Merck & Co. v. Apotex Inc. (2003), 315 N.R. 175 (FCA)

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Temp. Cite: [2004] N.R. TBEd. JA.013

Merck & Co., Inc., Merck Frosst Canada & Co., Syngenta Limited, AstraZeneca UK Limited and AstraZeneca Canada Inc. (appellants/plaintiffs) v. Apotex Inc. (respondent/defendant)

(A-108-03; 2003 FCA 488; 2003 CAF 488)

Indexed As: Merck & Co. et al. v. Apotex Inc.

Federal Court of Appeal

Richard, C.J., Décary and Létourneau, JJ.A.

December 22, 2003.


The plaintiffs commenced a patent in­fringement action against the defendant respecting the plaintiff’s compound lisino­pril. A prothonotary granted the defendant leave to file an amended statement of defence and counterclaim. The plaintiffs appealed respecting two categories of amend­ments.

The Federal Court of Canada, Trial Divi­sion, in a decision reported at [2003] F.T.R. Uned. 98, dismissed the appeal. The plain­tiffs appealed respecting one category of amendments (those concerning the chemical compound lisinopril dihydrate).

The Federal Court of Appeal allowed the appeal, set aside the orders of the applica­tions judge and the prothonotary respecting the first category of amendments, and denied those amendments.

Courts – Topic 2583

Registrars and prothonotaries – Appeals from – Scope of review – The Federal Court of Appeal slightly reformulated the test for the standard of review to be ap­plied to discretionary orders of prothono­taries as set out in Canada v. Aqua-Gem Investments Ltd. – The new test was: “Discretionary orders of pro­thono­taries ought not be disturbed on appeal to a judge unless: a) the questions raised in the motion are vital to the final issue of the case, or b) the orders are clearly wrong, in the sense that the exer­cise of discretion by the prothonotary was based upon a wrong principle or upon a misap­prehension of the facts.” – See para­graph 19.

Practice – Topic 2105

Pleadings – Amendment of pleadings – Pre­judice or presumed prejudice – What con­stitutes – The Federal Court of Appeal stated that the absence of a specific allega­tion of prejudice by the opposing party was not decisive of whether to allow an application to amend pleadings – The court referred to the principle that, in the ab­sence of prejudice to any opposing party, an amendment to pleadings should be al­lowed, if otherwise proper – The court stated that other factors, including that of the interests of justice, could militate against allowing an amendment even where no prejudice was expressly alleged – Fur­ther, some prejudice could appear on the face of the record without there being any need for the opposing party to expressly rely on it – See paragraph 42.

Practice – Topic 2123.1

Pleadings – Amendment of pleadings – State­ment of defence – Adding new de­fence – The plaintiffs commenced a patent infringement action against the defendant -A prothonotary granted the defendant leave to file an amended state­ment of de­fence and counterclaim – An applications judge dismissed the plaintiffs’ appeal – The Federal Court of Appeal, exercising its dis­cretion de novo denied the amendments – The proposed amendments raised ques­tions which were vital to the final issue of the case – They sought to withdraw an admis­sion of patent infringe­ment and to raise a new defence that would go to the heart of the plaintiffs’ patent claim (i.e., construc­tion of the patent) and would require ex­pert evidence – The new defence was not rea­sonable – Alterna­tively, the interests of justice required that the amend­ments be denied – The new defence did not reflect the true questions in controversy in the action – See paragraphs 43 to 54.

Practice – Topic 2128

Pleadings – Amendment of pleadings – Statement of defence – To withdraw admis­sion – The Federal Court of Appeal agreed with the proposition set out in Andersen Consulting v. Canada that: “We must ensure that the procedure to withdraw admissions is not made so complex and so stringent that virtually no admission will be made by the defendants.” – However, the court stated that “I do not read these words to say that the procedure should be made so simple and so relaxed that virtual­ly any withdrawal of admissions will be allowed. There is a burden to be met by the amending party and, while the factors to be considered are essentially the same for all amendments, the burden should be heavier when the amendments at issue purport to withdraw substantial admissions and would result in a radical change in the nature of the questions in controversy.” – See paragraph 32.

Practice – Topic 2128

Pleadings – Amendment of pleadings – Statement of defence – To withdraw admis­sion – [See
Practice – Topic 2123.1

Cases Noticed:

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) et al. (1995), 96 F.T.R. 189; 61 C.P.R.(3d) 190 (T.D.), revd. (1996), 206 N.R. 1; 69 C.P.R.(3d) 451 (F.C.A.), refd to. [para. 3].

Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425; 149 N.R. 273 (F.C.A.), refd to. [para. 17].

Pompey (Z.I.) Industrie et al. v. Ecu-Line N.V. et al. (2003), 303 N.R. 201; 224 D.L.R.(4th) 577 (S.C.C.), refd to. [para. 20].

Evans v. Bartlam, [1937] 2 All E.R. 646 (H.L.), refd to. [para. 24].

