Potency, Patenting and Preformation: The Patentability of Totipotent Cells in Canada

Abstract

The Canadian Intellectual Property Office’s (CIPO) publication entitled, Office Practice Regarding the Patentability of Fertilized Eggs, Stem Cells and Tissues, is examined with respect to the patentability of totipotent cells. It is conjectured that its position against the patentability of totipotent cells is based upon a mistaken view of animal development and stem cell differentiation called “genetic preformationism.” This view holds that the DNA in a totipotent cell is the sole determinant of development and differentiation so that a totipotent cell containing the DNA of a higher life form is a higher life form. It ignores the fact that modern biologists have recognised an increasingly important role for non-genetic, environmental factors in both animal development and stem cell differentiation. Given that the CIPO’s views on development and differentiation are incorrect and the process of developing the Notice lacked transparency, justification and intelligibility, it cannot justifiably reject an application for a patent on a fertilised egg or totipotent stem cell on the basis of the reasons given in the Office Practice Regarding the Patentability of Fertilized Eggs, Stem Cells and Tissues. This paper suggests that there are legal, practical and scientific limits of the ability of the CIPO, like other patent offices, to apply patent legislation wisely to fundamentally new technologies.