The European Court of Justice (CJEU) has handed down a landmark judgment concerning the patentability of stem cells in Europe. Stem cells have the potential to revolutionize the treatment of human disease because of their capacity to differentiate into almost any type of adult cell. This case, decided on December 18, is important for the regenerative medicine community in Europe.
In its decision, the CJEU has ruled that unfertilized human eggs which have been stimulated to divide in the absence of sperm (so-called parthenotes), notwithstanding that they lack any paternal DNA, are not "human embryos" within the meaning of the EC Biotech Directive. As a result, they should not be excluded from patentability.
About the litigation: “human embryos”?
The current litigation, in which International Stem Cell Corporation (ISCO) seeks patent protection for its technology in Europe, concerns the patentability of stem cells derived from unfertilized human eggs. DLA Piper represents ISCO in this case.
A key issue in the case was whether ISCO's technology uses "human embryos" and thus whether it is excluded from patentability under the EC Biotech Directive. A key policy aim of the Biotech Directive is the use of the patent system to encourage biotech research. But this is subject to the competing policy consideration that patent law must be applied "so as to respect the fundamental principles safeguarding the dignity and integrity" of individuals.
ISCO's technology involves stimulating an unfertilized human egg to divide (to form a sphere of cells known as a parthenote). But because a parthenote contains only maternal DNA, it has no innate capacity to develop into a human being. ISCO therefore argued that a parthenote cannot be a "human embryo" within the meaning of the Biotech Directive. Hence, the use of a parthenote as a source of stem cells cannot constitute use of a "human embryo," and thus the technology is patentable. The corresponding US Patents have already issued in the US.
The High Court in the UK referred the case to the CJEU last year. Five EU countries, as well as the EU Commission, submitted written observations to the CJEU about the issue. In view of its significance, a full chamber of 13 CJEU judges (rather than the usual five) heard the parties' oral submissions at the hearing in Luxembourg earlier this year.
Opening the door to stem cell technology patents
The long-awaited decision, closely watched in the life sciences sector, makes clear that certain human embryos are patentable without violating Article 6 of the EC Biotech Directive, which otherwise declares unpatentable inventions that could be considered contrary to order public or morality.
By recognizing that parthenotes are not "human embryos," the CJEU has opened the door to the patenting of stem technologies where stem cells are derived from parthenotes, as well as for stem cell technologies that use cells that do not “in itself, have the inherent capacity of developing into a human being.”