| Cover |
- Biodiversity Lost
Shawn H.E. Harmon
While the UN has celebrated (and focused attention on the importance of)
biodiversity by designating 2010 as the Year of Biodiversity, this piece
laments the loss of biodiversity, depicting a pallid frog before a tropical
background that is fading away. It was done with pen and ink, colour pencil
and Adobe Photoshop.
|
| Editorial |
- Health Legislation: Devolution, Reservation and Derogation
Murray Earle, pp.1-4
| HTML | DOC | PDF |
|
| Reviewed Articles |
- The Intellectual Property
Implications of Low-Cost 3D Printing
Simon Bradshaw, Adrian Bowyer and Patrick Haufe, pp.5-31
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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.
|
| Analysis |
- Compulsory Licensing Provision under TRIPS: A Study of
Roche vs Natco Case in India vis-ŕ-vis the Applicability of the
Principle of Audi Alteram Partem
Swarup Kumar, pp.135-154
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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
| HTML | DOC | PDF |
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.
|
| Reports |
- The Health Law Institute
Tracey M Bailey, pp.204-209
| HTML | DOC | PDF |
- Report on the Technoscience and Regulation Research Unit
(TRRU) and the Qualitative Research Commons and Studio (QuRCS)
Emily Uhrig, pp.210-215
| HTML | DOC | PDF |
|
| Book Reviews |
- Human Genetic Biobanks in Asia: Politics of Trust and
Scientific Advancement
By Margaret Sleeboom-Faulkner (Editor)
Reviewed by Don Chalmers, pp.216-220
| HTML | DOC | PDF |
- Indigenous Rights and United Nations Standards:
Self-Determination, Culture and Land
By Alexandra Xanthaki
Reviewed by Marcus Goffe, pp.221-225
| HTML | DOC | PDF |
- The Body In Bioethics
By Alastair V Campbell
Reviewed by Shawn H.E. Harmon, pp.226-229
| HTML | DOC | PDF |
- Gene Cartels: Biotech Patents in The Age of Free Trade
By Luigi Palombi
Reviewed by David Koepsell, pp.230-231
| HTML | DOC | PDF |
- Reputation, Celebrity and Defamation Law
By David Rolph
Reviewed by Lawrence McNamara, pp.232-235
| HTML | DOC | PDF |
- Law, Mind And Brain
By Michael Freeman and Oliver R Goodenough (eds)
Reviewed by Dennis Patterson, pp.236-241
| HTML | DOC | PDF |
|
| |
|
