AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36

Drug: esomeprazole

In this decision, the Supreme Court of Canada (SCC) overturned the decision of the Federal Court of Appeal (FCA), and held the patent to be valid and infringed. In so doing, the SCC established a new test for determining utility pursuant to the Patent Act and held that the so-called ‘Promise Doctrine’ is not the correct approach to determine utility. Our summary of the FCA decision can be found here, and the decision is here.

The SCC held that the utility requirement in s. 2 of the Patent Act is a necessary pre-condition to patentability. However, the question was: useful for what? The Federal Courts have answered this question with the Promise Doctrine. However, the SCC held that this doctrine is excessively onerous in two ways: (1) it determines the standard of utility by reference to the promises expressed in the patent; and (2) if there are multiple expressed promises, it requires that all be fulfilled for a patent to be valid.

The SCC held that the Promise Doctrine conflated s. 2 and s. 27(3) of the Patent Act. Section 2 is the requirement that an invention be useful – a condition precedent to an invention. Section 27(3) is the requirement to disclose the invention’s operation or use, which is independent of s. 2. In considering the allegation that the Promise Doctrine prevents a patentee from overpromising, the SCC held that numerous other sections of the Patent Act address this mischief.

Furthermore, the SCC held that requiring all promises to be met is also unfair. A single use makes a subject-matter useful. The Promise Doctrine risks an otherwise useful invention being deprived of patent protection because not every promised use was sufficiently demonstrated or soundly predicted by the filing date. The SCC held that such a result is punitive and has no basis in the Patent Act. In addition, the SCC held this requirement to be antagonistic to the bargain theory wherein patentees are asked to give fulsome disclosure in exchange for the limited patent monopoly.

The SCC then set out the correct approach to utility, holding that it is the subject-matter of an invention or improvement that must be useful. And this subject-matter must be capable of an actual relevant use and not be devoid of utility. To determine whether a patent discloses an invention with sufficient utility under s. 2, the following analysis is to be undertaken:

  1. Courts must identify the subject-matter of the invention as claimed in the patent.
  2. Courts must ask whether that subject-matter is useful – is it capable of a practical purpose (i.e. an actual result)?

The SCC confirmed that a scintilla of utility will do, and that a single use related to the nature of the subject-matter is sufficient. Furthermore, this utility must be established by either demonstration or sound prediction as of the filing date. The SCC held that the application of the utility requirement in s. 2 is to be interpreted in line with its purpose – to prevent the patenting of fanciful, speculative or inoperable inventions. Furthermore, a patentee is not required to disclose the utility of the invention in order to fulfill the requirements of s. 2.