Should the courts be moral censors of biotechnological innovation? An analysis of the morality provisions of patent law with specific reference to Rule 28(1)(c) of the Implementing Regulations to the EPC concerning embryonic stem cell patents
| Author | Louise Clarke |
| Pages | 114-142 |
(2021)
Vol. 11
114
Should the courts be moral censors of biotechnological innovation? An
analysis of the morality provisions of patent law with specific reference to
Rule 28(1)(c) of the Implementing Regulations to the EPC concerning
embryonic stem cell patents
Louise Clarke
*
Abstract
This dissertation considers the legal treatment of the morality provisions in patent law, exclusively in the context
of biotechnological inventions. Specifically, the dissertation will focus on Article 53(a) EPC and Rule 28(1)(c)
of the Implementi ng Regulations, the equivalents of Articles 6(1) and 6(2)(c) of the Biotechnology Directive,
respectively. First, I examine the jurisprudence of the European Patent Office and conclude that while the
morality pro visions wer e convention ally inter preted narro wly, this has now changed t o a liberal approach via
specific case law surrounding Rule 28(1)(c) (prohibition of inventions that use human embryos). These
decisions are then subjected to critical analysis, leading to the conclusion that the judgements, in particular
Brüstle v Greenpeace
, lacked merit in broadening the morality exclusions to patentability. Finally, I discuss the
potential consequences of these decisions in both a commercial and legal setting. Overall, I suggest that an
alternative, narrower approach to morality is warranted, so as to prevent the courts becoming moral censors of
biotechnological innovation.
Introduction
The need for intellectual property protection in today’s competitive global market is
increasingly apparent; however, the desire for inventors or researchers to obtain patents for
their inventions in a biotechnological context is ever more controversial. Economic arguments
are (correctly) always at the fore when justifying the patent system as a core aspect of
commercial development.
1
Against this view are the moral concerns of society, which believes
that granting monopoly rights over inventions that deal with living matter is inappropriate
and unethical.
2
In other words, intellectual property rights cannot and must not be placed
above the right of all human beings to live a full and productive life.
3
This conflict is
accentuated in the case of patents for human embryonic stem cell (hESC) technology. As
hESCs are pluripotent, meaning they can develop into any cell of the adult body,
4
technologies based on hESCs are unique in that they possess remarkable diagnostic and
therapeutic potential.
5
For instance, these cells can be used to support basic research on the
differentiation and function of human tissues and to provide material for testing that may
improve the safety and efficacy of human drugs.
6
Additionally, hESCs carry the potential to
provide an endless amount of tissue for transplantation therapies that could treat a wide range
of degenerative diseases including heart disease, leukaemia, and diabetes.
7
*
Dissertation submitted in partial fulfilment of the requirements for the degree of LLB.
1
Oliver Mills,
Biotechnology Inventions: Moral Restraints and Patent Law
(Revised edn, Ashgate 2010).
2
ibid.
3
ibid.
4
‘Pluripotency’ (Nature Research) <https://www.nature.com/subjects/pluripotency> accessed 10 March 2020.
5
A Leventhal and others, ‘The benefits and risks of stem cell technology’ (2012)18(3) Oral Diseases 217.
6
J Yu and J.A. Thomson, ‘Embryonic Stem Cells’ (National Institutes of Health)
<https://stemcells.nih.gov/info/Regenerative_Medicine/2006Chapter1.htm> accessed 18 March 2020.
7
ibid.
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Vol. 11
115
After a brief discussion of the moral debate, upon which a favourable stance to the economic
justification of patents is adopted, this dissertation analyses the relationship in practice
between ethics and patent law by examining how the morality exclusion to patentability,
namely Article 53(a) European Patent Convention (EPC) (the equivalent of Article 6(1) of
the Biotechnology Directive), is interpreted. Subsequently, I conduct an observation of case
law specifically in relation to Rule 28(1)(c) EPC (the equivalent of Article 6(2)(c) of the
Directive) concerning the use of the human embryo as it pertains to patent law. The decisions
are then subject to critical analysis, which ultimately answers the question of whether the
courts have gone too far in broadening their interpretation of morality. Lastly, the
consequences of the courts’ new broad approach to ethical considerations are investigated in
both a legal and commercial context.
Chapter 1: An Overview of the Patent System and the Biotechnology
Directive
1.1 Introduction
The biotechnology industry develops and capitalises on the commercial applications of
biological manipulation;
8
it is one of the most research-intensive and innovative industries in
its field.
9
In Europe specifically, the sector substantially contributes to fundamental EU policy
objectives such as job creation, economic growth, and public health.
10
This chapter provides context by outlining the legal framework of the EU in the application
of patent law to biotechnological products. It gives the background of the enactment of what
became known as the Biotech Directive, followed by a statement of the Directive provisions
which are relevant for the forthcoming discussion.
1.2 The European Patent Organisation
[The] European Patent Organisation is an international, intergovernmental
organisation, which the sovereign contracting states have entrusted with some of their
national powers in the field of patents.
11
The Organisation was established on 7 October 1977 on the basis of the European Patent
Convention, signed in Munich in 1973. The EPC provides a legal framework for the granting
of European patents
12
via the European Patent Office (EPO). Alongside the convention’s
articles are the ‘Implementing Regulations,’ the function of which is to detail how the articles
8
‘Biotechnology in the UK – Market Research Report’ (IBIS World, July 2019)
<https://www.ibisworld.com/united-kingdom/market-research-reports/biotechnology-industry/> accessed 5
February 2020.
9
Mills (n 1).
10
‘Biotechnology Industry in the European Union’ (Invest in EU)
<http://www.investineu.com/content/biotechnology-industry-european-union> accessed 5 February 2020.
11
President’s Reference/Programs for Computers
G3/08 [2011] [OJ EPO Published 12 May 2011].
12
Article 2(1) EPC.
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