Purdue Pharma v Collegium Pharmaceutical, Inc 2018 FC 199 O'Reilly J
Oxycodone
Purdue Pharma began an infringement action against Collegium for infringement of Purdue’s
patent related to oxycodone, on the basis that Collegium had taken various steps to obtain
marketing approval in Canada in respect of its oxycodone product. The steps alleged included
importing the drug for purposes of its NDS, filing an NDS, obtaining approval in the US,
publicly expressing its intention to market the drug in Canada, and invoking the NOC
Regulations by serving Purdue with an NOA [21].
Reversing Aalto J, O'Reilly J granted Collegium’s motion to strike. He held that these facts did
not allege anything going beyond the regulatory use exemption in s 55.2. There is no requirement
that the party seeking to strike on that basis tender evidence that the activity in question did not
go beyond attempting to meet regulartory requirement: “Rather, a statement of claim will be
deficient on its face if it merely alleges activity that falls within the statutory exemption in s 55.2"
[20].
Nor will these facts support a quia timet action. The prospect of Collegium launching at risk
after succeeding in the NOC proceeding is not in itself sufficient to satisfy the requirement of
imminence, given that it might never actually obtain the NOC prior to expiry of the
patent [26]-[28].
More generally, this decision implies that allegations which amount to saying that the defendant
was attempting to meet Canadian regulatory requirements will not survive a motion to strike
[28]. Note that Purdue has also instituted NOC proceedings, which are not affected [1]. Of
course, this will all be moot with the new NOC Regs.
Showing posts with label Quia Timet. Show all posts
Showing posts with label Quia Timet. Show all posts
Tuesday, February 27, 2018
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):
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:
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:
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].
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].
Wednesday, May 11, 2011
Guidance for Pleading Early Infringement
Apotex Inc v Allergan Inc / gatifloxacin 2011 FCA 134
Pharmaceutical patentees view damages as a poor substitute for a permanent injunction, and are therefore anxious to bring an action against a generic producer as soon as possible. The question of what acts constitute infringement, or are sufficient to support a quia timet action, are therefore important. The FCA decision in Allergan, affirming a decision of Beaudry J refusing to strike Allergan’s statement of claim, helps to fill in this picture.
Pharmaceutical patentees view damages as a poor substitute for a permanent injunction, and are therefore anxious to bring an action against a generic producer as soon as possible. The question of what acts constitute infringement, or are sufficient to support a quia timet action, are therefore important. The FCA decision in Allergan, affirming a decision of Beaudry J refusing to strike Allergan’s statement of claim, helps to fill in this picture.
The Federal Courts have consistently been unwilling to allow an infringement action to be brought simply on the basis that the generic has applied for or obtained an NOC. In Allergan the Court of Appeal stated that “the mere fact that a defendant pharmaceutical company has sought regulatory approval to market a medicine does not by itself support an action for patent infringement” [4]. This point had not previously been settled (see AstraZeneca 2010 FCA 112 [8-9], affm’g 2009 FC 1209), and while this statement was strictly obiter, it is consistent with the thrust of the prior case-law. The point must now be considered settled.
However, in Allergan the patentee did not rely on the generic having obtained an NOC. Rather, the main thrust of its allegations was that Apotex had obtained a tentative approval for a US ANDA, and that the ANDA indicated that Apotex had made infringing product in Canada, and that it had and intended to import infringing product into Canada for formulation and export to the US: see the decision appealed from, T-1267, 9 Nov 2010. Consequently, it was not a quia timet action at all: “[t]he claims of past and continuing infringement support the claim of future continuing infringement” [14].
This point is not directly relevant to the paradigmatic case in which the patentee seeks to prevent manufacture and sale into the Canadian market. Of more general interest is the holding respecting particularity of the pleading. The courts have consistently been unwilling to allow an action based on a bald general allegation of infringement, on the basis that an action cannot be allowed to serve as a fishing expedition: the leading case is AstraZeneca (see esp. 2009 FC 1209 [17]) and see Eli Lilly / olanzapine 2011 FC 255 [8-9], also striking the statement of claim. The particulars pleaded in Allergan did go beyond those pleaded in either AstraZeneca or Eli Lilly, and the FCA held at [8] that it was reasonably open to the trial judge to hold that they were adequate. Thus we now have case-law on both side of the line separating adequate from inadequate pleading of material facts.
In Allergan Apotex also argued that Allergan’s statement of claim should be struck on the basis that the regulatory use exception of s. 55.2(1) applies, as in Eli Lilly. However, as the FCA pointed out [12-13], Allergan is distinguishable as in Eli Lilly “there is absolutely nothing pleaded that is not part of the regulatory requirements” (2011 FC 255 [28]), while in Allergan the allegations clearly went beyond those requirements. The FCA also stated that “the existence of even a strong defence to a claim does not justify an order striking the claim” [9]. This is not entirely easy to reconcile with Eli Lilly, but in any event, the FCA relied mainly on the differences in the allegations.
Tuesday, March 29, 2011
Obtaining an NOC is Not Grounds for an Infringement Action
Eli Lilly Canada Inc v Nu-Pharm Inc / olanzapine 2011 FC 255 Snider J
When a generic pharmaceutical company obtains an NOC for a drug, it seems natural to assume that it intend to begin selling that drug, and patentee pharma companies are often anxious to begin infringement proceedings as soon as possible. The courts have been consistently unwilling to allow an action to proceed solely on the basis that the generic has obtained an NOC: AstraZeneca Canada Inc. v Novopharm Ltd. / rosuvastatin, 2009 FC 1209 Hughes J. affm’d 2010 FCA112 Noël JA: Pelletier, Dawson JJA, is the leading case, both for Hughes J’s review of the case law, and because his decision striking the Statement of Claim was affirmed by the FCA. The basic problem for the patentee is that the Federal Court has been unwilling to infer that the generic will enter the market prior to the expiry of the relevant patent, simply from the fact that it has obtained an NOC (see 2009 FC 1209 [14]). A quia timet claim for future infringement will fail for this reason [ibid 23]. A bare assertion that the defendant has manufactured the compound etc. will be disregarded as too speculative to support a claim of current infringement if made without any evidentiary foundation [ibid 18].
