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Patent Law and Scientific Information

QUT Faculty of Law Intellectual Property and Innovation Law Research Program

Tuesday, 9 July 2019

2:00 pm to 5:00pm

Z1064, The Gibson Room,

QUT Gardens Point Campus

OVERVIEW

This half-day research workshop considers the role of patent law in respect of scientific information.

A number of recent Australian law reform and public policy inquiries have highlighted the need for evidence-based policy-making in respect of patent law. The Australian Law Reform Commission made a number of recommendations in respect of patent law and biotechnology. The Productivity Commission has argued that there is a need for a rebalancing of Australia’s patent system, declaring that ‘it is clear that the system is poorly targeted and in many cases provides excessively strong patent rights.’ The Harper Review has highlighted the inter-relationship between patent law and competition policy.

Intellectual Property Offices have also sought to engage in data analysis. For its part, IP Australia has established the Office of the Chief Economist. The Office has sought to provide decision-makers with evidence-based advice to maximise the economic benefits of the Australian intellectual property system. The World Intellectual Property Organization has undertaken empirical research into patent landscapes in respect of breakthrough technologies — such as artificial intelligence, robotics, 3D printing, and nanotechnology.

This research workshop provides a forum for experts in patent law, policy, and practice to share their empirical research. It is designed to provide for a discussion of qualitative and quantitative research in respect of patent information. This research workshop will consider the historical value of patent information. It will explore the information function of patent law — as well as the role of patent law in respect of commercialisation and innovation. This event will also feature a discussion of patent landscapes in a range of scientific and technology fields — including information technology, 3D printing, medicine, biotechnology, genetic resources, and bioinformatics.

The keynote speaker is Professor Eva Hemmungs Wirten from Linköping University who is undertaking a five year European Research Council project on ‘Patents as Scientific Information, 1895–2020’. The event is hosted by the QUT Intellectual Property and Innovation Law Research Program. It is supported by an ARC Discovery Project on ‘Inventing the Future: Intellectual Property and 3D Printing’.

Section 1 Patent Law and Scientific Information

Patents as Scientific Information, 1895–2020

Professor Eva Hemmungs Wirten, the Department of Social Change and Culture, Linköping University

Abstract

“Patents as Scientific Information, 1895–2020” (PASSIM), is a multidisciplinary, five-year project (2017–2022) funded by an ERC Advanced Investigator Grant to Professor Eva Hemmungs Wirtén, Linköping University, Sweden. At the seminar, Professor Hemmungs Wirtén will present the project, talk about its various sub-projects and activities, give insights into the ERC grants scheme and application process, and discuss ideas for future research and collaborations.

Biography

Eva Hemmungs Wirtén is Professor of Mediated Culture at the Department of Social Change and Culture, Linköping University, Sweden, and also Co-Director of The International Society for the History and Theory of Intellectual Property (ISHTIP). She has written extensively on the cultural history of international copyright, the public domain and, more recently, on patents as documents. Her most recent book, Making Marie Curie: Intellectual Property and Celebrity Culture in an Age of Information was published by University of Chicago Press in 2015. In 2017, she was awarded an ERC Advanced Investigator Grant for the project “Patents as Scientific Information, 1895–2020,” (PASSIM www.passim.se), which runs between 2017–2022. Her first article in the PASSIM-project, “How Patents Became Documents, or Dreaming of Technoscientific Order, 1895–1937,” was published by Journal of Documentation in an early cite version in March 2019 and can be downloaded as OA via https://doi.org/10.1108/JD-11-2018-0193.

The Patent Dance: Biosimilars and the (Optional) Exchange of Information

Professor Jay Sanderson and Teddy Henriksen, the University of the Sunshine Coast

Abstract

With the rise of biosimilars and biosimilar litigation (particularly in the United States) this paper is part of a larger project examining biosimilars and intellectual property law. While there are questions around novelty, inventive step and sufficiency there are also broader issues around the exchange of information, and the role of patent law in the regulation and incentivisation of new pharmaceuticals. For example, the United States’ Biologics Price Competition and Innovation Act, establishes a framework (known as the “patent dance”) for the exchange of patent and related information between the biosimilar applicant and the reference product sponsor. This paper will critically consider some recent litigation on the so-called ‘patent dance’ and begin to compare the approaches taken by the United States, the European Union and Australia.

