Abbott Laboratories et al. v. Canada (Minister of Health) et al., 2010 FCA 168

• Judge: Noël, Dawson and Trudel, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: May 27, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FCA 168;(2010), 404 N.R. 356 (FCA)

Abbott Lab. v. Can. (2010), 404 N.R. 356 (FCA)

MLB headnote and full text

Temp. Cite: [2010] N.R. TBEd. JN.056

Sandoz Canada Inc. (appellant) v. Abbott Laboratories and Abbott Laboratories Limited and The Minister of Health (respondents)

(A-369-09; 2010 FCA 168)

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

Federal Court of Appeal

Noël, Dawson and Trudel, JJ.A.

June 22, 2010.

Summary:

Sandoz Canada Inc. served a notice of allegation (NOA) on Abbott Laboratories Ltd. The NOA advised that Sandoz had filed an Abbreviated New Drug Submission (ANDS) with respect to clarithromycin extended-release 500 mg tablets. The ANDS compared the Sandoz product with BIAXIN XL 500 mg clarithromycin extended release tablets marketed in Canada by Abbott Laboratories. The three relevant patents addressed by the NOA were Canadian Patent No. 2,285,266 ('266 patent), No. 2,325,541 ('541 patent), and No. 2,358,395 ('395 patent). The patents were owned by Abbott Laboratories Ltd. Abbott applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, challenging the NOA and seeking to prohibit the issuance of a Notice of Compliance to Sandoz for its product until the expiry of the impugned patents.

The Federal Court, in a decision reported at 347 F.T.R. 159; 2009 FC 648, found the allegations of invalidity contained in the NOA to be unjustified with respect to the '266 patent. Thus, an order issued prohibiting the Minister of Health from issuing a Notice of Compliance to Sandoz until the expiry of the '266 patent. The court went on to find that Abbott had failed to adequately respond to Sandoz' allegation of invalidity with respect to the double patenting of claim 22 of the '395 patent over the '541 patent. Accordingly, Abbott's request for an order of prohibition in relation to the '395 patent was dismissed. Sandoz appealed, arguing that the judge erred in holding that its allegation of obviousness in respect of the '266 patent was not justified. Abbott cross-appealed, arguing that the judge erred in law by assessing the allegations in the NOA as of the wrong date.

The Federal Court of Appeal dismissed Sandoz's appeal and allowed Abbott's cross-appeal.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The applicant applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, challenging the respondent's Notice of Allegation (NOA) and seeking to prohibit the issuance of a Notice of Compliance to the respondent for its product until the expiry of the impugned patents - The patents addressed by the NOA included the '266 patent and the '541 patent, both owned by the applicant - The '541 patent, which formed the basis for the allegation that claim 22 of the '395 patent was invalid on the ground of double patenting, was dedicated to the public during the course of the litigation - The respondent argued that the applicant provided insufficient evidence to establish that it intended to dedicate the '541 patent or that the patent was actually dedicated - The trial judge considered the issue of double patenting as of the date the NOA was served, not as of the date of the hearing - Thus, she did not give effect to the dedication of the '541 patent because the dedication was not "executed prior to the service of the NOA" - On appeal, the applicant argued that the trial judge erred in law by applying the wrong date on which allegations in the NOA were assessed - The Federal Court of Appeal concluded that it was correct to assess the justification of allegations contained in a Notice of Allegation as at the date of the hearing, at least where assessment as at the date of the hearing would promote the purpose of the Regulations - Had the trial judge taken cognizance of the dedication by considering the '541 patent as of the date of the hearing, she would have concluded that the allegation of double patenting was not justified; in the court's view, that was the correct result - See paragraphs 29 to 58.

