StemCell Therapy

iStockphoto.com/Ssolbergj

*New 18 June 2012*: The EU ban on embryonic stem cell patents is legally flawed, argues a paper and public lecture by Aurora Plomer, Chair of Law and Bioethics at the University of Sheffield, UK. Find out more.

June 2011: Lately there have been several cases on the patentability of inventions related to human embryonic stem cells (hESC) in Europe. Now the first case has reached the European Court of Justice (ECJ), the highest European court, whose decision will be binding for all EU member states.

The judgement of the ECJ is still outstanding. However, the Advocate General Yves Bot offered his opinion on the case, which points towards a complete prohibition of patents for inventions relating to hESC. While the court does not have to follow the opinion, it does so in a majority of the cases.

The case history The current case arose in Germany from a patent of belonging to Prof. Oliver Brstle. The patent covers neural progenitor cells (precursors of nerve cells), neuronal cells derived from these progenitors, and a method for producing them from hESC lines. hESC lines are typically derived from surplus fertilized egg cells, which are produced in large numbers during in vitro fertilization (IVF) and otherwise discarded. Once established, hESC lines can be permanently maintained and proliferated and thus serve as a source of tissue-specific cells, such as neuronal precursors.

Brstles patent was originally filed in 1997 and granted by the German Patent Office in 1999. In 2004 Greenpeace filed a nullity action against the patent based on reasons of ordre public and morality. A decision of the German Federal Patent Court in 2006 rendered the patent partially invalid, eliminating all claims relating to cells derived from hESC lines. Following Brstles appeal against this decision, the German Federal Court of Justice referred the dispute to the ECJ, arguing that its decision in the case depends on the interpretation of Article 6 of the European Biopatent Directive (Art. 6).

The legal situation The EU Biopatent Directive (Directive on the Legal Protection of Biotechnological Inventions 98/44/EC) was meant to assure harmonized patent protection for biotechnological inventions in the EU. The directive also contains exemptions from patentability including Art. 6(1), which states that patents contrary to ordre public and morality are excluded from patentability. To provide national courts and patent offices with guidance on how to interpret this clause, an illustrative list of examples was incorporated in Art. 6(2) of the Biopatent Directive.

One of these examples has now proven to be key for the patentability of stem-cell-based inventions: Art. 6 (2) (c), which states that in particular uses of human embryos for industrial or commercial purposes shall be excluded from patentability. However, there is no definition of any of the terms used in this provision found within the Directive, neither of the term human embryo nor of what is to be understood by uses for industrial or commercial purposes.

Consequently and contrary to the aim of the European legislator to achieve harmonisation, there are significant differences in how the Directive has been implemented in the EU member states, and even more variation in how the corresponding provisions of national patent law have been applied in the member states. As a result, some countries have adopted a rather liberal approach to patenting. For example, in the UK about 100 patents on hESC-based inventions had already been granted by 2009 [1]. Others, such as Germany at least with the first instance ruling of the German Federal Patent Court - have so far opted for a much more restrictive interpretation of the Directive.

The opinion of the Advocate General Yves Bot European Court of Justice: Image by SsolbergjIn his opinion the Advocate General made a suggestion on how Art. 6 (2) (c) of the Biopatent Directive and its terms should be understood. Bot rightly argues that the concept of a human embryo must be subject to a common understanding in all EU member states. Furthermore, he states clearly that hESC are not included in that concept, because they do not in themselves have the capacity to develop into a human being. Nevertheless, he surprisingly took a restrictive approach on patenting of hESC-based inventions: even inventions based on legally established hESC lines are excluded from patentability due to the fact that hESC lines are originally derived from fertilized human eggs.

Read the original here:
Stem cell patents: legal aspects | Europe's stem cell hub ...

This entry was posted on June 8, 2015 at 3:50 pm and is filed under Legal Issues Stem Cells. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |