ASKED & ANSWERED

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Compiled by Amber Lepage-Monette

Among the major developed countries, significant uncertainty characterizes Canadian patent law with respect to living organisms. While the recent Supreme Court decision on the Harvard Mouse case drew a vague distinction between higher and lower life forms — where the latter are patentable subject material while the former are not — the recent Supreme Court decision on the Monsanto vs. Schmeiser patent infringement case upheld the notion that specific modifications to living organisms are patentable regardless of whether or not the organism is of a higher or lower life form.

What is the impact of this patent law uncertainty upon Canadian life science businesses?
Are there alternative strategies that Canadian life science businesses can employ to protect their intellectual assets?
This month’s question was prepared for Asked & Answered by students of University of Saskatchewan’s (Saskatoon, SK) Biotechnology Management MBA program and associate professor Grant Isaac, PhD.
While the Harvard Mouse case (President and Fellows of Harvard College vs. Canada (Commissioner of Patents) [2002] 4 SCR 45) drew a distinction between higher life forms and lower life forms, confirming that the former is not patentable subject matter in Canada, the recent Supreme Court of Canada (SCC) case of Monsanto Canada Inc. vs. Schmeiser ([2004] SCJ No 29) did not change the position on the patentability of higher life forms in Canada.

Monsanto has a patent that protects its technology surrounding glyphosate-resistant crops (CA Patent 1,313,830). As higher life forms are not patentable in Canada, it was not possible for Monsanto to obtain claims to the transgenic plants. Its patent, however, contained claims to a chimeric gene and glyphosate-resistant plant cell containing the chimeric plant gene. One of the issues before the SCC, therefore, was whether Schmeiser, in growing transformed canola containing the patented gene, was infringing Monsanto’s patent.

The SCC found that Schmeiser was infringing Monsanto’s patent. The Court was split 5-4. The majority dismissed Schmeiser’s argument, finding that the entire genetically modified plant infringed the claims to the gene and cells. The following analogy was used: “If an infringing use were alleged in building a structure with patented Lego blocks, it would be no bar to a finding of infringement that only the blocks were patented and not the entire structure. If anything, the fact that the Lego structure could not exist independently of the patented blocks would strengthen the claim, underlining the significance of the patented invention to the whole product, object, or process.”

In the dissenting opinion, the position was put forward that the gene and cell claims should only protect the invention, as it existed in isolation (for example, in a laboratory setting). If this opinion had prevailed it would have been unfortunate for the biotechnology industry, which would have been left with no protection for the commercial embodiment of its invention.

Therefore, I disagree with the initial premise that significant uncertainty exists as a result of the most recent SCC decision. On the contrary, the decision of whether higher life forms are patentable was not before the court, although a number of overtures were made to the Court that they may want to take the opportunity to revisit the issue. Higher life forms continue to be unpatentable in Canada. The importance of the Schmeiser decision is that it was clearly stated that higher life forms can be protected. Therefore, a biotechnology company will be able to protect all aspects of its invention, while in Canada it will not be able to claim the higher life form per se. Therefore, this decision did not create uncertainty for the Canadian life science industry. This decision states that while higher life forms — in this case, plants — cannot be patented, a patent containing claims to a modified or isolated gene, or a cell containing such a gene, effectively gives the patentee exclusive rights over a plant containing patented cells or genes.

As a result of this decision, Canadian life science companies that are making inventions should ensure that all aspects of their inventions are disclosed and have claims. This is not a new strategy, but what any patent agent would normally do in the course of preparing a patent application for his or her clients.

Judy Erratt, PhD, is a partner in the Ottawa, Ont. office of Gowling Lafleur Henderson LLP. Her practice involves the preparation and prosecution of national and international patent applications with a focus in biotechnology. Erratt received her PhD from the University of Western Ontario (London, ON), where she specialized in genetics. Erratt is a registered patent agent in both Canada and the United States.

During the years in which we waited for President and Fellows of Harvard College vs. Commissioner of Patents (the Harvard Oncomouse case) to make its slow way up to the Supreme Court of Canada, there was great uncertainty as to whether, in the end, the Supreme Court would find higher life forms such as plants and animals to be patentable.

There was further uncertainty as to what scope of protection was afforded by the available gene and cell claims, such as those in the patent that was at the heart of the Monsanto vs. Schmeiser case, as that case made its way to the Supreme Court. Indeed, the assertion of invalidity of gene and transformed cell claims in that case raised doubts about issues long settled in other major developed countries.

During those years, Canadian life science businesses had to wonder whether it was worthwhile to pursue patent protection in Canada for their animal- and plant-related inventions. Since many, if not most, biotechnology companies count their intellectual property rights as their major assets, the attractiveness of such companies to investors, at least with respect to their potential activities in Canada, was undoubtedly diminished.

