Materials transfer agreements

17.99 The sharing of genetic materials within the research community is important for the progress of research. Living organisms are difficult to describe and often impossible to duplicate from a written patent description.^[106] While some genes may be isolated easily, cloning into vectors and generating transgenic cell lines and animals can be costly and time consuming. In fact, it may be impossible to improve upon a biotechnology invention without a physical exchange of genetic material.

17.100 In the past, this often occurred informally. However, the increased commercialisation of research results has created a need to develop more formalised arrangements, often referred to as materials transfer agreements (MTAs). An MTA is a written agreement defining the terms and conditions governing the transfer of biological or other research materials from the owner or authorised licensee to a third party for internal research purposes only. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives created during the ensuing research.

17.101 For the provider, the advantages of having an MTA include the ability to restrict the use of the material to non-commercial research and reduce legal liability for the recipient’s use of the material.^[107] Importantly, the terms of an MTA may enable the provider of material to gain access to the results of research and to manage and extend its intellectual property rights. A provider may be entitled to outright ownership or to a licence in respect of intellectual property generated by the recipient’s research.^[108]

17.102 Most commercial organisations, and an increasing number of research organisations, will only release genetic materials if there is an MTA in place between the provider and the recipient.^[109] It was suggested in consultations that although Australian universities sometimes negotiate MTAs, this is not always the case.^[110] Informal transfers may exacerbate problems involving patent ownership and reach-through claims to subsequent inventions.

Model materials transfer agreements

17.103 One Australian approach to streamlining processes for materials transfer for research purposes is that initiated by the Garvan Institute of Medical Research (Garvan Institute). The Garvan Institute uses an MTA based on the uniform agreement recommended by the United States Association of University Technology Managers and has created an automated, web-based system to streamline processes for settling the terms of MTAs with researchers wishing to have access to the Garvan Institute’s research materials.^[111]

Submissions and consultations

17.104 DP 68 proposed that Biotechnology Australia, in consultation with state and territory governments and other relevant stakeholders, should develop model MTAs for use by universities and other research organisations, along the lines of the models developed by the United States Association of University Technology Managers.^[112]

17.105 Most submissions supported this proposal strongly.^[113] The Queensland Government noted, however, that the ‘danger of model licence agreements is that they are not sufficiently tailored to the particular circumstances of each individual case’. However, it supported the proposal:

[on] the basis that these agreements contain a number of different clauses, consider different scenarios and are used only as guidance. It should be clear that these agreements need to be tailored to meet the requirements of the particular circumstances and that independent legal advice may also be required.^[114]

17.106 The Centre for Law and Genetics noted that concerns about using model agreements may be less acute for MTAs than for licensing agreements generally as MTAs are often more uniform.^[115] DITR commented that Biotechnology Australia may not be the appropriate body to develop these model agreements. It suggested that AusBiotech Ltd or KCA may be better placed to do so.^[116]

ALRC’s view

17.107 The ALRC is of the view that there is a need to encourage better practice in the transfer of technology and materials between research organisations. The ALRC considers that some of the concerns surrounding materials transfer could be met by the introduction of model MTAs to reduce arbitrary variation across agreements and to encourage organisations to formalise transfer arrangements.

17.108 To address this concern, the ALRC recommends that Biotechnology Australia, in conjunction with its member departments, should collaborate with the peak national bodies with an interest in technology transfer to develop model MTAs. In doing so, they should draw on those developed by the United States Association of University Technology Managers. The ALRC considers that, in particular, Biotechnology Australia should collaborate with the Australian Institute for Commercialisation, Knowledge Commercialisation Australia and the Licensing Executives Society to draw on their expertise in this area.^[117]