Medical 3D printing, regulation and patent policy in China
- Principal Investigator: Dr Phoebe Li, University of Sussex
- Start Date: April 2015; End Date: March 2017
- Amount: £1,247
Summary of the Project:
3D printing is a fascinating disruptive technology which has unveiled the third industrial revolution by transforming traditional subtractive production methods into digital additive layer manufacturing (AM), by which a wide variety of ink made up with plastic, metal, glass, or even human biomaterials, can be used for computer-aided-design (CAD) manufacturing. The customisation of health products delivered by 3D printing increases the quality and efficiency in access to health technologies. It sketches a blueprint of digitisation for future healthcare delivery, particularly in personalised and/or regenerative medicine; yet, risks remain and approaches to regulation are dubious. Issues concerning intellectual property (IP) and equitable access are under-explored.
By distinguishing different levels of realisation in 3D printing, the project explored the implications on research and commercial terms. Bileta funding was used to support five stakeholder interviews in China in 2016, the outcome of which was drawn to reflect upon the contemporary patent and innovation policy. Research on Chinese IP policy has primarily focused on copyright and counterfeiting issues. There exists the distinct defence of an Asian Confucian approach to IP, yet such debates rarely extend to the realm of state innovation policy, development issues, and patent monopoly. This project is one of the few works that interprets the Chinese characteristics emerging in the new Patent Law, which is currently under the fourth amendment.
Key findings:
3D printing is a means for realising mass entrepreneurship and innovation is through fostering digital intelligent manufacturing. The Chinese Government is now keen to facilitate mass entrepreneurship and innovation by means of promoting the development of makerspaces in specific pilot sectors such as information, biotech, modern agriculture, high-end device manufacture, new energy, new materials, energy efficiency, and modern service industry. From the finding from my empirical work in China, small and medium enterprises (SMEs) still find it difficult to compete against big corporations in securing funding, and are also less resourceful in managing a healthy IP portfolio due to insufficient awareness or capacity to do so. IP is generally not recognised as an effective company asset. Some feel uneasy about applying patent monopolies on the knowledge taught by teachers”; others may use patent applications solely as a means of securing Government funding. In order to build the IP infrastructure for crowd and mass innovation, strategic considerations for fostering mass innovation is suggested to be given priority over corporate innovation. For example, customising the patent regime for SMEs in relation to patent application, licensing platforms, and mechanisms for maintaining rights.
Inventions developed from mass entrepreneurship and innovation are mostly incremental, and typically lower than the standard “novelty” requirement. The rise of aesthetic functional objects also blurs the traditional dichotomy between patents and copyright. The quick turn-around rate of consumer products does not fit neatly into the lengthy patent term. Therefore, in response to the above challenges posed on patents, alternative proposals for a differentiated patent regime should be considered by accommodating micro-patents, partial patents, quasi-patents and semi-patents, weakening patents that are tailored for mass innovation in the digital economy.
Outputs:
- Bileta’s generous support is acknowledged in a paper published in the WIPO Journal: Li, P. (2016) ‘Intellectual property and development: Patents, mass innovation and the xiaokang society, WIPO Journal 8(1) 97-108, available at: http://www.wipo.int/edocs/pubdocs/en/wipo_journal_wpj8n1.pdf
- Invited presentations: Li, P. (2016) Towards mass entrepreneurship and innovation: the case of 3D printing in healthcare delivery, School of Public Administration, April, Central South University, Changsha, China, http://csuspa.csu.edu.cn/html/201604/13/20160413221200.htm Li, P. (2015) Medical 3D printing, risk regulation, and intellectual property, Conference on Innovation and Communications Law, Xiamen, China
- Press coverage https://capturingthevalue.wordpress.com/2016/05/06/introducing-the-3dp-rdm-feasibility-studies-a-feasibility-study-of-mass-customisation-governance/
(period covered by initial application, although funding provided only to support one meeting, held in March 2016)
Amount: £300 awarded, £253.65 used
Summary of the project (maximum 500 words)
Delivery of sustainable and secure energy, and the contribution made to this by information, intellectual property (IP) and technology, are key issues for society. They can involve a wide range of laws – information control and freedom, IP, human rights, international trade and investment, competition, climate change and biodiversity. These exist largely in their own spheres with differing addressees and forms of enforcement and compliance; this can lead to decision making within legal silos, with different priorities applied, and to some regimes having more practical impact than others. The project explored this, notably the need for and basis of new arguments to require all decision makers to look widely, beyond what seems immediately relevant to them. This was done using as a base a case study, the starting point of which is a combination of anonymised actual events, and which was presented in the sustainability stream of BILETA 2015. The case study involves a UK company working in Scotland and which is part of an international group, biomass renewable energy, patents, privacy, smart systems, industry standards, constitutional law and international investment. The meeting also drew on the findings of a public engagement element held by the PI in Aberdeen in November 2015 as part of the AHRC Being Human Festival Careful What We Wish for?
