- Health Legislation: Devolution, Reservation and Derogation
Murray Earle, pp.1-4
- The Intellectual Property Implications of Low-Cost 3D Printing
Simon Bradshaw, Adrian Bowyer and Patrick Haufe, pp.5-31
In the late 1970s 3D printing started to become established as a manufacturing technology. Thirty years on the cost of 3D printing machines is falling to the point where private individuals in the developed world may easily own them. They allow anyone to print complicated engineering parts entirely automatically from design files that it is straightforward to share over the Internet. However, although the widespread use of 3D printers may well have both economic and environmental advantages over conventional methods of manufacturing and distributing goods, there may be concerns that such use could be constrained by the operation of intellectual property (IP) law.
This paper examines existing IP legislation and case law in the contexts of the possible wide take-up of this technology by both small firms and private individuals. It splits this examination into five areas: copyright, design protection, patents, trade marks, and passing off. Reassuringly, and perhaps surprisingly, it is concluded that – within the UK at least – private 3D printer owners making items for personal use and not for gain are exempt from the vast majority of IP constraints, and that commercial users, though more restricted, are less so than might be imagined.
- Knowledge Management and the Contextualisation of Intellectual Property Rights in Innovation Systems
David Castle, Peter W.B. Phillips, Abbe Brown, Keith Culver, Daniela Castrataro, Tania Bubela, Shawn H.E. Harmon, Graham Dutfield and Patricia Barclay, pp.32-50
Intellectual property rights play a central role in biotechnology innovation. Patents, in particular, preoccupy research funding agencies, venture capitalists and governments, despite the fact that the value of patents is disputed and their impact continues to foster controversy. Perhaps more crucially to a fuller understanding of innovation, focus on instruments of intellectual property protection over-illuminates one stage of the flow of knowledge in innovation, leaving up- and down-stream phases in relative obscurity. Knowledge is an intangible asset, and is produced, tracked, managed, and accounted for in innovation systems. Yet what remains unclear, and this is problematic, are the respective roles of knowledge and intellectual property management, their relation, and the potential of a broadened perspective on knowledge flows in innovation. Participants at a Canada-U.K. workshop in Edinburgh examined the relationship between intellectual property rights and knowledge management by framing innovation in terms of knowledge management while attempting to bracket off the effects of patenting – the “Un-IP” approach. Eight critical issues arising at the heart of knowledge management and intellectual property rights were articulated, and general consensus emerged that, conceptually speaking, intellectual property rights needed to be subsumed under knowledge management as a particular class of intangible asset. At the same time, however, practical issues associated with patents continued to dominate the discussion, causing deviation away from the primary theme of the workshop, and highlighting the need to more fully explore eight emerging themes and contextualise the role of intellectual property rights.
- The Right to Anonymous Association in Cyberspace: US Legal Protection for Anonymity in Name, in Face, and in Action
Minjeong Kim, pp.51-70
The Internet has become a communication medium of intense group interaction, and individuals with marginalised identities have used anonymity as a tool with which to participate in online interaction. In order to capture the full spectrum of the role that anonymity plays in cyberspace, I explore in this article the US constitutional right to anonymous association. I draw on the concepts of anonymity defined in the social science literature — identity protection, visual anonymity, and action anonymity — and analyse US case law regarding the right to anonymous association in both offline and online worlds. The examination suggests that (1) the right to anonymous association has been especially meaningful for those who are marginalised in society; (2) future courts — in light of established legal rules governing the right to anonymous association — must give careful consideration to the question as to who is seeking anonymity; (3) different concepts of anonymity have greater independence in cyberspace and, therefore, need to be distinguished by scholars and courts. Overall, the right to anonymous association in cyberspace can be understood as the positive right of individuals to control information about themselves in order to find and associate with others. The examined case law shows that strong support for such a right is embedded in the US legal tradition.
- The Need for Italian Biobank Regulation
Elisa Stefanini, pp.71-82
There is no general legal framework applicable to biobanks for scientific research in Italy. Some of the most important issues are not addressed by Italian legislation, such as, informed consent issue with particular reference to research carried out on human tissue samples and the legal status of samples stored in biobanks. The only applicable regulation is the General Authorisation for the processing of genetic data issued by the Italian Data Protection Authority, which does not distinguish between genetic data and human samples since the latter are considered only in their informational dimension, as genetic data containers. This situation creates uncertainty which affects research. Therefore, a systematic regulatory framework able to support genetic research starting from basic concepts and definitions is especially needed in Italy.
