Stem Cell Patent: European Patent Law and Ethics

Specific objectives

Specific objectives within these aims are:

The identification of existing legal controls in national legal regimes and analysis of points of convergence and divergence.

Focus areas will be:

  • Identification and analysis of European patenting practices of inventions relating to human embryonic stem cell research .
  • Analysis of national patent regimes, as applied to biotechnological inventions in general and to human embryonic stem cell related technology in particular.
  • Determination of what system of regulation governs the patenting of human embryonic stem cells in different states in Europe and in the USA, which will be compared and analysed to identify similarities and differences in the light of the European Patent Convention and the Biotech directive, including a future Community Patent.

Analysis of perspectives on the rights of the human embryo and mediating institutions and processes.    decorative image <

Focus areas will be:

  • The nature and the scope of legal protection of relevant fundamental ethical principles or values such as the right to life, in international and regional human rights instruments as well as constitutional courts and the European Court of Human Rights.
  • Overall analysis of national differences in legal or ethical regulation of human embryonic stem cell research, including differences in legislative approaches as well as the jurisprudence of State courts on the rights of the human embryo.
  • Analysis of the role of institutions such as National Bioethics Commissions and the European Group on Ethics in particular, through which ethical principles are formulated and suggestions as to how the role of these institutions as mediators between society and policy makers may be strengthened to facilitate the resolution of ethical disagreement in pluralist democratic societies.

A European roadmap with the provision of benchmarks which would satisfy the ‘morality’ requirement without hindering competitiveness and investment in European biotechnology and human embryonic stem cell industry.

Focus areas will include:

  • Definitional problems and boundaries of key concepts such as human ‘body’, ‘body as such’, ‘body part’, ‘human embryo’, etc … A comparative analysis of the existing definitions and their scope and meaning in scientific, ethical and legal contexts to ease resolution of differences.
  • Assessment of the interplay between the principle of subsidiarity, national regimes on patent law and human rights and  the public morality clause in the European Patent Convention and the Biotech Directive and
  • Suggestions to resolve legal uncertainty and recommendations on possible emerging principles, where there is a balance between ethical and commercial interests, which could form the basis of a common European policy aimed at facilitating research and commercial application without a risk of instrumenalisation and commercialisation of the human embryo.

 

 

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