Allergan Inc. et al. v. Canada (Minister of Health) et al., (2012) 440 N.R. 269 (FCA)

• Judge: Noël, Stratas and Webb, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: October 30, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2012), 440 N.R. 269 (FCA);2012 FCA 308

Allergan Inc. v. Can. (2012), 440 N.R. 269 (FCA)

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Temp. Cite: [2012] N.R. TBEd. DE.003

Apotex Inc. (appellant) v. Allergan Inc., Allergan Sales Inc. and Allergan, Inc. (respondents) and The Minister of Health (respondent)

(A-312-12; 2012 FCA 308; 2012 CAF 308)

Indexed As: Allergan Inc. et al. v. Canada (Minister of Health) et al.

Federal Court of Appeal

Noël, Stratas and Webb, JJ.A.

November 23, 2012.

Summary:

Allergan Inc., Allergan Sales Inc., and Allergan, Inc., applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a topical ophthalmic product to be known as APO-BRIMONIDINE-TIMOP, a generic version of Allergan's COMBIGAN (an eye drop medicine used to treat glaucoma), until the expiry of Allergan, Inc.'s Canadian Letters Patent No. 2,440,764 (the '764 patent) on April 9, 2023. The basic issue was whether Allergan had discharged its burden of demonstrating that Apotex's allegations of invalidity of the '764 patent were not justified. In determining that matter, there were several discrete issues, including the effect of the previous Federal Court decision in Allergan Inc. et al. v. Canada (Minister of Health) et al. (2011), 400 F.T.R. 164.

The Federal Court, in a decision reported at (2012), 414 F.T.R. 56, allowed the application, for reasons of comity. On the evidence, Apotex's allegations as to obviousness were justified. However, serious issues had been raised as to comity. "The somewhat contradictory decisions of the Court of Appeal should be considered by that Court and clear instruction given as to how, in an NOC context, previous decisions of a Court on the same issues respecting the same patent, should be considered. The only practical way to get the matter before the Court of Appeal is for me to grant the Order for prohibition in the likely expectation that Apotex will appeal." Apotex appealed. Allergan, for its part, asked that the prohibition order be upheld, for reasons that went to the merits of its application.

The Federal Court of Appeal dismissed the appeal. Although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued.

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - A Federal Court judge granted the order sought by Allergan prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex for a topical ophthalmic product (a generic version of Allergan's COMBIGAN, an eye drop medicine used to treat glaucoma), until the expiry of Allergan's Patent No. 2,440,764 (the '764 patent) - Although the judge held that Apotex's allegation of invalidity on grounds of obviousness was justified and that the prerequisite for the issuance of the prohibition order sought by Allergan had therefore not been established, he nevertheless issued it - In so doing, the judge adhered to the judgment given in another NOC proceeding involving the same patent, even though he disagreed with the reasons and the conclusion reached in that case - He explained that he wanted to make sure that his concerns about the application of the doctrine of comity in the context of NOC proceedings could be addressed on appeal - The Federal Court of Appeal concluded that "it was not open to the Federal Court judge to grant the prohibition in order to further his desire to clarify the jurisprudence. As to the merits, I agree with Allergan that the Federal Court judge failed to have regard to the inventive concept properly construed and that had he done so, he could not have found that the invention was obvious. I would therefore dismiss the appeal and confirm that the prohibition order was properly issued, but would do so on the ground that the alleged invalidity of the '764 patent asserted by Apotex in its Notice of Allegation has not been established." - See paragraph 6.

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - The Federal Court of Appeal commented on the doctrine of comity - "This doctrine is sometimes described as a modified form of stare decisis, i.e. horizontal rather than vertical ... . Stare decisis requires judges to follow binding legal precedents from higher courts. Although not binding in the same way, the doctrine of comity seeks to prevent the same legal issue from being decided differently by members of the same Court, thereby promoting certainty in the law ... . As a manifestation of the principle of stare decisis, the principle of judicial comity only applies to determinations of law. It has no application to factual findings. ... The assumption that underlies the doctrine of comity is that in theory there can only be one correct answer to a question of law. ... [W]hile judges are not bound to apply this doctrine by any strict rule of stare decisis, what is avoided by adhering to this doctrine is the uncertainty which diverging answers create." - See paragraphs 43 to 46.

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - The Federal Court of Appeal commented on the doctrine of comity - "It is up to the judges of the Federal Court to determine how this doctrine is to be applied to their decisions. I note in this respect that different considerations may arise depending on the jurisdiction being exercised ... for example, immigration where decisions of the Federal Court are final in the absence of a question being certified .... However, the general view appears to be that the conclusions of law of a Federal Court judge will not be departed from by another judge unless he or she is convinced that the departure is necessary and can articulate cogent reasons for doing so. On this test, departures should be rare." - See paragraph 48.

