CIPO Practice Notice on Stem Cells Issued

On June 20, 2006, the Canadian Intellectual Property Office (CIPO) issued an Office Practice Notice entitled "Office Practice Regarding Fertilized Eggs, Stem Cells, Organs and Tissues", setting out that animals at any stage of development are not patentable subject matter under section 2 of the Canadian Patent Act, because they are considered to be higher life forms. The Practice Notice confirms CIPO's examination practice in light of the statutory requirements, as they have been interpreted in recent case law, including the "Harvard Mouse" case. Totipotent stem cells (which have the same potential as fertilized eggs to develop into an entire animal) are considered to be the equivalent of fertilized eggs and are not considered patentable. On the other hand, embryonic, multipotent and pluripotent stem cells do not have the potential to develop into an entire animal and therefore are considered patentable subject matter. CIPO also takes the position that organs and tissues "are created by complex processes, elements of which require no human intervention, and do not consist of ingredients or substances that have been combined or mixed together by a person" and are not considered compositions of subject matter for the purposes of the definition of "invention" under section 2 of the Patent Act. Artificial organ-like or tissue-like structures, however, may be considered compositions of matter but their patentability will be determined on a case-by-case basis. For the text of the Practice Notice, see: http://strategis.ic.gc.ca/sc_mrksv/cipo/patents/notice_jun20_06-e.html Summary by: Clare McCurley