Snider J's decision in the olanzapine case confirms and extends this line of cases. In the rosuvastatin case, the generic had not obtained an NOC at all, which added an layer of speculation, particularly as the patentee was seeking an order of prohibition at the same time that it sought to launch an infringement action. In the olanzapine case, Nu-Pharm had obtained an NOC, days after the patent had been declared invalid in infringement proceedings (Eli Lilly Canada Inc. v. Novopharm Ltd. / olanzapine 2009 FC 1018) and before the trial decision invalidating the patent was reversed and remanded (2010 FCA 197). However, Snider J nonetheless held that the Statement of Claim should be struck, as there was no allegation of activity outside of the regulatory safe-harbor of section 55.2(1). Snider J made this holding on the assumption that the preparation of the ANDS and the obtaining of the NOC are in themselves acts of infringement [25], a point which is not yet settled.
Beyond these details, the case affirmed the general point that a patentee cannot launch an infringement action merely because the generic has obtained an NOC: “the pleadings disclose nothing beyond an assertion that Nu-Pharm is positioning itself, through an unnamed third party, to enter the market for olanzapine and, that by doing so, Nu-Pharm will infringe the patent. . . .[T]he Statement of Claim is, at least in part, very much a quia timet proceeding to which the findings of Justice Hughes and the Court of Appeal in AstraZeneca FCA are applicable” [31].
Direct evidence of commercial stockpiling would presumably suffice. But what about the patentee’s basic point that one can reasonably infer an intent to infringe from the fact that the generic has obtained an NOC? (While the question of whether obtaining an NOC is itself an act of infringement is in principle open, I cannot see how getting permission to make or sell is the same as making or selling.) It would be interesting to have statistical evidence on this point. If it turned out that a generic that obtained an NOC only launched during the term of the relevant patent 30% the time, then the view that obtaining an NOC cannot support a quia timet action would seem sound. But if that figure is 95%, the common sense inference would be stronger. Of course, it is not clear whether a court would find statistical evidence relevant to the intent of a particular defendant, and in any event I am not aware of any such study. I’d certainly be curious to find out what those stats are.
When a generic pharmaceutical company obtains an NOC for a drug, it seems natural to assume that it intend to begin selling that drug, and patentee pharma companies are often anxious to begin infringement proceedings as soon as possible. The courts have been consistently unwilling to allow an action to proceed solely on the basis that the generic has obtained an NOC: AstraZeneca Canada Inc. v Novopharm Ltd. / rosuvastatin, 2009 FC 1209 Hughes J. affm’d 2010 FCA112 Noël JA: Pelletier, Dawson JJA, is the leading case, both for Hughes J’s review of the case law, and because his decision striking the Statement of Claim was affirmed by the FCA. The basic problem for the patentee is that the Federal Court has been unwilling to infer that the generic will enter the market prior to the expiry of the relevant patent, simply from the fact that it has obtained an NOC (see 2009 FC 1209 [14]). A quia timet claim for future infringement will fail for this reason [ibid 23]. A bare assertion that the defendant has manufactured the compound etc. will be disregarded as too speculative to support a claim of current infringement if made without any evidentiary foundation [ibid 18].
Snider J's decision in the olanzapine case confirms and extends this line of cases. In the rosuvastatin case, the generic had not obtained an NOC at all, which added an layer of speculation, particularly as the patentee was seeking an order of prohibition at the same time that it sought to launch an infringement action. In the olanzapine case, Nu-Pharm had obtained an NOC, days after the patent had been declared invalid in infringement proceedings (Eli Lilly Canada Inc. v. Novopharm Ltd. / olanzapine 2009 FC 1018) and before the trial decision invalidating the patent was reversed and remanded (2010 FCA 197). However, Snider J nonetheless held that the Statement of Claim should be struck, as there was no allegation of activity outside of the regulatory safe-harbor of section 55.2(1). Snider J made this holding on the assumption that the preparation of the ANDS and the obtaining of the NOC are in themselves acts of infringement [25], a point which is not yet settled.
Beyond these details, the case affirmed the general point that a patentee cannot launch an infringement action merely because the generic has obtained an NOC: “the pleadings disclose nothing beyond an assertion that Nu-Pharm is positioning itself, through an unnamed third party, to enter the market for olanzapine and, that by doing so, Nu-Pharm will infringe the patent. . . .[T]he Statement of Claim is, at least in part, very much a quia timet proceeding to which the findings of Justice Hughes and the Court of Appeal in AstraZeneca FCA are applicable” [31].
Direct evidence of commercial stockpiling would presumably suffice. But what about the patentee’s basic point that one can reasonably infer an intent to infringe from the fact that the generic has obtained an NOC? (While the question of whether obtaining an NOC is itself an act of infringement is in principle open, I cannot see how getting permission to make or sell is the same as making or selling.) It would be interesting to have statistical evidence on this point. If it turned out that a generic that obtained an NOC only launched during the term of the relevant patent 30% the time, then the view that obtaining an NOC cannot support a quia timet action would seem sound. But if that figure is 95%, the common sense inference would be stronger. Of course, it is not clear whether a court would find statistical evidence relevant to the intent of a particular defendant, and in any event I am not aware of any such study. I’d certainly be curious to find out what those stats are.
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