Stoicevski v. Casement (1983), 43 O.R.(2d) 436 (C.A.), refd to. [para. 24].

Nicholas (Trevor) Construction Co. v. Canada (Minister of Public Works), [2003] F.T.R. Uned. 528 (T.D.), affd. [2003] N.R. Uned. 232 (F.C.A.), refd to. [para. 25].

Scannar Industries Inc. et al. v. Minister of National Revenue (1994), 69 F.T.R. 310 (T.D.), affd. (1994), 172 N.R. 313 (F.C.A.), refd to. [para. 25].

Louis Bull Indian Band v. Canada (2003), 235 F.T.R. 228 (T.D.), refd to. [para. 25].

Minister of National Revenue v. Canderel Ltd., [1994] 1 F.C. 3; 157 N.R. 380 (F.C.A.), refd to. [para. 30].

Ketteman v. Hansel Properties Ltd., [1988] 1 All E.R. 38; 72 N.R. 321 (H.L.), refd to. [para. 30].

Continental Bank Leasing Corp. et al. v. R. (1993), 93 D.T.C. 298 (T.C.C.), refd to. [para. 30].

Andersen Consulting v. Canada, [1998] 1 F.C. 605; 220 N.R. 35 (F.C.A.), refd to. [para. 31].

Glisic v. Canada, [1988] 1 F.C. 731; 80 N.R. 39 (F.C.A.), refd to. [para. 33].

Visx Inc. v. Nidek Co. et al. (1996), 209 N.R. 342; 72 C.P.R.(3d) 19 (F.C.A.), refd to. [para. 36].

Cardinal et al. v. Canada, [1994] 3 C.N.L.R. 41; 164 N.R. 301 (F.C.A.), refd to. [para. 36].

Enoch Band of Stony Plains Indians v. Canada – see Cardinal et al. v. Canada.

Sawridge Indian Band et al. v. Canada, [2002] 2 F.C. 346; 283 N.R. 107 (F.C.A.), refd to. [para. 40].

Montana Indian Band v. Canada et al., [2002] N.R. Uned. 185 (F.C.A.), refd to. [para. 40].

Merck & Co. et al. v. Apotex Inc. (2003), 312 N.R. 273 (F.C.A.), refd to. [para. 40].

Scottish & York Insurance Co. et al. v. Canada (1999), 239 N.R. 131 (F.C.A.), refd to. [para. 42].

International Business Machines Corp. et al. v. Printech Ribbons Inc. et al., [1994] 1 F.C. 692; 69 F.T.R. 197 (T.D.), refd to. [para. 48].

Blatch v. Archer (1774), 1 Cowp. 63; 98 E.R. 969, refd to. [para. 49].

R. v. Jolivet (D.), [2000] 1 S.C.R. 751; 254 N.R. 1, refd to. [para. 49].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al., [1996] 3 F.C. 40; 197 N.R. 241; 67 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 53].

Charette v. Delta Controls (2003), 312 N.R. 295 (F.C.A.), refd to. [para. 63].

Camoplast Inc. v. Soucy International Inc. (2003), 310 N.R. 242 (F.C.A.), refd to. [para. 64].

Authors and Works Noticed:

Sgayias, David, Kinnear, Meg, Rennie, Donald, J., and Saunders, Brian J., Federal Court Practice 2003 (2002), p. 387 [para. 48].


Gunars A. Gaikis and Nancy P. Pei, for the appellant, AstraZeneca;

Judith Robinson and Frederique Amrouni, for the appellant, Merck & Co.;

David M. Scrimger, for the respondent.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the appellant, AstraZeneca;

Ogilvy Renault, Montreal, Quebec, for the appellant, Merck & Co.;

Goodmans LLP, Toronto, Ontario, for the respondent.

This appeal was heard at Ottawa, Ontario, on December 4, 2003, before Richard, C.J., Décary and Létourneau, JJ.A., of the Federal Court of Appeal. On December 22, 2003, the judgment of the Court of Appeal was delivered and the following opinions were filed:

Décary, J.A. (Létourneau, J.A., concurring) – see paragraphs 1 to 55;

Richard, C.J., dissenting – see paragraphs 56 to 68.


Merck & Co. et al. v. Apotex Inc.

(2003), 315 N.R. 175 (FCA)

Federal Court of Appeal (Canada)
Reading Time:
32 minutes
Décary, Létourneau, Richard 

Décary, J.A.
: At issue is the decision of an applications judge (reported at (2003), 24 C.P.R.(4th) 240) to dismiss the appeal from an order of a prothonotary (reported at (2002), 19 C.P.R.(4th) 354) that granted the respondent Apotex Inc. (Apotex) leave to file another Amended Statement of Defence and Counterclaim. The only amendments that the appellants take issue with in this appeal are those described by the prothonotary as forming “the first category of amendments”, i.e., those concerning the chemical com­pound known as lisinopril dihydrate.

Relevant facts and proceedings

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