Ordinary Skill

It’s not often that we get four(!) appellate decisions on one specific legal doctrine in less than a year. But here we are with four decisions from the Federal Court of Appeal on inducement of infringement:

1. Teva v Janssen (paliperidone), 2023 FCA 68
2. Apotex v Janssen (macitentan), 2023 FCA 220
3. Apotex v Janssen (paliperidone), 2024 FCA 9
4. Pharmascience v Janssen (paliperidone), 2024 FCA 10

In all four cases, the patentee was successful in arguing that the defendant indirectly infringed by inducement. This is striking, for reasons mentioned below, but mostly because it had for many years always been said (including in these very judgments!) that inducement was a difficult test to meet. Yet, upon a close inspection of these judgments, it seems clear that the landscape has materially changed. As one might put it, one decision is an anomaly, two is a coincidence, three is a pattern, and four is a rule.

Although all four cases involve Janssen, and three of the cases involved paliperidone, each case had differing twists on the facts and arguments which further cements the notion that this is not just a fact-dependent exercise, but is indeed illustrative of a new approach to inducement.

What hasn’t apparently changed is the statement of the test itself. Proof of induced infringement requires meeting a “three-prong” test set out in the FCA’s decision in Corlac,¹2011 FCA 228 requiring the patentee to establish that:

1. the act(s) of infringement must have been completed by the direct infringer;
2. the completion of the act(s) of infringement were influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
3. the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement.

This formulation of the test is said to be a refinement, or restatement, of case law dating back to the 1980s (or even earlier, to the 1990s depending on whether you think Copeland-Chatterson is an inducement case).²Valmet Oy v Beloit Canada Ltd, (1988) 20 CPR (3d) 1 (FCA); Hatton v Copeland-Chatterson Co (1906), 37 SCR 651. In any case, the wording of this test is curious and important, particularly in the second prong and in the third prong. As it reads on its face, the Corlac formulation of the second prong is a high bar: it not only has an active verb (“influenced“), but also an explicit threshold (“to the point that, without the influence…”).

A reasonable reader might call this second prong a “but for” test, in that the defendant’s act must be a necessary cause of the action. Indeed, this is how the trial courts have been reading it until now. However, despite all four cases affirming that this is the correct test, each case provided a new factual lens to all three prongs of the test and will play a role in lowering the threshold for induced infringement.

Apotex v Janssen (Macitentan), 2023 FCA 220

I’ll start with Apotex-Macitentan, since in some ways it was the most conventional of the inducement cases. Factually, this was a classic “skinny labeling” case. The patent at issue covered the combination of macitentan and a PDE-5 inhibitor to treat pulmonary arterial hypertension (PAH). Apotex’s proposed product monograph (PM) was for macitentan monotherapy to treat PAH. Apotex argued, predictably, that because their product was to be indicated only for the non-patented use (monotherapy), it would not infringe or induce infringement of the patented use (combination therapy).

The case mostly turned on the second prong of the Corlac test, as to whether physicians would be influenced by Apotex’s product monograph into prescribing the infringing combination therapy.

After a trial, the Federal Court held that Apotex would induce infringement due to its product monograph. This was a surprising result because for many years, skinny labelling was viewed as a reality of Canadian patent law – generic drug companies routinely carved out patented indications from their draft monographs, and generally, courts found these carved out monographs to be non-infringing. Most of the time, “new use” patents had little teeth under the precedent that had developed for over a decade.

This case was notable because it bucked the trend and represented a possible turning point. Factually, the trial judge focused on the fact that Apotex’s monograph (despite omitting the combination therapy and most references to PDE-5 inhibitors) referred to a clinical trial that would have been known by the skilled person as a pivotal trial for a combination therapy – and since this was a relatively rare disease managed by specialists, that appeared to be an important distinction over other cases. Further, the Court found that the standard of care for PAH was the combination therapy claimed in the patent. The vast majority of patients would be treated with the combination therapy regardless of the indication.

The FCA, in a relatively short set of reasons, affirmed this decision, holding, on the second prong of the test, that “[w]hile explicit instruction and intention may be relevant to the issue of influence,” it did not “accept that either is required.” [17] The FCA was not satisfied that there was any palpable and overriding error in the trial judgement: “The Federal Court was clearly convinced that the PM would influence physicians to prescribe combination treatment, even though it does not explicitly mention such treatment.”

