15 - Patent Governance, Ethics and Democracy: How Transparency and Accountability Norms Are Challenged by Patents on Stem Cells, Gametes and Genome Editing (CRISPR) in Europe

Summary

The chapter discusses the relationship between patent governance, ethics, and democracy, referring to limits in patent law set in democratic decisions by the EU legislator in the EU Biotech Directive. The ordre public clauses in Articles 5 and 6 attempt to "upstream" ethics and anticipatory impact assessment in biotechnology patent law. However, the interpretation of these clauses, especially for inventions concerning human embryonic stem cells, gametes, parthenotes, and genome editing (CRISPR-Cas) techniques, has ignited intense policy debates. Granting practices and case law of the European Patent Office (EPO) and its Boards of Appeal have circumvented some of these legal restrictions, and thus pose challenges for transparency and accountability norms in patent practice. Case law of the Court of Justice of the European Union (CJEU) and empirical analyses of patent application and granting practices are scrutinised. The chapter states that interpretation of legal statutes must not be narrowly literal but must also include the history and purpose of the Biotech Directive and the socio-technical and economic implications of its application. This requires that the EPO and the European Commission act transparently and account for their application of the legal rules as set by the European legislator and interpreted by the CJEU.