A one day workshop was held in London in March 2016, attended by legal scholars (also with professional practical expertise) from Britain and Ireland. Some participants attended in person and some via SKYPE. Other experts, from the UK and throughout the world, also contributed to developing the project, case study, and approach of the meeting. Details of the contributions were shared with the project team in advance of the meeting. The travel costs of the PI and catering were covered with the BILETA funds and a room and technical support was kindly provided by the law firm Arnold Porter.
Key findings (maximum 500 words) It is expected that these will be presented at a BILETA conference.
There is indeed a need for decision makers to be able to look widely, outwith the immediate apparent base of the action and to limit the consequences of choosing a particular pathway. There are varying views, however, about the extent to which laws should and must still be left in their own boxes and the risk of conferring undue power on decision makers, particularly in the case of investment arbitration.
Uniformity in decision making is rarely desirable – but a holistic and informed approach is.
In encouraging decision makers to look widely, one must be wary of imposing an undue burden on decision makers, and introducing so many fields that one decision maker cannot be expert in them all, even with the support of additional training. The wide range of relevant fields identified in decision making (in addition to those initially put forward) support this
There is a limit on what can be done by law, and also by technology and regard must be had to this in framing solutions; influencing societal attitudes, through laws which may be criticised as less immediately effective such as human rights and sustainable development
In developing solutions, one must be wary of different scenarios, jurisdictions and values and of the risk of imposing solutions on others.
Outputs – including any evidence of impact (maximum 400 words) Please remember to credit BILETA on any related outputs.
A blog reporting on the funded meeting is available on the University of Aberdeen law school blog (May 2016): https://aberdeenunilaw.wordpress.com/2016/05/02/decision-making-across-the-information-technology-and-sustainability-landscape-towards-breadth-and-coherence-project-report/
Given the commitments of project team members it was considered not appropriate to proceed with a special edited collection of the IRLCT (a proposed output). The editor of the journal has been informed. Rather, it is proposed that the PI and one of the project team prepare a piece for publication in IRLCT in late 2016/early 2017.
One other possible output had been an article for a professional journal and the development of training for decision makers and for presentations at All Energy in Glasgow in 2016. The meeting outputs suggests that these activities would be premature although engagement with the profession, activists and industry remains a key goal of the project.
A key element of requiring wider regard to fields in decision making (and arguably through conferring greater power on courts) is through statutory interpretation. The PI is presenting a paper on this in the Intellectual Property stream of the Society of Legal Scholars in Oxford, 2016, which will draw on this project.
Final Comments (eg avenues for future research/acknowledgements/lessons learned)
The project findings will be the base for future research of the PI, and the base for a large research grant, possibly AHRC Leadership Fellow or ERC Consolidator Grant. This will explore three interlinked questions: (1) decision making and conflict; (2) foundations of legal regimes and the extent to which there is in fact conflict; (3) the contribution of exploring ultimate goals of legal regimes, rather than their foundation and detail. Future work will hopefully involve members of the wider project team, including those involved in the workshop:
Details of the project and its present position will be shared at the BILETA conference in 2017.
