Apotex Inc. v. Pfizer Canada Inc.

Apotex Inc. v. Pfizer Canada Inc.
Court (s) Database
Federal Court of Appeal Decisions
Date
2014-10-30
Neutral citation
2014 FCA 250
File numbers
A-194-14, A-94-14
Decision Content
Date: 20141030
Dockets: A-194-14
A-94-14
Citation: 2014 FCA 250
CORAM:
NOËL C.J.
TRUDEL J.A.
BOIVIN J.A.
BETWEEN:
APOTEX INC.
Appellant
and
PFIZER CANADA INC. AND G.D. SEARLE & CO.
Respondents
AND BETWEEN:
MYLAN PHARMACEUTICALS ULC
Appellant
and
PFIZER CANADA INC. AND G.D. SEARLE & CO.
Respondents
Heard at Ottawa, Ontario, on September 30, 2014.
Judgment delivered at Ottawa, Ontario, on October 30 2014.
REASONS FOR JUDGMENT BY:
NOËL C.J.
CONCURRED IN BY:
TRUDEL J.A.
BOIVIN J.A.
Date: 20141030
Dockets: A-194-14
A-94-14
Citation: 2014 FCA 250
CORAM:
NOËL C.J.
TRUDEL J.A.
BOIVIN J.A.
BETWEEN:
APOTEX INC.
Appellant
and
PFIZER CANADA INC. and G.D. SEARLE & CO.
Respondents
AND BETWEEN:
MYLAN PHARMACEUTICALS ULC
Appellant
and
PFIZER CANADA INC., G.D. SEARLE & CO.
Respondents
REASONS FOR JUDGMENT
NOËL C.J.
[1] These are two appeals brought by Mylan Pharmaceuticals ULC (A-94-14) and Apotex Inc. (A-194-14) (Mylan and Apotex, or the appellants) from decisions of the Federal Court (2014 FC 38, the Mylan decision, and 2014 FC 314, the Apotex decision), wherein Harrington J. (the Federal Court judge) allowed applications brought by Pfizer Canada Inc. and G.D. Searle & Co. (together, the respondent) and issued orders prohibiting the Minister of Health (the Minister) from issuing notices of compliance (NOC) in respect of celecoxib. These prohibition orders will cease to have effect on November 14, when Canadian Patent No. 2,177,576 (the ‘576 Patent) which conveys a monopoly over this compound expires.
[2] The main issue in both appeals turns on whether the Federal Court judge properly held that the patent in issue did not promise certain specified results thereby declining to hold that the appellants’ allegations of invalidity were justified by reason of the patent’s alleged failure to procure these results.
[3] The two decisions under appeal were rendered by the Federal Court judge in separate reasons which however share common lines of reasoning. For that reason, the two appeals were heard together. The reasons which follow dispose of both appeals.
BACKGROUND [4] For over a century now, inflammation in humans and certain animals has been treated using a particular class of pharmaceuticals known as non-steroidal anti-inflammatory drugs (NSAIDs). These drugs reduce inflammation by inhibiting a certain enzyme called cyclooxygenase (COX).
[5] In the 1970s, researchers began to notice that NSAIDs can have dangerous side effects in the long-run, particularly in the gastrointestinal (GI) tract, where bleeding, ulcers and perforations can take place. The reason for this was determined to be that COX plays an important role in maintaining many tissues, particularly in the GI tract. From that point onwards, North American regulators required that NSAIDs be sold with a warning label addressing these risks.
[6] In the 1990s, researchers discovered that there exist two different COX enzymes. It was hypothesized that, while COX-1 plays a general maintenance role in many tissues, the body produces COX-2 in response to injury, and it is this second enzyme that causes inflammation. The “COX-2 hypothesis” developed by NSAIDs researchers was that, if one could develop a “COX-2 selective” drug that either inhibited COX-2 exclusively or at least inhibited COX-2 significantly more than it did COX-1, then that drug could reduce inflammation without producing the sort of side effects associated with the set of NSAIDs on the market at the time.
[7] It was in this context that the respondent developed a new class of NSAID compounds, including celecoxib. The ‘576 Patent was granted to the respondent with an effective filing date of November 14, 1994. The Minister subsequently added celecoxib to the Register of Patented Medicines maintained under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations).
