The Federal Court of Appeal’s Decision against the Commissioner of Patents on the Harvard Onco-mouse Case

Context:

1. On June 21st, 1985, Harvard filed a patent application for an invention entitled “Transgenic Animals”. This application sought patents on both (a) the process of producing transgenic (i.e. genetically-modified) mice that were susceptible to cancer, and (b) the products of that process- the Harvard Onco-mouse and its transgenic offspring. The Patent Examiner granted Harvard patents on its method of genetic modification, but refused to allow patents on its transgenic mice. The Commissioner affirmed this decision. Harvard appealed to the FTD (Federal Court Trial Division).

2. The FTD upheld the decisions of both the Examiner and the Commissioner. The FTD judge ruled that although the definition of “invention” in the Patent Act had been previously extended to include lower life forms (e.g., yeast), it was inappropriate to stretch it even further to include higher life forms (e.g., transgenic animals) because of the level of control over the inventive subject matter. As such, the FTD judge held that the Harvard Onco-mouse and other similar transgenic, non-human mammals were not patentable subject matter in Canada.

3. The case was then directed to the Federal Court of Appeal (FCA) whose decision is an appeal from the FTD. On August 3, 2000 the Canadian Federal Court of Appeal delivered it’s judgement. By a majority ruling, the court found in favour of the appellant and awarded costs to Harvard for the proceedings before the FCA and the FTD.

4. Non-human higher life forms are considered patentable by both the United States Patent and Trademark Office and the European Patent Office. Canada would be better able to contribute to forthcoming multilateral negotiations on biological Intellectual Property if a domestic policy was established prior to the commencement of these negotiations.

Federal Court of Appeal Finding:

5. In this case, the Federal Court of Appeal ruled that the wording of Canada’s Patent Act, as it currently stands, permits the patentability of genetically altered non-human mammals for use in carcinogenicity studies

6. The Harvard Onco-mouse patent application is specifically directed to a transgenic animal, particularly a mouse. The Commissioner of Patents and the Federal Court of Appeal (Trial Division) previously refused this application on the grounds that they did not consider a genetically modified animal to be an invention within the definition of the Patent Act. The Federal Court of Appeal’s decision overturns these rulings. The majority judgement states that the Harvard onco-mouse qualifies as a new, useful and non-obvious composition of matter within the definition of the Patent Act, and therefore is patentable subject matter in Canada. It also refers the matter back to the Commissioner of Patents with the direction to grant a patent on the Harvard onco-mouse.

7. The majority’s rationale for overturning the lower court’s decision and determining that the Harvard Onco-mouse was, in fact, patentable subject matter in Canada was based upon, amongst other things, seven critical findings.

   The first finding, and the one with the most public significance, was that it was inappropriate for the courts to take into account public policy arguments when deciding this case. The Honourable Justice Rothstein, writing for the majority, stated that the proper forum for addressing public policy issues on the patentability of complex life forms was Parliament, and not the appeal courts.

   The second finding was that the Supreme Court of Canada’s (“SCC”) past analysis of the patentability of complex life forms indicated that it had accepted that living things were not necessarily excluded from patent protection in Canada. Hence, the majority found that it had a duty to be cautious, but not necessarily restrictive when determining whether the Harvard Oncomouse was patentable under the current parameters of the Patent Act.

   The third finding was that Parliament’s intentions regarding the interpretation of Canada’s Patent Act were similar to that of Congress because our Act was modeled on the U.S. statute and used the same broad language. As such, the majority held that the U.S. Supreme Court’s (“U.S.S.C.”) conclusion that their Patent Act was intended to include higher life forms within the definition of “invention” was relevant and had persuasive value for Canadian courts. On the basis of this finding, the majority found that the Harvard Onco-mouse and its transgenic offspring qualified as non-naturally occurring “compositions of matter” under our Patent Act.

   The fourth finding was that the FCA was obliged to allow Harvard’s appeal in this case if it found the legal reasoning of the FTD judge and the Commissioner to be incorrect. The rationale for applying such a high level of judicial review to the lower court’s and the Commissioner’s decisions was that this case involved the interpretation of a fundamental clause of the Patent Act, the definition of “invention”, and would likely have significant precedential value.

   The fifth finding was that the Commissioner and the FTD judge had erred in law in deciding that the Harvard Onco-mouse and its transgenic offspring were not “useful inventions” because all of their physical characteristics were not under the full control of their inventors. In the majority’s opinion, the correct test for usefulness was much narrower. It was whether or not an inventor had control over the elements of an invention that made it useful (i.e. in this case, the fact that the mice were susceptible to cancer). The majority found the Harvard Onco-mouse and its transgenic offspring met this much narrower test for usefulness.

   The sixth finding was that the Commissioner had erred in law in splitting the invention of the Onco-mouse into two phases- phase one that involved inventive ingenuity and was considered patentable; and phase two that involved the laws of nature and was considered unpatentable. According to the majority, this distinction was illogical. The Commissioner incorrectly denied Harvard a patent on its Onco-mouse on the grounds that these transgenic animals were only the products of phase two, the unpatentable phase, when in reality they were the products of both phases.

   The seventh, and final critical finding, was that the Patent Act’s definition of “invention” could not be extended to include human beings. The majority’s reasoning for this assertion was that patenting is a form of ownership and ownership concepts cannot be extended to human beings under the common law and the Canadian Charter of Rights and Freedoms.

8. The Honourable Justice Issac dissented from the majority, on the grounds that the majority should have accorded a more deferential standard of review to the Commissioner’s decision. Justice Issac considered the question of patentability of inventions to fall squarely within the expertise of the Commissioner. Consequently, he considered the proper standard of review for the Commissioner’s decision to be reasonableness and not correctness. In addition, Justice Issac concluded that Commissioner’s rationale for denying a patent on the Harvard Onco-mouse was properly informed by public interest considerations. These considerations justified a very deferential standard of review, especially in light of the morally divisive nature of this case.

