Pfizer Canada Inc. et al. v. Apotex Inc. et al., (2014) 465 N.R. 306 (FCA)

• Judge: Noël, C.J., Trudel and Boivin, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: September 30, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 465 N.R. 306 (FCA);2014 FCA 250

Pfizer Can. Inc. v. Apotex Inc. (2014), 465 N.R. 306 (FCA)

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[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

Temp. Cite: [2014] N.R. TBEd. NO.011

Apotex Inc. (appellant) v. Pfizer Canada Inc. and G.D. Searle & Co. (respondents)

Mylan Pharmaceuticals ULC (appellant) v. Pfizer Canada Inc. and G.D. Searle & Co. (respondents)

(A-194-14; A-94-14; 2014 FCA 250; 2014 CAF 250)

Indexed As: Pfizer Canada Inc. et al. v. Apotex Inc. et al.

Federal Court of Appeal

Noël, C.J., Trudel and Boivin, JJ.A.

October 30, 2014.

Summary:

Mylan Pharmaceuticals ULC and Apotex Inc. brought appeals from separate decisions of the Federal Court, reported at 446 F.T.R. 274; 2014 FC 38 (the Mylan decision) and 451 F.T.R. 158; 2014 FC 314 (the Apotex decision). In those decisions, the court allowed applications brought by Pfizer Canada Inc. and G.D. Searle & Co. and issued orders prohibiting the Minister of Health from issuing Notices of Compliance in respect of celecoxib until November 14, 2014, when Canadian Patent No. 2,177,576, which conveyed a monopoly over that compound, expired. The main issue in both appeals turned 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 those results.

The Federal Court of Appeal dismissed the appeals.

Administrative Law - Topic 24

Abuse of process - What constitutes - [See first Patents of Invention - Topic 1721 ].

Courts - Topic 7

Stare decisis - Authority of judicial decisions - General principles - Authority and use of precedents - Issues or arguments not raised in precedent - [See Courts - Topic 82 ].