[This article was presented at the SCRIPTed “Governance of New Technologies” conference held in Edinburgh on 29-31 March 2009.]
- Assessing the Morality of the Commercial Exploitation of Inventions Concerning Uses of Human Embryos and the Relevance of Moral Complicity: Comments on the EPO’s WARF Decision
Sigrid Sterckx and Julian Cockbain, pp.83-103
In late 2008, the Enlarged Board of Appeal of the European Patent Office (EPO) reached a decision supporting the rejection of a patent application on human embryonic stem cells filed by the Wisconsin Alumni Research Foundation (WARF). This article comments on some of the shortcomings of the decision. The key legal provisions at issue in this case were Rule 28(c) EPC, which forbids the granting of patents in respect of biotechnological inventions which concern uses of human embryos for industrial or commercial purposes, and Article 53(a) EPC, the morality provision of the European Patent Convention. The Board rightly found the Rule to exclude WARF’s claims (but, we argue, left a “deposit loophole”). However, one of the issues the Board had to address was whether the Rule might not apply because it extended the scope of prohibited subject matter beyond that prohibited by the Article. We argue that, unless the Article had been found to exclude patentability, the applicability of the Rule could not be determined. Even though at the oral hearing before the Board, both WARF and the EPO President identified the question whether the Article (the morality provision) constituted a barrier to patentability as the core issue in this case, the Board astonishingly decided that this question did not need answering (even though the Board did hint at the basis for the answer). We argue that this is a major shortcoming of the decision. Finally, we comment on the relevance of moral complicity to the question of patentability.
- Creating an Innovation Exception? Copyright Law as the Infrastructure for Innovation
Dilan Thampapillai, pp.104-134
Innovation is clearly essential for economic growth, cultural development and personal autonomy. Yet the relationship between innovation and copyright law in Australia is uncertain and perhaps overly restrictive. After the Australia-United States Free Trade Agreement Australia now has a copyright regime that can broadly be described as a lock up and lock out scheme. Whilst the Australian Government has paid lip service to innovation the Australian Copyright Act, which provides the essential legal infrastructure for innovation, now privileges the rights of owners over the interests of the public. In particular, the Copyright Act neglects to create a specific exception for technology innovation. If there is to be some coherence in Australia thinking with regards to innovation and copyright policy it is crucial that such an exception be created. Arguably, it is possible that such an exception can withstand the scrutiny of the three step test. At present the only ‘exception’ that can be said to exist is in the form of the limits of the authorisation liability provisions or the ISP safe harbour scheme. Australian copyright law needs something more substantial than that and needs for there to be a clear hierarchy between the exceptions and the liability provisions.
- Compulsory Licensing Provision under TRIPS: A Study of Roche vs Natco Case in India vis-à-vis the Applicability of the Principle of Audi Alteram Partem
Swarup Kumar, pp.135-154
In keeping with the relatively new waiver of the requirement of domestic production under Article 31(f) of TRIPS, the Indian Patents Act 1970 was amended allowing for compulsory license in certain exceptional circumstances.
Unlike in other sections relating to compulsory licensing in the Indian Patent Act, there is no reference to a patentee being extended the “opportunity of being heard”. This appears surprising since it is the generic version of patentee’s patented drug which is intended to be manufactured and exported to other countries by a third party. Despite this exclusion, the Indian Controller in the relatively recent Roche vs Natco compulsory licensing case upheld the merit of one of the basic tenets of common law, i.e. no one’s interest should be prejudiced without such person being provided with an opportunity of presenting his or her case. In fact, the Controller held that, besides it being fair that the party whose interest is at stake be heard, the submissions of such parties could be of extreme value in arriving at a decision regarding the terms and conditions of grant of a compulsory license.
This article enquires whether giving a plain or literal interpretation to a relatively unambiguous statute is all that is expected from an adjudicating authority, or whether it is equally important for such authority to give effect to the cardinal principle of audi alteram partem as far as a patentee when such interpretation could yield results liable to be construed ultra vires the primary intention of the amended provision.
