Patented Medicines (Notice of Compliance) Regulations, Section 4, Re

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Federal Court (Canada)
• Judge: Gibson, J.
• Citation: (2002), 225 F.T.R. 55 (TD)
• Date: 03 September 2002

Patented Medicines Regulations, s. 4, Re (2002), 225 F.T.R. 55 (TD)

MLB headnote and full text

Temp. Cite: [2002] F.T.R. TBEd. OC.038

In The Matter Of a Reference by the Minister of Health under Subsection 18.3(1) of the Federal Court Act, R.S.C. 1985, c. F-7, regarding a Question as to the Application of Section 4 of the Patented Medicines (Notice of Compliance) Regulations, S.O.R. 93-133 as amended

(T-139-02; 2002 FCT 1000)

Indexed As: Patented Medicines (Notice of Compliance) Regulations, Section 4, Re

Federal Court of Canada

Trial Division

Gibson, J.

September 25, 2002.

Summary:

The Minister of Health initiated a proceeding by a "Notice of Application for a Reference" regarding a question as to the application of s. 4 of the Patented Medicines (Notice of Compliance) Regulations. The Minister then applied ex parte under Federal Court Rule 322 for directions respecting the procedure to be followed on the reference.

A Prothonotary of the Federal Court of Canada, Trial Division, issued directions, which inter alia, provided that Eli Lilly Canada Inc. et al. should be given notice of the reference, the Minister of Health would be a party to the reference and "the Record of Decision to Apply for a Reference ... particularly the matters set out therein under the heading 'The Facts', shall constitute the case to be determined on the reference". Eli Lilly et al. filed a notice of intention to participate and thus became parties to the reference. Eli Lilly applied under rule 399 to, inter alia, vary the ex parte directions of the prothonotary to replace the facts constituting the case or to be permitted to file evidence to correct and complete the factual record.

A Prothonotary of the Federal Court of Canada, Trial Division, in a decision reported as Schedule A below, held that the facts were not clearly articulated by the Minister and therefore struck the Notice of Application for Reference with leave to the Minister to amend the facts that constituted the case for the reference. The Minister did not file an amended pleading, but appealed the Prothonotary's decision. Eli Lilly cross-appealed.

The Federal Court of Canada, Trial Division, dismissed the appeal and cross-appeal, except that the court amended the order of the prothonotary to provide that the Notice of Application for A Reference was struck without leave to amend. The court stated that it was "satisfied that it is plain and obvious that it would be an abuse of the process of this Court to allow the Minister's reference to proceed on the basis of a factual underpinning that is clearly in dispute, that could not be rationalized without full presentation of evidence and an opportunity for cross-examination, and that would thus be essentially incapable of eliciting an informed response from this court".

Practice - Topic 3793

References and inquiries - References by tribunals to the courts - Striking out notice of reference - The Federal Court of Canada, Trial Division, discussed the authority of the court to strike out a reference on a preliminary motion where the substance of the reference was established on an ex parte motion - See paragraphs 20 to 21.

Practice - Topic 3793

References and inquiries - References by tribunals to the courts - Striking out notice of reference - The Minister of Health filed a "Notice of Application for a Reference" (the notice) regarding a question as to the application of s. 4 of the Patented Medicines (Notice of Compliance) Regulations - The Minister then applied ex parte for procedural directions - A prothonotary directed that Eli Lilly et al. should be given notice of the reference and "the Record of Decision to Apply for a Reference ... particularly the matters set out therein under the heading 'The Facts', shall constitute the case to be determined on the reference" - Eli Lilly sought to vary the prothonotary's ex parte directions to replace the facts constituting the case or to be permitted to file evidence to correct and complete the factual record - The prothonotary struck the Minister's notice, with leave to amend where the facts articulated by the Minister lacked clarity - The Minister appealed and Eli Lilly cross-appealed - The Federal Court of Canada, Trial Division, dismissed the appeal and cross-appeal, except for ordering that the notice of reference was struck, without leave to amend.

Cases Noticed:

Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425; 149 N.R. 273 (F.C.A.), refd to. [para. 16, footnote 8].

Inuit Tapirisat of Canada and the National Anti-Poverty Organization v. Canada (Attorney General), [1980] 2 S.C.R. 735; 33 N.R. 304; 115 D.L.R.(3d) 1, refd to. [para. 20, footnote 9].

Canada (Minister of Citizenship and Immigration) v. Seifert (2002), 221 F.T.R. 228 (T.D. Protho.), refd to. [para. 20, footnote 9].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48 (F.C.A.), dist. [para. 21, footnote 10].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) - see Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al.

Air Canada v. Canada (Commissioner of Official Languages) - see Air Canada, Re.

Air Canada, Re (1997), 144 F.T.R. 161 (T.D.), affd. (1999), 241 N.R. 157 (F.C.A.), dist. [para. 22, footnote 11].

Rosen, Re, [1987] 3 F.C. 238; 80 N.R. 47 (F.C.A.), refd to. [para. 24, footnote 12].

Apotex Inc. v. Canada (Minister of Health) et al. (1999), 165 F.T.R. 42; 87 C.P.R.(3d) 271 (T.D.), affd. [2001] N.R. Uned. 25 (F.C.A.), refd to. [Schedule B].

Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) et al. (2001), 199 F.T.R. 142; 10 C.P.R.(4th) 318 (T.D.), affd. (2002), 288 N.R. 24 (F.C.A.), refd to. [Schedule B].

Statutes Noticed:

Federal Court Rules (1998), rule 320, rule 321, rule 322, rule 323 [para. 5]; rule 399(1), rule 399(3) [para. 9].

Counsel:

F.C. Woyiwada, for the applicant, Minister of Health;

Anthony G. Creber and Cristin Wagner, for the respondent, Eli Lilly Canada Inc.;

David Scott, Q.C, and Kevin LaRoche, for the respondent, Canada's Research-Based Pharmaceutical Companies (Rx&D);

Edward Hore, for the respondent, Canadian Drug Manufacturers Association (CDMA).

Solicitors of Record:

Morris Rosenberg, Deputy Attorney General of Canada, Ottawa, Ontario, for the applicant, Minister of Health;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the respondent, Eli Lilly Canada Inc.;

Borden Ladner Gervais LLP, Ottawa, Ontario, for the respondent, Canada's Research-Based Pharmaceutical Companies (Rx&D);

Hazzard & Hore, Toronto, Ontario, for the respondent, Canadian Drug Manufacturers Association (CDMA);

Smart & Biggar, Toronto, Ontario, for the interveners, Astrazeneca Canada Inc. and Hoffman-LaRoche Ltd.;

Ogilvy Renault, Toronto, Ontario, for the intervener, Glaxosmithkline Inc.;

Torys LLP, Toronto, Ontario, for the intervener, Pfizer Canada Inc.

This appeal and cross-appeal was heard at Ottawa, Ontario, on September 3, 2002, before Gibson, J., of the Federal Court of Canada, Trial Division, who delivered the following decision on September 25, 2002.