[8] The claimed compounds, including celecoxib, were new compounds as of the filing date. At issue are claims 4 and 8 to 13. Claim 4 claims celecoxib; claim 8 claims a therapeutically-effective amount of celecoxib; claims 9 to 13 claim the use of celecoxib to treat inflammation and other specified conditions or disorders (Mylan appeal book, vol. 1, pp. 304 to 305). Also at issue is claim 16 which is directed at the prevention of colorectal cancer.
[9] In the “Description of the Invention” section of the ‘576 Patent’s specification, the inventor described the issue of side effects in the class of NSAIDs on the market around the filing date, and wrote “(t)he compounds are useful as anti-inflammatory agents, such as for the treatment of arthritis, with the additional benefit of having significantly less harmful side effects”. In the next paragraph of that section, the inventor stated that the invention “preferably includes” compounds selectively inhibiting COX-2 over COX-1 and that “(s)uch preferred selectivity may indicate an ability to reduce the incidence of common NSAID-induced side effects” (Mylan appeal book, vol. 1, p. 119).
[10] In 2007, the respondent was successful in preventing the Minister from issuing another party an NOC in respect of celecoxib. Novopharm Ltd. had made in respect of the ‘576 Patent allegations of insufficiency, lack of utility, obviousness and abandonment. Though the Federal Court (Hughes J.) ruled that the respondent had demonstrated that the first two allegations were not justified, it held that the respondent had failed to make that demonstration with respect to the last two. The respondent’s application was accordingly dismissed (G.D. Searle & Co. v. Novopharm Ltd., 2007 FC 81, [2008] 1 F.C.R. 477 [Novopharm FC]). The decision was reversed on appeal, where this Court upheld the conclusions on insufficiency and lack of utility, but found that the respondent had also demonstrated that the allegations of obviousness and abandonment were not justified (G.D. Searle & Co. v. Novopharm Ltd., 2007 FCA 173, [2008] 1 F.C.R. 529 [Novopharm FCA]).
[11] Five years later, the respondent was again called upon to defend its monopoly over celecoxib further to notices of allegation (NOA) filed by Mylan and Apotex. Each of the two ensuing prohibition applications filed by the respondent were heard by the Federal Court judge, who allowed both in decisions issued on January 28, 2014 (the Mylan decision) and on April 15, 2014 (the Apotex decision). These are the decisions now under appeal.
THE MYLAN DECISION [12] Before the Federal Court judge, Mylan argued that because the ‘576 Patent promised reduced side effects in humans and celecoxib did not procure such reduced side effects, the ‘576 Patent was invalid for lack of utility.
[13] Mylan supported this contention by reference to the language in the specification itself, particularly where it describes the COX-2 hypothesis and where it states “(t)he compounds are useful as anti-inflammatory agents … with the additional benefit of having significantly less harmful side effects” (Mylan appeal book, vol. 1, pp. 118 to 119).
[14] Mylan also relied on Hughes J.’s construction of the ‘576 Patent in Novopharm FC. In describing the patent in general, he stated “(a)fter some discussion, counsel for the applicants conceded that both the anti-inflammatory properties and lesser side effects were necessary to the utility of the claimed invention” (Mylan decision at para. 74, quoting Novopharm FC at para. 14). In construing claim 4 of the patent specifically, he further stated (Mylan decision at para. 74, quoting Novopharm FC at para. 27):
[No use of (celecoxib) is stated in that claim but,] as conceded by counsel for the applicants, the utility of that compound is set out in the specification as being the duality of treatment of inflammation and reduction of unwanted side effects such as ulcers of the gastrointestinal system.
[15] Relying on the above passages, Mylan argued before the Federal Court judge that because the respondent had conceded in Novopharm FC that reduced side effects were necessary to establish celecoxib’s utility, its attempt to argue against this very premise before him amounted to an abuse of process.
[16] The respondent resisted these allegations on three alternative grounds, arguing that the ‘576 Patent did not promise reduced side effects; that, if it had so promised, the promise did not extend to humans and that, if the promise had so extended, celecoxib was in fact proven to have reduced side effects in humans. The respondent placed great emphasis on the equivocal nature of the specification statement that celecoxib “may” reduce side effects.
[17] The Federal Court judge accepted the respondent’s first argument, ruling that the ‘576 Patent did not promise reduced side effects. As to the effect of the prior decision in Novopharm FC, he rejected Mylan’s contention that this decision bound him to construe the patent so as to promise the utility of reduced side effects in humans. Citing paragraphs 102 and 103 of that decision, he observed that Hughes J. found demonstrated utility in that case (Mylan decision at para. 75). However, it was not clear that reduced side effects in humans had been demonstrated (Mylan decision at para. 77). The Federal Court judge added that he would have been bound by Hughes J.’s decision had it “turned on” patent construction, as this is a question of law (Mylan decision at para. 78). However, he went on to find that as utility, whether demonstrated or predicted is a question of fact, he was not bound by Hughes J.’s decision.
