A Leading Canadian IP Case: The Harvard Mouse Case

Harvard College v Canada (Commissioner of Patents), 2002 SCC 76 In 1985, the President and Fellows of Harvard College (Harvard) applied for a Canadian patent for technology for creating transgenic non-human mammals that are prone to cancer. The patent application particularly described a process for producing mice that have cancer-promoting genes (oncomice). Since oncomice have a heightened susceptibility to cancer and tumour development, they are useful for animal carcinogenic studies, such as tests for evaluating suspected carcinogens or cancer-protective agents. The technology in Harvard’s patent application entails injecting cancer-promoting genes (oncogene) “spliced” onto pieces of bacterial DNA (plasmids) into fertilized mouse eggs, preferably at the one-cell stage. The eggs are then implanted into a female host mouse, and permitted to develop to term. The offspring of the host mouse are tested for the presence of the oncogene; those that contain the oncogene are called “founder” mice. Founder mice are mated with mice that have not been genetically altered. Fifty percent of these offspring have the oncogene in all of their cells. Harvard sought to protect the process by which the oncomice are produced, and also the genetically modified mice. The Commissioner of Patents (Commissioner) allowed the claims to the process to be patented, but refused to grant claims to the mice. Although the Canadian Patent Office had previously regularly granted patents for genes, proteins, cells and DNA sequences, it was unwilling to grant a patent for a “higher” life form. The Commissioner determined that the transgenic mouse was not an “invention” because it was not “reproducible” — that is, the development of the eggs in the host mouse relied on the laws of nature to produce the mammalian end product, and the inventors did not have full control over all of the characteristics of the resulting mouse. This battle between the Commissioner and Harvard continued in the courts, eventually reaching the Supreme Court of Canada (SCC). As expected, by the time this case reached the SCC, it had garnered much attention from various religious, environmental and animal rights groups, many of which sought to make submissions. Ultimately, a majority of five judges of nine determined that the claims for the oncomice were not patentable, while four judges vigorously dissented from this conclusion. Jennifer Jannuska comments on how this “Harvard Mouse” case continues to be significant today:

“The impact of this case went far beyond the “life forms” question. It really considered the scope of discretion that the Commissioner has to reject patents on subject-matter grounds. This was very influential in the Amazon.com case, which dealt with patentability of business methods. Madam Justice Sharlow specifically cites Justice Bastarache’s judgment in “Harvard Mouse” in her reasons: “The decision of the Commissioner to grant or refuse a patent application is not a matter of discretion.” (Amazon.com, para. 31) That’s a very powerful statement for those of us doing patent prosecution.”

Summary by: Cheryl Cheung