The FCA also briefly commented on the third prong of the test and re-affirmed the idea that knowledge of the influence was sufficient, without requiring knowledge that the acts of the direct infringer would be infringing.

Standing alone, this case seemed mostly to be a fact-specific determination or an outlier. But taken with the other three decisions, below, it now seems clear that there was a shift in the winds.

Teva-Paliperidone (2023 FCA 68)

This was the first of the series of three cases in which generic manufacturers sought to market paliperidone palmitate (Janssen’s INVEGA SUSTENNA). The patent at issue claimed a dosing regimen involving, generally, a 150 mg-eq. loading dose, followed 8 days later by a 100 mg-eq. loading dose, then monthly 75 mg-eq. maintenance doses in the treatment of schizophrenia. The patent had product claims, use claims, and Swiss-type claims.

The Teva-Paliperidone case was a full trial involving both validity and infringement. The trial judge (Manson J.) held that the asserted claims were valid, and held that the product (syringe) claims and Swiss-type would be directly infringed, but found that the use claims would not be infringed either directly or by inducement. ³Strictly speaking, the trial judge did not have to deal with the issue of induced infringement – since this was a PMNOC action, a finding of validity and direct infringement would have resulted in a prohibition order against issuance of the NOC and dispositive of the action; though it seems that the parties spent a lot of time on this issue at trial. The inducement discussion should not be considered obiter, though, because it was dispositive of at least the “use” claims at issue.

There was a lot of contested evidence at trial on the inducement issue relating to whether physicians and pharmacists would consult generic product monographs for prescription and dispensing. Ultimately the trial judge found based on expert evidence on this issue, that physicians and pharmacists do not “blindly follow” recommendations in a monograph, but rather that they “consider individual patient characteristics when prescribing and dispensing depot formulations”. On the strength of this finding, the trial judge found that the Teva monograph would not influence physicians to such a degree as to meet the inducement test.

Somewhat surprisingly – since this appeared to be a fact-suffused question – the trial judge’s inducement holding was overturned on appeal. After a very lengthy (for the FCA) exposition of the history and development of the inducement test, the FCA “confirmed” the Corlac test, including the second prong:

[109] From this review of the case law, it is clear that Corlac did not change the law regarding the requisite element for inducing infringement. At the second step of the analysis, what is required is proof that the putative infringer influenced the party that directly infringes to the point that, without such encouragement, infringement would not have occurred (or, in the context of an application under the PMNOC Regulations, would not occur). (emphasis added)

In the FCA’s rationale, the significance of the fact that Corlac did not “change the law” is that there were a number of prior generic product monograph cases where the court had held that, if one of the indicated uses of the generic drug was the patented use, then it was “sufficient to constitute the requisite encouragement to satisfy the second prong of the test for inducement”. (It should be observed that this was not a skinny labelling case, unlike Macitentan.)

Two things appear to have happened here: the first is that the FCA felt it was applying well-established precedent on generic product monographs; the second was that the FCA equated the word “encouragement” with “influence”. The former seems true in a strict sense – there have been cases where generic monographs were found to have induced infringement, though the court did not address the cases that went the opposite way (mostly “skinny labelling” cases, discussed above). On the latter issue, despite the FCA saying twice that Corlac hadn’t changed the law, the Court’s holding equating “influence” with “encouragement” should be viewed as a material step change in the test. In fact, Corlac itself never uses the word “encouragement”, nor do the plethora of inducement cases cited in the FCA decision,⁴ Copeland-Chatterson, 1906 10 Ex CR 224; Slater Steel (1968) 55 CPR 61 (Ex Ct); MacLennan, 2008 FCA 35; Dableh v Ontario Hydro, 1996 CanLii 4068 (FCA), AB Hassle, 2001 FCT 1264, AB Hassle v Genpharm, 2003 FC 1443, aff’d 2004 FCA 413. with one exception.

The word “encouragement” comes from what appears to be a single decision of the Federal Court (von Finckenstein J.) in Abbott Laboratories v Canada (Minister of Health) [Novo-Lansoprazole], 2006 FC 1411, aff’d 2007 FCA 251.⁵One case cited in the lengthy list provided by the FCA does contain the word “encouragement”, AB Hassle v Genpharm Inc, 2003 FC 1443, but it appears only within a quote from the respondent’s affidavit evidence; it also appears in Windsurfing (1985), but only as a summary of counsel’s argument. In the context of Lansoprazole (an old-PMNOC application), the word “encourage” became prominent because the patentee Abbott used that word in its notice of application and written argument, alleging that Novopharm’s monograph “will encourage and promote the use of Novo-Lansoprazole for the treatment of ulcers caused by H. pylori”. The Court did rely on this word to find that Novopharm’s monograph in that case “would be an encouragement to infringe” [40]. In Lansoprazole, von Finckenstein J. concluded that:

[47]           The Court is driven to the conclusion that the inclusion of the amount, the frequency and the duration of the dosage for triple therapy on the label for Novo-Lansoprazole under the rubric ‘Adult dosage’ and the absence of any other clinically indicated use for that dosage, on the balance of probabilities, will have the effect of inducing or encouraging physicians to prescribe Novo-Lansoprazole for triple therapy. (emphasis added)

These references to the word “encourage”, in the context of responding to the applicant’s arguments, do not seem to be sufficient foundation for a legal test. To my eyes, the difference between the word “encourage” and “influence” is what the reader/recipient of the information does with it. One can encourage another to commit a crime, but that doesn’t mean they are necessarily influenced by that encouragement. One does not get arrested for driving under the “encouragement” of alcohol, one gets arrested for driving under the “influence”.

(We’re not supposed to use the dictionary to interpret legal doctrines, but the contrast between the two definitions in the Merriam-Webster dictionary is telling: “encourage (verb), 1 a: to inspire with courage, spirit or hope; b: to attempt to persuade” vs. “influence (verb), 1: to affect or alter by indirect or intangible means; 2: to have an effect on the condition or development of”.)

In my view, the original statement of Corlac seemed to require (1) that the direct infringer in fact acted on the information presented to them by the alleged inducer, and/or (2) that there was some provable but-for causal connection between the influence and the outcome.

By equating the word “encouragement” with “influence”, the FCA implicitly omitted a crucial factor in the test, that is, what the direct actor does with the information. Indeed, in Novo-Lansoprazole, although “encouragement” was a factor, so was the evidence of what actual physicians would do with that information – this appeared so crucial to the decision, that the Court reproduced two different passages of cross-examination containing admissions relating to how a physician would use the indications in the generic monograph, specifically highlighting the “testimony of Novopharm’s most renowned witnesses” on their interpretation of the PM.⁶2006 FC 1411 at paras 39-45.

In contrast to Novo-Lansoprazole, in Teva-Paliperidone, the FCA rejects the agency of the direct infringer entirely: “It matters not that physicians use their own skill and judgment in dispensing the drug, nor that they must make an active choice to perform the infringing use, as physicians invariably exercise similar skill and judgment whenever a drug is prescribed to a patient.” [110] This statement, made unequivocally by the FCA, appears to be new. Although some judgments did previously give less weight to evidence of physician skill in prescribing drugs, the statement of irrelevance has never been made as clear as this.

The FCA’s rejection of agency also pervades its interpretation of the third prong of the Corlac test. The Court found that, because Teva was “presumed to have been aware of the contents of its PM and what is recommended”, it necessarily had knowledge of its influence over the infringing acts. This again presupposes that the direct infringer’s agency is irrelevant to the question of influence, and minimizes the strict wording of the Corlac test, particularly the portion which read “knowledge that the influence is being exercised“.

Indeed, as a counterpoint to the FCA, the wording of the third prong suggests that my interpretation of the second prong (above, i.e. that the direct infringer must have acted on the information given to them) was the one originally intended in Corlac, since it requires an “exercise” of influence and not merely the “existence” of influence. It does not make sense to speak of “encouragement” as something that is “being exercised”.

In other words, if one substituted the word “encourage” for “influence” in the Corlac test, it would have made no sense on its own terms:

i. the act(s) of infringement must have been completed by the direct infringer;

ii. the completion of the act(s) of infringement were influenced encouraged by the acts of the alleged inducer to the point that, without the influence encouragement, direct infringement would not take place; and

iii. the influence encouragement must knowingly be exercised by the inducer, that is, the inducer knows that this influence encouragement will result in the completion of the act of infringement.

Practically speaking, the result for the third prong is – if a pharmaceutical company is genuinely of the view that it did not and cannot exercise influence, because it doesn’t believe that it can “cause” a physician to change their prescribing practices, then how can it be taken to have the requisite “knowledge” of influence? Because of the way in which the FCA applied the third prong of the test, it appears now sufficient that the inducer merely knew that it was performing an act of encouragement (a low mens rea), and it does not appear to require knowledge that the inducer’s activity in fact caused any change of behaviour in a direct infringer.

This is an extension of the FCA’s interpretation of the second prong but also renders the third prong virtually redundant (it would be quite rare for a fact scenario to occur where an indirect infringer has no actual knowledge of the contents of its own communications).

Apotex-Paliperidone (2024 FCA 9)

This case followed Teva-Paliperidone, in a summary trial brought by Apotex to take advantage of the precedent created by Justice Manson’s initial holding that Teva would not induce infringement on the same drug. That strategy appeared to have backfired, when due to seemingly minor differences in the factual record of the two cases (the details of which are unclear given that most of the portions of the trial judgments referring to the respective parties’ product monographs were redacted), Justice Manson found that unlike Teva, Apotex would induce infringement of Janssen’s patent.

Apotex’s problems were further compounded when, in the decision above, the FCA reversed Justice Manson’s decision and found that Teva would induce infringement based on their PM.

Apotex’s appeal argument was simple: since its proposed product monograph “would essentially be a copy of that for INVEGA SUSTENNA” [14], and physicians would not change their prescribing practices whether or not Apotex’s product was marketed, there would not be sufficient “influence” under the second prong of the inducement test.

Since the facts were hardly in dispute by the time of appeal, it seemed this could have won the day. If the Corlac formulation of the inducement test were taken literally, in that “the inducer influenced the third party to the point that the infringing act would not have occurred without the influence,” the conclusion of non-infringement on these facts should have been inescapable. However, the Court did not see it this way. Instead, the FCA held:

[24] It is important to bear in mind that the ultimate act of direct infringement in the present case could be either by a prescriber (e.g. a physician or a nurse practitioner) or by a patient: Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, [2020] F.C.J. No. 179 at para. 40, citing AB Hassle v. Genpharm Inc., 2003 FC 1443, 243 F.T.R 6 at para. 127, aff’d 2004 FCA 413, [2004] F.C.J. No. 2079. The Federal Court recognized this at paragraphs 74 and 104 of its reasons. It is also important to understand that inducing patent infringement can occur even where there is no direct contact between the inducer and the direct infringer: MacLennan at para. 43, citing Procter & Gamble Co. v. Bristol-Myers Canada Ltd., [1978] F.C.J. No. 812, 39 C.P.R. (2d) 145 at 167. Accordingly, Apotex could be found to induce infringement by a patient even if they have no direct communication.

[25] It follows that, even if the practices of prescribing physicians were to remain unchanged following the introduction to the market of Apotex’s generic version of INVEGA SUSTENNA, the fact would remain that activities by patients (and by prescribers) that had previously been non-infringing (because the drug was sourced from Janssen) would be infringing once the drug was sourced from Apotex, an unlicensed supplier. As indicated at paragraph 11 above, the Federal Court concluded at paragraphs 147 and 148 of its reasons that such infringement would be influenced by Apotex to the point that, without the influence, direct infringement would not take place. It is in this sense that the Federal Court was entitled to conclude that the second prong of the test for inducing patent infringement was met. (emphasis added)

This passage in Apotex-Paliperidone seems to have gone further than Teva-Paliperidone, in that the FCA expressly acknowledges that even without any change of behaviour in the direct infringer(s), inducement can be made out. This passage, combined with the above, appears to definitively remove all agency from the direct infringer, and likely severs the requirement of a causal (“but for”) link between the influence and the direct infringement.

