International Stem Cell Corporation v Comptroller General of Patents, Patents Court, London, UK, 17 April 2013, Case No. [2013] EWHC 807 (Ch)
Following an appeal by International Stem Cell Corporation (“ISCC”) against a decision that the inventions disclosed in two of its patent applications relating to human stem cells were excluded from patentability, the UK High Court (Deputy Judge Carr QC) has made a reference to the Court of Justice of the European Union (“CJEU”), requesting that the term “human embryos” in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (“Biotech Directive”) be clarified. In particular whether this includes unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings.
This follows guidance given by the CJEU on the correct interpretation of Article 6(2)(c) in Brüstle (Case C-34/10) in which it ruled inter alia that any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitutes a ‘human embryo” within the meaning of Article 6(2)(c) due to it being capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.
In a fundamental decision on 27 November 2012 (BGH Decision of 27 November 2012, case no.: X ZR 58/07) the Bundesgerichtshof ruled that a patent (DE 197 56 864) registered in favour of the German stem cell researcher, Oliver Brüstle, is invalid in part.
The subject of the patent, which was applied for in 1997, is the protection of neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects. Using the invention by Mr Brüstle upon which the patent is based, transplantation of neural precursor cells in the nervous system can play an important role in treating Parkinson's disease and multiple sclerosis in the future. Such neural precursor cells are usually obtained from embryonic stem cells and can then be used as transplant material.
The European Patent Office deemed that such neural precursor cells, the method for producing them and their use in therapy of neural defects were patentable, and in 1999 granted the patent which Oliver Brüstle applied for, and registered it in the patent register.
Greenpeace e.V. filed an action for annulment of this patent before the Federal Patent Court. According to Greenpeace the subject of this patent violated public policy and accepted principles of morality insofar as it concerned precursor cells which were developed from human embryonic stem cells. Use of such cells is also being discussed because the state of the art at the time destroyed the embryo when the neural precursor cells were produced.
Brüstle v. Greenpeace, CJEU, Opinion of the Advocate General, 10 March 2011, Case C-34/10
According to Advocate General M. Yves Bot, totipotent cells carrying within them the capacity to evolve into a complete human being must be legally classified as human embryos and must therefore be excluded from patentability.
Nor can a procedure using other embryonic stem cells, known as pluripotent cells, be patented where it first requires the destruction or modification of the embryo.
Read the opinion (available in various languages) here.
German Federal Supreme Court refers questions regarding the interpretation of the EC “Biotech Directive” (Directive 98/44/EC) to the European Court of Justice – patenting embryonic stem cells, by Tilman Mueller-Stoy and Thomas Friede, Bardehle & Pagenberg
On November 12, 2009, the German Federal Supreme Court indicated that in the Brüstle ./. Greenpeace Case, Docket No. Xa ZR 58/07, questions on the interpretation of the exclusion clause that a patent shall not be granted on the use of human embryos for industrial or commercial purposes be referred to the European Court of Justice. Said provision was implemented into the German patent act on the basis of Article 6 of the Directive 98/44/EC on the legal protection of biotechnological inventions.
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