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The appellants had argued that the Federal Court judge was bound by the construction of the '576 Patent reached in G.D. Searle & Co. v. Novopharm Ltd. (Novopharm FC) and affirmed on appeal (Novopharm FCA) and was therefore required to conclude that reduced side effects were necessary to the utility of the claimed invention - On appeal, Mylan argued that the Federal Court judge failed to abide by the doctrine of stare decisis - The Federal Court of Appeal dismissed this argument - The court stated that "Mylan cites Allergan [2012 FCA] for the proposition that a Federal Court judge may only with certain justifications adopt a patent construction at odds with a colleague's prior construction. This decision does not go so far. Rather, this Court highlighted the uncertainty that is created when two judges of the same court reach distinct results on the same question of law without explanation. ... the only thing that an appellate court can do when this happens is to eliminate the uncertainty by settling the question of law ... There is no legal sanction for a judge's failure to abide by comity. It follows that, although I agree that the justification offered by the Federal Court judge in the Mylan decision falls short ... nothing turns on this in this appeal. As for Novopharm FCA, the central question is 'what did the case decide?' ... Whether the '576 Patent's utility included reduced side effects is not a question to which this Court turned its mind" - See paragraphs 109 to 118.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process (incl. abuse of process by relitigation) - [See first Patents of Invention - Topic 1721 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - With respect to Apotex's argument regarding insufficiency of disclosure, the Federal Court of Appeal stated that "This Court has long held that subsection 5(3) of the Regulations prevents any second person from resisting a prohibition application by advancing any legal or factual basis not stated in its NOA [Notice of Allegation] ... Critically, none of the insufficiency arguments made before this Court were included in Apotex' NOA, and none of the insufficiency arguments in its NOA are argued here. Apotex has therefore failed to provide this Court any procedurally legitimate arguments in support of its insufficiency allegation" - See paragraphs 90 to 92.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - [See first Patents of Invention - Topic 1721 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance (NOCs) in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - Before the Federal Court judge, the appellants had argued that, in disputing whether the '576 Patent promised reduced side effects, the respondent was abusing the process of the court, as it had conceded before Hughes, J., in G.D. Searle & Co. v. Novopharm Ltd. (2007 FC) that reduced side effects were necessary to the utility of the claimed invention - The Federal Court judge had dismissed that argument - He ruled that a concession made by the respondent in one NOC proceeding was not an admission binding upon it in another - Apotex challenged the Federal Court judge's decision on abuse of process - The Federal Court of Appeal held that "the Federal Court judge exercised his discretion to allow the respondent to take a position consistent with the law rather than to compel it to abide by a prior concession which based on the conclusion that he reached, did not conform with the law. I can detect no error in this exercise of discretion" - See paragraphs 94 to 108.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - Apotex argued not only that the '576 Patent promised utility in treating inflammation, but that this promise extended to humans - The crux of Apotex's argument was that, where a patent "lays claim" to a particular use, the patent could not conceivably be read as not including a promise for that very use - The Federal Court of Appeal stated that "Apotex has failed to establish how any of the '576 Patent's claims can be shown to describe use in humans as a particular advantage of the claimed compounds. When the '576 Patent is read in light of the approach set out in Plavix FCA, it becomes clear that no explicit promise of treatment in humans was made. Apotex itself recognizes that the claims speak only of 'subjects', and nothing outside the claims could be said to represent the sort of unequivocal language contemplated by the reasoning in Plavix FCA. In my view, the Federal Court judge correctly held that the promise of the patent did not extend to humans" - See paragraphs 70 to 73.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - The appellants submitted that the Federal Court judge erred in holding that a promise had to be explicitly stated in a patent's claims - They argued that a promise could also appear in the specification, provided that the language was clear and explicit - The Federal Court of Appeal stated that "No doubt that is so. However, I read the reasons of the Federal Court judge as merely acknowledging the principle that statements outside of the claim should not be presumed to be promises ... I can detect no error in this regard" - See paragraph 77.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - Mylan argued that, even if the promise of the '576 Patent was found to have excluded reduced side effects, it still had to be construed to have included elevated COX-2 selectivity "that is distinctly higher" than existing non-steroidal anti-inflammatory drugs because the Federal Court judge "appears to have recognized as much" in the Apotex decision - The Federal Court of Appeal held that the passages cited by Mylan did not support that interpretation - There was no indication whatsoever that the judge found some particular level of relatively enhanced selectivity to be promised - See paragraphs 78 to 79.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - The Federal Court of Appeal rejected Apotex's arguments on lack of utility in reducing side effects - First, Apotex argued that the specification clearly promised a reduction of harmful side effects, and merely equivocated when referring to common side effects - The principal basis for attacking the Federal Court judge's rejection of this view was that, in so holding, he abdicated his role by blindly adopting the opinion of the respondent's expert - Nothing in the reasons suggested that the Federal Court judge viewed the experts' perspectives as controlling his own - Rather, he simply relied on their views to support his own - Furthermore, his view that none of the experts adopted the interpretation advanced by Apotex was well-founded - Furthermore, Apotex argued that the less equivocal side effects statement promised reduced side effects in its invented compounds relative to pre-existing compounds, while the more equivocal side effects statement expressed doubt merely as to whether relative COX-2 selectivity among the invented compounds might correlate to relatively reduced side effects - This argument also failed as Apotex made no attempt to show that its interpretation was supported by any of the expert evidence - See paragraphs 80 to 84.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. ''promise of the patent'') - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The main issue in both appeals turned on whether the Federal Court judge properly held that the '576 Patent 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 those results - Apotex argued that any given promise had to be construed as overarching, and that, because the respondent had failed to rebut Apotex's allegation that the promise of preventing colorectal cancer was neither demonstrated nor soundly predicted as of the filing date, the validity of the patent as a whole was undermined - The respondent argued that not every promise need be construed as overarching, and that any promise of preventing colorectal cancer was limited to claim 16 of the '576 Patent - The Federal Court of Appeal stated that "Not one case cited by Apotex stands for the proposition that a promise, once made and shown not to have been met, must be construed as invalidating the invention as a whole. ... The issue is one of patent construction and the respondent's proposition in my view represents the correct approach. Though I accept that some promises may impose utility requirements across each of a patent's claim, Apotex has offered no reason to depart from the Federal Court judge's determination that the promise of colorectal cancer prevention, if any, can be severed" - See paragraphs 85 to 89.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See all Patents of Invention - Topic 1721 ].

Patents of Invention - Topic 8163

Practice - Appeals - Questions of law, fact or mixed fact and law (incl. applicable standard of review) - The Federal Court of Appeal stated that "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 ... 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 ... 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" - See paragraphs 58 to 60.

Patents of Invention - Topic 8163

Practice - Appeals - Questions of law, fact or mixed fact and law (incl. applicable standard of review) - Mylan Pharmaceuticals ULC and Apotex Inc. appealed from separate decisions of the Federal Court which prohibited the issuance of Notices of Compliance in respect of celecoxib until the expiry of Canadian Patent No. 2,177,576 ('576 Patent) - The Federal Court of Appeal stated that "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. The scope and application of the doctrine of stare decisis is a question of law for which the standard of review is correctness ... 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" - See paragraphs 61 to 62.

Cases Noticed:

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 477; 296 F.T.R. 254; 2007 FC 81, revd. [2008] 1 F.C.R. 529; 361 N.R. 290; 2007 FCA 173, consd. [para. 10].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 277; 2012 FC 741, refd to. [para. 19].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, leave to appeal granted (2014), 471 N.R. 390 (S.C.C.), consd. [para. 19].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 430 N.R. 326; 2012 FCA 103, refd to. [para. 24].

Teva Canada Ltd. v. Pfizer Canada Inc. - see Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., [2012] 3 S.C.R. 625; 436 N.R. 299; 2012 SCC 60, refd to. [para. 31].