Biography

Professor Jay Sanderson is an interdisciplinary researcher who holds degrees in law, psychology and science. From plant breeding and biodiversity to genetic engineering, much of Jay’s research examines the relations between science, law and people, particularly in the area of intellectual property. Read more about Jay at https://www.usc.edu.au/staff-repository/professor-jay-sanderson

Teddy Henriksen is a PhD candidate with the USC Law School with degrees in law and pharmacy. His research is concerned with the interface between pharmaceutical drug development and the law, particularly legal issues around biologic drug molecules and biosimilars.

Mapping the Global Influence of Published Research on Industry and Innovation

Professor Uwe Dulleck, QUT Business School

Abstract

Public research is critical to the economy and society. However, tangible economic and social impact only occurs when research outputs are combined, used and reused with other elements and capabilities, to deliver a product, practice, or service. Assessing the context and influence of scholarship during the dynamic process of innovation rather than measuring ex post impact, may improve performance. With this aim, we integrated and interconnected scholarly citations with global patent literature, and here we offer new tools enabling diverse stakeholders to freely evaluate the influence published research has on the generation and potential use of inventions as reflected by the patent system. We outline an evolving toolkit, Lens Influence Mapping, that allows assessment of individual scholarly works and aggregated outputs of authors for influence on industry and enterprise as measured by citations within patents. This performance measure, applied at many levels and normalized by either research disciplines or technology fields of use, may expose and highlight institutional strength and practices, and guide their future partnerships

Biography

Uwe obtained his PhD at Humboldt University Berlin in 1999. Before Uwe joined QUT he was a Professor of Economics at the University of Linz, Austria and an Assistant Professor at the University of Vienna. His publications can be found in the ‘American Economic Review’, ‘Journal of Economic Literature’, the ‘Economic Journal’, the ‘Journal of Public Economics’, the ‘International Journal of Industrial Organization’, the ‘Scandinavian Journal of Economics’, among others. His research has been discussed in the Economic Focus of ‘The Economist’, the Sydney Morning Heralkd and the ‘Frankfurter Allgemeine Sonntagszeitung’ (the Sunday edition of Germany’s leading quality newspaper), among others. Uwe was awarded several ARC Linkage Grants and one ARC Discovery Grant. He is a co-investigator of two Austrian Research grants. In total his research funding exceeds AUD 2,500,000). In 2015 Uwe was the Chairman of the Programme Committee for Australia’s Conference of Economists, the leading and largest conference for research and applied economists in Australia. He is an active public speaker on Behavioural Economics and its applications to Public Policy, Business Decision Making and Regulation.

Patent Law and Marine Genetic Resources

Dr Frances Humphries, Griffith Law School

Abstract

The United Nations is currently negotiating an oceans treaty that is reigniting debate about access to marine genetic resources and the scientific information they unlock. The treaty will be an implementing agreement under the United Nations Convention on the Law of the Sea (UNCLOS) for the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (ABNJ). Two of the treaty elements are the management or use of marine genetic resources and capacity building/technology transfer. The treaty options for the second negotiating session in March 2019 touched on intellectual property but it will be the third negotiating session in August 2019 when the real debate will begin about whether the new treaty should affect the status quo of international intellectual property minimum standards of protection. Options on the table include compulsory disclosure of origin of ABNJ genetic resources in patent applications.

While countries cannot make sovereign claims over biological resources located in ABNJ, patents over genetic resource inventions generate private interests that may control the resources’ use by others. Current technology transfer obligations under UNCLOS are subject to having ‘due regard to all legitimate interests’, which remains undefined. This raises an important question for the new treaty about how to determine and balance ‘legitimate interests’. This paper investigates the challenges and potential solutions for balancing the public interest in freely sharing scientific information with the interests of patent holders of ABNJ genetic resource inventions. It concludes that there may be a middle ground between divergent countries’ views on intellectual property under the new treaty.

Biography

Fran is a Senior Research Fellow and the Program Leader of the Law and Nature Research Program at the Law Futures Centre, specialising in genetic resource law and aquaculture. She is on the International Council of Environmental Law’s delegation for the United Nations negotiations of an Internationally Legally Binding Instrument under UNCLOS on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction.