A caveat, however: one apparently significant difference between Teva-Paliperidone and Apotex-Paliperidone was the expert testimony at the respective summary trials. In the Teva case, Justice Manson preferred the evidence of Teva’s experts who opined that physicians do not refer to generic PMs and found that Janssen’s expert was the “outlier” for “slavishly” following a generic monograph. In contrast, in Apotex, it appears that both of Apotex’s clinical experts admitted during cross examination that they at least sometimes referred to generic PMs, combined with additional evidence relating other uses of a generic monograph such as for formulary listings and in the pharmacy. One could perhaps make an argument that the factual record of both cases differed (and indeed the FCA in Apotex-Paliperidone was careful to say that this was based on the trial judge’s factual findings) – but this seems like a thin distinction and an unsatisfactory foundation for a legal precedent.

Pharmascience-Paliperidone (2024 FCA 10)

The last paliperidone case, Pharmascience-Paliperidone, is interesting because Pharmascience took an entirely different approach. Instead of arguing the factual intricacies of whether physicians would or would not have read and/or be influenced by generic product monographs, Pharmascience made a rather novel legal argument.

In brief, the argument went something like this: Pharmascience will not sell 75 mg-eq. doses of paliperidone. The patented dosing regimen requires three things: (i) a 150 mg-eq. loading dose, (ii) followed a week later by a 100 mg-eq. loading dose, then (iii) monthly 75 mg-eq. maintenance doses. According to Pharmascience, whatever else its proposed product monograph might say, they could not infringe the patent since they would not have a product meeting the third element of the claim. For a physician and patient to complete the infringing dosing regimen, they would have to purchase Janssen’s (the patentee’s) 75 mg-eq. product.

On the surface this does seem like a “lawyer’s argument”: a product missing an essential claim element, after all, cannot be said to be infringing. But even more – and here’s the interesting bit – Pharmascience argued that if physicians prescribe the 75 mg-eq. Janssen product in combination with Pharmascience’s approved doses and thereby end up infringing the patent, that could not result in liability, because by selling 75 mg-eq. doses, Janssen gave an implied licence to the purchaser to do whatever they wanted with that 75 mg-eq. dose.

Pharmascience, without calling it such, was invoking a version of the “doctrine of exhaustion” or “first sale doctrine” to claim immunity from infringement. In the context of patents, this doctrine is supposed to say that the purchaser of a patented article is allowed to deal with the goods as they please without fear of infringement.⁷ Eli Lilly & Co. v. Novopharm Ltd., [1998] SCR 129  There is good policy reason for this – if you’re buying a product from the patentee (and presumably paying them), you should not be subject to a lawsuit from the patentee complaining that you infringed their patent by using their own product. This doctrine is also about as close as patent law gets to the copyright concept of “user’s rights”. (The issue of whether Canada has a fully-recognized “first sale” or “exhaustion” doctrine is a thorny one, especially so in the world of “use” patents which involve an action of the user rather than transfer of a physical thing.)

Janssen responded to this argument with a long-held line of case law relating to selling of “parts” or “kits”. The argument goes that, if you sell an unpatented part for the purpose of being used with a patented system or combination (e.g. selling sheets designed to fit in a patented binder system ⁸Copeland-Chatterson Co. v. Hatton (1906), 10 Ex CR 224 or selling replica saw-teeth that only fit on a patented repairable saw blade and tooth combination ⁹MacLennan v. Les Produits Gilbert Inc., 2006 FC 1038, rev’d 2008 FCA 35) then you are still liable for infringement for depriving the patentee of their monopoly.

Thus, Pharmascience-Paliperidone did not turn on “influence” (prong 2), but turned on whether there would be “direct infringement” (prong 1). The Court was not persuaded by Pharmascience’s argument, finding instead that:

[21] … There appears to be no reason to conclude that either Janssen or its customers (a prescribing physician or a patient) would have understood that the purchase of paliperidone palmitate in a single dose from Janssen would include an implied licence to use the entire dosing regimen of the product in combination with other doses obtained from unlicensed sources, to practise the invention of the 335 Patent. It is difficult to accept that there could be such an implied licence in circumstances where neither the supposed licensor nor the supposed licensee would have understood such a licence to exist.

The theme in Pharmascience-Paliperidone is much the same as in Apotex-Macitentan in that the courts were not persuaded that the non-infringing use was relevant despite a legally and technically plausible interpretation of the facts where an essential claim element would be missing. It appears that the courts were more than willing to look past the non-infringing use and find infringement given the context (in both cases) that the standard of care or likely treatment will involve the patented combination or regimen. As such, the state of the law is now that, the mere existence of a non-infringing use will not suffice – even if the product monographs are only expressly directed to the non-infringing use.

