The room for ethical considerations in patent law applied to biotechnology

Date01 November 2017
AuthorMorten Walløe Tvedt,Ellen‐Marie Forsberg
DOIhttp://doi.org/10.1111/jwip.12087
Published date01 November 2017
DOI: 10.1111/jwip.12087
ORIGINAL ARTICLE
The room for ethical considerations in patent law
applied to biotechnology
Morten Walløe Tvedt
1
|
Ellen-Marie Forsberg
2
1
Fridtjof Nansen Institute (FNI), Oslo, Norway
2
Oslo and Akershus University College (HiOA), Work Research Institute, Research Group on Responsible Innovation, Oslo,
Norway
Correspondence
Morten Walløe Tvedt, Fridtjof Nansen
Institute (FNI), P.O. Box 326, 1326 Lysaker,
Oslo, Norway.
Email: mwt@fni.no
Funding information
Research Council of Norway's ELSA program,
Grant number: 220609/O70
Since the adv ent of the so-c alled patents on lifedebate
there have been frequent calls for patent policy to take into
account ethical concerns over and above the ethically
relevant justifications for issuing patents generally. The
degree to which the patent system is respondent to including
these ethical concerns varies. Ethical arguments frequently
encounter attitudes within the patent system that ethics has
little to do with patenting and that ethical issues concerning
biotechnology must be regulated in other areas of society
than in IPR law and practice. In this article, we explore the
room for ethical considerations in patent law-making, and
show that there is limited ability or will to use this room in
practice. We explore global, European and Norwegian
institutions and illustrate our point by looking at law-making,
administrative, and judicial practices (courts/boards of
appeal). We particularly assess the success of the counter-
measuresto undesired ethical effects of accepting the EU
Biotech Directive implemented by the Norwegian govern-
ment in 2003/4. We end the article by pointing to some key
tensions between the law-making and executive level in the
patent system when it comes to ethical considerations.
KEYWORDS
biotechnological inventions, ethical considerations, patent
system
PatentEthics: Ethical dimensions of patent law in non-human biotechnology.
© 2017 The Authors. The Journal of World Intellectual Property © 2017 John Wiley & Sons Ltd
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wileyonlinelibrary.com/journal/jwip J World Intellect Prop. 2017;20:160177.
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SETTING THE SCENE: PATENT LAW AND ETHICS
The purpose of this article is to explore the room for ethical considerations in patent law as it has developed in recent
decades, in particular pertaining to inventions in biotechnology. Ethical considerations were only marginal in the
patent system until the advent of the so-called patents on lifediscussion, which concerns the patenting of genes or
other biological material (Hettinger, 1995). With the notion that exclusive rights to inventions based on genetic
material is not only permissible, but should be incentivized in the patent system, a broad ethical discussion began to
emerge globally.
What we will refer to as the patent systemis not currently a single global patent system (Tvedt, 2007, 2010), but
rather a number of national and regional patent systems connected by international treaties and less formal
collaboration forums. The principle of territoriality makes a patent valid in the countries where national and regional
patent systems have granted it. Granting time-limited property rights creates incentives for innovation, thus patents
contribute to setting the research priorities of our time. The incentives of the patent system drive investment to areas
where there is a market that can pay for innovation at monopoly prices.
The patent system is closely linked to the research community and commercial actors pursuing research into
products in markets.Research and innovation in general is confronted withincreasing societal expectations of ethical
conduct and social responsibility. Since 2011, a discourse concerning ResponsibleResearch and Innovation (RRI) has
become one importantperspective on ethical considerationsrequired by the research and development community,in
particularon new technologies such as bio- and nanotechnology(Owen, Bessant, & Heintz,2013). Scrutinizing the room
for ethics in one of the core global legalinstitutions for research and innovation is therefore a pertinentresearch task.
The purposeof this articleis to identify the space for ethical considerations in patentlaw as it applies to biotechnology.
One obvious critical remark to approaching the patent system from an ethical explorative perspective is that it is
held to be value-neutral and that other legal regulations of science and innovation are the places where the ethical
considerations must be taken. In this view, the patent system was not set up for the purpose of judging whether a
certain invention is goodor badfor society. The system, one can argue, contrary to the research idea behind this
article, can therefore not be assessed from an ethical perspective. However, Rawls, in his A Theory of Justice, states
that any legal institution in society must be examined from an ethical perspective and be normatively justified to be
legitimate in society (Rawls, 1999). The patent system is also increasingly scrutinized by a larger public and a
strengthening of ethical aspects has been introduced into European patent legislation (specifications of the
established clause about ordre public and morality
1
). All these tendencies add to the interest in assessing the room for
ethical consideration in the patent system as applied to inventions in biotechnology. This article will explore the space
for ethical arguments in law-making for biotech patenting, the exercise of public executive power in selected
biotechnology patents and in judicial decision-making at international, regional, and national levels by looking at
examples. We will compare the identified space for ethical considerations in law-making with the exercise of ethical
discretion in practice, using the example of Norway, which introduced ethical countermeasuresto mitigate the
undesired ethical effects of implementing the European Commission (EC) Biotech Directive
2
in 2003/4. From this
example, we will reflect on inherent challenges in overcoming the gap between law-making and execution of the law.
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HOW TO APPROACH THE ROOM FOR ETHICAL CONSIDERATIONS
IN PATENT LAW?
For the purpose of discussing the room for ethical considerations one needs to develop a clearer understanding of
what we mean by ethical considerations. In this article we have chosen six perspectives onethics, which each provides
specific ethical considerations.
The first perspective looks at concerns that have been present in the debates on patents on biotechnological
inventions over the past two decades related to the moral acceptability of allowing patents on genetic and biological
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