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - Canadian Letters Patent No. 2,440,764 (the '764 patent), entitled "Combination of Brimonidine and Timolol for Topical Ophthalmic Use", were granted to Allergan - Allergan applied to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex for a generic version of Allergan's COMBIGAN until the expiry of the '764 patent - Apotex alleged that the '764 patent was invalid for obviousness - That was a question previously considered by Crampton, J., in Allergan Inc. et al. v. Canada (Minister of Health) et al. - Crampton, J., found that the allegation that the '764 patent was invalid for obviousness was not justified - The Federal Court judge found differently in this case, but issued a prohibition order for the purpose of having his concerns about the use of the doctrine of comity and the notion of abuse of process addressed on appeal - The Federal Court of Appeal held that it was not open to the judge to do so - The parties were entitled to have their dispute settled on the merits - "The Federal Court judge by issuing a formal judgment that was contrary to the conclusions that he reached on the merits, failed in his task." - In the result, there were now conflicting and equally authoritative decisions as to how the patent-at-issue was to be construed, and it fell upon the Court of Appeal to determine which was the correct one - See paragraphs 49 and 53.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - [See first Courts - Topic 82 ].

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court of Appeal stated that "[c]laim construction must be conducted in light of the patent as a whole" - In the present case, the Federal Court judge, in holding that the inventive concept was restricted to what was stated in paragraph 1 of the patent-at-issue (entitled "Combination of Brimonidine and Timolol for Topical Ophthalmic Use"), read that paragraph in isolation - A purposive and complete reading of the patent led to the conclusion that the improved safety profile of the combination drug formed part of the claimed invention - Given that conclusion, the last two steps of the analysis conducted by the court below (differences between state of the art and inventive concept; and obviousness) could not stand - One option was to return the matter to the judge to complete the analysis based on a correct understanding of the inventive concept - However, as this was a summary proceeding based on paper evidence, and as the record contained the relevant evidence, it was more efficient for the Court of Appeal to complete the analysis - The court concluded that the improved safety profile had not been shown to be obvious - The result was that, although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued - See paragraphs 72 to 94.

Patents of Invention - Topic 1505

Grounds of invalidity - General - Combination patents - [See Patents of Invention - Topic 1026 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1026 ].

Cases Noticed:

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2011), 400 F.T.R. 164; 2011 FC 1316, refd to. [para. 2].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 5].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 2007 FCA 163, refd to. [para. 39].

Janssen-Ortho Inc. et al. v. Apotex Inc. et al. (2009), 392 N.R. 71; 2009 FCA 212, refd to. [para. 39].

Sga'nisim Sim'augit (Chief Mountain) et al. v. Canada (Attorney General) et al., [2011] B.C.T.C. Uned. 1394; 2011 BCSC 1394, refd to. [para. 43].

Glaxo Group Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 103 F.T.R. 1; 64 C.P.R.(3d) 65 (T.D.), refd to. [para. 43].

Delta Acceptance Corp. v. Redman, [1966] 2 O.R. 37 (C.A.), refd to. [para. 44].

Almrei, Re (2009), 337 F.T.R. 160; 2009 FC 3, refd to. [para. 45].

Canada Steamship Lines Ltd. v. Minister of National Revenue, [1966] Ex. C.R. 972 (Ex. Ct.), refd to. [para. 46].

Police Authority for Huddersfield v. Watson, [1947] 1 K.B. 842, refd to. [para. 46].

dela Fuente v. Canada (Minister of Citizenship and Immigration) (2005), 276 F.T.R. 241; 2005 FC 992, refd to. [para. 47].

Stone v. Canada (Attorney General) (2012), 404 F.T.R. 104; 2012 FC 81, refd to. [para. 47].

Ziyadah v. Canada (Minister of Citizenship and Immigration), [1999] 4 F.C. 152; 169 F.T.R. 282 (T.D.), refd to. [para. 48].

671905 Alberta Inc. et al. v. Q'Max Solutions Inc. (2003), 305 N.R. 137; 2003 FCA 241, refd to. [para. 50].

Laboratoires Servier et al. v. Apotex Inc. et al. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 50].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495; 262 N.R. 137 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 50].

Western Electric Co. v. Baldwin International Radio of Canada Ltd., [1934] S.C.R. 570, refd to. [para. 50].

Weatherford Canada Ltd. et al. v. Corlac Inc. et al. (2011), 422 N.R. 49; 2011 FCA 228, refd to. [para. 50].

Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al. (2010), 376 F.T.R. 104; 2010 FC 746, refd to. [para. 56].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 56].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 75 C.P.R.(4th) 165; 2009 FC 320, refd to. [para. 64].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 65].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 65].

American Cyanamid Co. v. Berk Pharmaceuticals Ltd., [1976] R.P.C. 231 (Ch. D.), refd to. [para. 65].

Xerox of Canada Ltd. et al. v. IBM Canada Ltd. (1977), 33 C.P.R.(2d) 234 (F.C.T.D.), refd to. [para. 65].

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), 436 N.R. 299; 2012 SCC 60, refd to. [para. 73].

Authors and Works Noticed:

Hayhurst, W.K., The Distinction between Letters Patent and Patent Specification, How Did We Get Where We Are? (2007), 57 C.P.R.(4th) 161, generally [para. 52].

Counsel:

Andrew Brodkin and Richard Naiberg, for the appellant;

Andrew J. Reddon, Steven G. Mason and Steven Tanner, for the respondents, Allergan Inc., Allergan Sales Inc. and Allergan, Inc.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the appellant;

McCarthy Tétrault LLP, Toronto, Ontario, for the respondents, Allergan Inc., Allergan Sales Inc. and Allergan, Inc.

This appeal was heard at Ottawa, Ontario, on October 30, 2012, before Noël, Stratas and Webb, JJ.A., of the Federal Court of Appeal. In reasons written by Noël, J.A., the Court delivered the following judgement on November 23, 2012.