Left unstated by the Court is the relationship between the first and second prongs of the test. There is reason to think that, if there were many other uses for the product other than the patented one, there might have been a factual question of whether direct infringement would have occurred on a balance of probabilities.

Interestingly, unlike in Apotex-Paliperidone, the intention of the manufacturer appeared to be relevant. However, here, it was the intention of the patentee (in whether they provided an implied licence) rather than the intention of the defendant. The FCA held at [29] that for an implied licence argument to succeed, it would require that “the parties’ intended use of the component at the time of sale contemplated its use in the patented combination”. This seems like an odd place to draw the line, because it runs counter to intuition (and implicitly, counter to Janssen’s argument in the Apotex-Paliperidone case). This may be an issue of evidence at the application – but at least as of the date of this writing, the Product Monograph for Janssen’s INVEGA SUSTENNA 75 mg/0.75mL product includes instructions for the specific patented dosing regimen at issue. ¹⁰[See Janssen’s Product Monograph, at Page 6: https://pdf.hres.ca/dpd_pm/00072646.PDF] It seems to me that if the FCA was applying the stated test from Slater Steel, it would be clear that the seller and purchaser of INVEGA SUSTENNA did, in fact, contemplate use of the patented combination (purchasing the 75 mg-eq. dose for use with the recommended dosing regimen in the PM).

Takeaways

These four decisions collectively represent a turning point in the law of inducement. While there are (as of this writing) some pending applications for leave to the Supreme Court, absent further decisions, the FCA’s rulings will now be the new state of the world.

The decisions collectively held that: (1) skinny-labelling is no longer as bulletproof a strategy as previously thought for generic pharmaceutical companies – context of the standard of care and level of knowledge of the skilled person is paramount; (2) “influence” under the Corlac test is, more or less, the same as “encouragement” – specifically, there is no requirement that any person actually changed their behaviour; (3) the existence of a non-infringing use is not sufficient to overcome an infringement case, even if the generic only explicitly mentions the non-infringing use.

In sum, the risk of a finding of infringement on second-medical use patents for generic companies has now materially increased on the strength of four appellate decisions in favour of the patentee. It remains to be seen whether the Supreme Court will take up the issue and consider the policy angle of whether this reflects a correct balance between expiry of old patent rights versus incentives for patentees.

Footnotes

• 1
  2011 FCA 228
• 2
  Valmet Oy v Beloit Canada Ltd, (1988) 20 CPR (3d) 1 (FCA); Hatton v Copeland-Chatterson Co (1906), 37 SCR 651.
• 3
  Strictly speaking, the trial judge did not have to deal with the issue of induced infringement – since this was a PMNOC action, a finding of validity and direct infringement would have resulted in a prohibition order against issuance of the NOC and dispositive of the action; though it seems that the parties spent a lot of time on this issue at trial. The inducement discussion should not be considered obiter, though, because it was dispositive of at least the “use” claims at issue.
• 4
  Copeland-Chatterson, 1906 10 Ex CR 224; Slater Steel (1968) 55 CPR 61 (Ex Ct); MacLennan, 2008 FCA 35; Dableh v Ontario Hydro, 1996 CanLii 4068 (FCA), AB Hassle, 2001 FCT 1264, AB Hassle v Genpharm, 2003 FC 1443, aff’d 2004 FCA 413.
• 5
  One case cited in the lengthy list provided by the FCA does contain the word “encouragement”, AB Hassle v Genpharm Inc, 2003 FC 1443, but it appears only within a quote from the respondent’s affidavit evidence; it also appears in Windsurfing (1985), but only as a summary of counsel’s argument.
• 6
  2006 FC 1411 at paras 39-45.
• 7
  Eli Lilly & Co. v. Novopharm Ltd., [1998] SCR 129 
• 8
  Copeland-Chatterson Co. v. Hatton (1906), 10 Ex CR 224
• 9
  MacLennan v. Les Produits Gilbert Inc., 2006 FC 1038, rev’d 2008 FCA 35
• 10
  [See Janssen’s Product Monograph, at Page 6: https://pdf.hres.ca/dpd_pm/00072646.PDF]