Practical Reasoning, Impartiality and the European Patent Office: The Legal Regulation of Biotechnology

• DOI: http://doi.org/10.1111/eulj.12005
• Date: 01 November 2012
• Author: Katerina Sideri
• Published date: 01 November 2012

Practical Reasoning, Impartiality and the

European Patent Office: The Legal

Regulation of Biotechnology

Katerina Sideri*

Abstract: The article argues in favour of a different conceptualisation of the role of the

European Patent Office, and of the mode of reasoning that the EPO ought to deploy, so

as to decide cases concerning the patentability of gene related inventions such as diag-

nostic tests, and questions regarding the regulation of therapeutic cloning. Richardson’s

model of specifying norms offers an important alternative to the models based on

cost-benefit analysis and neutral application of the appropriate norm by administrative

agencies. Specificationism stresses the importance of revising the ends of policy, coming

up with a new norm, the product of creative synthesis of the content of conflicting norms.

The article adds to this model the idea that the revision of ends requires a strong

deliberative democracy, based on the notion of the practically wise regulator, who can

apply principles correctly, as these cannot be usefully applied in difficult situations

by people who lack experience, insight, and character. Given the current discussion to

establish a unitary EU patent, the thesis advanced here is that the patent system in

Europe ought to endorse elements of deliberative democracy, enhancing the importance

of civil society in the European decision making processes.

I Introduction

Who ought to decide whether it is desirable or not to patent inventions relating to

genes, such as diagnostic tests, or inventions relating to therapeutic cloning, involving

the destruction of 14-day embryos? The obvious answer would be that this is a job for

the legislature, such as the European Parliament and the Council of the European

Union (for EU legislation such as the Biotechnology Directive),1and the Diplomatic

Conference of the Contracting States in the case of an international agreement such

as the European Patent Convention (EPC). However, in Europe, neither the Biotech-

nology Directive nor the EPC provides us with clear answers to these matters, for the

technologies they seek to regulate currently manifest a kind of plasticity that law

not only has serious difficulty in apprehending, but also the power to stifle, at least

temporarily. The Biotechnology Directive prohibits research on the embryo with a

* Associate Research Fellow, Centre for Socio-Legal Studies, University of Oxford, UK.

1Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal

Protection of Biotechnological Inventions.

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European Law Journal, Vol. 18, No. 6, November 2012, pp. 821–843.

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commercial end, yet it is not clear whether therapeutic cloning ought to be banned on

this basis. The EPC stipulates that diagnosis and treatment are excluded from pat-

entability, yet there is controversy as to the exact way this provision applies in the

case of diagnostic tests using patented genetic technology. It appears that in these and

many other cases, legal regulation will have to gradually evolve; biotechnology is a

new science, and even scientists cannot foretell the exact direction it will take in the

future, hence we could assume that national courts2and the European Patent Office

(EPO) will gradually develop case-law addressing these issues, once we have more

information. Yet the problem is not only that we do not know enough about these

technologies; importantly, there is profound public disagreement about the ethics of

promoting such technologies. Interestingly,3patent law in Europe stipulates that a

patent may not be granted if it is deemed to be of immoral nature. Public perception

of potential benefits and risks is strong and emotional; environmentalists, animal

welfare groups, religious groups, scientists and many others all suggest different views

as to the optimal way to regulate these technologies.

Following the diagnosis of discretionary powers, value pluralism and information

limits, we can return to the question asked at the beginning: who ought to decide how

we go about regulating these technologies? The first response to this question could be

that in cases where there is deep disagreement because of competing values, public

discussion is important, so that we find some common ground on the basis of which

we will begin exchanging views, so as to finally arrive at a conclusion acceptable to

all. This is obviously an argument against judicial activism. We do not need a final,

conclusive answer in the form delivered by courts; rather, in cases of uncertainty as to

the nature and number of parameters that will shape how we understand important

goods, (such as the good of health), and the way these goods relate to new technolo-

gies, we need to be given the opportunity to discuss again and again as a society how

broad legislative mandates ought to be specified in concrete contexts. This is because

specifying is a learning process on both sides: on the side of the law and on the side

of social groups, which will have to seek accommodation of their views, and possibly

revise them in the course of public discussion. Specifying the ends of policy will have

to be an ongoing project, so that the law does not crystallise the elusive, and the

public is given the opportunity to reappraise its values. When patent law regulates

inventions in the field of biotechnology, it brings foreword important questions as to

the proper way to come to grips with the good of health. The latter means many

things for different people, and its content changes overtime. Patents eventually

regulate things, such as who has access to expensive diagnostic tests, whether and

under what circumstances human health is more important than animal welfare, or

the conditions under which patents involving the destruction of 14-day blastocysts

ought to be allowed.

2Of course, in the case of the Biotechnology Directive, Member States have the discretion to interpret

general terms such as ‘ordre public’ in a manner consistent with their legal values and traditions when

implementing these in national legislation. However, national courts will still have to answer important

questions such as the ones relating to definitions of ‘discovery’ and ‘invention.’

3Unlike the US patent law and Japanese patent laws, which do not have similar provisions. For the

argument against including the morality provision in patent laws, see D.M. Gitter, ‘Led Astray by the

Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law’, (2001) 19

Berkeley Journal of International Law 1; B.D. Emerson, ‘Protecting Society from Patently Offensive

Inventions: The Risk of Reviving the Moral Utility Doctrine’, (2004) 89 Cornell Law Review 685.

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