Apotex Inc. c. Merck & Co., Inc., 2010 FC 287 (2010)

Extrait

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Apotex Inc. c. Merck & Co., Inc., 2010 FC 287 (2010)

Federal Court - Apotex Inc. v. Merck & Co., Inc.

Source: http://decisions.fct-cf.gc.ca/en/2010/2010fc287/2010fc287.html

Federal Court

Cour fédérale

Date: 20100312

Docket: T-411-01

Citation: 2010 FC 287

Ottawa, Ontario , March 12 , 2010

PRESENT: The Honourable Mr. Justice O'Reilly

BETWEEN:

APOTEX INC.

Plaintiff and

MERCK & CO., INC. and

MERCK FROSST CANADA & CO.

Defendant

AND BETWEEN:

MERCK & CO., INC. and

MERCK FROSST CANADA & CO.

Plaintiff by Counterclaim and

HER MAJESTY THE QUEEN IN RIGHT OF CANADA

as represented by

THE ATTORNEY GENERAL OF CANADA

Defendant to the Counterclaim

REASONS FOR JUDGMENT AND JUDGMENT

I. Overview

[1] The defendant Merck Frosst Canada & Co. holds the rights to a patented drug called norfloxacin. (On consent, the action against the other named defendant Merck & Co., Inc. was dismissed). In the early 1990s, Apotex Inc. tried to enter the market with a generic version of norfloxacin and, to that end, applied to the Minister of Health for a Notice of Compliance (NOC). Apotex alleged that it would not infringe the defendant’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.

[2] Merck filed two applications to prohibit the Minister from issuing an NOC to Apotex. In respect of the first, relating to the use of a non-infringing method of making norfloxacin, Justice Marshall Rothstein granted the order Merck sought, and the Federal Court of Appeal dismissed Apotex’s appeal ( Merck Frosst Canada Inc . v. Canada ( Minister of National Health and Welfare ), [1999] F.C.J. No. 209 (F.C.A.) (QL)).

[3] In respect of the second application, relating to the use of licensed material, Justice Sandra Simpson granted Merck its order in 1995 ( Merck Frosst Canada Inc . v. Canada (Minister of National Health and Welfare ) (1995), 65 C.P.R. (3d) 483 (F.C.T.D.)). Apotex appealed her decision unsuccessfully to the Federal Court of Appeal ( Merck Frosst Canada Inc . v. Canada (Minister of National Health and Welfare ) (1996), 67 C.P.R. (3d) 455 (F.C.A.)). Apotex appealed again to the Supreme Court of Canada and succeeded in having the prohibition order set aside on July 9, 1998 ( Merck Frosst Canada v. Canada , [1998] 2 S.C.R. 193). A week later, the Minister issued Apotex its NOC.

[4] Apotex now seeks compensation from Merck under s. 8 of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133, as amende...

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