Mike McHugh, who does work for Thompson Cooper on pharmaceutical and biochem patents, shares the following insights on the Promise of the Patent.
In the last few years there have been some interesting developments with respect to assessing whether or not a patent has met the utility requirements for patentability. The so-called “promise doctrine” is a rather controversial approach to assessing the utility of an invention, and has arisen largely in the context of pharmaceutical patent litigation. Under the doctrine, a patentee who “promises” a specific result (for example, that a compound has a specific property, utility or advantage), may be held to a higher standard of utility that that required by the Patent Act. Under the Act, the utility threshold is met if any level of utility is demonstrated (i.e. a compound has to work as described, but it does not have to work “well”).
There have been a number of decisions, both at the Federal Court and Court of Appeal level which have invalidated patents for lack of utility because the Court found that the promise of the patent had not been met. In some cases a patent was invalidated despite the lack of an explicit “promise” i.e. the Court inferred a promise, based upon statements made in the specification.
More recently, however, courts have taken a more restrained approach. In Eli Lilly Canada v Novopharm, 2010 FCA 197, the Federal Court of Appeal (FCA) described the heightened utility requirement as follows:
Where the specification does not promise a specific result, no particular level of utility is required; a “mere scintilla” of utility will suffice. However, where the specification sets out an explicit “promise”, utility will be measured against that promise. The question is whether the invention does what the patent promises it will do. (at 76)
In Sanofi-Aventis v Apotex, 2013 FCA 186, the Court held that it is improper to assume that all patents make a promise of utility and emphasized that a promise should only be construed when “the inventor makes an explicit promise of a specific result”. Otherwise, a “mere scintilla” of utility is sufficient.
However, such restraint has not been universally applied; in Alcon v Cobalt Pharmaceuticals, 2014 FC 14, the Federal Court construed the promise of the patent even in the absence of explicit language. As a result, it is still not clear how the promise doctrine will be applied going forward.
It was hoped that the Supreme Court of Canada would provide some guidance on this issue when it granted leave for Apotex to appeal the decision in the Sanofi-Aventis case mentioned above, but the case was discontinued (by Apotex) just before it was due to be heard.
The application of the promise doctrine in Canadian jurisprudence does have some serious implications for those drafting patents. Statements which could potentially be construed as a promise of some enhanced utility or advantage should be avoided. “Object” clauses (e.g. “it is particular object of the invention to provide compounds having fewer side effects”) seem to be safe, as these have been construed as being no more than a prospective aim of the invention (AstraZeneca v. Mylan, 2011 FC 1023, aff’d 2012 FCA 109).
Particular attention should be made to claim language, as statements made in claims are more likely to be construed as promises compared to statements made in the specification.
Eli Lilly have launched a NAFTA challenge against Canada with regard to the doctrine, taking the position that it has caused a dramatic and unprecedented shift in Canada’s utility standard and is inconsistent with the utility standard embodied in NAFTA. Hearings on the issue should begin some time in 2016.