The Canadian Patent Office issued a practice note on June 20, 2006 stating that animals from any stage of development from fertilized eggs on are higher life forms and thus not patentable subject matter. The practice note further states that the Patent Office has taken the position that organs and tissues are not compositions of matter for the purpose of the definition of invention and thus are not patentable subject matter. However, on a more positive note, embryonic, multipotent and pluripotent stem cells that do not have the potential to develop into an entire animal are patentable subject matter.
In 2002 in a 5-4 decision of the Supreme Court of Canada ( Commissioner of Patents v. President and Fellows of Harvard College ), it was decided that a higher life form is not patentable because it is not a "manufacture" or "composition of matter" within the definition of invention provided by the Patent Act . However, both the majority and minority of the court were in agreement that fertilized, genetically altered eggs are patentable subject matter, regardless of their ultimate development into a mouse. This position was reiterated in a subsequent decision of the Supreme Court in 2004 ( Schmeisser et al. v. Monsanto Canada et al. ), where the validity of a patent to plant cells was upheld. While the Canadian Patent Office has not offered guidance as to their consideration of these decisions, it appears that the Supreme Court's obiter statements concerning fertilized eggs have been disregarded.
The Patent Office has for some time been holding patent applications that contain claims to stem cells in abeyance awaiting this policy paper. We will likely see these applications moving forward. The full text can be found at: http://strategis.gc.ca/sc_mrksv/cipo/patents/notice_jun20_06-e.html .
