Sunday, April 3, 2016

“Imminence” in a Quia Timet Action

Gilead Sciences, Inc v Teva Canada Ltd 2016 FC 336 Barnes J aff'g 2016 FC 31 Tabib J
     2,261,619 / 2,298,059 / tenofovir disoproxil / TRUVADA ATRIPLA VIREAD

In this decision Barnes J upheld Prothonotary Tabib’s refusal to strike Gilead’s quia timet action. The most interesting aspect of the decision concerns what is meant by “imminent” activity.

In the prior NOC proceeding 2013 FC 1270 (blogged here), Gilead had sought an order of prohibition based on the ‘619 and ‘059 patents. Barnes J held that the ‘059 patent, for the fumarate salt form of tenofovir disoproxil, was invalid as obvious, but he held the ‘619 patent, to tenofovir disoproxil itself, was valid and he granted an order prohibiting in the Minister from issuing an NOC to Teva in respect of its tenofovir disoproxil fumarate product until the expiry of the ‘619 patent. Gilead is now seeking to bring a quia timet infringement action, presumably based on the ‘059 patent (though that is not stated expressly in the decision).

Teva sought to strike Gilead’s Statement of Claim on the basis that it did not satisfy the test for maintaining a quia timet proceeding which was set out in Connaught Labs, [1998] FCJ No 1851, 86 CPR(3d) 36, [18] (my numbering):

[1] the statement of claim must allege a deliberate expressed intention to engage in activity the result of which would raise a strong possibility of infringement;
[2] the activity to be engaged in must be alleged to be imminent and the resulting damage to the plaintiff must be alleged to be very substantial if not irreparable; and,
[3] finally, the facts pleaded must be cogent, precise and material.

Barnes J held that the first part of the test was satisfied, as Teva had declared an intention to come to market with a competing version of Gilead’s tenofovir disoproxil product as soon as it could obtain an NOC, and while this was not completely inevitable, the “strong possibility” found by Tabib J was consistent with Connaught and other cases [9].

Teva also argued that the allegedly infringing activity was not “imminent” because the probable date of launch was 22 months away, on expiry of the ‘619 patent. Barnes J at [10] rejected this argument, approving Tabib J's statement that:

The purpose of a quia timet action is to stop an event before it happens. Given that streamlined infringement actions may now be heard and determined in two years, it is neither premature nor pointless to institute such an action 22 months before the occurrence of the event to be avoided.

Moreover, Barnes J helpfully clarified why there is a requirement of imminence at all. The purpose of the restrictions on the quia timet proceeding is to avoid wasting judicial resources on an action that may turn out to be pointless. On that rationale, if the allegedly infringing action is inevitable, it shouldn’t matter whether it will happen tomorrow or ten years from now. But, as Barnes J explained:

[11] [T]he requirement of imminence in the temporal sense may be relevant in the determination of the likelihood of a future event. A potential event that is more distant in time may be an event that is less likely to occur.

Imminence is not directly relevant, but only in so far as it affects the probability of the future event. This implies that “imminence” is not to be judged solely temporally, but in a balance with other evidence of the likelihood of the future event. By the same token, “temporal imminence appears to be a subordinate consideration in a case where the likelihood of future harm appears high” [11].


  1. I don't understand--how can there be any risk of infringement (imminent or otherwise) if '059 has been declared invalid, and Teva won't enter the market until '619 is declared invalid or expires?

  2. The '059 wasn't strictly declared invalid - it was an NOC proceeding, so the declaration was not in rem, but only for the purposes of that proceeding. I was speaking loosely.