The Innovation Pool in Australian Biotechnology: Assessing Strategies for Fostering Innovation Through Patenting and Patent Pooling
External Partners: Prof Reiko Aoiki (CI), Prof Geertrui Van Overwalle
External Collaborators: Prof Tim Caulfield, Prof John Walsh, Prof Beth Webster, Sarah Bull (RA - ANU)
UTAS Collaborators: Ben Mee (RA), , Prof Anthony Arundel, Dr Eric Iversen
Funding Source: ARC Grant DP0985077
Commencement Date: 2009
Project Status: Complete
Researchers
Research Background
There is great expectation about the future of biotechnology, both economically and in terms of the benefit it may provide to society. In the health sector, genetic diagnostic testing, gene therapy and gene-based drug development all have the potential to reduce suffering caused by disease. Arguably, a robust patent system is crucial in providing the necessary incentive to encourage innovation in this field. However, patenting in biotechnology is controversial, particularly because it is unclear whether patents and other innovation tools actually inhibit rather than facilitate biotechnology research and translational developments.
About the Project
This study, conducted between 2009 and 2014, involved an exploration of the relationship between patenting, patent management and innovation in the Australian biotechnology industry, including analysis of the legal, regulatory and economic environments. A key aim was to assess for the need to reform regulatory frameworks in order to foster innovation in the biotechnology industry, and to evaluate the use of patent pools.
The project came at a time when much reform was being undertaken in Australia in the patent area. As such the CIs highly prioritised the writing of submissions to public inquiries to assist in law reform.
Key analyses of the project
Mapping the Australian biotechnology industry landscape, through searches of web-based information, company documentation, use of other publicly available information, patent analysis and clinical trials analysis.
Statistical analysis of different industry sectors in an Australia-wide inventor survey
Conduct of face to face interviews with biotech industry participants, including CEOs, intellectual property mangers and business managers.
Conduct of face to face interviews and surveys with providers of diagnostic genetic testing services.
Doctrinal and policy analysis of patent law, with particular focus on law reform proposals and recent case law.
Outputs
The CIs on this project actively engaged in many law reform debates. This included making written and oral submissions to six law reform bodies during the time this project was active.
The CIs presented at a number of conferences including the European Policy on Intellectual Property Annual Conference (2011, 2012, 2013, 2014), the Asia Pacific Innovation Conference (2012), the Human Genome Meeting: Genetics and Genomics in Personalized Medicine (2012) and various workshops in the UK, Australia and the US.
Publications
D Nicol, 'Are the Courts Solving the
Emerging Challenges of Biotech Patents?' in: K Bowrey, M Handler and D Nicol
(eds), Emerging Challenges in
Intellectual Property (Melbourne: Oxford University Press; 2011) pp145-163
D Nicol and J Nielsen, 'Opening the Dam:
Patent Pools, Innovation and Access to Essential Medicines' in: T Pogge, M
Rimmer and K Rubenstein (eds), Incentives for Global Public Health: Patent Law and Access
to Essential Medicines (Cambridge: Cambridge University Press; 2010)
pp235-262
J Nielsen, 'Competition Law and
Intellectual Property: Establishing a Coherent Approach' (2011) in K Bowrey, M
Handler and D Nicol (eds), Emerging
Challenges in Intellectual Property (Melbourne: Oxford University Press;
2011) pp 183-201.
E van Zimmeren, D Nicol, ER Gold, J
Carbone, S Chandrasekharan, AL Baldwin and R Cook-Deegan, 'The BRCA Patent
Controversies: an International Review of Patent Disputes' in S Gibbon, G
Joseph, J Mozersky, A zur Nieden and S Palfner (eds) Breast Cancer Gene Research
and Medical Practices: Transnational Perspectives in the Time of BRCA
(Routledge, 2014) Chapter 8 pp151-174
J Liddicoat, T Whitton and D Nicol, 'Gene Patent Storm Clouds Dissipating? A Global Snapshot' (2015) 33 Nature Biotechnology 347-352
T Bubela, ER Gold, GD Graff, DR Cahoy, D Nicol and D Castle, 'Patent Landscaping for Life Sciences Innovation: Toward Consistent and Transparent Practices' (2013) 31 Nature Biotechnology 201-206
D Nicol, 'Collaborative Licensing in Biotechnology: A Survey of Knowledge, Experience and Attitudes in Australia' (2010) 29 Biotechnology Law Report 465-483
D Nicol, 'Implications of DNA Patenting: Reviewing the Evidence' (2011) 21 Journal of Law, Information and Science 7-36
D Nicol, 'More from the United States and Europe on Patenting of Biotechnology Inventions and the Potential Impact on Australia' (2012) 24(8) Intellectual Property Law Bulletin 205-206
D Nicol, 'Recent Decisions from the United States and Europe on Patenting of Biotechnology Inventions and their Potential Impact on Australia' (2011) 24(2) Intellectual Property Law Bulletin 48-51
D Nicol and J Liddicoat, 'Do Patents Impede the Provision of Genetic Tests in Australia?' (2013) 37 (3) Australian Health Review 281-285
D Nicol and J Liddicoat, 'Legislating to Exclude Gene Patents: Difficult and Unhelpful or Useful and Feasible' (2012) 22 Journal of Law, Information and Science 32-54
D Nicol, J Liddicoat and C Critchley, 'A Role for Virtual Biotechnology Companies in Drug Discovery and Development?' (2013) 19 Journal of Commercial Biotechnology 10-19
D Nicol and O Owoeye, 'Time for Rich Countries to Enact TRIPS-compliant Legislation to Facilitate Access to Medicines by Poorer Countries?' (2013) 91 Bulletin of the World Health Organisation533-539
A Ridley and D Nicol, 'Is There Still a Place for Gene Patents in Australia? Implications of Recent US and European Case Law' (2011) 19 Journal of Law and Medicine 282-299
J Liddicoat and D Nicol, 'Top US Court Blocks Patents on Breast Cancer Genes' (14 June 2013) The Conversation
D Nicol and J Liddicoat, 'Do Patents Promote Innovation' (21 February 2012) The Conversation
D Nicol, 'Challenge to the Breast Cancer Gene Patents in the US' (2009) InstitutoRoche Ethics and Legal Area: Current Comments
D Nicol, 'Editorial: The Role of the Law in DNA Patenting' (2012) 22 Journal of Law, Information and Science i-iii
D Nicol, 'For Myriad Genetics, the Gene Patent Fight Isn't Over Yet' (11 October 2013) The Conversation
D Nicol, 'Genetic Land-grab or Reward for Ingenuity? Australian Court To Rule on Gene Patents' (27 February 2012) The Conversation
D Nicol, 'Gene Patents and Personalised Medicine' (2009) InstitutoRoche Ethics and Legal Area: Current Comments
D Nicol, 'Legitimacy of Patenting Genes – after Thirty Years Do We Have a Definitive Answer?' (2013) InstitutoRoche Ethics and Legal Area: Current Comments
D Nicol, 'Recent Decisions from the United States and Europe on Patenting of Biotechnology Inventions and their Potential Impact on Australia' (2011) 24(2) Intellectual Property Law Bulletin 48-51
Opportunities for further research or PhD study
Although this project has concluded, Professor Dianne Nicol and Dr Jane Nielsen welcome inquiries for patent focused PhD study.