[18] Turning to the construction of the patent, the Federal Court judge accepted the respondent’s more limited construction of the patent on two principal grounds. First, he found that the word “may” as it appeared in the specification represented a clear indication that the patent made no promise of reduced side effects. Whether read within the context of standard statutory interpretation principles or from the perspective of a skilled addressee, the word “may” could not be taken to imply anything more than a possibility of reduced side effects (Mylan decision at para. 65).
[19] Second, the Federal Court judge observed that the claims themselves were devoid of any mention of reduced side effects. Citing Federal Court jurisprudence, he held that uses which do not appear in the claims specification ought to be considered as mere statements of advantage, absent clear and unequivocal language promising such uses (Mylan decision at para. 70, citing Fournier Pharma Inc. v. Canada (Health), 2012 FC 741, [2012] F.C.J. No. 901 at para. 126 [Fournier]). He found further support for the distinction between promises and statements of advantage or potential use in the concurring opinions issued by this Court in Sanofi-Aventis v. Apotex Inc. 2013 FCA 186, [2013] F.C.J. No. 856 (Leave to Appeal to SCC granted on January 30, 2014, 35562) [Plavix FCA] (Mylan decision at paras. 68 and 69).
THE APOTEX DECISION [20] Before the Federal Court judge, Apotex made two submissions very similar to those made by Mylan. First, it argued that the patent promised reduced side effects in humans and that such utility could now be proven not to have been achieved. Second, it argued that, because the respondent conceded before Hughes J. in Novopharm FC that utility necessarily included reduced side effects, it would constitute an abuse of process for the respondent to dispute that premise before the Federal Court judge.
[21] Apotex advanced a number of additional arguments. First, it took the position that utility in respect of celecoxib’s use as an anti-inflammatory in humans was neither demonstrated nor soundly predicted. Though Apotex conceded that celecoxib had since been proven to be so useful, it asserted that the respondent could neither demonstrate such utility nor provide a sound basis for predicting it, as of the filing date.
[22] Second, Apotex argued on the basis of language in the specification as well as that in claim 16 that the patent had promised the utility of preventing colorectal cancer and that this utility was neither demonstrated nor soundly predicted as of the filing date.
[23] Finally, Apotex attacked the ‘576 Patent for insufficiency of disclosure. The essence of this argument was that the respondent buried its “true invention”, namely the use of celecoxib for treating inflammation, among a smattering of other compounds and claims which it knew in fact to be useless or unfounded. For instance, one particular compound claimed in claim 5 was known to be toxic at the filing date, and was therefore useless.
[24] The Federal Court judge rejected these contentions. On the question of utility in treating inflammation, he accepted the respondent’s argument that rats could be considered to constitute “subjects” and that, to the extent that the patent had promised to treat inflammation in a subject, this promise had been demonstrated to have been met (Apotex decision at paras. 28 and 29, citing Plavix FCA and Mylan Pharmaceuticals ULC v. Pfizer Canada Inc., 2012 FCA 103, 2012 F.C.J. No. 386 [Donepezil FCA]).
[25] On the question of utility in treating side effects in humans, the Federal Court judge rejected Apotex’ argument on the basis of a revised version of his reasons in the Mylan decision. He conceded the “inappropriate” nature of some of his justifications in that decision for ruling that the ‘576 Patent did not promise reduced side effects in humans, namely his discussion at paragraph 44 of the principle that what is not claimed is generally disclaimed (Apotex decision at paras. 30 and 36).
[26] The Federal Court judge concluded, however, that his earlier ruling was nevertheless correct, and reiterated that the side effects statements were excluded from the specification’s claims, that the law generally presumes such statements to be aimed at advantages (as opposed to promises) and that the word “may” as it appears in the specification reflected a critical degree of equivocation.
[27] Further, he rejected Apotex’ argument that the less equivocal side effects statement (“…with the additional benefit of … significantly less harmful side effects”) referred to one set of side effects (i.e. harmful side effects) while the more equivocal statement (“… may indicate an ability to reduce the incidence of common … side effects”) referred to another (i.e. common side effects). Finally, he rejected Apotex’s invitation to apply an English case constructing the European celecoxib patent such that its utility included reduced side effects. In essence, he reasoned that English patent law varies from Canadian patent law in a number of areas, including questions of utility and, more specifically, promise.
