Posted By Kaitlin Soye – Nov. 21, 2011
On October 18th, the European Court of Justice blocked patents for procedures using human embryonic stem cells in a case on appeal from the Federal Patent Court in Germany.
The European Court interpreted relevant provisions of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 (the Directive) which dictates that the human body, at any stage of development, cannot be patented (Article 5(1)).
In its decision, the Court adopted a broad definition of “human embryo” to mean a fertilized human ova if that fertilization is such as to commence the process of development of a human being (Directive, Article 6(2)c).
In adjudicating whether the human ES cells that serve as the base material in the patented process held by Brüstle should be included within the concept of “human embryos”, the Court found in the affirmative. The block on these patents on human embryos apply to both scientific research as well as commercial and industrial purposes.
Embryonic stem (ES) cells have almost unlimited self-renewal and differentiation capacity. Groundbreaking ES cell research offers a wide variety of biomedical applications including addressing issues of donor tissue shortages.
The ruling cannot be appealed and applies to all member states of the European Union. It specifically bans procedures that create ES cell lines by destruction of the embryo and use previously developed cell lines. The decision is based on concerns of ethics and public policy. Clara Sattler de Sousa e Brito, patent attorney for the plaintiff, suggests that current patents in good standing will not be invalidated, but they remain difficult to enforce.
Similar scientific procedures maintain patent protection elsewhere in the world, including the USA. This ruling has the potential to restrict European scientists and companies from progressing both academic and commercial research. It has been speculated that the lack of patent protection may dissuade companies from investing in European research and negatively impact funding for basic research of ES cells.1
Although this ban has blocked ES cell-based patents in Europe, scientific research continues to advance. This may be an opportunity to revisit the field for research into induced pluripotent stems cell (adult somatic cells forced into pluripotency) based therapies in Europe.
1 Callaway, E, “European court bans patents based on embryonic stem cells” (18 October 2011) available online: Nature.
Oliver Brustle v. Greenpeace e.V, 2011 (C-34/10)
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 (L213/13)
Bishop, AE, LDK Buttery and J M Polal. Embryonic stem cells. The Journal of Pathology. July 2002, 197(4) 424-429.
Briggs, H. European court ruling ‘threatens stem cell work.’ BBC (Online). 18 October 2001.