QUT Intellectual Property and Innovation Law Research Program

11 December 2017

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Bioprinting Regulation, QUT, 11 December 2017, https://www.eventbrite.com.au/e/20171211-ipil-workshop-bioprinting-regulation-tickets-39539306129

Date: Monday 11 December 2017
When: 9.00am — 4.30pm
Venue: Seminar Room, KG-Z9–607
QUT Kelvin Grove Campus,
Victoria Park Road, Kelvin Grove

About the Event

3D printing, Bioprinting, and additive manufacturing promise to revolutionise healthcare, medicine, and surgery. There have been high hopes that the field will result in the next industrial revolution. Governments have invested in makerspaces, fab labs, incubators, and accelerators in order to encourage innovation in the area.

Nonetheless, this disruptive technology poses a range of legal, ethical, and regulatory challenges. There has been a debate about the regulation of 3D printing by food and health regulators. There has been emerging conflicts in the field of intellectual property over 3D printing, bioprinting, and additive manufacturing. Moreover, there have been larger issues in respect of product liability and 3D printing.

3D printing raises larger questions about the relationship between creativity, art, design, and science. There has been much interest in the role of 3D printing in education. 3D printing and bioprinting have also featured in popular culture — from Westworld to Ghost in the Shell.

This research workshop brings together an interdisciplinary range of researchers from science, law, geography, history and art to consider the various dimensions of bioprinting. The event hopes to raise public policy questions about the regulation of 3D printing, bioprinting, and additive manufacturing. The event will provide practical recommendations about intellectual property management and regulation to bioprinting researchers, scientists, and engineers.

Speakers

Patentability and Bioprinting: Where to From Here?

Professor Dianne Nicol, University of Tasmania

Dr Jane Nielsen, University of Tasmania

Abstract: As research into bioprinting products and processes continues to progress, questions arise as to how we balance incentive and access, the perennial problem in the innovation sphere. Inventors in this space are likely to seek patents to protect their inventions, and reap benefits from their investments. Patents are invaluable for protecting inventions that comprise patentable subject matter, are new, useful and contain an inventive step. Many bioprinting inventions might fulfil these criteria, but the reality is that patents are expensive to apply for and maintain. In the bioprinting world where a major benefit is customised production, patents over methods will predominate. Patents over bioprinted products are less likely to be useful because of the tendency toward bespoke rather than mass produced products. The level of specificity required in patent claims means that claims for each bioprinted product will differ sufficiently that they are effectively different products.

Recent case law has demonstrated that courts have grappled with whether patents over innovative methods constitute patentable subject matter. The jurisprudence in question crosses disciplinary boundaries and there is recent case law in the areas of biomedicine, information technology and methods of medical treatment that will potentially impact on the patentability of biomedical inventions. It includes cases such as D’Arcy v Myriad Genetics and its US counterpart, Mayo v Prometheus, Ariosa v Sequenon, Alice v CLS Bank and Apotex v Sanofi-Aventis. This paper will briefly consider this case law, and attempt to draw some conclusions as to when bioprinting methods will satisfy the patentable subject matter requirement.

Given that the patentability of bioprinting methods is likely to be contentious, it is not out of the question that the exclusion of certain methods used in the treatment of human beings, might be contemplated in Australia. International IP legislation provides for such an exclusion, and the question that arises should such an exclusion be contemplated, is its potential scope and applicability to bioprinting methods. This paper argues that a better approach would be to consider whether perceived access barriers to the technology might be better addressed through exemptions to patentability, like the experimental use exemption, or a therapeutic exception to infringement, such as that which operates in the US. The way in which these exemptions to infringement might operate in practice will be considered in this paper.

Patentability and Bioprinting: Where to From Here? Professor Dianne Nicol and Dr Jane Nielsen https://www.youtube.com/watch?v=rtH0-uKnwGM

Hospitals of the Future: Bioprinting, Intellectual Property, Innovation Law and Public Health

Professor Matthew Rimmer, QUT

Abstract: This paper will consider the topic of intellectual property and bioprinting. It will examine the public policy issues raised in respect of intellectual property and bioprinting. In terms of patentable subject matter, there has been concern of late in the judiciary about the limits of what is patentable. This study will consider the position of bioprinting — in light of recent rulings of the Supreme Court of the United States and the High Court of Australian in respect of eligible patentable subject matter in a string of cases. The project will chart the landscape for patents in respect of bioprinting. In particular, it will focus upon leaders in the field — such as Organovo Inc., Koninklijke Philips, Wake Forest University, Hewlett-Packard, the University of Texas, Medprin Regenerative Medical Technologies Co Ltd, and Corning Incorporated. This data analysis will look at the databases of the World Intellectual Property Organization, IP Australia, the United States Patent and Trademark Office, the European Patent Office, and the Japanese Patent Office. The study will seek to illuminate patent trends in the field. Moreover, it will seek to analyse patent thickets and white spaces in the field of bioprinting. This will be of considerable importance in determining the freedom to operate for researchers and scientists working in the field. 3D printing and bioprinting also raises larger questions about the nature of patent infringement, and the role and scope of patent exceptions. There has been interest in public licensing, patent pools, and open innovation in respect of bioprinting. The historical conflicts over access to essential medicines also highlight the need to consider questions in respect of intellectual property, bioprinting, and public health. This paper was also consider the relevance of other fields of intellectual property — most notably, there has been a trademark conflict over BioBots. This paper will also investigate the intersection between intellectual property, regulation, innovation law, and public health.

Hospitals of the Future: Bioprinting, Intellectual Property, Innovation Law and Public Health — Professor Matthew Rimmer https://youtu.be/Joy1s6RDP4U

Talking to experts: what we are learning about medical 3D printing, regulation and innovation from 3DPIP Futures workshops

Dr Angela Daly, QUT

Abstract: This presentation will present some initial findings from the UK IPO-funded 3DPIPFutures project. We have been conducting innovative horizon-scanning workshops with 3D printing industry and ecosystem stakeholders in a number of countries during 2017 in order to understand the state of 3D printing in that location, interactions with the IP system and possible future outlooks for the relationship between 3D printing and IP. Alongside these questions, focus group participants have pointed to broader issues for the relationship between 3D printing in the medical field and law, as well as how different cultural norms may influence applications of the technology and may present barriers to take-up­­­­­­­­­­.

Talking to Experts: What We Are Learning from 3D Printing IP Futures Workshops — Dr Angela Daly https://youtu.be/zlsrkdor7NI

3D Printing and Development

Dr Thomas Birtchnell, University of Wollongong

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Abstract: In this presentation I give attention to various actors relevant to the technologies, designs, Intellectual Property, materials, and infrastructures of 3D printing: its innovation ecosystem. These actors are dubbed in this presentation ‘indicators’ and ‘forerunners’ because they give a guide to how this niche innovation might scale up to become socially significant and even ubiquitous. From a 3D printing ‘go-to-guy’ to an not-for-profit entrepreneurial venture to turn stone powder into jewellery, the case studies in this presentation draw on insights from research in the global South.­­­­­­­­­­

3D Printing — Food Safety and Regulation

Dr Hope Johnson, QUT

Abstract: From increasing access to farming tools to improving food supply stability following natural disasters, 3D-printing food poses several opportunities for addressing current challenges facing food systems. This presentation begins with a pragmatic analysis of the contributions 3D-printing technologies could make to the converging challenges facing food systems. Of these contributions, this presentation argues that the development of synthetic meat using 3D-printing technologies is the optimal technological trajectory for 3D-printed food. This presentation outlines the potential drivers and counter-forces to the development of synthetic meat, which are likely to influence acceptability of 3D-printed synthetic meats, as well as how such products and processes are regulated. To capture the benefits of 3D-printed, synthetic meat, regulatory actors in Australia and internationally will need to undertake significant regulatory review and reform. This presentation briefly maps the implications of 3D printed, synthetic meat for intellectual property and food labeling laws as well as the regulatory standards across meat processing and importation. To conclude, this presentation outlines complementary alternatives to synthetic meat that already exist, but are less consistent with the dominant technological paradigm for food systems.