[28] The Federal Court judge concluded that part of his analysis by highlighting what was demonstrated by the evidence before him (Apotex decision at para. 41):
What the in vitro tests demonstrated was that the compounds tested were COX II selective. That might have led the inventors to hope that eventually it would be established that this COX II selectivity equated with reduced side effects. Perhaps, they could have made a promise, but they did not. Consequently, it is not necessary to decide whether or not the tests as set out in the record establish that Celebrex® has fewer side effects. Pfizer does not have to meet a promise it never made.
[29] Concerning the claim regarding prevention of colorectal cancer, the Federal Court judge concluded that Apotex had provided evidence of the claim’s invalidity, but agreed with the respondent that, under section 58 of the Patent Act, R.S.C., 1985, c. P-4 (the Act), this claim could be severed from the rest, and that the remaining claims could support the prohibition order sought by the respondent.
[30] The Federal Court judge also rejected Apotex’ submissions on insufficiency. Although the compound claimed in claim 5 was indeed known to be toxic at high doses, it was nevertheless an effective anti-inflammatory, and the respondent could not be seen to have promised that the compound would receive regulatory approval.
[31] With respect to the question whether the respondent had “obscured” its true invention, the Federal Court judge distinguished the case at bar from Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 [Teva], where the Supreme Court of Canada found that the patentee, in claiming two different compounds while knowing that only one was effective, had done exactly that. The Federal Court judge explained that in the case at bar, each of the three compounds claimed had been demonstrated to reduce inflammation (Apotex decision at para. 59). Though celecoxib may have been the central compound in the respondent’s commercial designs, such designs need not be disclosed, and the ‘576 Patent’s “true invention” remained a class of compounds including celecoxib, rather than celecoxib alone.
[32] The Federal Court judge finally rejected Apotex’ claim of abuse of process, observing that the construed utility in Novopharm FC had been demonstrated on the basis of proven COX-2 selectivity and not on the basis of the reduction of side effects in humans (Apotex decision at para. 62). He further explained that patent construction is a matter of law, and the court is not bound by a party’s concession or admission on such questions (Apotex decision at para. 61).
POSITION OF THE APPELLANTS [33] Before this Court, Apotex advances four distinct arguments, namely lack of utility in treating inflammation in humans, lack of utility in reducing side effects, lack of utility in preventing colorectal cancer and insufficient disclosure. Though it frames matters slightly differently, Mylan’s submissions all go to the second of these four arguments. The following is a joint summary of the submissions made by the appellants.
[34] In arguing lack of utility in treating inflammation, Apotex argues that the ‘576 Patent promised to treat inflammation in humans and that, as of the filing date, it could only be demonstrated that celecoxib could reduce inflammation in rats.
[35] Both in stating the utility of its invention and in claiming its monopoly, the ‘576 Patent speaks of treatment in “a subject”. According to Apotex, this subject must be understood to include humans, as the disorders in respect of whose treatment the invented compounds are described and claimed are all suffered by humans and some of them are suffered exclusively by humans. No person of skill in the art (skilled person), asserts Apotex, would take the view that the respondent intended to monopolize the use of the claimed compounds to treat a given set of disorders in a group of “subjects” incapable of suffering the disorders in question (Apotex memorandum at paras. 64 and 65). Furthermore, a patent which lays claim to a particular use necessarily includes a promise in respect of that use (Apotex memorandum at para. 67, citing Bauer Hockey Corp. v. Easton Sports Canada Inc., 2010 FC 361, [2010] F.J.C. No. 431 at para. 289 [Bauer FC], aff’d 2011 FCA 83, [2011] F.C.J. No. 331 and Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 at para. 92 [AZT]).
[36] Apotex further argues that the Federal Court judge erred in citing two cases from this Court to justify rejecting the interpretation advocated by Apotex. First, his reliance on Plavix FCA was misplaced, as the patent in issue in that case contained no claims of treatment, let alone treatment of human disorders (Apotex memorandum at para. 70). In Donepezil FCA, neither the claims nor the testing mentioned humans, but the promised utility was construed to include treatment of humans on the basis that the specification and claims mentioned treatment of a human disorder (Apotex memorandum at para. 71).