9. It must be noted that the Honourable Justices Linden and Rothstein state in the majority reasoning for their decision, that “it is Parliament and not the Court that defines the limits of patentability.” This is significant to CBAC, as a portion of our mandate is to seek out the views of Canadians and provide policy advice to the Canadian government on how it should proceed with the issue of patenting of higher life forms.

10. The Federal Court of Appeal has given the Government of Canada the right to seek leave to appeal this matter to the Supreme Court of Canada within 60 days following the August 3, 2000 judgement.

Summation of Relevant Concerns:

11. CBAC notes that the Commissioner of Patents can apply to the Federal Court of Appeal for an order staying execution of its own Judgment, prior to appealing to the Supreme Court. If the Judgment is not appealed, then the Commissioner is required to comply with the Judgment and to grant a patent for the contested claims. The Commissioner would also be bound by the Judgment to allow patents for life forms which are within the scope of the Judgment.

12. It is also important to note that in the appeal judgement it is stated that the issue on appeal is directed to the interpretation of the Patent Act and whether or not the subject matter (pertaining to a higher life form) is patentable subject matter. There is no consideration of whether or not the subject matter is a non-human higher life form, for example, a primate or a plant. There is also no stated limit that section 2 applies only to non-human higher life forms, since this requirement can also be satisfied by other higher life forms that are new and useful.

13. It is also important to note that on inquiry with the Patent Office, our legal counsel was advised that if the Judgment is not appealed, any life form “below” an animal may also be considered patentable, for example plants. However, there has been no official policy set on this matter by the Canadian Patent Office at the present time. In addition, it is stated in [127] that the Patent Act cannot extend to cover human beings in part due to Section 7 of the Charter of Rights and Freedoms. Furthermore, there is no analysis in the Judgment of whether or not elements of a human body, including human genes, products or processes at the genetic level are patentable subject matter. Rather, in [128] it is stated that this matter requires determination by the Courts or Parliament.

14. We also observe that although no comment is made in the Judgment on the patentability of primates, as primates are non-human animals, any invention that pertains to a primate, and that is new, useful, non-obvious, a composition of matter, and involves inventiveness or ingenuity (and not just laws of nature) would, arguably, also be patentable subject matter.

15. From a global perspective, biotechnology patenting issues will be considered in international negotiating fora. The next round of multilateral trade negotiations is expected to commence this year. The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) addresses the question of patentability of higher life forms in Article 27.3(b). The operation of this section allows WTO Members to exclude from patentability plants and animals and essentially biological processes for the production of plants and animals. Some Members are advocating for the Article’s expansion, while other Members (e.g., the United States) are advocating for a narrowing of the Article and possibly its elimination. Canada would be better able to contribute to this debate if a domestic policy was developed prior to the commencement of these negotiations.

Conclusions

16. On the basis of the foregoing observations CBAC advises as follows:

    1. First, CBAC concurs with the Federal Court of Appeal’s finding that Parliament, not the Courts, should determine Canada’s policy with respect to the patenting of higher life forms (and the distinction between “lower” and “higher” life forms).

    2. Second, CBAC believes that to date, Canadians have not had an opportunity to debate the full range of moral, ethical and social issues that are at stake in this case. CBAC believes that Canada’s laws must reflect the values Canadians share.

    3. Third, a decision on whether or not to appeal the Court’s ruling is, for CBAC, a moot consideration. If the decision stands, the Courts will have de facto decided on a policy issue that CBAC believes to be the proper prerogative of Parliament. Moreover, until Parliament deals with these issues, the current public concerns as to what biological products or processes are patentable will remain. Even if the Court’s finding is appealed, it will not obviate the need for Parliament to address what is, ultimately, a policy issue.

    4. Fourth, CBAC encourages the Government of Canada to take all reasonable and feasible steps to facilitate Parliamentary review of the issue of patenting of biological products and processes. In doing so, it would be desirable to use an appropriate mechanism to “stop the clock” while the policy review process is undertaken. In that regard, 2 options were considered by CBAC:

       1. Option 1
          CBAC encourages the Government of Canada to immediately begin the Parliamentary process to consider an amendment to the Patent Act, to explicitly forbid, if required, particular classes of higher life forms such as primates, the human body and certain plant species. Parliament may also want to consider the addition of a policy provision (e.g the ordre publique and morality clause found in The European Patent Convention), within the current Patent regime, which would allow the explicit consideration of policy issues with each patent application. Upon initiation of this interim process the Government of Canada would advise Parliament if necessary to amend the relevant provisions of the Patent Act. CBAC would assist in this process by consulting Canadians on the issues at stake in this debate and reporting on their views.

       2. Option 2
          CBAC encourages the Government of Canada to file an application for leave to appeal the Federal Court of Appeal’s Judgement on the Harvard Onco-mouse case to the Supreme Court of Canada. While this application is being considered, the Government of Canada would advise Parliament if necessary to amend the relevant provisions of the Patent Act. CBAC would assist in this process by consulting Canadians on the issues at stake in this debate and reporting on their views.

          A majority of CBAC members favoured option 1. There was minority support for Option 2 based on the argument that this highly important issue of public policy should not be determined by the courts but by Parliament, and that a full public debate on the issue of the patenting of higher life forms should inform Parliament’s deliberations. An appeal accompanied by a stay of the judgement of the Federal Court of Appeal could provide an opportunity for such a process to be implemented. Those supporting Option 1 acknowledged this point, but believed an appeal could result in a lengthy court process and that Parliament would await the Supreme Court of Canada’s decision prior to beginning the desired review.