In the Oncomouse decision, the Supreme Court concluded that higher life forms, whether animal or plant, are not within the meaning of “invention,” as defined in the Canadian Patent Act, and are not patentable. This conclusion was reached without any real analysis of what was meant by “a higher life form,” although clearly it was a given, in the Court’s eyes, that a mammal such as a mouse is a higher life form.

The Court declined to review where to draw the line between higher and lower life forms, holding that this was a matter for Parliament and that, until Parliament dealt with the issue, the patent office’s imposed line — that between unicellular and multicellular organisms — should continue. The Supreme Court’s decision in the Oncomouse case made the decision in Monsanto vs. Schmeiser all the more crucial to protection for life science companies in Canada. If one could not obtain claims to a transgenic animal or plant in Canada, could one stop an infringer who used such plants and animals on the basis of claims to transgenic cells and the genes they contained?

The answer of the majority of the Supreme Court in Monsanto vs. Schmeiser was a clear “yes.” Schmeiser was found to have used the claimed invention (claims to a new chimeric gene and to plant cells transformed with that gene) by knowingly sowing transgenic seed and growing transgenic plants.

This decision goes a long way to overcoming the problems created by the Oncomouse decision for those seeking protection in Canada for inventions involving the creation of new, unobvious higher life forms, and creates the much-needed certainty required by potential investors.

Canadian and non-Canadian life science companies seeking patent protection in Canada should therefore adopt the strategy of claiming genes and cells, with the reassurance that they can rely on Monsanto vs. Schmeiser to back their claims of infringement, even in the absence of claims to the animal or plant itself.

Patricia Rae, PhD is a partner in the Advanced Sciences Group of Sim & McBurney and in the law firm, Sim, Hughes, Ashton & McKay LLP, which successfully represented Monsanto Inc. in Monsanto vs. Schmeiser.

There is no doubt that the Harvard and Monsanto decisions will be viewed as sending conflicting messages regarding patentability of life forms. On the one hand, the Supreme Court has held that higher life forms such as plants and animals do not constitute patentable subject matter in Canada. The relevance of this decision, however, appears to be diminished by the more recent judgement in Monsanto in which the Supreme Court not only confirmed the patentability of genetically modified genes and the cells incorporating these genes, but also established that rights in patented genes/cells extend to life forms containing them. So, despite the fact that life forms such as plants and animals are not patentable (Harvard), their use may still be an infringement of patent rights (Monsanto). This is due to the courts’ assertion that “Infringement does not require use of the gene or cell in isolation.” It is quite interesting to note, however, that natural products such as genes and cells are patentable only in a form not found in nature, i.e., in ‘isolated’ form.

Notwithstanding these apparent patent law uncertainties, the impact on Canadian life science businesses, or indeed, any life science business seeking patent protection in Canada, appears to be nominal. For the patentee business, the distinction between patentable versus non-patentable life forms was arbitrarily determined by the patent office to be unicellular versus multicellular life forms as a result of a decision rendered 20 years prior to the Harvard decision (Abitibi (62 CPR (2d)). Thus, the judgement in Harvard, although disappointing, did not impact on available patent scope in Canada. In fact, the door to broader patent coverage appears to have been opened with the Monsanto decision in which claims to modified genes and cells have been construed to cover life forms transformed with such genes/cells. Thus, life science businesses pursuing life-form-related patent protection in Canada, are encouraged to include claims to genes including variant but functionally equivalent genes, vectors incorporating these genes, and cells/cell lines including the genes/vectors in order to capitalize on any available reach-through coverage to the life form itself.

Businesses that utilize life forms, particularly transgenic life forms, should be cognizant of the patent protection surrounding the life form, i.e., patents to the building blocks necessary to give rise to a particular plant or animal, to ensure that commercial gain does not arise from a patented feature. The decision rendered in Monsanto does give weight to the fact that liability for an infringing use of a life form incorporating patented genes/cells is linked to commercial gain resulting from the patented gene/cell. Thus, should a plant/animal incorporating a patented feature come unknowingly into the possession of an ‘innocent bystander,’ failure to take advantage of the patented feature may result in exemption of liability for infringement.

The Plant Breeders’ Rights Act (PBRA) provides an alternative means of intellectual property protection for plants in Canada. Although it does not offer the same scope of protection as patent rights, the holder of rights granted under the PBRA does get protection over the commercial production and sale of reproductive or propagating material (e.g., seeds, cuttings, etc.) of a protected plant variety. However, in contrast to patent rights, there are no provisions in the PBRA to prevent others from using the seeds of a protected plant variety as propagating material for personal use or to produce another variety.

Similar legislation for the protection of animal varieties does not exist.

Susan Tandan is a patent agent working out of the Toronto, Ont. office of Ogilvy Renault. She specializes in biotechnology and life science-related patents.