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Harvard College v. Canada (Commissioner of Patents)

Harvard College v Canada (Commissioner of Patents)
Supreme Court of Canada
Hearing: May 21, 2002
Judgment: December 5, 2002
Full case name Commissioner of Patents v. President and Fellows of Harvard College
Citations 2002 SCC 76, 219 D.L.R. (4th) 577, 21 C.P.R. (4th) 417, [2004] 235 F.T.R. 214
Docket No. 28155
Prior history Judgment for Harvard from the Federal Court of Appeal.
Ruling Gov't appeal allowed
Holding
Higher life-forms are not patentable under the meaning of "invention" in section 2 of the Patent Act
Court Membership
Chief Justice: Beverley McLachlin
Puisne Justices: Claire L'Heureux-Dubé, Charles Gonthier, Frank Iacobucci, John C. Major, Michel Bastarache, Ian Binnie, Louise Arbour, Louis LeBel
Reasons given
Majority Bastarache J., joined by L'Heureux-Dubé, Gonthier, Iacobucci, and LeBel JJ.
Dissent Binnie J., joined by McLachlin, Major, Arbour JJ.

Harvard College v Canada (Commissioner of Patents) is a leading Supreme Court of Canada case concerning the patentability of higher life forms within the context of the Patent Act. At issue was the patentability of the Harvard oncomouse, a mouse that had its genome genetically altered by a cancer-promoting gene (oncogene). In a 5-4 split, the Supreme Court held that the oncomouse and higher life forms in general are not patentable subject matter in Canada.

Harvard College researchers (the respondents) developed a process by which they could create transgenic animals whose genomes are altered by a cancer-promoting gene (called an activated oncogene). The researchers injected the oncogene into fertilized mouse eggs close to the one-cell stage and implanted them into a female host mouse where they developed to term. The resulting offspring were then tested for the presence or absence of the oncogene. Those with the gene are referred to as “founder” mice and are mated with unaltered mice. Offspring that contain the oncogene and have every cell in their body affected (including germ cells and somatic cells) by it are referred to as oncomice. Oncomice are useful for carcinogenic studies as they are more susceptible to carcinogens. Such mice can be given material suspected of being a carcinogen and if tumours develop, it is an indication that the material is carcinogenic.

In 1985, the President and Fellows of Harvard College applied for a patent for an invention called “transgenic animals.” In particular, they applied for a process patent for the process by which they created the mice as well as a product patent for the end product of the process, namely the “founder” mice and the oncomice, offspring whose cells are affected by the gene. These patent claims also extend to all non-human mammals whose genomes have been altered in a similar manner. Patent applications on the oncomouse were filed in many countries including the United States, Canada, Europe (through the European Patent Office) and Japan.


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