As a result, discerning whether the specification has a promise of a specific result can have significant impact on the validity of a patent. The recent Federal Court of Appeal decision of Apotex Inc v Sanofi-Aventis Canada Inc (“Sanofi”), for which the Supreme Court has granted leave to appeal, advocates for a degree of constraint when determining whether a patent contains a promise.

In Sanofi, the Court held that it must look to the patent to determine whether it contains an explicit promise that the invention will achieve a specific result. Since there is no obligation on the part of the inventor to disclose the utility of his invention in the patent, not every patent contains an explicit promise of a specific result.

The idea of a “promise doctrine” is the subject of a NAFTA challenge by Eli Lilly. Central to Lilly’s argument is that two of Lilly’s patents were invalidated on the ground they were not useful, notwithstanding their approval by Health Canada and their commercial success. Lilly alleges that the promise doctrine is inconsistent with NAFTA as it imposes a significantly higher burden on the patentee than the standard of utility mandated by NAFTA.�� Specifically, Lilly alleges that Canada’s failure to abide by its NAFTA obligations has resulted in the unlawful expropriation of its patent rights.�� Lilly argues that the “promise doctrine” has caused a dramatic and unprecedented shift in Canada’s utility standard and is inconsistent with the utility standard embodied in NAFTA.��  Lilly pointed out that one of the patents was challenged and upheld in 18 countries throughout the world, and Canada was the only jurisdiction to invalidate on the basis of inutility.

Canada, in response, has argued that the “promise doctrine” was endorsed by the Supreme Court as early as 1981 in Consolboard v MacMillan, while NAFTA came into force in 1994. There is no requirement to make a promise, but a promise may be made for a variety of reasons, including where a new and non-obvious use of a known compound is the essence of the invention or in selection patents where a sub-species of the genus has a surprising and non-obvious advantage. Canada further notes that NAFTA does not provide direction as to how the core patent concepts of “new”, “inventive”, and “industrial application” are to be interpreted and applied in particular patent cases.

The Sanofi decision appears to have pushed back on certain elements of the “promise doctrine” that Lilly complains of in its NAFTA challenge. Lilly alleges that the Courts read into the patents an “implied promise” that the drugs would work in the longer term based on the chronic nature of the conditions being treated. In Sanofi, the Court of Appeal finds that the Trial Judge erred in finding a promise on the basis of inferences, in the absence of clear and unambiguous language. Sanofi thus draws a distinction between the potential use of an invention and an explicit promise to achieve a specific result, and finds that a goal is not necessarily a promise.

As noted by Canada in its Statement of Defence, domestic patent law continues to evolve, including the promise doctrine.

One possible way forward is to limit the promise doctrine in a manner similar to the Federal Court’s recent treatment of the heightened requirements for a “sound prediction” of utility.�� In a July 2014 Apotex v. AstraZeneca (“�����ٰ����ܱ�Ա𳦲�”) decision, Justice Rennie concludes that the patentee should only face a higher burden for disclosed utility in “new use for known compound” type patents.�� The rational was that, for these “new use” patents, the entire invention resides in the new utility, hence there should be a higher standard for showing utility.

The appeal of Astrazeneca to the Federal Court of Appeal, the Sanofi appeal to the Supreme Court of Canada, and Lilly’s NAFTA challenge will continue the evolution of these doctrines.

David Heller is a Partner at the Toronto office of Ridout & Maybee LLP, where he specializes in the areas of pharmaceuticals, biotechnology, and chemistry.��David has been recognized as a leading IP lawyer in the Chambers Global Guide 2014, 2013, and 2012 rankings.

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The “Promise of the Patent” Doctrine and its Latest Interpretation

The interpretation of what is considered “useful” as a requirement of patentability in the has been at issue over the last few years, with jurisprudence over the last decade seemingly taking us away from the “” benchmark that has been used historically. As set out in the landmark SCC decision in , in the context of pharmaceutical patents, there is frequently an estimation or “promise” at the time of filing that sets out the pharmaceutical’s clinical effectiveness before it has been (or can be) factually demonstrated.�� The jurisprudence has set out that, in order for the patent to subsequently be held valid, one must be able to factually establish this promise of utility or alternatively, establish it through the doctrine of sound prediction. The sometimes difficult and somewhat paradoxical requirement of demonstrating a “promise” of utility at the time of filing as set out in Wellcome has created a judicial environment that has seen many pharmaceutical patents recently being invalidated for lack of utility, much to the chagrin of the innovative pharmaceutical industry.

The case , revolves around Eli Lilly’s claim that Novopharm infringed their patent for the schizophrenia drug olanzapine. , the case was eventually remanded back to Federal Court where the . In the court’s judgment, it was held that the patent had a “promise” that olanzapine was “substantially better” in the treatment of schizophrenia than other known anti-psychotics, and that the individual advantages asserted in this comparison with other compounds “form the foundation for the overall promise of the patent”  (paras 124-125). The court goes on to conclude that at the time of filing, “there is no sound and articulable line of reasoning, or a prima facie reasonable inference, that would have led the inventors from the evidence available at the relevant time to the explicit promise of the substantial advantage set out” (para 267), and subsequently found the patent invalid for lack of demonstrated utility. An appeal to the FCA of the decision was , and the most recent with no reasons given, even after the court granted leave to hear oral submissions on the application, a rare occurrence.

What is most interesting about the Canadian “promise of the patent” doctrine is that it is not explicitly found in the or in . In fact, both the and courts have come to contrasting decisions on the same olanzapine patent held by Eli Lilly, both courts choosing not to adopt the Canadian “promise of the patent” approach to utility. In doing so, these courts declined to invalidate the patent on these grounds. This judicial interpretation requires a higher standard in demonstrating utility for pharmaceutical patents from patent applicants in Canada than any of the country's largest trade and political partners

Criticism of the Doctrine at an Important Time

The extra hurdles that are presented by the “promise of a patent” utility requirement have been criticised by both the innovative pharmaceutical industry and Canada’s trading partners. The conflict has spilled out of the courtroom and into the political sphere when Eli Lilly served a under chapter 11 of the NAFTA agreement. Eli Lilly claims that the promise doctrine is non-statutory judicial law-making, violating Canada’s treaty obligations by invalidating useful pharmaceutical patents. In addition, a recent criticized the heightened utility requirements of Canadian pharmaceutical patents, putting pressure on a Canadian government that is in final negotiations for the landmark which .��

Choosing Not to Address the Issue: An Expression of Deference to the Executive Branch?

It is odd and perhaps disheartening that the SCC has not chosen to clarify the issue and lay out a clear judicial test for the contentious “promise of the patent” utility requirement. It is difficult to imagine that resolving this issue, one that has garnered so much scholastic and political attention, would not be in the public’s best interest. It could be that the SCC is trying to stay out of - what it views to be - an issue for the legislature, and is waiting for the outcome of political maneuvering before attempting to determine the issue according to its own reasoning. Although something like the NAFTA tribunal has limited powers and could not make direct amendments to legislation, the that Canada is currently facing means that any outcome of this issue is sure to have large diplomatic ramifications.

On the other hand, as this doctrine is seemingly one of judicial interpretation outside the explicit text of the - and is clearly a heightened utility requirement when compared to the US and the EU - one may feel that the SCC has an obligation to give a definitive justification and clarify the promise doctrine. If Canada is to be the “lone rebel” with this doctrine, the SCC must come out and address this issue. Delaying or avoiding this will only further the deleterious effects that uncertainty will have on all parties involved in these disputes.

Adam Falconi is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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