- Opt-in Dystopias
Nicklas Lundblad and Betsy Masiello, pp.155-165
This paper examines the possible consequences of mandatory opt-in policies for application service providers on the Internet. Our claim is that focusing the privacy debate on the opt-in / opt-out dichotomy creates false choices for end users. Instead, we argue for a structure in which providers are encouraged to create ongoing negotiations with their users.
- Countdown 2010, All Eyes on Oryza: The Current Access and Benefits-Sharing Provisions of International Instruments Will Keep the 2010 Biodiversity Target Out of Reach
Blake M. Mensing, pp.166-184
The 2010 Biodiversity Target, which aims to significantly reduce the rate of biodiversity loss, will not be achieved. The Convention on Biological Diversity (“CBD”) and the International Treaty on Plant Genetic Resources for Food and Agriculture (“ITPGR”) lack strong enough access and benefit-sharing (“ABS”) provisions to facilitate the transfer of high yield seed varieties that have the potential to protect biodiversity. This article presents the historical origins of the CBD and its ABS provisions, as well as an outline of the ITPGR’s ABS system. High yield seeds can reduce the land needed for agriculture, which holds great potential for habitat preservation and the conservation of terrestrial species. The CBD and ITPGR need to be revised so that they may work in better harmony in regard to intellectual property rights. Harmonisation of the treatment of intellectual property rights in the plant genetic resources context is the first step in facilitating faster transfers of high yield seed varieties.
- The Online Public or Cybercitizen
Andrew Power, pp.185-195
As both citizens and the state increasingly use online mediated environments, the nature of the public and thus public law has changed. As individuals and state actors use avatars as their online representatives in virtual environments, the notion of the cybercitizen is growing in importance.
In these environments, rules, protocols and acceptable behaviours exist amongst participants and are no less respected by the community they affect for their current lack of legal status. As governments move more of their activities online the state is recognising and legitimising a new public, or at least a new expression of public.
This paper looks at examples of the application of law to this new constituency and seeks to examine different ideas of identity and governance in an online mediated environment. It seeks to answer the question of whether the public can have coherent, congruent meanings across disparate areas of law, and to broaden the understanding of cyberlaw.
- In Case of Emergency Only: The Difficult Role of Ethics in Small Biotechnological Companies
Michael Steinmann and Thomas Potthast, pp.196-203
The paper concerns the role of biomedical ethics in the process of product development in small start-up companies in the field of tissue engineering. It is based on two surveys sent to companies and research institutions in this field. The role of ethics – as a systematic reflection on the moral dimension of human practice – still seems very unclear, both for companies and for parts of the research community. Appeals to ethics are used only in case of emergency, when ethical concerns are strong enough to provide a serious obstacle to product development. In all other cases companies seem to disregard the need for ethical reflection. They claim to be fully informed about ethical questions, and express no need for further discussion. The problems that start-up companies face, however – which they tend to attribute only to technical, economic or legal causes – have to be seen at least partially as ethical problems. In the case of the acceptance of tissue engineered products by the larger public, ethical reflection is necessary for the assessment of the legitimate interests of all stakeholders, and to determine how these can be best accommodated in the translational process. Ethics should be seen as a tool that accompanies and guides technological innovations from their very first planning stage to their practical application.
- The Health Law Institute
Tracey M Bailey, pp.204-209
- Report on the Technoscience and Regulation Research Unit (TRRU) and the Qualitative Research Commons and Studio (QuRCS)
Emily Uhrig, pp.210-215
- Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement
By Margaret Sleeboom-Faulkner (Editor)
Reviewed by Don Chalmers, pp.216-220
- Indigenous Rights and United Nations Standards: Self-Determination, Culture and Land
By Alexandra Xanthaki
Reviewed by Marcus Goffe, pp.221-225
- The Body In Bioethics
By Alastair V Campbell
Reviewed by Shawn H.E. Harmon, pp.226-229
- Gene Cartels: Biotech Patents in The Age of Free Trade
By Luigi Palombi
Reviewed by David Koepsell, pp.230-231
- Reputation, Celebrity and Defamation Law
By David Rolph
Reviewed by Lawrence McNamara, pp.232-235
- Law, Mind And Brain
By Michael Freeman and Oliver R Goodenough (eds)
Reviewed by Dennis Patterson, pp.236-241