There are few career changes as great as that from science to law – Professor Dianne Nicol has not only made the transition, but discovered a new passion and drive.
I started my research career as a cell biologist, examining the development of the nervous system in simple organisms. This was at a time when the hot fields in biology were ecology and molecular genetics, not developmental neuroscience – so my timing was not perfect. Coincidentally, I arrived in Tasmania with my family before it was viewed as an enviable lifestyle choice. Yet I am eternally grateful to my husband for getting a job here, liberating me from the Britain I knew and introducing me to this island paradise.
“Learning law was so much fun, and it surprised me that my scientific skills in logic and problem solving were perfectly adaptable to this new environment.”
The lack of demand for people with my research interests at the time provided me with the opportunity to reflect on my skill sets and consider my options. On a whim I enrolled in a law degree, thereby setting my career path for the next 30 years. Learning law was so much fun, and it surprised me that my scientific skills in logic and problem solving were perfectly adaptable to this new environment.
This era was at the start of the Human Genome Project (HGP). Fortuitously, my first lecturers in contract and torts law were health lawyers keen to explore the relationship between new technologies and the law. From the start of the HGP, it was recognised globally that a Pandora’s box of ethical, legal and social implications (ELSI) was bursting open. It was pledged that 3-5% of the generous HGP funding would be allocated to examine ELSI. My team was fortunately able to persuade the Australian Research Council that an Australian voice was needed in these debates.
“patenting was necessary to attract commercial partners, and that this was the only way for their brilliant research ideas to have practical application”
Consent, privacy and discrimination were seen as key ELSI, but it was the availability of patents for genetic inventions that particularly piqued my interest. Without doubt, patents have an important role in the translation of biomedical discovery from the laboratory to the clinic. With too little patent protection there is not enough incentive to traverse this long and winding path. But too much protection could block off whole translational pathways to all but the patent holder and their chosen partners. And too many patent holders could create an ‘anticommons’; a series of ‘tollbooths on the road to product development’, using the words of Michael Heller and Rebecca Eisenberg.
Views in the biomedical community were mixed. For some, the mere idea of patents was antithetical to the whole research endeavour, which should surely support open sharing. The more entrepreneurial scientists recognised that patenting was necessary to attract commercial partners, and that this was the only way for their brilliant research ideas to have practical application.
The controversy surrounding patenting of biomedical endeavours reached a crescendo when it came to the patenting of nucleotide sequences. How could a nucleotide sequence possibly be an invention? Despite the controversy, it took over 30 years from the grant of the first so-called gene patents to the decisions of the highest courts in the USA and Australia that claims to subject matter of this nature were not ‘patent eligible’. In the interim there was a veritable gene patent gold rush.
Were scientists and their institutions right in pursing gene patent claims and forming partnerships with private companies to exploit them? Were patent offices around the world right in granting such patents? Were the courts right in invalidating them? It’s complicated.
“My research, and research undertaken by many scholars globally, reveals that working solutions are being found to problems associated with commercialisation and patenting in biomedicine.”
So, what do I do as a legal researcher in this area? My research has three key aspects. One is doctrinal. This means that I study legal doctrine – I read statutes and cases. I look at words and how they are interpreted. Despite what many might think, it’s not at all dull – I find it totally fascinating. I still get excited by each new decision.
I also study policy and law reform. Do we have the law right, and if not how should it be changed? What would motivate policy makers to change the law?
Finally, I collect empirical evidence. I use social sciences methodologies to examine the implications of particular legal and policy decisions. I examine patent and industry landscapes. I interview participants. I do public opinion surveys. I run citizen deliberation forums. This all helps in understanding what we, as a society, expect and desire from the scientific endeavour, and how close we are to achieving it.
My research, and research undertaken by many scholars globally, reveals that working solutions are being found to problems associated with commercialisation and patenting in biomedicine. Both do indeed play an important role in the translation of biomedical research from the laboratory to the clinic. But more nuanced approaches are needed to ensure there is an appropriate balance between transfer of technology and openness of science.
“It has provided me with years of rewarding experiences, convincing me that my career decisions, which might have seemed counterintuitive at the time, were patently correct.”
My background training in science and law and the support I have received from colleagues with expertise in bioethics and social sciences have put me in an ideal place to examine these issues. It may be complicated, but it’s also important and inspiring. It has provided me with years of rewarding experiences, convincing me that my career decisions, which might have seemed counterintuitive at the time, were patently correct.
Dianne Nicol is a distinguished professor of law at the University of Tasmania in Australia. A fellow of the Australian Academy of Law and the Australian Academy of Health and Medical Sciences, she has a background in science with a PhD in cell biology. She is also Director is of the Centre for Law and Genetics at the University of Tasmania. Her current research focusses on the regulation and governance of emerging technologies such as personalized medicine, genomic data sharing, biobanking and genome editing, and commercialisation of biotechnology and patenting of biotechnological inventions.
You can find out more about Professor Dianne Nicol’s research here: https://www.utas.edu.au/profiles/staff/law/dianne-nicol.
These are some short articles in Science and Nature recommended by Professor Nicol by other scholars in the field that expand on some of the points in her piece:
- Rebecca S Eisenberg, ‘Genes, Patents and Product Development’ (1992) 257 Science 903.
- Michael A Heller and Rebecca S Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science.
- Jon F Merz, et al, ‘Diagnostic Testing Fails the Test’ (2002) 415 Nature.
- John P Walsh, Ashish Arora and Wesley M Cohen, ‘Working Through the Patent Problem’ (2003) 299 Science.
- Kyle Jensen and Fiona Murray, ‘Intellectual Property Landscape of the Human Genome’ (2005) 310 Science.
- Sibylle Gaisser, et al, ‘The Phantom Menace of Gene Patents’ (2009) 458 Nature 407.
- Jorge L Contreras and Jacob S Sherkow, ‘CRISPR, Surrogate Licensing, and Scientific Discovery’ (2017) 355 Science.