[37] Because the Federal Court judge held that the respondent had neither demonstrated nor been able to soundly predict treatment of inflammation in humans, a finding of invalidity for lack of utility would result automatically if this Court were to conclude that the word “subject” in the ‘576 Patent extends to humans.
[38] In arguing lack of utility in reducing side effects, the appellants both take the position that Novopharm FC was binding on the Federal Court judge so that he had to find a promise of reduced side effects in humans. If the Federal Court judge wanted to depart from this earlier construction, he had to justify that departure, whether on the basis of an error in the earlier construction or because of distinct evidence (Mylan memorandum at para. 43, citing Apotex Inc. v. Allergan Inc., 2012 FCA 308, [2012] F.C.J. No. 1467 [Allergan] at paras. 48 and 51; Apotex memorandum at para. 97). As the Federal Court judge provided no such justification, he erred in not following Hughes J.’s construction.
[39] Apotex further asserts that an innovator cannot relitigate an issue “with additional evidence it chose not to adduce” in earlier proceedings to which it was a party (Apotex memorandum at para. 88 citing Sanofi-Aventis Inc. v. Novopharm Ltd., 2007 FCA 163, [2008] 1 F.C.R. 174 at para. 50 [Ramipril FCA]). Nor can an innovator accept and reject the same position in different proceedings under the Regulations in respect of the same patent (Apotex memorandum at para. 89, citing Apotex Inc. v. AstraZeneca Canada Inc., 2012 FC 559, [2012] F.C.J. No. 621 [Omeprazole FC] at paras. 137 and 138, citing Johnson v. Agnew, [1980] A.C. 367 (HL)).
[40] Finally, Mylan submits that, in limiting its NOA to the issue of utility, it expressly relied on the construction of the ‘576 Patent rendered in Novopharm FC and left undisturbed in Novopharm FCA (Mylan memorandum at paras. 37 and 41).
[41] Turning to the Federal Court judge’s own construction of the ‘576 Patent, Mylan cites two decisions of this Court in which a promise was found to extend to reduced side effects (Mylan memorandum at paras. 55 and 56, citing Eli Lilly Canada Inc. v. Novopharm Limited, 2010 FCA 197, [2012] 1 F.C.R. 349 [Olanzapine] at paras. 27 and 99 and Apotex Inc. v. Pfizer Canada Inc., 2011 FCA 236, [2011] F.C.J. No. 1234 [Latanoprost]) and two decisions in which a promise was found not to so extend (Mylan memorandum at paras. 58 and 59, citing Plavix FCA at para. 67 and Mylan Pharmaceuticals ULC. v. AstraZeneca Canada Inc., 2012 FCA 109, [2012] F.C.J. No. 422 [Anastrozole] at paras. 6, 22, 29 and 30). Mylan argues that the ‘576 Patent is “qualitatively more similar” to the patents in the first set of cases (Mylan memorandum at para. 60).
[42] Mylan also argues that, in relying on the testimony of the respondent’s expert, Dr. Young, to support his construction, the Federal Court judge failed to follow this Court’s guidance in Olanzapine. While that case made it clear that the judge is required to analyze the expert testimony, the Federal Court judge merely “parlayed and ‘broadly agreed’” with the perspective offered by Dr. Young (Mylan memorandum at paras. 75 and 76). Had the Federal Court judge truly analyzed this testimony, he would have noticed multiple statements supporting the view that, at the filing date, the chief goal of NSAID researchers was to develop a COX-2 selective drug with reduced side effects (Mylan memorandum at para. 77).
[43] Mylan further argues for the first time on appeal that, even if the Court finds that the promise of the ‘576 Patent excludes side effect superiority, it must find that it at least included COX-2 selectivity distinctly higher than existing NSAIDs (Mylan memorandum at para. 85, citing the Apotex decision at paras. 38 to 42, 59 and 62).
[44] Finally, consistent with its argument that the ‘576 Patent did promise reduced side effects, Mylan contends that celecoxib can be shown not to have achieved this result. Specifically, Mylan points to the refusal by the North American regulators to conclude that celecoxib possesses a side effect advantage over pre-existing NSAIDs (Mylan memorandum at paras. 98 to 108) and alleges that the respondent itself cannot provide studies supporting any side effect superiority unless it presents them in a misleading fashion (Mylan memorandum at paras. 109 to 116). Mylan contends that if the Court construes the ‘576 Patent as promising an enhanced degree of COX-2 selectivity, celecoxib can be shown to be no more than slightly more selective than pre-existing NSAIDs (Mylan memorandum at paras. 117 to 122).
