Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193 (1998)

Supreme Court of Canada

Docket Number: 25419

Linked as:

Extract

Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193 (1998)

Merck Frosst Canada Inc. v. Canada (Minister of National

Health and Welfare), [1998] 2 S.C.R. 193

Apotex Inc. Appellant v.

Merck Frosst Canada Inc. and Merck & Co. Inc. Respondents and

The Minister of National Health and Welfare and

Kyorin Pharmaceutical Co., Ltd. Respondents

Indexed as: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare)

File No.: 25419.

1998: January 21; 1998: July 9.

Present: L'Heureux-Dubé, Gonthier, Cory, McLachlin, Iacobucci, Major and Bastarache JJ.

on appeal from the federal court of appeal

Patents -- Notice of allegation (NOA) -- Proper date for assessing NOA -- Patent Act, R.S.C., 1985, c. P-4, ss. 39.11, 39.14 -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(1), (3), 6, 7.

Patents -- Infringement -- Sublicensing -- Licensee agreeing to supply patented medicine to unlicensed third party -- Licence expressly prohibiting sublicensing -- Breach of licence conditions grounds for termination of licence -- Whether supply agreement between licence holder and third party a sublicence or having legal effect of creating a sublicence.

Kyorin held a Canadian patent for the antibiotic Norfloxacin. Merck & Co. was the exclusive holder of a licence for Canada, and Merck Canada its sole sublicensee. Apotex applied to the Commissioner of Patents for a Notice of Compliance (NOC) for the formulation and sale of 400 mg tablets of Norfloxacin. The application did not specify where the tablets would be sold. The Notice of Allegation (NOA) alleged that use by Apotex of the drug would not infringe Kyorin's patent because Apotex would obtain bulk Norfloxacin from or through Novopharm under a supply agreement. Novopharm was the holder of a compulsory licence issued before the 1993 revisions to the Patent Act which eliminated the compulsory licence regime.

Under its compulsory licence, Novopharm was entitled to manufacture or import bulk Norfloxacin, and to combine it with other ingredients to make final-dosage forms for sale outside of Canada at any time after October 15, 1991. However, pursuant to certain provisions of the Patent Act, it could not produce Norfloxacin for sale for consumption in Canada until July 2, 1993, or import it until July 2, 1996. Furthermore, the compulsory licence expressly proh...

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