Actavis Pharma Co. v. Alcon Canada Inc. et al., (2015) 476 N.R. 309 (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. 309 (FCA);2015 FCA 192

Actavis Pharma Co. v. Alcon Can. Inc. (2015), 476 N.R. 309 (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: [2015] N.R. TBEd. SE.007

Actavis Pharma Company (appellant) v. Alcon Canada Inc., Alcon Pharmaceuticals, Ltd. and Bayer Intellectual Property GmbH (respondents)

(A-286-14; 2015 FCA 192; 2015 CAF 192)

Indexed As: Actavis Pharma Co. v. Alcon Canada Inc. 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 '114. A separate appeal was filed respecting Patent '211. The ruling respecting Patent '418 was not appealed.

The Federal Court of Appeal dismissed the appeal respecting Patent '114.

Editor's Note: This appeal and the related appeal reported as 476 N.R. 301; 2015 FCA 191, 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 '114 Patent for Vigamox, alleging obviousness - Vigamox was an antibacterial eye drop, containing moxifloxacin hydrochloride, an antibacterial agent belonging to the fluoroquinolone class - The '114 Patent claimed a class of quinolone compounds which included moxifloxacin characterized by a fused pyrrolidine bicycle at the C-7 position of the quinolone ring - Cobalt claimed that both the choice of modifying the C-7 position of the quinolone and the choice of a fused pyrrolidine bicycle substituent were obvious or obvious to try - The Federal Court rejected Cobalt's arguments - The matter of obviousness was not made out - Actavis appealed - The Federal Court of Appeal dismissed the appeal - See paragraphs 24 to 27.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - In Notice of Compliance proceedings, a generic drug manufacturer (Actavis, formerly Cobalt), challenged the validity of Alcon's '114 Patent for Vigamox, alleging a lack of utility and sound prediction - Vigamox was an antibacterial eye drop, containing moxifloxacin hydrochloride, an antibacterial agent belonging to the fluoroquinolone class - The '114 Patent claimed a class of quinolone compounds which included moxifloxacin characterized by a fused pyrrolidine bicycle at the C-7 position of the quinolone ring - The Federal Court dismissed the allegation of lack of utility, holding that the utility of moxifloxacin was soundly predicted based on the data disclosed in the '114 Patent - Actavis appealed, challenging the trial judge's evidentiary basis for sound prediction - The Federal Court of Appeal dismissed the appeal - See paragraphs 18 to 23.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1724 ].

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 an application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations - The court stated that "Appeals from prohibition applications such as the one at issue are subject to the appellate standards set forth in Housen v. Nikolaisen, 2002 SCC 33 ... Pharmascience Inc. v. Canada (Health), 2014 FCA 133 ... The construction of the patent itself is a matter of law that must be reviewed under the correctness standard ..." - See paragraph 8.

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 an application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations - The court stated that "Matters of mixed fact and law require the governing legal principles to be correctly articulated and applied ( Housen at paragraphs 26 and 27). As a judge's function necessarily involves weighing the evidence put forward by the parties and particularly in the face of conflicting expert opinions, the facts and evidentiary foundation on the basis of which the judge reaches his decision will stand absent a palpable and overriding error ... Demonstrating a palpable and overriding error in connection with this evidentiary exercise is subject to a high threshold ..." - See paragraph 9.

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 an application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations - The court stated that "Sound prediction and obviousness are matters of mixed fact and law ... It follows that absent a palpable and overriding error, a judge's finding in this regard will not be disturbed" - See paragraph 10.

Practice - Topic 8800.1

Appeals - General principles - Duty of appellate court regarding mixed law and fact by a trial judge - [See second and third 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:

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. 8].

AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al. (2014), 460 N.R. 343; 2014 FCA 133, refd to. [para. 8].

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. 8].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 8].

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2015), 474 NR 311; 2015 FCA 116, refd to. [para. 94].

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. 9].

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. 10].

Allergan Inc. et al. v. Canada (Minister of Health) et al., [2015] N.R. Uned. 127; 2015 FCA 137, refd to. [para. 10].

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. 21].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 21].

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. 24].

Counsel:

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

Peter Wilcox, Marian Wolanski and Frederic Lussier, for the respondents, Alcon Canada Inc., Alcon Pharmaceuticals, Ltd. and Bayer Intellectual Property GmbH.

Solicitors of Record:

Deeth William Wall LLP, Toronto, Ontario, for the appellant, Actavis Pharma Company;

Belmore Neidrauer LLP, Toronto, Ontario, for the respondents, Alcon Canada Inc., Alcon Pharmaceuticals, Ltd. and Bayer Intellectual Property GmbH.

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.