[45] For its part, Apotex makes two unique submissions attacking the Federal Court judge’s conclusion that the ‘576 Patent’s promise did not extend to reduced side effects.
[46] First, Apotex reiterates its proposed distinction between the harmful side effects to which the specification’s less qualified statement on side effects would have been directed and those common side effects at which the specification’s more qualified statement would have been directed. Furthermore, it attacks the Federal Court judge’s rejection of this argument. Although the Federal Court Judge stated that none of the experts saw this distinction, patent construction is a matter for the Court alone to decide (Apotex memorandum at para. 83, citing Plavix FCA at para. 33).
[47] Second, Apotex advances a new distinction between these two statements on side effects, suggesting that the less qualified statement set out an explicit promise that the ‘576 Patent’s COX-2 selective compounds would have less side effects than other NSAIDs existing at the time (Apotex memorandum at para. 76). The more qualified statement was not directed at comparing the invention with other NSAIDSs, but rather at comparing different subsets of the compounds disclosed in the specification. Thus, while the first statement went to the utility of the invention, the second one went merely to issues of relative safety among the invented compounds. The word “may” in the latter only reflects uncertainty as to whether relative COX-2 selectivity among those compounds would result in relative side effect superiority (Apotex memorandum at paras. 78 and 79).
[48] In arguing lack of utility in preventing colorectal cancer, Apotex argues that the Federal Court judge improperly considered its argument on this point as going to insufficiency of disclosure, when Apotex had argued the point in respect of utility (Apotex memorandum at para. 73). The patent explicitly promised utility “for the prevention of colorectal cancer”, however, and monopolized this use of the disclosed compounds through claim 16 (Apotex memorandum at para. 72). Where a promise is made in a patent, that promise is “overarching and inherent to the invention and thus all of the claims” (Apotex memorandum at para. 54, citing Apotex Inc. v. Merck & Co., [1995] 2 F.C. 723 (FCA) at para. 33, Merck & Co. Inc. v. Apotex Inc., 2006 FC 524 at paras. 122 to 125 and Sanofi-Aventis Canada Inc. v. Apotex Inc., 2009 FC 676 [Sanofi]at paras 119 to 124 and 138, aff’d 2011 FCA 300 at para. 3). Where this promise cannot be met the entire patent is rendered invalid (Apotex memorandum at para. 55, citing AZT at para. 92, Plavix FCA at para. 54, Pfizer Canada Inc.v. Pharmascience Inc., 2008 FC 500 at para. 95, New Process Screw v. PL Robertson Manufacturing (1961), 39 C.P.R. 31 [New Process Screw] at paras. 27 to 28, 31, and 38 to 39 (CT) and Turner v. Winter (1787), 99 ER 1274 at 1276 (KB)). As the Federal Court judge found that the compounds of the invention are not useful in preventing colorectal cancer, this lack of utility goes to the validity of the entire ‘576 Patent and the respondent’s application must be dismissed (Apotex memorandum at para. 104).
[49] In arguing insufficiency of disclosure, Apotex submits that the ‘576 Patent “played games” with its reader, in that the specification concealed the “true invention” of celecoxib among two other compounds (those claimed in claims 5 and 6) known at the filing date to lack utility (Apotex memorandum at para. 113). The reader would have had to complete more work than the reader in Teva in order to discover the true invention of the ‘576 Patent, and the amount of work required in Teva was too great to support a finding of sufficient disclosure (Apotex memorandum at para. 114).
[50] Apotex criticizes the Federal Court judge’s specific finding that “the fact that tests had revealed high doses of the compound in [c]laim 5 were toxic in rats does not detract from the fact that [c]laim 5 works as an anti-inflammatory” (Apotex memorandum at para. 116, citing the Apotex decision at para. 44). This statement reveals two errors, submits Apotex. First, the Federal Court judge speaks of “high doses”, but the actual evidence was not qualified in this respect (Apotex memorandum at para. 117). Second, it is nonsensical to suggest that toxicity in rats would not detract from utility in treating inflammation in rats (Apotex memorandum at para. 117).
[51] Finally, Apotex criticizes the Federal Court judge’s conclusion that the compound claimed in claim 6 “worked” because it was “the basis of a treatment of arthritis in dogs” (Apotex memorandum at para. 120, citing the Apotex decision at para. 59). That, as it turned out after the filing date, the compound could be put to such use is irrelevant to the sufficiency of the disclosure of the invention as of that date (Apotex memorandum at para. 121).
