In late 2007, the Canadian Intellectual Property Office (CIPO) published a draft update to Chapter 17 of the Manual of Patent Office Practice (MOPOP). In response, the Intellectual Property Institute of Canada (IPIC) made a thorough submission for CIPO's consideration.
While all aspects of biotechnology subject matter are covered by Chapter 17 of MOPOP, it is noteworthy that multi-cellular inventions remain the topic of much debate. On the positive side, applications relating to transgenic animals and plants have for the most part been able to move forward in Canada in view of the guidance given by two Supreme Court decisions, namely Harvard College v Canada (Commissioner of Patents) (2002), and Monsanto v Schmeiser (2004). While, in view of the Harvard mouse decision, claims to an animal or plant per se are not considered allowable, the Schmeiser decision supports the notion that claims directed to an "animal cell" or a "plant cell" are patentable, and the notion that such claims should be enforceable against an infringing animal or plant containing the claimed "cell".
However, there are specific cells, namely totipotent stem cells and fertilized eggs, that in the view of the Patent Office still do not qualify as patentable subject matter based on their interpretation of the Harvard mouse decision. In draft Chapter 17, in referring to the Harvard mouse decision, the Patent Office states:
This decision 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 form proscription.
Close examination of the Supreme Court decision, however, arguably does not support this interpretation. When commenting on fertilized eggs, Justice Bastarache, for the majority in the Harvard mouse decision, said:
Owing to the fact that the technology by which a mouse predisposed to cancer is produced involves injecting the oncogene into a fertilized egg, the genetically altered egg would appear to be cognizable as "[a] substance or preparation formed by combination or mixture of various ingredients".
This statement was interpreted by another Supreme Court judge, Justice Binnie, in the same decision, speaking for the minority, as acknowledgement that a "fertilized genetically modified egg is patentable". It also follows that if a genetically modified fertilized egg is considered patentable by the Supreme Court, then a genetically modified totipotent stem cell should also be considered patentable, regardless of inherent potential.
The final version of Chapter 17 is eagerly awaited by the biotechnology community as it will set the tone for the prosecution of biotechnology patent applications in Canada for the foreseeable future.
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| Ian D Clark |
Marks & Clerk Canada
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