Marsden Grant Recipient - Dr Jessica Lai
Congratulations to Dr Jessica Lai in the School of Accounting and Commercial Law who has won a $622,000 Marsden grant in the latest round, administered by The Royal Society Te Apārangi.
Dr Lai is co-leading the research with Professor Susy Frankel from the Faculty of Law. The research focuses on the relationship between patents and regulatory data exclusivity with respect to pharmaceutical, and its impact on innovation and health.
Globally, lawmakers have tightened what can be patented to ensure that only ‘worthy’ inventions are granted 20 years of exclusivity. At the same time, the pharmaceutical industry argues that patent protection is unsuitable for biologics (products that are produced from living organisms or contain components of living organisms). The changes to the patent system together with the increasing importance of biologics has resulted in the pharmaceutical industry pushing for stronger protection of confidentiality data submitted for the regulatory review of medicines.
This shift in protection from patents to regulatory data exclusivity is problematic as patents are the established form of protection for pharmaceuticals and, importantly, the patent regime is justified as necessary for innovation and includes checks and balances. In contrast, the regulatory review regime is primarily a framework to ensure the health and safety of pharmaceuticals. Making it more difficult to get a patent might have inadvertently led to a move from pharmaceuticals being protected by a system that assesses whether an invention is worthy of 20 years of exclusivity, to a system that does not. This is ‘mission creep’, and it may have negative implications for innovation and for health and safety.
Dr Lai’s project analyses why the regulatory system has become more important for some pharmaceutical interests, and why the patent system is no longer the only regime in which pharmaceutical companies lobby for protection.
By analysing changes in technology and the application of patent law over the past 30 years, combined with the rise in protection of regulatory data, this project critically assesses the possible consequences for innovation and public health and safety.