In Teva Canada v. Novartis Canada 2016 FCA 230, the Federal Court of Appeal confirms that in assessing the utility of a patented invention, different patent claims can have different promised utilities.
This decision was made in Teva’s appeal from the Federal Court’s judgment (2015 FC 770) in which the Minister of Health was prohibited from granting an NOC to Teva in respect of its generic version of Novartis’ EXJADE® (deferasirox).
The only issue on appeal was whether the lower court erred in law in its construction of the so-called “promise of the patent”.
Before the Federal Court, Teva argued that Canadian Patent No. 2,255,951 (the “951 Patent”) was invalid on the basis of obviousness, insufficiency and a lack of utility.
The Federal Court held that Teva’s allegations of obviousness and insufficiency and lack of utility were not justified and prohibited the Minister of Health from issuing a NOC to Teva in respect of its generic version of EXJADE®.
With respect to its inutility allegation, Teva argued that the 951 Patent promises that the compounds had been tested in humans and found to be both non-toxic and useful in the therapeutic treatment of iron-excess disorders. Teva argued that this promise applied to all claims.
On appeal, Teva argued that the Federal Court erred in its construction of the patent promise in three ways: (1) relying on the patent’s abstract to construe the promise; (2) distinguishing the promise with respect to different classes of compounds; and (3) applying the doctrine of claim differentiation.
With respect to the first appeal argument, Dawson J.A. writing for the Federal Court of Appeal agreed that the Federal Court should not have considered the patent abstract in its decision. However, the Court found that this error was not material to the Federal Court’s decision given that the Court had supported its construction interpretation with reference to specific patent passages and had construed key passages in the patent prior to its discussion of the abstract.
The Federal Court of Appeal rejected Teva’s second argument, that patent claims to different classes of compounds should be found to have the same promise merely because one class of compound was a subset of the other. The Federal Court’s construction of the promise of the patent was found by the Federal Court of Appeal to be consistent with the differentiation contained within the patent disclosure and the claims. In this regard, the Federal Court of Appeal held that different claims can have different utilities for the same compound and noted that:
…the promise of the patent doctrine will hold an invention to an elevated standard of utility “only where a clear and unambiguous promise has been made.” Where a patent’s validity is “challenged on the basis of an alleged unfulfilled promise, the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person as excluding this promise” (Celebrex, at paragraph 66).
Finally, the Federal Court of Appeal rejected Teva’s third argument, that the Federal Court erred by applying “claim differentiation” to construe the promise of one class of compounds claims to be different from the promise of another class of compounds, for the same reasons.