Are totipotent cells patentable in Canada?

Greg Hagen is an Assistant Professor in the Faculty of Law at the University of Calgary.

While James Thomson’s claims to primate embryonic stem cells in U.S. Patent 5,843,780 (granted December 1st, 1998) were finally upheld on reexamination by the U.S. Patent and Trade-mark office in 2008, no Canadian patent was ever granted on these claims. Canadian patent application 2190528 claims a purified preparation of primate embryonic stem cells that is capable of proliferation in vitro for over a year while maintaining its ability to differentiate into any of the three main germ cell layers or into an embryo itself. (See description, p. 21) The remarkable capability of these primate totipotent cells to develop into primate embryos and ultimately a primate (including a human being) raises the issue of whether totipotent stem cells, generally, are a patentable kind of subject matter in Canada.      This issue seemed to have been settled by the Supreme Court in Harvard College v Canada (Commissioner of Patents), 2002 SCC 76 (“Harvard”), the famous case which held that higher life forms, including genetically modified mice, are not patentable in Canada. In Harvard, the Court also noted at para 162 in obiter dicta that the fertilized egg of the mouse was a composition of matter. Later, in Monsanto Canada Inc. v Schmeiser, 2004 SCC 34 (“Monsanto), the majority states at para 23 that “… all members of the Court in Harvard Mouse noted in obiter that a fertilized, genetically altered oncomouse egg would be patentable subject matter, regardless of its ultimate anticipated development into a mouse …”. Then, in 2006, the Canadian Intellectual Property Office (“CIPO”) released its Office Practice Regarding Fertilized Eggs, Stem Cells, Organs and Tissues (“Stem Cell Notice”). Notwithstanding the pronouncement by the Supreme Court in Harvard and Schmeiser, the CIPO took the position that fertilized eggs and totipotent stem cells, which have the potential to develop into a higher life form, are higher life forms. It reasoned further that, since higher life forms are not patentable under Canadian law, fertilized eggs and totipotent stem cells are not patentable subject matter.

There are a number of reasons why this conclusion is unpalatable. First of all, it runs contrary to the fact that totipotent cells are compositions of matter. Second, it obviously contradicts the statement in Harvard that a fertilized mouse egg is a composition of matter and the implication of Schmeiser that totipotent cells are a kind of patentable subject matter. In the draft biotechnology chapter of the Manual of Patent Office Practice the CIPO states, as if in Wonderland, that “[Harvard] has been interpreted by the Patent Office to mean that animals at any stage of development are not statutory matter for letters patent, and consequently that fertilized eggs and totipotent stem cells (which have the inherent ability to develop into animals) are included in the higher life form proscription.” In internal documents, it adopts a different tact, arguing that it is entitled to ignore the Supreme Court’s view on the patentability of fertilized eggs because it is obiter dicta, missing the fact that obiter can be authoritative. Third, the CIPO illegitimately side-steps its own view that unicellular (lower) life forms are patentable by making an ad hoc exception in the case of totipotent cells. Finally its view that totipotent plant cells are patentable subject matter is difficult to reconcile with its proscription against patenting totipotent animals cells. Its rationale that only totipotent plant cells can be produced en masse is dubious.

The CIPO considers totipotent cells to be higher life forms because they have the potential to be higher life forms. But why does the CIPO identify potential and actual higher life forms? It does not provide any explicit reason for its identification in the Stem Cell Notice. Hence, in “Potency, Patenting and Preformation: The Patentability of Totipotent Cells in Canada“, (2008) 5:2 SCRIPTed 515, I speculate as to the reason for this identification. These speculations are aided by internal documents obtained under the Access to Information Act but, disappointingly, there is no explicit answer provided in them. The first possible rationale appears to be that fertilized animal eggs and totipotent cells have moral status so that it would slight their dignity to patent them. In its review of foreign law, the CIPO referred to the U.K. Inventions involving human embryonic stem cells. That document provides that human totipotent stem cells are not patentable in the UK because the human body at the various stages of its formation and development is unpatentable. The CIPO Stem Cell Notice adopts the UK principle generalized to animals but the problem with such a generalization is that the UK principle is based upon moral considerations embodied in European law which do not exist in Canadian law.

A second possibility is that one might by definitional fiat say that a totipotent cell is a bird, for instance, in virtue of the fact that its genetic blueprint is the same as that possessed by a bird. That would allow the CIPO to say that a totipotent cell that contains the DNA of a higher life form is itself a higher life form. But why would one identify kinds of life forms only in virtue of their genetic makeup rather than phenotypic features as well? This identification might be thought to be supported by the theory of genetic preformationism, according to which genetic information determines development. Such a theory is indeed hinted at by the Australian Deputy Commissioner of Patents in Fertilitecentrum AB v Luminis PTY Ltd [2004] APO 19, referred to by the CIPO in its review of foreign law. The problem with genetic preformationism, however, is that there are subtle ways in which non-genetic, environmental factors play a crucial role in the development of embryos and the differentiation of stem cells. It is a consequence of this very principle that totipotent animal stem cells can be used for therapeutic purposes, such as tissue repair, without any chance of them developing into an animal. Because of this, it makes more sense, from a developmental perspective, not to necessarily identify totipotent stem cells with the higher life forms that they could theoretically become based upon their shared DNA.

The paper concludes that refusing a patent on a totipotent cell in Canada based upon the Stem Cell Notice would be unjustified.