Pfizer Canada Inc. et al. v. Apotex Inc. et al., (2002) 223 F.T.R. 1 (TD)

• Judge: Heneghan, J.
• Court: Federal Court (Canada)
• Case Date: July 19, 2002
• Jurisdiction: Canada (Federal)
• Citations: (2002), 223 F.T.R. 1 (TD)

Pfizer Can. Inc. v. Apotex Inc. (2002), 223 F.T.R. 1 (TD)

MLB headnote and full text

Temp. Cite: [2002] F.T.R. TBEd. AU.004

Pfizer Canada Inc. and Pliva d.d. (applicants) v. Apotex Inc. and the Minister of Health (respondents)

(T-1325-00; 2002 FCT 805)

Indexed As: Pfizer Canada Inc. et al. v. Apotex Inc. et al.

Federal Court of Canada

Trial Division

Heneghan, J.

July 19, 2002.

Summary:

The applicants applied under s. 6(2) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. relative to 250 mg azithromycin capsules for oral administration, until Canadian Patent 1,191,843 had expired.

The Federal Court of Canada, Trial Division, allowed the application.

Food and Drug Control - Topic 1102

Drugs - New drugs - Legislation re - A Regulatory Impact Analysis Statement (RIAS) accompanied the Patented Medicines (Notice of Compliance) Regulations when they were introduced in 1993 - The Federal Court of Canada, Trial Division, held that although the RIAS was not part of the Regulations, it served as a guide to parliamentary intention as to the purpose and effect of the proposed legislation - See paragraph 63.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The respondent's Notice of Allegation provided, in part, as follows: "The legal and factual basis for the aforesaid allegation is that we hereby undertake that, notwithstanding the issuance of the Notice of Compliance, we will not make, construct, use or sell the capsules other than as deemed to be noninfringing pursuant to Sections 55.2(1) and 55.2(2) of the Patent Act." - The Federal Court of Canada, Trial Division, held that this statement was sufficient to meet the regulatory requirement that the respondent state the legal foundation for its Notice of Allegation - See paragraphs 50 to 51.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The respondent's Notice of Allegation provided, in part, as follows: "More specifically, we want to have a Notice of Compliance issued prior to patent expiry in order to be able to submit to the provinces, so as to enable sales under the provincial programs to commence soon after patent expiry, exactly as intended by sections 55.2(1) and 55.2(2) of the Patent Act." - The Federal Court of Canada, Trial Division, held that this statement adequately set out the factual underpinning for the Notice of Allegation - See paragraphs 52 and 53.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The respondent relied on ss. 55.2(1) and 55.2(2) of the Patent Act in its Notice of Allegation - Section 55.2(2) was repealed - The respondent abandoned its reliance on s. 55.2(2) - The Federal Court of Canada, Trial Division, held that the respondent was not attempting to rewrite its Notice of Allegation by ceasing to rely on s. 55.2(2) - The respondent was simply not proceeding on one legal basis of its allegation - See paragraphs 55 to 58.

Patents of Invention - Topic 2883

Infringement of patent - Acts constituting an infringement - Sale of unascertained goods (e.g., goods not yet manufactured) - Provincial formularies were lists maintained by the provinces of all drug products approved by the provincial Ministries of Health - The Federal Court of Canada, Trial Division, rejected the submission that the mere act of applying for listing on a provincial formulary was an offer to sell and consequently, an act of infringement - See paragraph 80.

Patents of Invention - Topic 2923

Infringement of patent - Acts not constituting an infringement - Development and submission of information required by law - The respondent applied for a Notice of Compliance in respect of a medicine - In its Notice of Allegation, the respondent relied on. s 55.2(1) of the Patent Act, which provided that "It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product." - The Federal Court of Canada, Trial Division, held that the respondent could not rely on a provincial legislative regime over the interchangeability of drug products and their inclusion in provincial drug plans to justify an application for a Notice of Compliance - The provincial legislation served a regulatory purpose over the use and sale of drug products, but only after the federal process had been engaged and completed - The provincial regimes were subordinate to the federal scheme mandated by the Food and Drug Act and Regulations - See paragraphs 59 to 80.

Statutes - Topic 1660

Interpretation - Extrinsic aids - Legislative history - Regulatory Impact Analysis Statements - [See Food and Drug Control - Topic 1102 ].

Cases Noticed:

Merck Frosst Canada & Co. et al. v. Canada (Minister of Health) et al. (2000), 189 F.T.R. 126 (T.D.), refd to. [para. 20].

AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 27, footnote 20].

Schering Canada Inc. et al. v. Nu-Pharm Inc. et al. (1996), 114 F.T.R. 310; 68 C.P.R.(3d) 332 (T.D.), refd to. [para. 20].

Smith Kline and French Laboratories v. Douglas Pharmaceuticals Ltd., [1991] F.S.R. 522 (N.Z.C.A.), refd to. [para. 24].

Pharmaceutical Manufacturers Association of Canada v. British Columbia (Attorney General) (1997), 96 B.C.A.C. 165; 155 W.A.C. 165; 74 C.P.R.(3d) 417 (C.A.), refd to. [para. 27].

Reference re Proposed Federal Tax on Exported Natural Gas, [1982] 5 W.W.R. 577; 42 N.R. 351; 37 A.R. 541 (S.C.C.), refd to. [para. 40].

Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R.(3d) 1 (F.C.A.), dist. [para. 57].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 59].

Bayer Inc. v. Canada (Attorney General) et al. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), refd to. [para. 63].

Apotex Inc. v. Canada (Attorney General) et al., [2000] 4 F.C. 264; 255 N.R. 319 (F.C.A.), refd to. [para. 67].

Apotex Inc. v. Ontario (Minister of Health) et al. (1989), 36 O.A.C. 355; 71 O.R.(2d) 525 (Div. Ct.), refd to. [para. 71].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, refd to. [para. 78].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-5, sect. 55.2(1) [para. 17].

Authors and Works Noticed:

Regulatory Impact Analysis Statement (1993), Canada Gazette, Part II, vol. 127, no. 6, pp. 1388, 1389 [para. 64].

Counsel:

Anthony Creber, for the applicants;

Harry Radomski, for the respondent, Apotex Inc.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

Morris Rosenberg, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This application was heard at Ottawa, Ontario, on May 6 and 7, 2002, by Heneghan, J., of the Federal Court of Canada, Trial Division, who delivered the following decision on July 19, 2002.