“Overpromising” following Esomeprazole SCC

In this decision, Justice Manson was called upon to decide whether certain amendments Apotex sought to make to its pleadings ought to be allowed.

Apotex had pleaded that the subject patent, Canadian Patent Number 1,339,132 for latanoprost, was invalid for, among other grounds, inutility, applying the “promise doctrine”.  Apotex’s pleading had been drafted prior to the release of the Supreme Court’s judgment in Esomeprazole SCC which effectively set aside the promise doctrine (see our previous post here). After the release of Esomeprazole SCC, Apotex sought to make certain amendments, described by the Court as follows:

[20] … While Pfizer does not object to most of the proposed amendments, Pfizer takes issue with three of Apotex’s proposed new pleas:

i. In paragraph 10B, Apotex alleges that in the but-for world from 2007 to 2011, the Court would have invalidated Pfizer’s patent using the “Promise Doctrine”, which was the applicable law at that time, not the current law as recently determined by the SCC in the Esomeprazole decision. Pfizer takes the position that Apotex is alleging that it would have been able to invalidate Pfizer’s patent using an unsound legal doctrine, which is a vexatious and ultimately an absurd plea (the “hypothetical invalidity plea”);

Pfizer states that in paragraphs 136A and 145A and 145B, Apotex essentially re-argues the Promise Doctrine, asserting the patent “over promises” because the inventors had not demonstrated or soundly predicted the utility rendering the disclosure and claims invalid for:

ii. Insufficiency; and

iii. Overbreadth.

Justice Manson allowed the first proposed amendment – that the Court hearing the invalidity arguments prior to the release of Esomeprazole SCC would have applied the promise doctrine, However, Justice Manson noted that “[n]otwithstanding it may be a difficult argument for Apotex at trial, this is not a straight-forward question of law to determine on a motion to amend. The Court should have a fulsome record before it, in order to decide what is no doubt an important legal question, with lasting and long-reaching implications for the parties and for others who face the same question. It should be left for consideration by the trial judge, after final argument in the context of the relevant facts and law…”

The amendment alleging insufficiency was not allowed. Justice Manson considered the application of Esomeprazole SCC and reasoned that Apotex’s insufficiency argument had no reasonable prospect of success as it was based on the argument that the 132 Patent overpromised by stating “an unsubstantiated use or operation of the purported invention”. This was seen to amount to the conflation of the disclosure requirement under section 27(3) of the Patent Act and the requirement that the invention have utility, which Justice Manson found to be impermissible.

Justice Manson explicitly considered Apotex’s argument that Esomeprazole SCC states that “[t] scheme of the Act treats the mischief of overpromising in multiple ways”, including through the disclosure requirement. Ultimately, however, Justice Manson was not persuaded that this argument had a reasonable prospect of success, as the SCC had not specifically said that overpromising could be raised in the context of disclosure.  He adopted Justice Pelletier’s observation in Teva atazanavir, at paragraph 68, that “… the Supreme Court does not change substantive law by implication, particularly when it has shown a cautious approach to change in the same context: see Apotex Inc v Eli Lilly Canada Inc, 2016 FCA 267 at para 37” (see our previous post here).

Justice Manson allowed the amendment that pleaded overbreadth.  This argument, too, raised the fact that certain claims of the 132 Patent overpromised, by claiming the use of latanoprost for “the treatment of glaucoma or ocular hypertension … without causing substantial ocular irritation” and “use … in the treatment of glaucoma or ocular hypertension.” Apotex alleged that the claims were overly broad as the use of latanoprost for chronic treatment without causing the unwanted side effects had not been demonstrated or soundly predicted as of the filing date of the 132 Patent. Although Justice Manson observed that Apotex might well have difficulty making out this plea at trial, he allowed it to be made as he saw that it had a reasonable prospect of success.

In allowing the proposed amendments, Justice Manson also found that they would not result in an injustice not capable of being compensated by costs and that it was in the interests of justice to allow them.

A copy of the decisison may be found here.