POSITION OF THE RESPONDENT [52] The respondent argues that each of the Federal Court judge’s decisions withstands the appellants’ attacks.
[53] On the question of utility in treating inflammation in humans, the respondent submits that Apotex’ argument conflates the scope of a patent’s claims with the extent of any utility it may have promised. Once the proper principles on patent construction are applied, one can see that no “promise of (the) specific result” of treatment of inflammation in humans appears in the ‘576 Patent (memorandum of the respondent in response to Apotex at para. 35, citing Plavix FCA at paras. 49 and 50). In any event, the respondent submits that the evidence is clear that treatment in humans was soundly predicted (memorandum of the respondent in response to Apotex at paras. 61 to 67). Although Apotex insists that the Federal Court judge found otherwise at paragraph 17 of the Apotex decision, the respondent submits that he was merely describing the position taken by Apotex.
[54] With respect to abuse of process and related doctrines, the respondent submits that Novopharm FC was not binding on the Federal Court judge and, even if it had been, it would not have led to the outcome argued before this Court by the appellants, as Hughes J. found utility to have been demonstrated through experiments on rats (memorandum of the respondent in response to Apotex at paras. 80 to 83).
[55] The respondent adds that a change in the law is an important exception to abuse of process and comity. In this respect, the principles for construing the promise of a patent had yet to be articulated when Novopharm FC was decided seven years ago (memorandum of the respondent in response to Apotex at para. 82). Given the change in the law, culminating in Plavix FCA, the Federal Court judge properly refused to follow Novopharm FC (memorandum of the respondent in response to Apotex at para. 83, citing R. v. Bernard [1988], 2 S.C.R. 833 at 849 and 855 and R. v. Chaulk [1990], 3 S.C.R. 1303 at 1352).
[56] With respect to the claim relating to colorectal cancer, the respondent argues that different claims can contain different promises, and that, contrary to Apotex’ claim, not every promise need be construed as “overarching and inherent” to a patent’s invention and each of its claims (memorandum of the respondent in response to Apotex at para. 41, citing Pfizer Canada Inc. v. Apotex Inc., 2007 FC 26 at paras. 42 to 43, Teva Canada Ltd. v. Novartis AG, 2013 FC 141 [Imatinib]at paras. 174 to 180, Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC, 2011 FC 547 at paras 191 to 193 and s. 58 of the Act). Furthermore, if the ‘576 Patent made any promise of utility in preventing colorectal cancer, it would be limited to claim 16 as none of the other claims can sensibly be construed to contain such a promise (memorandum of the respondent in response to Apotex at para. 77). As for the statement in the specification that the compounds would be useful for the prevention of colorectal cancer, this was the disclosure that would have enabled claim 16, and not a promise that could be imported into each of the patent’s claims (Ibidem).
[57] With respect to Apotex’ arguments of insufficiency, the respondent submits that these arguments never appeared in Apotex’ NOA, and can therefore not be advanced before this Court (memorandum of the respondent in response to Apotex at paras. 87 and 99 to 100).
ANALYSIS AND DECISION Standard of Review [58] Broadly speaking, these appeals concern three separate allegations of lack of utility and one allegation of insufficient disclosure. The allegations pertaining to utility raise distinct issues of patent construction and demonstrated or predicted utility.
[59] The parties are in agreement that patent construction gives rise to a question of law which stands to be assessed on a standard of correctness (Plavix FCA at para. 33; Housen v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235 at para. 8 [Housen]).
[60] However, whether utility has been made out, by being demonstrated or predicted, is a question of fact to be reviewed only for palpable and overriding error (Novopharm Limited v. Pfizer Canada Inc., 2010 FCA 242, [2012] 2 F.C.R. 69 [Pfizer] at paras. 91-93; Housen at para. 10). Finally, sufficiency of disclosure, because it gives rise to a mixed question of fact and law, is reviewed only for palpable and overriding error absent an extricable error of law (Housen at paras. 36 to 37).
[61] In addition to alleging that the Federal Court judge erred in his construction of the ‘576 Patent, the appellants also argue that he breached the principles of comity and stare decisis in failing to follow the construction reached by Hughes J. in Novopharm FC and affirmed by this Court in Novopharm FCA. Pursuing the same theme, the appellants argue that the Federal Court judge improperly countenanced an abuse of process on the part of the respondent by allowing it to plead that reduced harmful side effects were not promised whereas it had conceded that point in Novopharm FC.