Privacy: Gathering insights from lawyers and technologists
- Principal Investigators: Dr. Maria Helen Murphy and Dr. Leighton Evans
- National University of Ireland, Maynooth
- Start Date: Jan 2015 End Date: July 2015
- Amount: £1160
Summary of the Project:
The technological infrastructure of the modern networked world constitutes a significant challenge to the law’s capacity to respond to contemporary circumstances and to communicate effectively with other critical disciplines engaged with the social, epistemological and ontological effects of this pervasive environment. While the importance of technological understanding has long been recognised in the law and policy sphere, recent developments have, once again, thrown the communication gap between lawyers, policy-makers, and technologists into sharp relief.
Representatives from each of these communities came together at Maynooth University on July 1 in order to formulate strategies to address this gap and foster increased collaboration across disciplines. A key goal of the event was to bring together a diverse group of experts and encourage open discussion. The final programme, included below, illustrates the diversity of the speakers in attendance. Such diversity and expertise was reflected in the composition of the audience.
Key findings:
The day was a significant success and demonstrated clear appetite amongst the various communities for increased interdisciplinary collaboration. As the core purpose of the event was to encourage open communication between a diverse group of experts with an interest in privacy, the decision was made to impose strict speaking times on panellists but provide ample discussion time. This approach proved successful as highly qualified audience members engaged in direct discussion with the panellists. Both panellists and attendees praised the expansive and inclusive discussion time as it enabled more direct questioning and communication than is often the norm at similar events. Multiple connections were made on the day and it is likely that several collaborative efforts will grow from these.
The topics of the two roundtables were chosen in order to explore key points of intersection between lawyers and technologists in the field of privacy.
The first roundtable, Privacy in a Digital World: Notions and Understandings of Privacy in a Digital Infrastructure, illustrated how both technologists and lawyers recognise the importance of open discussion and engagement with other relevant professions, but struggle to identify effective ways to address lack of fluency. A key take-away from the first roundtable was the need for better, and more integrated education. The introduction of compulsory ethics training for computer scientists was generally supported. The concept of privacy itself was challenged, and the theme of how privacy has been remediated as both a concept and a practice was a theme of the session. In addition, the attitudes of both the NSA and GCHQ towards privacy were critiqued through theory and a posteriori observations. The session emphasised that privacy as a concept is both shifting through the use of digital technologies and is approached very differently by different disciplines, but that open dialogues between disciplines are fruitful in creating understanding between disciplines.
The second roundtable, The Right to be Forgotten Demystified, aimed to address claims of technical impracticability and considered whether the Court of Justice of the European Union had acted appropriately in how it applied data protection law to the facts in the Mario Costeja Gonzalez decision. In our funding application, we identified a knowledge gap between the legal and technology communities on these issues. On the day of the event, however, it seemed clear that the expert groups in attendance had, to a large degree, remedied the disjuncture. The vibrant discussion that followed the panel certainly suggested this, as the debate that ensued was informed and highly specific. The discussion certainly met a key goal of our proposal, by encouraging cross-disciplinary discussion of the right to be forgotten. What was most telling, however, was how the debate did not linger over technical legal or technological points and instead focused on the question of norms and considered what was desirable from a societal perspective.
Outputs:
– A project website (including repository and recordings from the event) has been established . The Bileta logo is prominent on the site.
– In addition to trending on Twitter in Ireland, the event attracted significant press coverage
– Karlin Lillington, Google committed to transparency on user access to personal data The Irish Times 2 July 2015
– Ronan Leonard, The right to be forgotten Irish Tech News 7 July 2015
– Erin McGuire, Data commissioner eyes up improvement in an ever-changing world Irish Times 13 July 2015 .
– Maynooth University, Privacy Law Event a Big Success 3 July 2015 .
Final Comments:
The investigators would like to thank Bileta for the generous support and funding they received. It is hoped that the project website will facilitate future collaboration. A repository of useful resources has been compiled and the organisers will continue to curate this resource into the future.