Bioprinting: Development and Sustainability — Dr Hope Johnson https://youtu.be/e8sBDxprDFc

Immortal Selves: Biofabrication at the Intersection of Art and Science

Svenja Kratz, University of Tasmania

Abstract: In this presentation, Svenja Kratz provides insight into the critical and creative potentials of cross-disciplinary art and science engagements. Using her research interests and creative work as a springboard for discussion, she provides insight into the development of her practice from early engagements within the area of cell and tissue culture, to more recent engagements with 3D scanning and biofabrication processes. In particular, the presentation provides an overview of the collaborative Biosynthetic Systems project developed in partnership with the Centre for Regenerative Medicine at QUT. Engaging speculatively with the concept of immortality through technological intervention, the project is designed to highlight the potentials of 21st century biomedical sciences and invite viewers to consider the creative applications of the Centre’s research and contemplate the possibilities, and philosophical implications, of living engineered systems and mergers of artificial life and biotechnology.

Immortal Selves: Biofabrication at the Intersection of Art and Science — Dr Svenja Kratz https://youtu.be/aA2IzNaj8hg

Speculative Biology: Cultural Perspectives on Biofabrication and Bioprinting

Associate Professor Elizabeth Stephens, University of Queensland

Abstract: SymbioticA, the Centre for Biological Arts at UWA, will consider the cultural impact of recent work in speculative biology and design. The last decade has seen an increasing number of experimental fields in which biological materials are re-engineered as technical objects, and in which technical objects are designed with integrated organic components. The result is the emergence of a whole new class, or perhaps species, of things: what Oron Catts and Ionat Zurr have called “semi-living” machines and “partially alive” organisms. These new hybrid bio-technological entities problematize the distinction between the living and non-living, and thus raise a number of important philosophical and political questions. Most urgently: how must our current understanding of biopolitics and bioethics be reconfigured in light of this transformation of the category of the “bio” itself? And how is the general public to understand the significance of these new hybrid objects? Such challenges and questions provide an important cultural space in which the commercial, critical and creative potential of art-science engagements comes to the fore.

Speculative Biology: Cultural Perspectives on Biofabrication and Bioprinting — Associate Professor Elizabeth Stephens https://youtu.be/D5oIHOtsd5A

The Science of Bioprinting

Naomi Paxton, QUT and University of Würzburg, Felix Wunner, QUT, Jo Maartens, QUT

The Science of Bioprinting — Naomi Paxton, Felix Wunner and Jo Maartens https://youtu.be/bNRl7ui9TB4

Naomi Paxton

PhD student, QUT and University of Würzburg

Printability of Shear-Thinning Hydrogels for 3D Bioprinting

Extrusion-based 3D bioprinting systems have seen a surge in popularity as a biofabrication technique due to their ability to fabricate a wide range of biomaterials in cell-friendly conditions. However, despite their widespread success, the factors influencing ‘printability’ of shear thinning materials, including many hydrogel systems, has yet to be well understood. Here, a ‘printable’ material is defined as that which can be successfully extruded within the range of printing pressures, collector plate velocities and needle sizes available for a specific bioprinting system, known as the ‘bioprinting window’. Printability is therefore strongly influenced by a material’s rheological properties and the degree of shear thinning exhibited can be quantified using rheological measurements of a material’s shear rate-viscosity plot. In this study, a series of mathematical equations were developed to predict the pressure-driven flow of hydrogels through bioprinting needles within the ‘bioprinting window’, the realistic operational limits of bioprinters. Furthermore, the effects of various printing parameters were investigated theoretically and experimentally to provide a useful insight into fibre diameter control for the fabrication of stable 3D structures. Finally, by calculating the shear rate experienced by the materials during extrusion, trends in the viscosity profile of printable materials were investigated. Four hydrogels were used to test this model, both theoretically and experimentally, including pluronic, sodium alginate, alginate-gelatin blend and Nivea Crème, as examples of widely-used, biocompatible, thermoresponsive and colloidal materials respectively. Overall, this study provides a useful tool for examining the printability of hydrogels for 3D bioprinting applications.

