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Abelman, Frayne, &Schwab

THE EUROPEAN COURT OF JUSTICE HOLDS INVENTIONS INVOLVING HUMAN EMBRYONIC STEM CELLS TO BE UNPATENTABLE

    On October 18, 2011, the European Court of Justice handed down a significant ruling regarding the patentability of inventions involving human embryonic stem cells.

    The Court held that an invention which requires the destruction of a human embryo is per se unpatentable. In the course of reaching its decision, the Court held that any human ovum must be considered to be a human embryo immediately upon fertilization, as are ova which have received a cell nucleus from a mature human cell, and ova which have been stimulated into development by parthenogenesis.

    Embryonic stem cells are obtained from blastocysts, which are structures which develop after fertilization, and consist of 70-100 cells. Blastocysts are destroyed in the process of obtaining embryonic stem cells. Notwithstanding its decision that embryos result immediately after fertilization, and blastocysts develop thereafter, the Court of Justice referred the case back to the originating German Federal Patent Court for determination of whether stem cells, obtained from blastocysts, should be considered to be "embryos," i.e., are capable of developing into human beings. If the German Court answers this question in the affirmative, the patent is invalid as violating regulations prohibiting the use of human embryos in industrial processes.

    It is worth noting that the Court of Justice held that there was no difference between embryonic stem cells prepared specifically for an invention, and embryonic stem cell lines, which are obtained from pre-existing cell cultures, since the cells either will, or will not possess the ability to develop into humans.

    The Court of Justice's decision appears to eliminate the possibility of any European patents which would cover human embryonic stem cells. Possibilities for drafting valid claims which involve stem cells remain, as the Court did not eliminate patents involving stem cells per se.

    Any questions concerning this Decision may be directed to Jeffrey Schwab or Norman Hanson.




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