Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., (2009) 354 F.T.R. 280 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: November 12, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 354 F.T.R. 280 (FC);2009 FC 1165

Pfizer Can. Inc. v. Can. (2009), 354 F.T.R. 280 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. NO.026

Pfizer Canada Inc. and Pfizer Limited (applicants) v. The Minister of Health and Ratiopharm Limited (respondents)

(T-1350-04; 2009 FC 1165)

Indexed As: Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Federal Court

Hughes, J.

November 16, 2009.

Summary:

Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application). An application judge dismissed the application (see 288 F.T.R. 215; 2006 FC 220). The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition until the expiry of the patent (see 351 N.R. 189; 2006 FCA 14) (2006 order). A trial judge found that the '393 patent was invalid (see 350 F.T.R. 250; 2009 FC 711). Pfizer appealed. The appeal was pending. Ratiopharm received its NOC where the patent had been declared invalid. Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application. Pfizer moved to quash or adjourn Ratiopharm's motion pending determination of the appeal.

The Federal Court dismissed the motions.

Courts - Topic 2004

Jurisdiction - General principles - Inherent jurisdiction (incl. parens patriae jurisdiction) - Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application) - An application judge dismissed the application - The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition, valid until the expiry of the patent (2006 order) - A trial judge found that the '393 patent was invalid (impeachment action) - Pfizer appealed - Ratiopharm received its NOC where the patent had been declared invalid - Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application - Ratiopharm asserted that the court had inherent jurisdiction over its own orders, including prohibition orders in an NOC proceeding, such that when events changed, the order could be revisited - The Federal Court dismissed the motion - Ratiopharm had its day in court in the NOC application, it raised the issues that it believed to be important, adduced the evidence that it chose and, made the arguments that it wished - The result was a prohibition order valid until the "expiry" of the patent - The judgment given in the impeachment action which was a different proceeding caused the patent to "expire" but it did not "dismiss" the NOC proceedings - Accordingly, the 2006 order was dispositive of the matter and no order of dismissal of the NOC application could now be made - See paragraphs 25 to 30.

Courts - Topic 2286

Jurisdiction - Bars - Academic matters or moot issues - Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application) - An application judge dismissed the application - The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition until the expiry of the patent (2006 order) - A trial judge found that the '393 patent was invalid - Pfizer appealed - Ratiopharm received its NOC where the patent had been declared invalid - Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application - The 2006 order was rendered moot since the NOC, which was prohibited by the order, had been given to Ratiopharm - Ratiopharm asserted that there was a second matter still outstanding which was whether the NOC application should be dismissed, thus, opening the gateway to Ratiopharm under s. 8 of the Patented Medicines (Notice of Compliance) Regulations to make a claim for monetary recovery - The Federal Court dismissed the motion - The Court of Appeal heard the case on its merits and made a decision to order prohibition - The matter was finally determined - There was no longer a live controversy respecting s. 8 - All matters were now moot - There was no reason to hear the motion by Ratiopharm - See paragraphs 17 to 20.

Courts - Topic 4077

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Setting aside judgments or orders - [See Courts - Topic 2004 and Courts - Topic 2286 ].

Courts - Topic 4077

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Setting aside judgments or orders - Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application) - An application judge dismissed the application - The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition until the expiry of the patent (2006 order) - A trial judge found that the '393 patent was invalid - Pfizer appealed - Ratiopharm received its NOC where the patent had been declared invalid - Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application - The Federal Court dismissed the motion - The court had no jurisdiction to set aside an order of the Court of Appeal - The powers of the Federal Court of Appeal in the case of an appeal from the Federal Court were set out in s. 52(b) of the Federal Courts Act and included the power to give the judgment and award the process or other proceedings that the Federal Court should have given or awarded - This statutory provision did not say that the Federal Court of Appeal judgment was a judgment of the Federal Court, it said that it was a judgment that the Federal Court should have given - The judgment remained that of the Federal Court of Appeal - Once the Court of Appeal had disposed of the matter, it was for that court, not the Federal Court, to deal with that disposition - See paragraphs 8 to 16.

