August 15, 2000
Court Of Appeal Finds Higher Life Forms Are Patentable In Canada
In a landmark decision in President and Fellows of Harvard College v. Commissioner of Patents (3 August 2000), Ottawa A-334-98 (F.C.A.), a majority of the Canadian Federal Court of Appeal held that Harvard’s transgenic "oncomouse" was patentable subject matter under the Canadian Patent Act [the "Act"].
Although the government may further appeal the decision to the Supreme Court of Canada, this decision has immediate implications on the patentability of higher life forms such as seeds, plants and animals. We would advise anyone having patent applications currently pending in Canada to consider whether any claim amendments are warranted.
In the decision, the Court of Appeal applied traditional administrative law principles to interpret the Act and found that higher life forms were encompassed within the definition of "invention" therein. In interpreting the Act, the Court stated that one cannot read words of limitation into the statute not placed there by Parliament and that any policy questions regarding patentable subject matter are to be addressed by Parliament and not by the Court.
The Court applied Monsanto Co. v. Commissioner of Patents [1979] 2 S.C.R. 1108 in finding that when a process or product satisfies the requirements of the Patent Act, an application for a patent must be granted.
The requirements of patentability under the Act are that an invention must be a new, useful and non-obvious (inventive) art, process, machine, manufacture or composition of matter. The Court recognized that laws of nature, physical phenomena and abstract ideas are not patentable per se as they would be mere discoveries and would lack inventive ingenuity. However, the Court went on to state that all inventions, to some degree or another use the laws of nature and that if coupled with inventive ingenuity could be patentable.
The Court overturned the Trial Division’s finding that the transgenic mouse lacked sufficient control and reproducibility to be patentable because the inventors only had control over one of many genes and not all offspring were transgenic. The Court held that the issue of control and reproducibility in patent law goes to the requirement of utility and the ability to use the invention as described. The Court stated that the usefulness of the product (ie. the use of the oncomouse in carcinogenicity studies), was dependant on whether, by using the methods described by the inventors, a mouse is produced with all of its cells affected by the oncogene. It was not relevant that the myriad of other genes of the mouse are not under the control of the inventors. With regard to reproducibility, the Court held that the oncomouse was sufficiently reproducible to be useful.
In determining that the transgenic mouse was a "composition of matter" under the Act, the Court recognized that there was no dispute that lower life forms were compositions of matter and it did not see any difference between lower and higher life forms on this issue. It is significant to note that the Court took guidance from the U.S. case of Diamond, Commissioner of Patents and Trademarks v. Chakrabarty (1980) 206 U.S.P.Q. 193, which dealt with the same issue under the U.S. Patent Act. The Court stated that although United States patent decisions are obviously not binding on Canadian Courts, where the statutory language which is being interpreted is similar, and where the reasoning underlying the United States Court’s interpretation of the language is persuasive, there is no reason why Canadian courts should ignore the U.S. jurisprudence. This may have a significant impact on patent prosecution and litigation in Canada, where caselaw is minimal.
For these reasons, the Court held that the "oncomouse" was a non-obvious, new and useful composition of matter, a product of human ingenuity and not merely an observation or discovery of the laws of nature.
In obiter, the Court addressed the issue of patentability of human beings. It stated that there is no concern that human beings would be patented in the way the oncomouse is, given that the concept of ownership, which applies to non-human animals, cannot be extended to human beings. The Court distinctly stated that these observations do not apply to human genes or products or processes at the genetic level.
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