Principal Investigator: Dr Abbe E. L. Brown Aberdeen University Start Date: Dec 2015 End Date: March 2016 Amount: £300 awarded, £253.65 used
Summary of the Project:
Delivery of sustainable and secure energy, and the contribution made to this by information, intellectual property (IP) and technology, are key issues for society. They can involve a wide range of laws, information control and freedom, IP, human rights, international trade and investment, competition, climate change and biodiversity. These exist largely in their own spheres with differing addressees and forms of enforcement and compliance; this can lead to decision making within legal silos, with different priorities applied, and to some regimes having more practical impact than others. The project explored this, notably the need for and basis of new arguments to require all decision makers to look widely, beyond what seems immediately relevant to them. This was done using as a base a case study, the starting point of which is a combination of anonymised actual events, and which was presented in the sustainability stream of BILETA 2015. The case study involves a UK company working in Scotland and which is part of an international group, biomass renewable energy, patents, privacy, smart systems, industry standards, constitutional law and international investment. The meeting also drew on the findings of a public engagement element held by the PI in Aberdeen in November 2015 as part of the AHRC Being Human Festival Careful What We Wish for?.
A one day workshop was held in London in March 2016, attended by legal scholars (also with professional practical expertise) from Britain and Ireland. Some participants attended in person and some via SKYPE. Other experts, from the UK and throughout the world, also contributed to developing the project, case study, and approach of the meeting. Details of the contributions were shared with the project team in advance of the meeting. The travel costs of the PI and catering were covered with the BILETA funds and a room and technical support was kindly provided by the law firm Arnold Porter.
Key findings:
There is indeed a need for decision makers to be able to look widely, outwith the immediate apparent base of the action and to limit the consequences of choosing a particular pathway. There are varying views, however, about the extent to which laws should and must still be left in their own boxes and the risk of conferring undue power on decision makers, particularly in the case of investment arbitration.
Uniformity in decision making is rarely desirable, but a holistic and informed approach is.
In encouraging decision makers to look widely, one must be wary of imposing an undue burden on decision makers, and introducing so many fields that one decision maker cannot be expert in them all, even with the support of additional training. The wide range of relevant fields identified in decision making (in addition to those initially put forward) support this.
There is a limit on what can be done by law, and also by technology and regard must be had to this in framing solutions; influencing societal attitudes, through laws which may be criticised as less immediately effective such as human rights and sustainable development
In developing solutions, one must be wary of different scenarios, jurisdictions and values and of the risk of imposing solutions on others.
Outputs:
A blog reporting on the funded meeting is available on the University of Aberdeen law school blog (May 2016): https://aberdeenunilaw.wordpress.com/2016/05/02/decision-making-across-the-information-technology-and-sustainability-landscape-towards-breadth-and-coherence-project-report/
Given the commitments of project team members it was considered not appropriate to proceed with a special edited collection of the IRLCT (a proposed output). The editor of the journal has been informed. Rather, it is proposed that the PI and one of the project team prepare a piece for publication in IRLCT in late 2016/early 2017.
One other possible output had been an article for a professional journal and the development of training for decision makers and for presentations at All Energy in Glasgow in 2016. The meeting outputs suggests that these activities would be premature although engagement with the profession, activists and industry remains a key goal of the project.
A key element of requiring wider regard to fields in decision making (and arguably through conferring greater power on courts) is through statutory interpretation. The PI is presenting a paper on this in the Intellectual Property stream of the Society of Legal Scholars in Oxford, 2016, which will draw on this project.
Final Comments:
The project findings will be the base for future research of the PI, and the base for a large research grant, possibly AHRC Leadership Fellow or ERC Consolidator Grant. This will explore three interlinked questions: (1) decision making and conflict; (2) foundations of legal regimes and the extent to which there is in fact conflict; (3) the contribution of exploring ultimate goals of legal regimes, rather than their foundation and detail. Future work will hopefully involve members of the wider project team, including those involved in the workshop:
Details of the project and its present position will be shared at the BILETA conference in 2017.
