Pfizer Can. Inc. v. Novopharm, 2005 FCA 270

• Judge: Rothstein, Evans and Malone, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: June 16, 2005
• Jurisdiction: Canada (Federal)
• Citations: 2005 FCA 270;(2005), 341 N.R. 330 (FCA)

Pfizer Can. Inc. v. Novopharm (2005), 341 N.R. 330 (FCA)

MLB headnote and full text

Temp. Cite: [2005] N.R. TBEd. AU.008

Novopharm Limited (appellant) v. Pfizer Canada Inc., Pfizer Inc. and the Minister of Health (respondents)

(A-665-04; 2005 FCA 270)

Indexed As: Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

Federal Court of Appeal

Rothstein, Evans and Malone, JJ.A.

August 9, 2005.

Summary:

Pfizer alleged that Novopharm's notice of allegation relating to its 250 mg azithromycin monohydrate tablets was inadequate. Pfizer applied for an order prohibiting the Minister of Health from granting a notice of compliance to Novopharm respecting the drug.

The Federal Court, in a decision reported at [2004] F.T.R. Uned. B08, allowed the application. Novopharm appealed.

The Federal Court of Appeal allowed the appeal.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Novopharm filed a notice of allegation (NOA) relating to its azithromycin monohydrate tablets - Pfizer applied for a prohibition order, asserting that the NOA was inadequate - Pfizer alleged that its patent for crystalline azithromycin dihydrate would be infringed - Neither claim that was allegedly infringed was a process claim - Pfizer alleged, inter alia, that Novopharm's NOA failed to address a ground of infringement asserted by Pfizer, namely that the dihydrate was formed as an intermediate during the process used to manufacture the bulk monohydrate - The Federal Court of Appeal held that the applications judge erred in requiring Novopharm to "put into play" all aspects of the non-infringement issue in its NOA - The NOA was not deficient where Pfizer's ground of infringement was merely speculative and Novopharm's detailed statement adequately informed Pfizer of the case it had to meet - See paragraphs 12 to 18.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Novopharm filed a notice of allegation (NOA) relating to its azithromycin monohydrate tablets - Pfizer applied for a prohibition order, asserting that the NOA was inadequate - Pfizer alleged that its patent for crystalline azithromycin dihydrate would be infringed - Neither claim alleged to be infringed was a process claim - Pfizer alleged, inter alia, that Novopharm's NOA failed to address a ground of infringement asserted by Pfizer, namely that the dihydrate was formed as an intermediate during the process used to manufacture the bulk monohydrate - An applications judge granted the prohibition order - The Federal Court of Appeal held that the applications judge erred in placing an evidential burden on Novopharm respecting the intermediate issue - Where, as here, the NOA was adequate, the legal burden remained squarely on Pfizer to prove, on a balance of probabilities, that the allegations in the NOA were inadequate - Novopharm had no evidential burden to support the allegations in its NOA and detailed statement - Novopharm only had to file evidence supporting its detailed statement to counter any evidence submitted by Pfizer in the course of the proceedings - See paragraphs 19 to 21.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - A judge found that Novopharm's notice of allegation (NOA) was deficient and granted an order prohibiting the Minister of Health from granting a notice of compliance to Novopharm respecting the drug in issue - Novopharm appealed - The Federal Court of Appeal held that where the correct legal test for determining the adequacy of a notice of allegation had been properly formulated by the judge below, the dispute would revolve around the application of the test to the facts - However, where a legal error in the formulation of the correct legal test could be identified, a correctness standard of review would apply - See paragraph 11.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof - [See second Food and Drug Control - Topic 1105 ].

Cases Noticed:

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 4].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 4].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 329 N.R. 152; 38 C.P.R.(4th) 400 (F.C.A.), refd to. [para. 4].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1, refd to. [para. 11].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2002), 298 N.R. 323; 22 C.P.R.(4th) 1; 2002 FCA 421, refd to. [para. 13].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 16].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 191 N.R. 157; 64 C.P.R.(3d) 450 (F.C.A.), affing. (1995), 92 F.T.R. 253; 60 C.P.R.(3d) 328 (T.D.), appld. [para. 19].

Glaxo Group Ltd. et al. v. Canada (Minister of National Health and Welfare) and Apotex Inc. (1998), 147 F.T.R. 298; 80 C.P.R.(3d) 424 (T.D.), refd to. [para. 24].

Counsel:

Robert W. Staley, Dino Clarizio and Ruth Promislow, for the appellant;

Anthony G. Creber and Jennifer Wilkie, for the respondents.

Solicitors of Record:

Bennett Jones LLP, Toronto, Ontario, for the appellant;

Gowling Lafleur Henderson LLP, for the respondents.

This appeal was heard at Toronto, Ontario, on June 16, 2005, by Rothstein, Evans and Malone, JJ.A., of the Federal Court of Appeal. Malone, J.A., delivered the following reasons for judgment for the court at Ottawa, Ontario, on August 9, 2005.