Courts - Topic 4077

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Setting aside judgments or orders - Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application) - An application judge dismissed the application - The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition until the expiry of the patent (2006 order) - A trial judge found that the '393 patent was invalid (impeachment action) - Pfizer appealed - Ratiopharm received its NOC where the patent had been declared invalid - Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application under rule 399(2)(a) of the Federal Court Rules - The Federal Court dismissed the motion - Rule 399(2)(a) stated that the court could set aside or vary an order "by reason of a matter that arose or was discovered subsequent to the making of that order" - There had been a separate proceeding, an impeachment action of the '393 patent, which had caused that patent to "expire" - The prohibition order was no longer operative by its very terms - That did not mean that the NOC application had to be dismissed - See paragraphs 31 and 32.

Courts - Topic 4077

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Setting aside judgments or orders - Pfizer Canada Inc. and Pfizer Ltd. (Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm Ltd. with respect to Canadian Patent 1,321,393 (the '393 patent) (NOC application) - An application judge dismissed the application - The Federal Court of Appeal allowed an appeal and issued an Order of Prohibition until the expiry of the patent (2006 order) - A trial judge found that the '393 patent was invalid (impeachment action) - Pfizer appealed - Ratiopharm received its NOC where the patent had been declared invalid - Ratiopharm moved for an order setting aside the 2006 order and dismissing the NOC application under rule 399(2)(b) of the Federal Court Rules - The Federal Court dismissed the motion - Rule 399(2)(b) stated that the court could set aside or vary an order "where the order was obtained by fraud" - The court found that it was to consider the NOC application in isolation from the impeachment action - The findings and judgment in the impeachment action, were not to affect the finding and judgment in the NOC application - This was particularly so since in the NOC application there was no violation of s. 53 of the Patent Act and no fraud allegations were raised - Therefore, rule 399(1)(b) could not apply since there was no fraud, or s. 53 violation, at issue in the NOC application - See paragraphs 33 to 47.

Food and Drug Control - Topic 1108.3

Drugs - New drugs - Notice of compliance - Prohibition order - Setting aside - [See Courts - Topic 2004 , Courts - Topic 2286 and third, fourth and fifth Courts - Topic 4077 ].

Cases Noticed:

Grenier v. Minister of National Revenue, [2008] N.R. Uned. 217; 2008 FCA 63, refd to. [para. 9].

Allied Signal Inc. v. DuPont Canada Inc. and Complax Corp. (1996), 192 N.R. 282; 65 C.P.R.(3d) 230 (F.C.A.), refd to. [para. 12].

Nu-Pharm Inc. v. Canada (Attorney General) et al. (1999), 247 N.R. 227; 2 C.P.R.(4th) 49 (F.C.A.), refd to. [para. 14].

Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342; 92 N.R. 110; 75 Sask.R. 82; [1989] 3 W.W.R. 97, refd to. [para. 19].

Bayer AG et al. v. Apotex Inc. et al. (2004), 325 N.R. 289; 2004 FCA 242, dist. [para. 19].

AB Hassle et al. v. Apotex Inc. et al. (2008), 384 N.R. 372; 2008 FCA 416, refd to. [para. 25].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2007), 370 N.R. 140; 2007 FCA 359, refd to. [para. 27].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (2009), 352 F.T.R. 124; 2009 FC 494, refd to. [para. 28].

ratiopharm Inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 2009 FC 711, refd to. [para. 34].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (1998), 166 F.T.R. 67; 1 C.P.R.(4th) 99 (T.D.), refd to. [para. 37].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 2007 FCA 163, refd to. [para. 41].

Janssen-Ortho Inc. et al. v. Apotex Inc. et al. (2009), 392 N.R. 71; 2009 FCA 212, refd to. [para. 43].

Statutes Noticed:

Federal Courts Act, R.S.C. 1985, c. F-7, sect. 52(b) [para. 8].

Federal Courts Rules, rule 399(2)(a) [para. 31]; rule 399(2)(b) [para. 33].

Counsel:

John Laskin and Jennifer Conroy, for the applicants;

Glen Bloom and Bryan Norrie, for the respondent, Ratiopharm.

Solicitors of Record:

Torys, LLP, Toronto, Ontario, for the applicant;

Osler, Hoskin & Harcourt, LLP, Ottawa, Ontario, for the respondent, Ratiopharm.

These motions were heard on November 12, 2009, at Toronto, Ontario, by Hughes, J., of the Federal Court, who delivered the following judgment on November 16, 2009.