Merck Frosst Can. Inc. v. Apotex Inc., (1999) 240 N.R. 195 (FCA)

Judge:Décary, Létourneau and Noël, JJ.A.
Court:Federal Court of Appeal (Canada)
Case Date:April 21, 1999
Jurisdiction:Canada (Federal)
Citations:(1999), 240 N.R. 195 (FCA)
 
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Merck Frosst Can. Inc. v. Apotex Inc. (1999), 240 N.R. 195 (FCA)

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Temp. Cite: [1999] N.R. TBEd. MY.029

Merck Frosst Canada Inc. and Merck & Co., Inc (appellants/applicants) v. The Minister of National Health and Welfare and Apotex Inc. (respondents/respondents)

(A-265-97)

Indexed As: Merck Frosst Canada Inc. et al. v. Apotex Inc. et al.

Federal Court of Appeal

Décary, Létourneau and Noël, JJ.A.

April 21, 1999.

Summary:

Merck patented the drug lovast­atin. Apo­tex developed a generic form of lovastatin. Merck sought an order prohibiting the Min­ister from issuing a notice of com­pliance to Apotex. The 30 month statutory stay pre­scribed by the Patented Medi­cines (Notice of Compliance) Regulations expired before the application could be heard. A one year ex­ten­sion was granted on consent. The hear­ing could not be scheduled until after the expiry of the one year exten­sion. Merck obtained a further extension. Apotex appealed.

The Federal Court of Appeal, in a decision reported 208 N.R. 388, set aside the exten­sion where the only basis for alter­ing the stay was under s. 7(5) of the Regula­tions, which was not argued before the court. Merck applied for an extension order under s. 7(5) of the Regula­tions. At issue was whether the court had jurisdiction to extend time under s. 7(5) or to issue a pro­hibition order under s. 6(2) after expiry of the statu­tory stay.

The Federal Court of Canada, Trial Divi­sion, in a decision reported at 128 F.T.R. 210, held that it was without jurisdiction to is­sue a prohibition order or to extend time af­ter expiry of the statutory stay. Merck ap­pealed.

The Federal Court of Appeal dismissed the appeal for mootness.

Editor's note: for related proceedings see 133 F.T.R. 1 and 136 F.T.R. 3.

Estoppel - Topic 386

Estoppel by record (res judicata) - Res ju­di­cata as a bar to subsequent proceedings -Is­sues decided in prior proceedings - [See sec­ond Food and Drug Control - Topic 1111.1 ].

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compli­ance - Practice - The Federal Court of Canada, Trial Division, held that it was without jurisdiction to issue a prohibition order under s. 6(2) or to extend time under s. 7(5) after expiry of a statutory stay under s. 7 of the Patented Medicines (Notice of Compliance) Regulations - The court con­sid­ered that: a patentee had no statutory remedy when a notice of compli­ance was is­sued after expiry of a stay and based on an unjus­tified alle­ga­tion; the Regulations pro­­vided a sum­mary me­ch­anism; and ex­ten­sion or short­en­ing appli­cations must be made within the period of the statutory stay - Further­more, an in­fringe­ment action was still open to the pat­entee - The Federal Court of Appeal dismissed an appeal for moot­ness where the Minister had issued a notice of com­pliance.

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compli­ance - Practice - Merck patented the drug lo­va­sta­­tin - Apotex developed a generic form of lovastatin - Merck filed a prohib­ition ap­plication - The statu­tory stay under the Patent Medi­cines (Notice of Compli­ance) Reg­u­lations expired before the ap­pli­cation could be heard - A one year exten­sion was granted - The hearing could only be sched­uled after the one year ext­ension - Merck obtained another exten­sion - On appeal, the ex­tension was set aside where the only bas­is for altering the stay was under s. 7(5) of the Regulations, which was not argued be­fore the court - Merck sought an exten­sion order under s. 7(5) - The trial judge held that the ext­ension issue was res ju­di­ca­ta and Merck could not reapply regard­less of its new arguments, available at the time of the original litiga­tion - There were no special circumstances warranting the court redeci­ding the issue - The Feder­al Court of Appeal dismissed an appeal for moot­ness where the Minister had issued a no­tice of compliance.

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compli­ance - Practice - Merck patented the drug lo­va­sta­­tin - Apotex developed a generic form of lovastatin - Merck filed a prohib­ition ap­plication - The statu­tory stay under s. 7 of the Patent Medi­cines (Notice of Com­pli­ance) expired before the application could be heard - Merck applied for an ex­ten­sion or­der, arguing that Apotex failed to reason­ably cooperate in expediting the ap­pli­ca­tion under s. 7(5) of the Regulations - The tri­al judge held that it was without jurisdic­tion to extend time under s. 7(5) after the ex­piry of the statutory stay - Al­ter­­natively, a 1.5 to two month delay was at­tributable to Apotex - How­ever, the addi­tion­al five month exten­sion required to pro­vide a rem­e­dy to Merck would be over and above the period attrib­utable to Apo­tex's failure to co­operate in expediting the ap­plication - The Federal Court of Appeal dis­­missed an ap­peal for mootness where the Minister had issued a notice of com­pli­ance.

Counsel:

Brian Daly and Robert Charlton, for the appellants;

H.B. Radomski and Andrew Brodkin, for the respondent, Apotex Inc.

Solicitors of Record:

Ogilvy Renault, Montreal, Quebec, for the appellants;

Goodman, Phillips & Vineberg, Toronto, Ontario, for the respondent, Apotex Inc.;

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

This appeal was heard on April 21, 1999, at Montreal, Quebec, by Décary, Létourneau and Noël, JJ.A., of the Federal Court of Appeal. Décary, J.A., delivered the following judgment from the Bench on the same date.

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