Abbott Laboratories et al. v. Canada (Minister of Health) et al., (2007) 361 N.R. 308 (FCA)

• Judge: Sharlow, Malone and Ryer, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: March 07, 2007
• Jurisdiction: Canada (Federal)
• Citations: (2007), 361 N.R. 308 (FCA);2007 FCA 153

Abbott Lab. v. Can. (2007), 361 N.R. 308 (FCA)

MLB headnote and full text

Temp. Cite: [2007] N.R. TBEd. AP.043

Abbott Laboratories and Abbott Laboratories Limited (appellants) v. The Minister of Health and Apotex Inc. (respondents)

(A-510-05; 2007 FCA 153)

Indexed As: Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Federal Court of Appeal

Sharlow, Malone and Ryer, JJ.A.

April 19, 2007.

Summary:

Abbott Laboratories applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. in respect of Apotex's brand of 250 mg. and 500 mg. clarithromycine tablets known as Apo-Clarithromycine until after the expiration of Canadian patent 2,261,732.

The Federal Court, in a decision reported at 281 F.T.R. 74, dismissed the application. Abbott appealed. Apotex asserted that the decision of the Federal Court in Abbott Laboratories et al. v. Canada (Minister of Health) et al. ((2007), 307 F.T.R. 271; 2006 FC 1558) rendered the appeal moot. Abbott conceded that the appeal was now moot, but argued that the appeal should be heard despite being moot because the principle from Hoffman-La Roche & Co. v. Commissioner of Patents (S.C.C.) was incorrectly applied by the Federal Court and was being relied on in a number of other matters soon to be heard in the Federal Court. The court permitted the appeal to continue on that one point only.

The Federal Court of Appeal dismissed the appeal. The conclusions of the Federal Court were supported by the evidence and the judge made no palpable or overriding error.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for (incl. compensation by first person) - [See Patents of Invention - Topic 1674 ].

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - The Federal Court of Appeal stated that the presumption of patent validity in s. 43(2) of the Patent Act was weakly worded - It could not determine the outcome of prohibition proceedings under the Patented Medicines (Notice of Compliance) Regulations if the record contained any evidence that, if accepted, was capable of rebutting the presumption - See paragraphs 9 to 10.

Patents of Invention - Topic 1503

Grounds of invalidity - General - Presumption of validity - [See Food and Drug Control - Topic 1111.4 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention - Abbott Laboratories appealed the dismissal of its application for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. in respect of Apotex's brand of clarithromycine tablets until after the expiration of Abbott's patent - The only issue on appeal was Apotex's allegation that claims 16 through 21 of the patent were invalid as claims for a known substance, a form of clarithromycine known as clarythromycine II which was arrived at through methods in claims 1 to 15 - The allegation was based on Hoffman-La Roche & Co. v. Commissioner of Patents (S.C.C.) which held that the degree of novelty required for a patent could not be achieved by associating a known substance with a new process for making it - Abbott argued that the trial judge had misapplied Hoffman because clarithromycin II, unlike the substance in Hoffman, was not "known" at the relevant date (July 29, 1996) - The Federal Court of Appeal dismissed the appeal - The trial judge's conclusion that clarithromycin II was known at the relevant time was supported by the evidence, including an article published in 1993, the patent disclosure and evidence relating to the creation of clarithryomycin II by a heating technique known before 1996 - See paragraphs 11 to 23.

Cases Noticed:

Hoffman-La Roche & Co. v. Commissioner of Patents, [1955] S.C.R. 4114, consd. [para. 4].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 10].

Rubbermaid (Canada) Ltd. v. Tucker Plastic Products Ltd. (1972), 8 C.P.R.(2d) 6 (F.C.T.D.), refd to. [para. 10].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 10].

Hoffman-La Roche & Co. v. Commissioner of Patents, [1954] Ex. C.R. 52, refd to. [para. 12].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 43(2) [para. 9].

Counsel:

Andrew J. Reddon and Steven G. Mason, for the appellants;

Andrew Brodkin, for the respondent, Apotex Inc.

Solicitors of Record:

McCarthy Tétrault LLP, Toronto, Ontario, for the appellants;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of Health;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.

This appeal was heard at Ottawa, Ontario, on March 7, 2007, by Sharlow, Malone and Ryer, JJ.A., of the Federal Court of Appeal. Sharlow, J.A., delivered the following reasons for judgment for the Court on April 19, 2007.