Abbott Laboratories Ltd. v. Canada (Attorney General) et al., (2008) 329 F.T.R. 190 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: June 02, 2008
• Jurisdiction: Canada (Federal)
• Citations: (2008), 329 F.T.R. 190 (FC);2008 FC 700

Abbott Lab. v. Can. (A.G.) (2008), 329 F.T.R. 190 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. JN.009

Abbott Laboratories Limited (applicant) v. Attorney General of Canada and Minister of Health (respondents)

(T-1564-07; 2008 FC 700)

Indexed As: Abbott Laboratories Ltd. v. Canada (Attorney General) et al.

Federal Court

Hughes, J.

June 4, 2008.

Summary:

Abbott Laboratories Ltd. applied for judicial review of a decision of the Minister of Health not to list Canadian Letters Patent No. 2,182,620 on the Patent Register in respect of a Notice of Compliance issued to Abbott in respect of a drug known as Meridia.

The Federal Court dismissed the application.

Administrative Law - Topic 3345.1

Judicial review - General - Practice - Evidence (incl. new evidence) - [See first Food and Drug Control - Topic 1109.1 ].

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Abbott Laboratories Ltd. applied for judicial review of a decision of the Minister of Health not to list Canadian Letters Patent No. 2,182,620 on the Patent Register in respect of a Notice of Compliance issued to Abbott in respect of a drug known as Meridia - An issue arose with respect to whether the court should receive new evidence in the way of an affidavit of an expert, Dr. Lewanczuk - The Federal Court held that it put no weight on any paragraphs of Dr. Lewanczuk's affidavit, other than paragraphs 44 to 51, which were directed to claim construction - See paragraphs 10 to 18.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Minister of Health refused to list Canadian Letters Patent No. 2,182,620 (the '620 Patent) on the Patent Register in respect of a Notice of Compliance (NOC) issued to Abbott Laboratories Ltd. in respect of a drug known as Meridia - The Minister determined that the use claimed in the '620 patent was not the use approved by the NOC - Abbott applied for judicial review - Abbott's position was that if the approved use could be said to include the claimed use, then the patent should be added to the register - The Minister had found, in brief, that the approved use was "treatment of obesity" whereas the claimed use was "improving glucose tolerance" - The Federal Court dismissed the application - The Minister agreed that treatment of obese people who also suffered from glucose intolerance with this medicine might result in treatment for glucose intolerance of those people - However that was not what the NOC was directed to, it was directed toward treatment of obesity - The Minster's decision that the NOC approved use was different from the claimed use in the '620 patent was reasonable such that adding the patent to the register under s. 4(2)(d) of the Patented Medicines (Notice of Compliance) Regulations could not be allowed - See paragraphs 29 to 54.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - Abbott Laboratories Ltd. applied for judicial review of a decision of the Minister of Health not to list Canadian Letters Patent No. 2,182,620 on the Patent Register in respect of a Notice of Compliance (NOC) issued to Abbott in respect of a drug known as Meridia - The Federal Court considered the applicable standard of review and concluded that: "1. Patent claim construction is a matter of law to be reviewed on a standard of correctness. 2. The uses approved by the existing NOC are questions of fact and are to be reviewed on this basis of reasonableness with considerable deference given to the Minister's decision. 3. The consideration as to how the uses claimed in the patent compare with those approved by the NOC for purposes of section 4(2)(d) of the [Patented Medicines (Notice of Compliance) Regulations] involves mixed fact and law and considerable deference should be given to the Minister's decision" - See paragraph to 28.

Cases Noticed:

Kante v. Canada (Minister of Public Safety and Emergency Preparedness), [2007] F.T.R. Uned. 831; 2007 FC 109, refd to. [para. 14].

GlaxoSmithKline Inc. v. Canada (Attorney General) et al. (2005), 334 N.R. 324; 2005 FCA 197, refd to. [para. 15].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 2008 FC 11, refd to. [para. 16].

New Brunswick (Board of Management) v. Dunsmuir (2008), 372 N.R. 1; 329 N.B.R.(2d) 1; 844 A.P.R. 1; 2008 SCC 9 (S.C.C.), refd to. [para. 19].

Lake v. Canada (Minister of Justice) (2008), 373 N.R. 339; 236 O.A.C. 371; 2008 SCC 23, refd to. [para. 21].

GD Searle & Co. et al. v. Canada (Minister of Health) (2008), 327 F.T.R. 133; 2008 FC 437, refd to. [para. 25].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 370 N.R. 263; 2007 FCA 276, refd to. [para. 26].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 32].

Abbott Laboratories Ltd. et al. v. Canada (Attorney General) et al. (2007), 315 F.T.R. 263; 2007 FC 797, refd to. [para. 51].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 354 F.T.R. 1; 2008 FC 352, refd to. [para. 53].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 4(1), sect. 4(2)(d) [para. 2].

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

Counsel:

Andrew J. Redden and Caroline R. Zayid, for the applicant, Abbott Laboratories Limited;

F.B. Woyiwada, for the respondent, The Minister of Health.

Solicitors of Record:

McCarthy Tetrault, Toronto, Ontario, for the applicant;

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

This application was heard on June 2, 2008, at Toronto, Ontario, before Hughes, J., of the Federal Court, who delivered the following decision on June 4, 2008.