Patentability Of Higher Life Forms In Canada

Transgenic non-human animals may now be patentable subject matter in Canada. This is the result of the decision of a majority of the Federal Court of Appeal in President and Fellows of Harvard College v. Commissioner of Patents ([2000] 4 F.C. 528), commonly known as "the Harvard mouse case." The Canadian government has obtained leave to appeal this decision to the Supreme Court of Canada.

To be patentable in Canada, an innovation must qualify as an "invention" as defined in the Patent Act. An "invention" is "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter."

The Harvard mouse case arose from the refusal of the Canadian Patent Office to allow claims to "a transgenic non-human mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage." The transgenic animal claimed is useful in testing substances to determine if they are carcinogenic.

A key issue in this case was whether a transgenic animal fell within the definition of an invention, for example as a composition of matter or a manufacture. In particular, it had been argued that the transgenic offspring of a transgenic animal could not be "inventions," as they were produced from their transgenic parents by purely natural processes.

Prior to this decision, the Patent Office had taken the position that "higher life forms", such as plants and animals, were not patentable subject matter, whereas "lower" life forms, such as bacteria and viruses were.

Justice Rothstein, writing for the majority, held that a transgenic mammal was patentable as a "composition of matter" within the meaning of the Patent Act. In reaching his conclusion, Mr. Justice Rothstein adopted the definition of "composition of matter" used by the majority of the Supreme Court of the United States in Diamond, Commissioner of Patents and Trademarks v. Chakrabarty (447 U.S. 303 (1980)) where it was determined that human-made micro-organisms were patentable subject matter in the United States.

In addressing the question of whether the transgenic offspring of a transgenic animal were patentable, Mr. Justice Rothstein noted that most inventions involve some use of the laws of nature. Thus, the mere fact that the laws of nature play a role in the development of the invention does not prevent it from being patentable. In this case, human intervention was needed to create the first transgenic animals. The fact that these animals, once produced, can reproduce to create transgenic off-spring does not render them unpatentable. The offspring exist due to a human-controlled process (the creation of the first transgenic animal). The fact that nature also plays a role in the creation of transgenic animals does not detract from the key role of human intervention. Thus, in Mr. Justice Rothstein’s view transgenic animals and their offspring can be patentable subject matter in Canada.

It had been suggested that the transgenic mouse was not patentable because it was not sufficiently reproducible. Two types of variability were discussed: (a) control over features of the mice other than the presence of the transgene; and, (b) the percentage of mice produced which contained the transgene. In relation to (a), the majority of the Court held that so long as the inventor controlled the feature necessary for usefulness, namely the transgene, it was not necessary to control other features. In relation to (b), the majority of the Court held that a low percentage of production of transgenic mice did not mean that the invention was not reproducible. It was sufficient that the invention could be reproduced, and was therefore useful.

If upheld, this decision would pave the way for much broader protection of transgenic organisms then is presently available in Canada. In particular, novel, non-obvious plant varieties created by genetic engineering would be patentable. Although some protection is currently available for plant varieties under the Plant Breeders’ Rights Act, patent law would provide further and better protection for those plants which qualify.

The decision in the Harvard mouse case is consistent with the earlier decision in Pioneer Hi-Bred case (1 S.C.R. 1623), which distinguished between plant varieties created by crossbreeding and those created by genetic engineering. Thus, organisms created by crossbreeding alone may not be patentable in Canada, unless inventive human intervention can be proven.

The current Harvard Mouse decision is a step toward bringing Canadian patent law in line with the law of the United States and Europe, which permit patents to transgenic plants and animals. (The corresponding United States patent application issued as United States Patent 4,736,866.) The Canadian government is presently looking into public opinion and concerns relating to the patenting of living materials, including higher life forms. Thus, any decision of the Supreme Court in the Harvard mouse case may be overshadowed by subsequent legislative changes.

As with any issue relating to genetically modified organisms, some public concern is to be expected. However, what must be emphasized is that patents provide protection only for novel and non-obvious products or processes disclosed and claimed. Thus, naturally occurring organisms and organisms created by third parties and known to the public before the filing of a patent application, will not be patentable. Additionally, the decision in the Harvard mouse case dealt only with non-human animals, and suggests that transgenic humans would not be patentable.