[62] The scope and application of the doctrine of stare decisis is a question of law for which the standard of review is correctness (Air Canada Pilots Association v. Kelly, 2012 FCA 209, [2013] 1 F.C.R. 308 at para. 40 [Kelly]). As to abuse of process, the decision of the Federal Court judge allowing the respondent to argue that reduced side effects were not promised is discretionary in nature, and cannot be overturned absent an error of law or principle, or a wrongful exercise of discretion with respect to the factors considered or not considered (Ramipril FCA at para. 13; Elders Grain Co. v. Ralph Misener (Ship), 2005 FCA 139, [2005] 3 F.C.R. 367 at para. 13).
Plan of Analysis [63] I propose to address these issues under the following headings: Utility in Treating Inflammation in Humans; Utility in Reducing Side Effects; Utility in Preventing Colorectal Cancer; Insufficiency of Disclosure; and Abuse of Process, Stare Decisis, and Comity. Consideration of these topics requires a brief discussion about the legal approach set out in Plavix FCA and specifically whether it amounts to new law, as the respondent contends.
[64] Under the Act, an invention must be useful in order to deserve protection (s. 2). The courts, however, have long held that the minimum requirements for utility under the Act are fairly forgiving. First, the inventor need not expressly set out the utility of the invention in the patent (Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504 at 525 and 526 [Consolboard]. It is merely required that, where the inventor is called upon to prove the utility of the invention, utility can be shown to be demonstrated or soundly predicted as of the patent’s filing date (AZT). Second, the threshold that must be proven to establish utility is generally quite low, described as being no more than a “scintilla of utility” (Olanzapine).
[65] The promise doctrine represents an exception to the above minimum statutory requirements. Though an inventor need not describe any particular utility for the invention, an inventor who explicitly promises a specific result will be held to that promise when called upon to prove utility (Plavix FCA at paras. 48 and 49). That the invention may well have satisfied the scintilla threshold is of no assistance in establishing utility where a promise, if it be made, cannot be met (Plavix FCA at para. 54).
[66] The promise doctrine will hold an inventor to an elevated standard only where a clear and unambiguous promise has been made. Where the validity of a patent 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. This approach can be traced back to the earliest mentions of the promise doctrine. In Consolboard, the source of the promise doctrine in Canadian law, the Supreme Court of Canada reiterated the longstanding principle that (Consolboard at 521, citing Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada, [1934] S.C.R. 574 at 570):
… where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction.
[67] This rule in favour of saving an invention rather than invalidating it in case of ambiguity has been consistently applied by this Court. While the principle is sometimes invoked by reference to the original language found in Consolboard (Anastrozole at paras. 17 and 19) affirming AstraZeneca Canada Inc. v. Mylan Pharmaceuticals ULC, 2011 FC 1023, [2011] F.C.J. No. 1262 at para. 88), it is at other times given effect through the requirement that promises be “explicit” (see Olanzapine at para. 76, Eli Lilly and Company v. Teva Canada Limited, 2011 FCA 220, [2011] F.C.J. No. 1028 at paras. 18 to 21 [Atomexetine], Plavix FCA at para. 49). Drawing an analogy with the threshold test applicable to selection patents, the Court in Plavix FCA expressed the need for explicitness by saying that a promise must be supported by language “… at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of a genus patent” (Plavix FCA at para. 66). It follows that it is not enough to merely label a promise as “explicit” if it can only be supported on the basis of equivocal inferences and ambiguous indications (Plavix FCA at paras. 64-66).
[68] It is apparent from the foregoing that Plavix FCA merely applies a long established legal approach to a new set of facts. Contrary to what the respondent asserts, it does not create new law.
[69] I now turn to the question whether the Federal Court judge correctly construed the ‘576 Patent in holding that no promise was made that celecoxib would be useful in treating inflammation in humans.
Utility in Treating Inflammation in Humans [70] Apotex raised the bar by arguing not only that the ‘576 Patent promised utility in treating inflammation, but that this promise extended to humans. The crux of Apotex’ argument is that, where a patent “lays claim” to a particular use, the patent cannot conceivably be read as not including a promise for that very use (Apotex memorandum at para. 67). The only authority cited in support of this categorical proposition is Bauer FC. In that case, Gauthier J