Apotex Inc. v. Merck & Co. Inc. et al., 2010 FC 287

• Judge: O'Reilly, J.
• Court: Federal Court (Canada)
• Case Date: March 12, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 287;(2010), 363 F.T.R. 137 (FC)

Apotex Inc. v. Merck & Co. Inc. (2010), 363 F.T.R. 137 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. MR.019

Apotex Inc. (plaintiff) v. Merck & Co., Inc. and Merck Frosst Canada & Co. (defendant) Merck & Co., Inc. and Merck Frosst Canada & Co. (plaintiff by counterclaim) v. Her Majesty The Queen in Right of Canada as represented by The Attorney General of Canada (defendant to the counterclaim)

(T-411-01; 2010 FC 287)

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

Federal Court

O'Reilly, J.

March 12, 2010.

Summary:

Merck Frosst Canada & Co. held the rights to a patented drug called norfloxacin. In the early 1990s, Apotex Inc. applied to the Minister of Health for a Notice of Compliance (NOC). Apotex alleged that it would not infringe Merck's patent as it would either use norfloxacin raw material acquired by a third company, Novopharm Ltd., under a license from Merck, or it would produce norfloxacin by a method that would not infringe the patent. Merck filed two applications to prohibit the Minister from issuing an NOC to Apotex.

The Federal Court, in a decision at 144 F.T.R. 299, allowed Merck's first application relating to the use of a non-infringing method of making norfloxacin. Apotex appealed.

The Federal Court of Appeal, in a decision reported at 236 N.R. 179, dismissed the appeal.

The Federal Court, in a decision reported at 106 F.T.R. 294, allowed Merck's second application, relating to the use of licensed material. Apotex appealed.

The Federal Court of Appeal, in a decision reported at 197 N.R. 294, dismissed the appeal. Apotex appealed.

The Supreme Court of Canada, in a decision reported at 227 N.R. 299, allowed the appeal. A week later, the Minister issued Apotex its NOC. Apotex now sought compensation from Merck under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, as amended.

The Federal Court held that "the 1998 version of the Regulations applies to this action and that Apotex would have entered the market sooner had it not been prohibited by the operation of the Regulations and the order Merck obtained in 1995. Therefore, Apotex is entitled under the Regulations to obtain compensation from Merck." Quantum of damages would be determined at a later date.

Food and Drug Control - Topic 1102

Drugs - New drugs - Legislation, re (incl. international treaty obligations) - Merck Frosst Canada & Co. held the rights to a patented drug called norfloxacin - In the early 1990s, Apotex Inc. applied to the Minister of Health for a Notice of Compliance (NOC) - Apotex alleged that it would not infringe Merck's patent as it would either use norfloxacin raw material acquired by a third company, Novopharm Ltd., under a license from Merck, or it would produce norfloxacin by a method that would not infringe the patent - In 1995, Merck filed two applications to prohibit the Minister from issuing an NOC to Apotex - Apotex was denied an NOC until 1998, when the Supreme Court of Canada allowed its appeal - A week later, the Minister issued Apotex its NOC - Apotex now sought compensation from Merck under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, as amended - At issue was, inter alia, which version of the Regulations applied: the 1993 version or the version that came into force in March 1998 - The Federal Court held that the 1998 Regulations applied - Merck's application was pending in March 1998 and therefore, according the transitional rule, the 1998 Regulations applied - See paragraphs 6 to 15.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Compensation by first person - Merck Frosst Canada & Co. held the rights to a patented drug called norfloxacin - In the early 1990s, Apotex Inc. applied to the Minister of Health for a Notice of Compliance (NOC) - Apotex alleged that it would not infringe Merck's patent as it would either use norfloxacin raw material acquired by a third company, Novopharm Ltd., under a license from Merck, or it would produce norfloxacin by a method that would not infringe the patent - Merck filed two applications to prohibit the Minister from issuing an NOC to Apotex - Apotex was denied an NOC until 1998, when the Supreme Court of Canada allowed its appeal - A week later, the Minister issued Apotex its NOC - Apotex now sought compensation from Merck under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, as amended - The Federal Court held that Apotex would have entered the market sooner had it not been prohibited by the operation of the Regulations and the order Merck obtained in 1995 - Therefore, Apotex was entitled under the Regulations to obtain compensation from Merck - Quantum of damages would be determined at a later date - See paragraphs 33 to 57.

Patents of Invention - Topic 5513

New substances licences (incl. compulsory licences) - Food and medicine - Patent Act Regulations - Interpretation - [See Food and Drug Control - Topic 1102 ].

Words and Phrases

Pending - The Federal Court discussed the meaning of the word "pending" as used in s. 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/98-166 - See paragraphs 16 to 32.

Cases Noticed:

Clagett's Estate, In re; Fordham v. Clagett (1882), 20 Ch. D. 637 (C.A.), refd to. [para. 19].

Hampton Lumber Mills Ltd. v. Joy Logging Ltd., [1977] 2 W.W.R. 289 (B.C.S.C.), refd to. [para. 19].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (2009), 352 F.T.R. 124; 2009 FC 494, refd to. [para. 20].

Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999), 235 N.R. 302 (F.C.A.), refd to. [para. 27].

Épiciers Unis Métro-Richelieu Inc. v. Collin, [2004] 3 S.C.R. 257; 326 N.R. 89; 2004 SCC 59, refd to. [para. 30].

Athey v. Leonati et al., [1996] 3 S.C.R. 458; 203 N.R. 36; 81 B.C.A.C. 243; 132 W.A.C. 243, refd to. [para. 34].

Laboratoires Servier et al. v. Apotex Inc. et al., [2008] E.W.H.C.(Ch.) 2347, refd to. [para. 34].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 2009 FC 991, refd to. [para. 34].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) (1998), 144 F.T.R. 299 (T.D.), affd. (1999), 236 N.R. 179 (F.C.A.), refd to. [para. 52].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 8 [Annex].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/98-166, sect. 8 [Annex].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

H.B. Radomski, Ken Crofoot and Jerry Topolski, for the plaintiff;

Patrick Kierans, Brian Daley, Azim Hussain and Andres Garin, for the defendants.

Solicitors of Record:

Goodmans, LLP, Toronto, Ontario, for the plaintiff;

Ogilvy Renault, LLP, Montreal, Quebec, for the defendants.

This action was heard on May 21, 22, 25-27, 2009, at Montreal, Quebec, by O'Reilly, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on March 12, 2010.