Teva Canada Limited v. Novartis Pharmaceuticals Canada Inc., 2016 FCA 230

The Federal Court of Appeal dismissed an appeal from a decision prohibiting the Minister of Health from issuing a Notice of Compliance to Teva for EXJADE®. The Federal Court had concluded that Teva's allegations of inutility, obviousness and insufficiency were not justified (the underlying application decision is 2015 FC 770 and summarized the week of July 6, 2016).

On appeal, the Court of Appeal characterized the sole issue as whether the trial judge had erred in law in its construction of the promise of the relevant patent. Teva acknowledged that the trial judge had correctly identified the principles of law relevant to the utility requirement but erred in the construction of the promise of the patent by:

  1. relying on the patent's abstract to construe the promise;
  2. distinguishing between the promise made in respect of the patented formula I and formula II compounds; and,
  3. applying the doctrine of claim differentiation.

While the Court of Appeal agreed that the trial judge ought not to have considered the abstract when construing the promise of the patent, this error was not material to the decision and the trial judge's construction was found to be correct.

The FCA concluded that the trial judge's construction of the promise of the patent was consistent with differentiation contained in the disclosure and the claims. Thus, the trial judge was correct to differentiate between the compounds and use claims. The Court of Appeal noted that Teva's argument that the trial judge erred in distinguishing between the promise made regarding the two classes of compounds ignored the fact that at law different claims can have different utilities for the same compound.

The Court of Appeal also reiterated that where an allegation of an unfulfilled promise is made, “the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person as excluding this promise” (see Apotex Inc. v. Pfizer Canada Inc., 2014 FCA 250 at para 66). The Court of Appeal agreed with the trial judge that this patent could be read by a person skilled in the art as excluding Teva's asserted elevated promise of utility.