Session 2 Patent Law and Biotechnology

A Cartography of the 3D Printing Patent Landscape

Professor Matthew Rimmer, QUT Faculty of Law

Abstract

As part of an ARC Discovery Project on Intellectual Property and 3D Printing, Rimmer and his team of researchers have been mapping the 3D Printing landscape in respect of intellectual property.

This research project has mapped the existing empirical research in respect of intellectual property and 3D printing. The research project has also reviewed the empirical work of Daly (2016) and Moilanen, Daly, Lobato, and Allen (2015) looking at the use of Creative Commons licensing of 3D printing works under copyright law. It has also looked at the empirical research undertaken by Mendis et al. (2015) for the United Kingdom Intellectual Property Office. WIPO has been providing a wider array of datasets to allow for analysis of key technological fields, particularly in respect of patent law, trade mark law, and designs law. WIPO (2015) produced an important report on patent law and breakthrough technologies — including 3D printing, robotics, and 3D printing. A number of patent attorney firms have also sought to map patent activity in relation to sub-fields of 3D printing — such as metal 3D printing, bioprinting, and aviation 3D printing.

The research team has worked closely with consultants, IFI Claims Patent Services, to analyse key trends in respect of families of patents related to 3D printing. This research has involved, analysing patent information, using key terms. It has conducted a family patent landscape analysis. This has revealed top assignees and applicants, top portfolio status, family publication activity, top classes, and top countries revealed by priority country. Drawing upon such sources, this project has analysed the landscapes for industrial property in respect of 3D printing, and highlight both thickets of activity, and white spaces. This data has also highlighted trends in respect of 3D printing — particularly in key subfields such as consumer 3D printing, metal 3D printing, bioprinting, food 3D printing, and industrial 3D printing.

This project will also seek to develop a database in respect of litigation over intellectual property and 3D printing. As yet, there is only emerging skirmishes in respect of patents and 3D printing.

This research project has also supplemented such data analysis with qualitative interviews with key members of the maker community in respect of patent law and 3D printing.

This presentation will provide a preliminary account of the key findings of the empirical research for the ARC Project in respect of Intellectual Property and 3D Printing.

Biography

Dr Matthew Rimmer is a Professor in Intellectual Property and Innovation Law at the Faculty of Law, at the Queensland University of Technology (QUT). He is a leader of the QUT Intellectual Property and Innovation Law research program, and a member of the QUT Digital Media Research Centre (QUT DMRC) the QUT Australian Centre for Health Law Research (QUT ACHLR), and the QUT International Law and Global Governance Research Program (QUT IP IL).

Rimmer has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, plain packaging of tobacco products, intellectual property and climate change, and Indigenous Intellectual Property. As a chief investigator of an ARC Project on intellectual property and 3D printing. Rimmer is currently working on research on intellectual property, the creative industries, and 3D printing. He is a co-editor of 3D Printing and Beyond: Intellectual Property and Regulation. He has also been researching intellectual property and trade, looking at the Trans-Pacific Partnership, the Regional Comprehensive Economic Partnership, and the Trans-Atlantic Trade and Investment Partnership, and the Trade in Services Agreement. His work is archived at QUT ePrints SSRN Abstracts Bepress Selected Works.

The Information Machine Is Broken: Life-Sciences Patents, Injury, Innovation and Social Licence

Assistant Professor Dr Bruce Baer Arnold, the University of Canberra

Abstract

This presentation considers patents as a key element of a global ‘information machine’ that results in fundamental social goods through the sharing of knowledge about lifeforms, diagnostics and therapeutics.

The machine encompasses peer-reviewed validation and dissemination of research, community understanding of life-science issues and responses by regulators or under tort law to harms attributable to patent-protected inventions. The machine is broken, given acceptance of fake health news, regulatory incapacity, dysfunction in scholarly publishing, weak implementation of the Doha exceptions and egregious rent-seeking exemplified by patent holders such as Martin Shkreli.

Fixing the machine and thereby fostering goods on a global basis requires us to review the social licence that underpins patent law. We both can and should shape rent seeking, alongside mandatory data sharing about harms, revivification of gatekeepers such as the FDA and TGA, and forward-looking incentive by bodies such as the ARC and NHMRC for open publishing.

