A decision of the European court of justice has severely restricted the ability to obtain patents for stem cell-based inventions in Europe. The court has ruled that inventions that use or incorporate human embryonic stem cells cannot be patented – a position which contrasts with that taken in countries such as the USA. This decision applies to both stem cells obtained directly from human embryos, and also to inventions using human embryonic stem cell lines.
The court's decision does not prevent research using embryonic stem cells taking place. However, the decision may influence the availability in Europe of therapies based on such technologies , since many companies are unwilling to commercialise their products without the benefit of patent protection. The decision should not adversely impact inventions using stem cells from adult or artificial sources, and these remain promising candidates for future therapies. However, these technologies are currently less developed than those based on embryonic cells.
Background
Stem cells, which have the capacity to develop into a range of cell types, are viewed as promising therapeutic agents, able to replace or regenerate diseased or damaged tissues throughout the body. Embryos represent a rich source of high quality stem cells, which may be used directly, or in the form of embryo-derived cell lines.
European laws governing the patentability of biotechnology inventions prevent patenting of the use of human embryos for industrial or commercial purposes since such uses cause the destruction of the embryo. However, prior to last week's decision it has not been clear whether this ban also extended to the uses of embryos for scientific research, or to methods or products based on embryonic cell lines.
The European court of justice had been asked to consider a referral from the German national court (the Bundesgerichtshof) in the case of Brüstle v Greenpeace e.V. This case involved Greenpeace's attempt to seek annulment of a German patent that Professor Brüstle had obtained in connection with neural precursor cells that may be used in the treatment of neurological defects.
Prof. Brüstle had invented a method by which embryonic cells obtained from blastocysts could be turned into neural precursors, potentially providing an almost unlimited supply of such cells. He had patented the neural progenitor cells, and their therapeutic use, as well as their methods of production from embryonic cells.
Greenpeace had sought to have the patent annulled on the basis that it contravened the ban on patenting of inventions relating to the use of human embryos for industrial or commercial purposes.
Before ruling on this annulment, the Bundersgerichsthof asked the European court of justice to decide.
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