Academic journal article The George Washington International Law Review

Coming out of the Maze: Canada Grants the Harvard Mouse Patent

Academic journal article The George Washington International Law Review

Coming out of the Maze: Canada Grants the Harvard Mouse Patent

Article excerpt


In light of the recent Supreme Court of Canada decision in President and Fellows of Harvard College v. Canada (Commissioner of Patents)1 to deny patentability to the Harvard Mouse, the history of the case takes on increased importance. The previous decisions, particularly the Federal Court of Appeal's (Appeal Division) holding, have added much material to the public debate regarding the patentability of higher life forms under the Canadian patent laws. As both public and Parliamentary debate will likely follow the recent Supreme Court of Canada decision, the Appeal Division decision and those leading up to it provide important legal arguments in favor of granting patent protection for advanced biotechnology in Canada.

The Appeal Division's allowance of a patent for a genetically altered mammal in Harvard2 marked an important departure from prior interpretations of the Canadian Patent Act (the Act). Specifically, it was the first time a higher life form received patent protection under the Act,3 indicating a more modern attitude towards biotechnology,4 which allows the creation of organisms with specially designed physical and genetic attributes.5 In its decision, the Appeal Division broadened the scope of statutory subject matter with regard to patents, bringing Canada's patent laws temporarily in line with those of other major countries, most notably the United States.6 By granting patent rights to higher life forms, the decision opened the door to an influx of biotechnology patent applications7 as well as biotechnology business.8

The specific patent at issue in Harvard concerned the creation of non-human mammals comprising an additional gene that makes them more susceptible to cancer.9 As examples of such an animal, the patent applicants included dependent patent claims covering a rodent and, more specifically, a mouse.10 Thus, the patent is commonly referred to as the "Harvard mouse" or "Oncomouse."11

In order to understand some of the patentability issues, it helps to describe the invention at issue. First, an oncogene-a gene that makes cells more cancer prone-is injected into a fertilized egg by means of a carrier plasmid12 (simply a medium by which to transfer the gene). The egg is subsequently transferred to a female "host" mouse for gestation.13 If all the cells are affected by the oncogene, a "founder mouse" has been created.14 This founder mouse bears all the desired characteristics of the genetic manipulation. Finally, the founder mouse is mated with genetically unaltered mice to produce offspring.15 Based on the tenets of Mendelian genetics,16 half of the offspring will exhibit the cancer-prone characteristics of the genetically manipulated founder mouse.17

This Note begins with a discussion detailing the history of the Harvard mouse patent in Part II. First, as relevant background information, the discussion provides a short history concerning the patentability of the Oncomouse in the United States. Second, the discussion considers the treatment of the Oncomouse patent before it reached the Canadian Appeal Division. The third section summarizes the majority's reasoning in declaring a reversal. Fourth, the discussion continues with an exploration of the major elements of the dissent. Finally, a brief summary of the Supreme Court of Canada reversal illuminates the importance of the Appeal Division decision.

The analysis then considers the intricacies and implications of the Appeal Division decision granting the Harvard mouse patent in Part III. The analysis section evaluates the similarities between that decision and decisions concerning biotechnology patents in the United States. Furthermore, it points out differences between the two countries' decisions. Next it evaluates several problems with the majority decision, some of which provided technical excuses for reversal. Thereafter, the analysis discusses the economic ramifications of the Canadian Appeal Division decision. …

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