Canadian Biotechnology & Pharmaceutical Law Bulletin

Volume 2 - February, 1996

This newsletter is not intended to constitute a legal opinion on any of the issues discussed. Readers should seek professional legal advice on issues of concern to them - we would be pleased to elaborate on any of the articles herein and discuss how it might apply to specific problems. Contact us for more information.

The 'Harvard Mouse' Rejected by the Commissioner of Patents: Ramifications for Potential Patentees of Plants and Animals

Against the background of currently heated public debate over how far biotechnology and genetics researchers should be allowed to obtain patent protection for the products of their research, the Commissioner of Patents has rendered a decision rejecting the 'Harvard Mouse' application.

The application itself, entitled "TRANSGENIC ANIMALS", dealt with a transgenic mouse which through alteration and breeding was genetically predisposed such as to be beneficially used in cancer research. The genes in question were identified and produced, and then implanted in a number of mouse embryos. The developed mice from these embryos were analyzed for the presence of the genes, and were then bred with unaltered stock to produce a line of genetically altered mice.

The widely drafted claims of that patent read in part as follows:

1. A transgenic non-human mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal, at an embryonic stage.

11. The mammal of claim 1, said mammal being a rodent.

12. The mammal of claim 11, said rodent being a mouse.

The Patent Examiner rejected the application and opined that the Commissioner of Patents was obliged to consider the public interest in evaluating a patent application.

The Commissioner points out in his own written decision that that would imply that he has been conferred with a policy discretion beyond the terms of the Patent Act and an invention could be found to be unpatentable even though it complied with interpretation under the terms of the Act. The Commissioner overrules this position, citing the decision of the Supreme Court of Canada in Monsanto Co. v. Commissioner of Patents, 42 C.P.R. (2d) 161. The first important holding of this decision, therefore, is that the Commissioner of Patents is bound to examine a patent application solely within the bounds of the Patent Act - there is no residual discretion on public policy grounds.

Having stated that the only basis upon which he could refuse to allow the application to go forward was to find it not in compliance with the terms of the Patent Act, the Commissioner goes on to deal with the invention at hand. He makes the following statement: ...although obiter, the [Supreme] Court [in Pioneer Hi-Bred v. Commissioner of Patents, 25 C.P.R. (3d) 257] commented on the patentability of creations that occur in accordance with the laws of nature. It suggests that creations of the reproductive process have never been allowed to form the basis of a patent because they are following the laws of nature, they are mere discoveries the existence of which man has simply uncovered.

Stepping back from the Supreme Court decision in Pioneer Hi-Bred, the commissioner goes on his decision to refer more specifically to the decision of the Federal Court of Appeal in that case. He indicates that on the basis of authorities cited therein the Court found that cross-breeding did not equate to 'manufacture' as that term is used in the Patent Act. The 'Harvard mouse' application consisted of two sets of claims - one set dealing with the transgenic mouse itself, and the second set of claims dealing with the method of identification, expression and production of the genes which were implanted into the mice. The Commissioner makes the same distinction here as did the Examiner - the second set of claims dealing with the production of the gene itself did identify patentable subject matter since that portion was all done as a result of work generated and controlled exclusively by the inventors. The first set of claims, with respect to the transgenic mouse containing the genes, however, were not allowable because the process of putting the genes into the new line of mice relied on the processes of nature in reproduction - the processes of nature being beyond the control of the inventors, that set of claims were not allowable.

Addressing the argument put forth by the applicant that the patent should be allowed to issue since the similar claims had been allowed in the United States and the language in the patent legislation in the two countries is very similar, the Commissioner indicated that he could not be bound to consider Canadian law in the light of American interpretation.

The Harvard mouse patent was widely expected to issue - opening the door for other potential patentees to apply for patent protection for genetically altered plants and animals. While the appeal process in this matter runs its course, potential patentees should avail themselves of existing avenues of alternative protection. Given the Commissioner's statement that there is no residual discretion in that office to refuse to grant patent protection on public policy grounds, it can be expected that some sort of protection will be allowed at some time. In the meantime, inventors should continue to file their patent applications drafted in similar broad language. Inventors of particular plant varieties or traits should at this point continue to file for protection under the Plant Breeders' Rights Act. Of peripheral relevance to this particular case, but indicative of the position to be taken by the Patent Office with respect to the patentability of plants, the Commissioner points out that the Federal Court of Appeal had noted in Hi-Bred that "plant breeding was well established when the Patent Act was passed so that if a new plant variety had been intended to be included in the definition of invention, Parliament would have included special provisions in the statute." This indicates that the Patent Office may take the position that plant varieties do not constitute patentable subject matter until legislative change is made.

The applicants/assignees, the President and Fellows of Harvard College, have filed an appeal from the decision of the Commissioner of Patents in the Federal Court of Canada.

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