Alcon Canada Inc. et al. v. Actavis Pharma Co. et al., (2015) 476 N.R. 301 (FCA)

• Judge: Dawson, Webb and Boivin, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: May 27, 2015
• Jurisdiction: Canada (Federal)
• Citations: (2015), 476 N.R. 301 (FCA);2015 FCA 191

Alcon Can. Inc. v. Actavis Pharma Co. (2015), 476 N.R. 301 (FCA)

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Temp. Cite: [2015] N.R. TBEd. SE.006

Alcon Canada Inc. and Alcon Pharmaceuticals, Ltd. (appellants) v. Actavis Pharma Company and The Minister of Health (respondents)

(A-284-14; 2015 FCA 191; 2015 CAF 191)

Indexed As: Alcon Canada Inc. et al. v. Actavis Pharma Co. et al.

Federal Court of Appeal

Dawson, Webb and Boivin, JJ.A.

September 16, 2015.

Summary:

Alcon Canada Inc., Alcon Pharmaceuticals Ltd. and Bayer Intellectual Property GmbH GP (the applicants) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Actavis Pharma Co. (formerly Cobalt Pharmaceuticals Co.) for its generic version of the drug Vigamox. Vigamox was an antibacterial eye drop commonly used during cataract surgery, containing moxifloxacin hydrochloride, an antibacterial agent belonging to the fluoroquinolone class. Vigamox was covered by Canadian Patents '114, '211, and '418. Cobalt admitted that certain of its activities would infringe the patents. In this context, issues of validity of the patents arose.

The Federal Court, in a decision reported 454 F.T.R. 265, found that Patent '114 was valid and granted the application for a prohibition order with respect to Canadian Patent '114. The court dismissed the application for a prohibition order with respect to Patent '211, the patent being invalid for obviousness. The court also dismissed the application prohibiting the issuance of a notice of compliance with respect to the Patent '418 as Alcon was unable to establish infringement. In this proceeding, Alcon Canada Inc. and Alcon Pharmaceuticals Ltd. appealed the ruling respecting Patent '211. A separate appeal was filed respecting Patent '114. The ruling respecting Patent '418 was not appealed. Bayer was no longer a party.

The Federal Court of Appeal dismissed the appeal respecting Patent '211.

Editor's Note: This appeal and the related appeal reported as 476 N.R. 309; 2015 FCA 192, both arose from one decision at trial. The trial decision was Indexed As: Alcon Canada Inc. et al. v. Cobalt Pharmaceuticals Co. et al. and may be found at 454 F.T.R. 265.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - In Notice of Compliance proceedings, a generic drug manufacturer (Actavis, formerly Cobalt), challenged the validity of Alcon's '211 Patent for Vigamox, alleging that the patent was invalid for obviousness - Vigamox was an antibacterial eye drop, containing moxifloxacin hydrochloride, an antibacterial agent belonging to the fluoroquinolone class - The '211 Patent claimed the use of moxifloxacin hydrochloride in an ophthalmic formulation for the treatment and prevention of bacterial infections, as well as the formulation itself - The Federal Court held that the '211 Patent related to the known compound moxifloxacin being used for a known use (treating and preventing ophthalmic infection) at a concentration known to be effective (0.1 to 1.0 wt %) - Therefore, it would have been obvious or obvious to try to use moxifloxacin in eye drops particularly given Alcon's success with its predecessor drug ciprofloxacin - The '211 Patent was invalid for obviousness - Alcon appealed - The Federal Court of Appeal dismissed the appeal, holding that it was unconvinced that the trial judge made a palpable and overriding error in his factual finding or reasoning - See paragraphs 8 and 9 and 13 to 27.

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 discussed the standard of review on an appeal from a trial judge's determination that a patent was invalid for obviousness - The court stated that "... the construction of the promise of the patent is a question of law and must therefore be reviewed under the standard of review of correctness ... A judge must therefore interpret the patent as it would be understood by a person skilled in the art to which it pertains, taking into account the evidence as to how persons skilled in the art would understand certain words and phrases used in the patent and determine what the patent discloses and claims ..." - See paragraph 10.

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 discussed the standard of review on an appeal from a trial judge's determination that a patent was invalid for obviousness - The court stated that "... the standard of review for factual determinations of the Judge with respect to utility and obviousness in the patent context is palpable and overriding error. Provided a judge does not misidentify or misapply the legal test, that deferential standard applies. Moreover, provided that a judge's reasons are alive to the issues, the judge is assumed to have considered all evidence before the court and does not make a palpable and overriding error by failing to refer to a particular piece of evidence ... Significantly, a judge's function necessarily involves weighing the evidence and choosing which evidence to rely upon in the face of conflicting expert opinions ... Demonstrating a palpable and overriding error is a high threshold: as our Court recently held in Zero Spill at paragraph 49, interfering in a judge's weighing of evidence in a patent case requires demonstrating a clear (palpable) and fundamental (overriding) error going to 'the very core of the outcome of the case''' - See paragraphs 11 and 12.

Practice - Topic 8800

Appeals - Duty of appellate court regarding findings of fact by a trial judge - [See second Patents of Invention - Topic 8163 ].

Practice - Topic 8800.2

Appeals - General principles - Duty of appellate court regarding findings of law - [See first Patents of Invention - Topic 8163 ].

Cases Noticed:

Apotex Inc. v. Sanofi-Aventis, [2015] 2 F.C.R. 644; 447 N.R. 313; 114 C.P.R.(4th) 1; 2013 FCA 186, refd to. [para. 10].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129; 2000 SCC 67, refd to. [para. 10].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 10].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 10].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 10].

AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al. (2014), 460 N.R. 343; 2014 FCA 133, refd to. [para. 11].

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al. (2013), 451 N.R. 246; 2013 FCA 244, refd to. [para. 11].

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. 11].

Zero Spill Systems (Int'l) Inc. et al. v. 614248 Alberta Ltd. et al. (2015), 472 N.R. 127; 2015 FCA 115, refd to. [para. 12].

Counsel:

Peter Wilcox, Marian Wolanski and Frederic Lussier, for the appellants, Alcon Canada Inc. and Alcon Pharmaceuticals, Ltd.;

Douglas N. Deeth and Heather E.A. Watts, for the respondent, Actavis Pharma Company.

Solicitors of Record:

Belmore Neidrauer LLP, Toronto, Ontario, for the appellants, Alcon Canada Inc. and Alcon Pharmaceuticals Ltd.;

Deeth William Wall LLP, Toronto, Ontario, for the respondent, Actavis Pharma Company.

This appeal was heard in Toronto, Ontario, on May 27, 2015, before Dawson, Webb and Boivin, JJ.A., of the Federal Court of Appeal. The following judgment was delivered in Ottawa, Ontario, on September 16, 2015, for the court, by Boivin, J.A.