Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 11, Num. 3, 2001, pp. 19

Australasian Biotechnology, Vol. 11 No. 3, 2001, pp. 19

REGULATORY NEWS

COMMERCIALISATION OF BIOTECHNOLOGY AND THE ROLE OF UNIVERSITIES

Anna Simpson, Senior Solicitor

Technology Group, McCullough Robertson Lawyers, Level 12 Central Plaza Two, 66 Eagle Street Brisbane Qld 4000, http://www.mccullough.com.au, asimpson@mccullough.com.au

Code Number: au01036

Although the Australian biotechnology industry is still in its infancy, the use of genetic engineering technologies and the commercialisation of derived products is progressing at a rapid rate. Due to the heavy dependence of biotechnology on research, universities and other research institutions play an increasingly important role in facilitating the generation of economic activity, through knowledge transfer mechanisms including the creation of spin-off companies, and joint ventures, and through licensing arrangements.

Universities and research organisations must be aware that adequate management and protection of intellectual property rights is essential to stimulate research and development and to attract investment capital.

One of the key issues which arises repeatedly in this area concerns ownership and control of intellectual property. Research in biotechnology often involves partnerships among university-based researchers, hospitals, government sectors and private industry, with all of these groups potentially creating commercially valuable IP.

At the university level, participants in research projects usually comprise undergraduate and postgraduate students, academic staff and consultants, each of whom may have a claim to intellectual property ownership independent of the university. Employment contracts for university staff and enrolment forms for postgraduate students often fail to include statements regarding rights to IP. In the absence of procedures to vest the IP in the correct entity, spin-off companies often require detailed assignments or licences of IP rights from these individuals before they can move forward with commercialising biotechnology innovations and products. Such assignments are often not forthcoming, and arrangements may not always be finalised in expected time frames.

Further, various contracts with third parties may limit the university's ability to negotiate arrangements with prospective investors. Agreements to advance research with industry collaborators, for government grant monies, or even with bodies sponsoring postgraduates through scholarships, may attempt to constrain exploitation of IP or define the IP rights of concerned parties.

To commercialise biotechnology successfully, universities and research institutions must adopt sound business practices before the onset of research. Transparent IP policies should be implemented, that will:

• appoint central IP officers to administer the policies and document all relationships and agreements;
• promote identification of emerging IP assets and foster a research environment conducive to the transfer of information and technology;
• provide a balance between protecting IP rights for commercial exploitation and rewarding participants;
• establish ownership and perfect interests through registrations, filings, assignments and licences;
• maintain confidentiality of research endeavours which is in the interests of all parties involved;
• prioritise internal R & D to capitalise on strategic market advantages for biotechnology products;
• provide appropriate training for all university staff, students and research assistants to recognise the value of IP; and
• facilitate ongoing management and monitoring of IP so that commercialisation can proceed, and infringements can be acted upon if necessary.

The emergence of biotechnology has raised awareness in the business sector that biological diversity constitutes an important source of chemical and genetic material of enormous commercial value. It is essential that those involved in the conduct and management of research and its outcomes in Australian institutions, develop an enterprising culture which will foster the exploitation of biotechnology innovations.

Strategic management and protection of the technology base is crucial, particularly given the often long lead times between discovery and commercialisation. A sound, comprehensive and focused IP strategy will benefit both universities and industry by promoting successful knowledge transfer and ease of market entry of innovations and products derived from biotechnology research.

To maximise the commercial value of bio-engineered products, problems should be identified and rectified before any third party due diligence is conducted or investment funds are sought. Above all, professional advice should be sought early to avoid and defuse potential tensions.

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