Defining “human embryos” broadly, The Court of Justice of the European Union has ruled that pluripotent stem cells derived from human embryos and totipotent stem cells derived from blastocysts are not patentable if they are obtained by destroying human embryos or using them “as base material”, at any point in the production of the stem cells. The definition of “human embryo” was also extended to cover enucleated oocytes that may incorporate nuclear material from other cells or be induced to divide by parthenogenesis. The later essentially bans “adult cell cloning” for research on the early stage cells, e.g., if it involves destruction of resultant “embryo.” Individual pluripotent stem cells were not included in that concept, e.g., neuronal stem cells, since they cannot develop into a human being. But since they are obtained by disassembling a blastocyst, this is a distinction without a difference. For a refresher on the science, see W. Woessner, JPTOS, 83, 830 (November 2001).
The EU decision was based on Article 72(2) of TRIPS which stipulates that Members may exclude from patentability inventions, the prevention of the commercial exploitation of which is necessary to protect ordre public or morality. Thus, Greenpeace and its friends have accomplished what organizations with similar political (if not religious) leanings have failed to accomplish in their attempts to ban Government funding for embryonic stem cell research in the U.S. Of course, such court battles will be refocused by the AIA. Sec. 33 bans patents with claims “directed to or encompassing a human organism.” This provision is retroactive to all pending applications, but not to issued patents. How broadly the term “human organism” will be defined is still an open question but, groups supporting a very broad definition will be encouraged by this decision.
The only exception “to the non-patentability of uses of human embryos for industrial and commercial purposes concerns only invention for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.” This exception would seem to permit some types of gene therapy or other medical treatments aimed at correcting genetic defects in the developing embryo. As noted above, this decision, which involved the isolation of pluripotent stem cells, does not purport to ban human cloning, so long as birth results – the embryo would not be harmed by such a procedure. This type of research, termed “therapeutic cloning” has not been banned in Europe. The charter of Fundamental Rights of the European Union prohibits reproductive cloning. In the U.S., the “Dickey-Wicker Amendment” to the annual HHS appropriations bill bars Federal funding for the creation of a human embryo for research purposes or for research in which human embryos are destroyed. In 2010, HR 4808 was introduced by Diana DeGette (D-CO) to expressly permit funding for embryonic stem cell research, but it has not been passed.