Bauer Hockey Corp. et al. v. Easton Sports Canada Inc. (2010), 366 F.T.R. 242; 2010 FC 361, affd. (2011), 414 N.R. 69; 2011 FCA 83, refd to. [para. 35].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 35].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 440 N.R. 269; 2012 FCA 308, consd. [para. 38].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 174; 364 N.R. 325; 2007 FCA 163, refd to. [para. 39].

Apotex Inc. v. Astrazeneca Canada Inc. (2012), 410 F.T.R. 168; 2012 FC 559, refd to. [para. 39].

Johnson v. Agnew, [1980] A.C. 367 (H.L.), refd to. [para. 39].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd., [2012] 1 F.C.R. 349; 405 N.R. 1; 2010 FCA 197, refd to. [para. 41].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, refd to. [para. 41].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 41].

Merck & Co. et al. v. Apotex Inc. (1995), 180 N.R. 373; 60 C.P.R.(3d) 356 (F.C.A.), refd to. [para. 48].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, refd to. [para. 48].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 2009 FC 676, affd. (2011), 426 N.R. 196; 2011 FCA 300 refd to. [para. 48].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 326 F.T.R. 88; 2008 FC 500, refd to. [para. 48].

New Process Screw v. PL Robertson Manufacturing (1961), 39 C.P.R. 31, refd to. [para. 48].

Turner v. Winter (1787), 99 E.R. 1274, refd to. [para. 48].

R. v. Bernard, [1988] 2 S.C.R. 833; 90 N.R. 321; 32 O.A.C. 161, refd to. [para. 55].

R. v. Chaulk and Morrissette, [1990] 3 S.C.R. 1303; 119 N.R. 161; 69 Man.R.(2d) 161, refd to. [para. 55].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 56].

Teva Canada Ltd. v. Novartis AG (2013), 428 F.T.R. 1; 2013 FC 141, refd to. [para. 56].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 2011 FC 547, refd to. [para. 56].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 59].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd.., [2012] 2 F.C.R. 69; 408 N.R. 166; 2010 FCA 242, refd to. [para. 60].

Air Canada Pilots Association v. Kelly et al., [2013] 1 F.C.R. 308; 434 N.R. 165; 2012 FCA 209, refd to. [para. 62].

Elders Grain Co. et al. v. Ship Ralph Misener et al., [2005] 3 F.C.R. 367; 334 N.R. 1; 2005 FCA 139, refd to. [para. 62].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 64].

Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada, [1934] S.C.R. 574, refd to. para. 66].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, refd to. [para. 67].

Novopharm Ltd. v. Eli Lilly & Co., [2010] F.T.R. Uned. 896; 2010 FC 1154, affd. (2011), 420 N.R. 188; 2011 FCA 220, refd to. [para. 67].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172 (F.C.A.), refd to. [para. 92].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 1 F.C. 402; 291 N.R. 339; 2002 FCA 290, refd to. [para. 92].

Hoffmann-La Roche Ltd. v. Apotex Inc. et al. (2011), 394 F.T.R. 142; 104 C.P.R.(4th) 233; 2011 FC 875, refd to. [para. 98].

AstraZeneca AB et al. v. Apotex Inc. et al. (2004), 248 F.T.R. 1; 33 C.P.R.(4th) 97; 2004 FC 313, refd to. [para. 101].

Apotex Inc. v. Pfizer Ireland Pharmaceuticals (2012), 431 F.T.R. 1; 2012 FC 1339, refd to. [para. 110].

Bedford et al. v. Canada (Attorney General) et al. (2012), 290 O.A.C. 236; 346 D.L.R.(4th) 385; 2012 ONCA 186, refd to. [para. 114].

R. v. Henry (D.B.) et al., [2005] 3 S.C.R. 609; 342 N.R. 259; 376 A.R. 1; 360 W.A.C. 1; 219 B.C.A.C. 1; 361 W.A.C. 1; 2005 SCC 76, refd to. [para. 114].

Counsel:

Andrew Brodkin and Jaro Mazzola, for the appellant, Apotex Inc.;

Tim Gilbert, Nathaniel Lipkus and Matthew Frontini, for the appellant, Mylan Pharmaceuticals ULC;

Andrew Bernstein, W. Grant Worden, Yael Bienenstock and Rachel Saab, for the respondents, Pfizer Canada Inc. and G.D. Searle & Co.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the appellant, Apotex Inc.;

Gilbert's LLP, Toronto, Ontario, for the appellant, Mylan Pharmaceuticals ULC;

Torys LLP, Toronto, Ontario, for the respondents, Pfizer Canada Inc. and G.D. Searle & Co.

These appeals were heard on September 30, 2014, at Ottawa, Ontario, before Noël, C.J., Trudel and Boivin, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered by Noël, C.J., on October 30, 2014.