Last month, the Supreme Court of Canada (SCC) denied leave to appeal in the case Eli Lilly Canada Inc v Novopharm Ltd, passing on an opportunity to clarify the controversial “promise of the patent” utility requirement for Canadian pharmaceutical patents.
The “Promise of the Patent” Doctrine and its Latest Interpretation
The interpretation of what is considered “useful” as a requirement of patentability in the Patent Act has been at issue over the last few years, with jurisprudence over the last decade seemingly taking us away from the “scintilla of utility” benchmark that has been used historically. As set out in the landmark SCC decision in Apotex Inc. v. Wellcome Foundation, 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 Eli Lilly Canada Inc v Novopharm Ltd, revolves around Eli Lilly’s claim that Novopharm infringed their patent for the schizophrenia drug olanzapine. Over a long course of litigation, the case was eventually remanded back to Federal Court where the patent was found invalid for utility. 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 dismissed from the bench, and the most recent leave to appeal to the SCC was denied 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 Patent Act or in legislation from other jurisdictions like the US or the EU. In fact, both the UK and US 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 Notice of Intent to submit a claim to arbitration 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 United States Trade Representative report criticized the heightened utility requirements of Canadian pharmaceutical patents, putting pressure on a Canadian government that is in final negotiations for the landmark Comprehensive Economic and Trade Agreement which purportedly involved extensive intellectual property reform.
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 precarious political climate 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 Patent Act – 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.