract dealing with IP and taking into effect contributing in-kind and financial resources. In the absence of an agreement, IP ownership will be negotiated between all parties taking into effect contributing in-kind and financial resources.

Independent Health Research and Research Institutes associated with ACT HealthACT Health may house, or be associated with, independent Health Research and Research Institutes, which carry out Health Research. ACT Health may support or resource such health research in a number of ways, including through direct ownership and legal responsibility, or through the provision of researchers and administrative staff, infrastructure and equipment, or direct funding.

Regardless of whether such institutes are an independent legal entity or not, when ACT Health resources are provided an agreement should be in place with the institute which makes appropriate arrangements regarding the rights of ACT Health in relation to IP created.



DGD15-025

Collaborative projects, joint ventures, arrangements with other organisations ACT Health may create IP in conjunction with other organisations in the public or private sector, for example, under collaborative projects or joint venture arrangements for specific research and development projects. The ownership, assignment or licensing of IP, which arises from such ventures, will depend upon the contractual arrangements between the parties.

Where ACT Health enters into collaborative activities, joint ventures, or similar arrangements with other organisations, ACT Health should ensure that there is a legally enforceable agreement between the parties.

Any such agreement should protect the interests of ACT Health proportionately to its resources contribution to the project. ACT Health should obtain legal advice in advance regarding proposed agreements on joint ventures and collaborative projects. Proposed agreements should be sent to the CIPO for review or created by the CIPO prior to sign off by the Director-General.

ExceptionsACT Health does not assert ownership over any IP in work created by staff or originators that is a work of a scholarly nature including, without limitation, a journal article, conference paper, creative works or proceeding or text (‘exempt IP’) but subject to the conditions that:

ACT Health retains a non-exclusive, royalty-free, perpetual license to Develop that exempt IP anywhere in the world and in any manner ACT Health thinks fit, subject to any obligation that ACT Health may have relating to any moral right subsisting in that work; and,

If ACT Health exercises its rights, then the originator identified is to get a share of any commercial benefit.

ACT Health grants to the author of any teaching material that is subject to this SOP, a non-transferable, perpetual, royalty-free license to use the material created for the sole purpose of teaching any course.

If you consider your IP situation is not covered by any of the above scenarios, contact the CIPO for further advice on how to proceed prior to entering into any contractual negotiations or arrangements.



DGD15-025

Attachment B

Intellectual Property Committee

Terms of Reference

PURPOSE

The purpose of the Intellectual Property Committee (IPC) is to:

Administer the ACT Health Intellectual Property Policy and associated policies to ensure efficient governance and management (including by way of protection and commercialisation as appropriate) of the knowledge resources of ACT Health.

FUNCTIONS

Develop, protect and optimise (including marketing and promotion) the intellectual property portfolio of ACT Health.

Oversee governance, management and review of all intellectual property assets and related matters.

Devise and promote appropriate activities across ACT Health that will enhance awareness and education of intellectual property issues.

Periodically review and make recommendations to the ACT Health Executive Council as appropriate.

METHOD

The Committee is chaired by the Director General or nominated delegate. Members with specific expertise may be co-opted as required. Specialist legal advice will be sought as appropriate. Records of proceedings shall be treated as commercial in confidence. Maintain records of ACT Health Intellectual Property issues.

Chair/Membership: The following positions will make up the core Committee members:

Director General, ACT Health (Chair) Deputy Director General, Strategy and Corporate Chief Finance Officer Chief Health Officer Chief Medical Administrator Director of Research ACT Chief Nurse



DGD15-025

Chief Allied Health Officer Executive Director, Health Care Improvement Branch Ex Officio - ACT Health Intellectual Property Office team

leader – consultant.

These positions may nominate a proxy in lieu of personal attendance if required.

Frequency: The committee will meet quarterly and hold additional meetings as required.

Secretariat: Secretariat support to be provided to deliver the following services Annual Scheduling of Meetings Annual Booking of Venues Agenda setting and distribution of papers two weeks

prior to subsequent meeting Distribution and follow up on meeting actions and

outcomes Ensure relevant reporting meetings/committees minutes

are included in the monthly agenda and papers.

Reporting Responsibility: The IPC is accountable to the Director General.

Quorum: 50% of membership plus one.

TOR Review Frequency: 12 months.

Conflict Of Interest: Any member with a personal conflict of interest in an IP project will be required to follow the conflict of interest management process and may temporarily stand down from the committee.

The Secretariat will maintain a conflict of interest register to further ensure transparency in decision making.



intellectual property management sop€¦ · web view1.1this standard operating procedure (sop) and...

Documents