Apotex inc. v. Janssen-Ortho Inc., 2009 FCA 212 (2009)

Extract

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Apotex inc. v. Janssen-Ortho Inc., 2009 FCA 212 (2009)

Date: 20090622

Docket: A-373-08

Citation: 2009 FCA 212

CORAM: NADON J.A.

LAYDEN-STEVENSON J.A.

TRUDEL J.A.

BETWEEN:

APOTEX INC.

Appellant and

JANSSEN-ORTHO INC. and

DAIICHI SANKYO COMPANY, LIMITED

Respondents and

THE MINISTER OF HEALTH

Respondent

Heard at Ottawa, Ontario , on April 28, 2009.

Judgment delivered at Ottawa, Ontario , on June 22, 2009.

REASONS FOR JUDGMENT BY: NADON J.A.

CONCURRED IN BY: TRUDEL J.A.

DISSENTING REASONS BY: LAYDEN-STEVENSON J.A.

Date: 20090622

Docket: A-373-08

Citation: 2009 FCA 212

CORAM: NADON J.A.

LAYDEN-STEVENSON J.A.

TRUDEL J.A.

BETWEEN:

APOTEX INC.

Appellant and

JANSSEN-ORTHO INC. and

DAIICHI SANKYO COMPANY, LIMITED

Respondents and

THE MINISTER OF HEALTH

Respondent

REASONS FOR JUDGMENT

NADON J.A.

[1] This is an appeal from a decision of Shore J. dated June 17, 2008, 2008 FC 744, prohibiting the Minister of Health (the “Minister”) from issuing a Notice of Compliance (a “NOC”) to the appellant Apotex Inc. (“Apotex”) in respect of its levofloxacin hemihydrate tablets until the expiry of Canadian Patent No. 1,304,080 (the “ ’080 patent”).

[2] The proceedings which led to the issuance of the learned Judge’s order of prohibition were commenced by the respondents pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations , S.O.R./93-133 (the “Regulations”).

[3] I conclude that the appeal must be allowed.

THE FACTS

The patent at issue:

[4] The ‘080 patent which issued to the respondent Daiichi-Sankyo Company, Limited (“Daiichi”), on June 23, 1992, discloses and claims levofloxacin, an antibiotic that treats the most severe forms of pneumonia. The patent expires on June 22, 2009.

[5] Daiichi is also the owner of Canadian Patent 1,157,840 (the “ ‘840 patent”) which expired on May 22, 2001. This patent disclosed and claimed the antibiotic ofloxacin, which Daiichi licensed to the respondent Janssen-Ortho Inc. (“Janssen”) for marketing in Canada .

[6] The only claim of the ‘080 patent which is at issue in these proceedings is claim 4, which reads:

S(-)-9-fluoro-3-methyl-10-1-piperazinyl)-7-oso-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxaine-6-carboxylic acid.

The parties are in agreement that another name for the compound described in claim 4 is levofloxacin.

[7] Levofloxacin is a chiral compound. Chiral compounds can exist in two different three-dimensional configurations, known as enantiomers. Enantiomers have the same two-dimensional structures, but are non-superimposable mirror images of each other. When the two enantiomers are present in a 50-50 mixture, the mixture is known as a racemate. In the case of levofloxacin, the racemate is given the name “ofloxacin”. Levofloxacin’s mirror enantiomer is called “dextrofloxacin”.

[8] While similar in many respects, enantiomers have different chemical properties and may have different biological effects when administered. The disclosure of the ‘080 patent reveals that levofloxacin has reduced toxicity, increased solubility and twice the antimicrobial activity as compared to racemic ofloxacin. The ‘080 patent also discloses processes to make levofloxacin substantially free of the dextrofloxacin enantiomer.

[9] As disclosed in the ‘080 patent, levofloxacin can exist in both hydrous and anhydrous forms. The anhydrous form (the anhydrate), consists of levofloxacin free from any associated water molecules. Hydrous levofloxacin (the hydrate) is formed of levofloxacin closely associated with water molecules. Levofloxacin hemihydrate is a type of hydrate.

[10] Janssen manufactures levofloxacin for sale in Canada . Apotex, a “generic” company or “second per...

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