Biography

Dr Bruce Baer Arnold is an Assistant Professor in the School of Law at the University of Canberra. He has a strong interest in privacy, data protection, intellectual property and health sector regulation. He is on the editorial board of Privacy Law Bulletin and an OECD Health Information Infrastructure panellist. His work has appeared in Melbourne University Law Review, Journal of Medical Ethics, International Journal of Communication Law & Policy, Local Government Law Journal, Alternative Law Journal and other publications.

Bio-rights, Wetware and Bioethics — Intellectual Property in the Bioinformational Age

Tess Watson, the University of Canberra

Abstract

The development of high-throughput genomic sequencing and the rise of public and commercial biobanks has raised legal, policy and bioethical questions about the ownership and control of bio-informational data. Bio-rights activists and theorists have focused on gene patent acquisition and enforcement, and the equity of commercialisation of intellectual property rights for use of technologies still rooted to the physical — tissue samples, blood products, genes and genomic profiles. However, increasingly personhood is no longer physical, in an age of big-data it is manifested in “living databases”, co-created biodata, socially-networked, and digital persons who can be commercialised and commodified in a myriad of ways.

While the autonomy, privacy and control concerns of construing people as walking databases has been considered, this presentation will examine the intellectual property implications. Thus, copyright may offer protections for researchers when patents are not available, both in the outputs of genomic sequencing (the trace outputs and associated texts) and the associated databases. As co-creators, they may also offer participants co-contribution and moral rights, recognising their ownership of their epigenetic, lifestyle and genomic profiles.

Biography

Tess Watson is a Juris Doctor student at the University of Canberra with a previous degree in English Literature and Psychology, who has previously worked in Disability, Aged Care and Family Law public policy. Her thesis focuses on autonomy, privacy, control and ownership of property in the body in bioinformatics and emerging technologies.

From the Population to the Personal: The Ethics of Market-driven Medical Innovation Regulation

Associate Professor Wendy Bonython, Bond University

Abstract:

Innovation in medicine typically relies on large scale population or epidemiological data for validation. Patent law, with its incentivisation of innovation through protection of access to markets, similarly privileges large populations, in the context of potential markets.

This presentation examines the application of population-scale legal frameworks, such as IP law, to problems that are highly individualistic in nature. It specifically focuses on structural barriers to developing therapies for rare diseases, or rare complications arising from common therapies, where potential market scale is limited. It explores mechanisms designed to liberalise access to therapies of relevance in responding to epidemic-scale public health issues, where potential markets may be large but arbitrarily devalued from the perspective of innovators. It considers the bioethical implications of these tensions, in particular the tension between the utilitarian and dignitarian philosophies evident in this intersection of law and medicine.

Biography:

Associate Professor Wendy Bonython (Bond University) teaches and researches in private law and medical/biotechnology law. Her current research examines the relationship between collectivised social benefits and individualised harms, in the regulation of medical innovation and healthcare. She has a PhD in Molecular Medicine in addition to her legal qualifications, and has previously worked in medical research, health administration, and health policy.

Bibliography:

Professor Eva Hemmungs Wirten, ‘Patents as Scientific Information, 1895–2020’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/nin0btsorwM

Professor Jay Sanderson and Teddy Henriksen, ‘The Patent Dance: Biosimilars and the (Optional) Exchange of Information’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/LJJdIEFkOgE

Professor Uwe Dulleck, ‘Mapping the Global Influence of Published Research on Industry and Innovation’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/JrpIcsyD_RA

Dr Frances Humphries, ‘Patent Law and Marine Genetic Resources’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/s0Vtcl3cNo0

Professor Matthew Rimmer, ‘A Cartography of the 3D Printing Patent Landscape’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/3f0NuzhJQxc

Dr Bruce Baer Arnold, ‘The Information Machine is Broken: Life-Sciences Patents, Injury, Innovation and Social Licence’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/_LOxXGAHdDY

Tess Watson, ‘Bio-rights, Wetware and Bioethics — Intellectual Property in the Bioinformational Age’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/jbBs4gtZNHQ

Dr Wendy Bonython, ‘From the Population to the Personal: the Ethics of Market-driven Medical Innovation Regulation’, Patent Law and Scientific Information, QUT IP and Innovation Law Research Program, 9 July 2019, https://youtu.be/IVfuoRS8X34

Written by

Professor of Intellectual Property and Innovation Law, QUT. #Copyright #Patent #Trademark #plainpacks #Access2meds #SDGs #Climate #IndigenousIP #trade #TPP

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