Felix Wunner

PhD student, QUT

Design and development of an additive manufacturing technology platform for melt electrospinning writing

The introduction of 3D printing principles to traditional fibre fabrication processes in 2011 is in a pioneering role at the vanguard of medical innovations and its effectiveness is increasingly evidenced for applications in the fields of additive biomanufacturing. Referred to as Melt Electrospinning Writing, this technological symbiosis is built on the functional benefits from both of its predecessors, namely additive manufacturing and electrospinning: high accuracy in material deposition and the capability of printing dimensions in the lower micron scale. The resulting highly porous architectures, electrostatically fabricated from biocompatible polymers, are implemented to effectively promote cell infiltration, proliferation and attachment in the field of tissue engineering or a cell culture lattices for T-cells. Within the last years, the exponential growths of published work and patent applications evidenced the enormous potential of MEW to become a standardised technology in the medical fields; yet additionally offers high potential for applications in the filtration, energy or textile industries.

The research area for MEW, however is still in its infancy and the major focus consisted in exploring the benefits of the resulting scaffolds/lattices, while bypassing the essentials of developing highly functional devices to gain reproducible results. From an engineering perspective, it became an inevitable milestone to reach a stable process with a high degree of control. Beyond that, this constitutes the most important prerequisite for transferring the process to industrial levels.

Therefore, this PhD project hypothesises that the application of systematic engineering methodologies assists in designing a technology platform to foster process control, reproducibility, and up-scale. The implementation of an automated monitoring and parameter control system is used to generate large data volumes which enable the identification of the optimum parameter settings for any given design. In particular, we draw a conclusion between the geometry of a fibre flight path and the quality of the final scaffold, which helps to assess from a manufacturing point of view the robustness and reproducibility of a process. Additionally, the novel hardware facilitates to increase the achievable scaffold fabrication height of 2–3 mm to 7 mm and helped to identify the influence of gravity on the process. In the last phase of this PhD project, the results and technologies are utilised to design and develop a large scale high-throughput MEW printer, which meets the requirements for industrial applications.

Jo Maartens

PhD student, QUT

Challenges and opportunities in the manufacture and expansion of cells for therapy

Cell therapy is poised to transit from proof-of-principle studies toward clinical validation and, ultimately, standardization, paving the way for next-generation of personalized medicine. If cells are to be used routinely for clinical or drug discovery applications, they need to be produced at an affordable cost of goods. This implies scaling up the labour intensive production of cells to a commercially viable level while optimising on the use of costly media and growth factors. Given these limitations, it is likely that manufacturing methodologies should include some elements of automation. This fact is strengthened by the growing market demand for cell quantities and therefore a concomitant step change in industrial manufacturing methods is required.

Unsurprisingly, the legacy laboratory-based ex vivo cell culture methods are notoriously expensive as a result of a combination of factors such as the high costs associated with the production of cells at high densities and in large volumes in cleanroom facilities, and the lack of automated cell culture methods, which still rely on manual pipetting and thus require a large number of highly trained technicians. Classical laboratory-based methods are very seldom subjected to optimisation for the purposes of maximising the processes underpinning cell yields and minimising the use of expensive reagents. An additional obstacle for cell-based products that are largely manual in their manufacturing processes, is meeting the regulatory requirements of process validation, quality control and reproducibility which is extremely difficult to achieve.

Applying Quality-by-Design (QbD) principles in the cell therapy industry in general and for cell therapy products in particular poses challenges at multiple levels. Given the complexity of interactions between cells and their environment it remains challenging to develop a high level of confidence in a design space for complex cell therapy systems. Design of Experiments (DOE) and systems modelling are complementary tools and a valuable adjunct to QbD and will be used to study the relationships between factors such as critical process parameters and outcomes of cell expansion such as cell purity, identity and potency. It is envisaged that employing techniques within the suite of DOE approaches will facilitate better understanding of the process which is the “product”. We hypothesise that “a combined quality-by-design / systems engineering approach facilitates a more efficient pathway to study proof-of-principle cell therapy scale-up concepts”. This will pave the way for modelling the system architecture for the proposed cell expansion framework.

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