Food and Drug Control - Topic 1108

Drugs - New drugs - Notice of compliance - Judicial review - Patent ' 541 formed the basis for the allegation that a claim of the '395 was invalid on the ground of double patenting - The applicant owned both patents - Patent '541 was dedicated to the public during the course of the litigation - The first notice given to the respondent about the dedication was contained in the applicant's memorandum of fact and law - The trial judge considered the issue of double patenting as of the date the NOA was served, not as of the date of the hearing - She did not give effect to the dedication of the '541 patent because the dedication was not "executed prior to the service of the NOA" - The applicant characterized the error as one of law - The respondent characterized the issue as one of mixed fact and law - The Federal Court of Appeal stated that it could only interfere with the trial judge's exercise of discretion (either to disallow the "new" evidence or to adjourn) if satisfied that the judge "gave insufficient weight to relevant factors, proceeded on a wrong principle of law, seriously misapprehended the facts, or where an obvious injustice would otherwise result ... However, once the evidence and submissions were received by the Court, the Judge was required to consider the effect of the dedication. This is a question of law reviewable on the standard of correctness" - See paragraphs 10 to 14.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - Sandoz Canada Inc. alleged in a Notice of Allegation (NOA) that the '266 and '395 patents of Abbott Laboratories and Abbott Laboratories Ltd. (collectively, Abbott) were invalid on several grounds, including obviousness, lack of actual utility, lack of sound prediction utility and double patenting - In response, Abbott applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, challenging the NOA and seeking to prohibit the issuance of a Notice of Compliance to Sandoz for its product until the expiry of the impugned patents - The trial judge issued an order of prohibition in relation to the '266 patent - Abbott had demonstrated on a balance of probabilities that the allegations of invalidity were not justified - While the court was satisfied that Abbott had rebutted the allegations respecting obviousness and the lack of utility of the '395 patent, they had failed to rebut the allegation of double patenting - Accordingly, the court dismissed the request for an order of prohibition in relation to the '395 patent - Sandoz appealed, arguing that the judge erred in holding that its allegation of obviousness in respect of the '266 patent was not justified - Abbott cross-appealed, arguing that the judge erred in law by assessing the allegations in the NOA as of the wrong date - The Federal Court of Appeal dismissed the appeal and allowed the cross-appeal - "Pronouncing the judgment the Federal Court ought to have pronounced, I would allow the application for an order of prohibition in respect of the '395 patent".

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Sandoz Canada Inc. applied for a Notice of Compliance to permit it to market its version of clarithromycin extended-release 500 mg tablets - The only allegation of invalidity raised by Sandoz against the respondent's '266 patent was obviousness - The '266 patent dealt with an extended release formulation of clarithromycin - Sandoz argued that before the priority date of the '266 patent, a patent application disclosed an extended release formulation almost identical to the formulation of the '266 patent, but for the different active ingredients - Sandoz, through its experts, advanced a "substitution" argument that in light of the similarity, a person skilled in the art would understand, and it would be obvious, that one drug could be substituted for another - The trial judge rejected the argument - The Federal Court of Appeal found no palpable and overriding error and dismissed the appeal - The trial judge's conclusion that there were specific differences between the properties of the two drugs which would not make them obvious candidates for substitution in the formulation was supported by general references in the prior art relied upon by the judge - Nor did the trial judge fail to properly assess the common general knowledge of the person skilled in the art - See paragraphs 15 to 28.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - A trial judge concluded that the respondent's allegation that the applicant's '395 patent was invalid for obviousness was not justified - The judge had construed the '395 patent "as revealing what is essentially the same invention as that claimed in the '266 patent, with the added limitation listed in Claim 22 that the composition must exhibit an improved taste profile" - The respondent had argued that it was obvious that an extended release composition would have an improved taste profile, and, on appeal, asserted errors of fact - The Federal Court of Appeal held that the judge's conclusion had not been shown to be tainted by any palpable and overriding error - First, the judge did not ignore the issue of the taste in the mouth left by the extended release formulation; she preferred the evidence tendered by the applicant's expert who found an improved taste profile - Second, with respect to the issue of obviousness, the admissions relied on by the respondent were sufficiently qualified that the judge was entitled to rely on the evidence with respect to the non-obvious nature of claim 22 of the '395 patent - See paragraphs 59 to 69.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See first Patents of Invention - Topic 1589 ].

Cases Noticed:

Apotex Inc. v. Governor-in-Council et al. (2007), 370 N.R. 336; 2007 FCA 374, refd to. [para. 13].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 15].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 27].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 27].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 2009 FC 991, refd to. [para. 27].

Searle (G.D.) & Co. et al. v. Merck & Co. et al. (2002), 219 F.T.R. 64 (T.D.), refd to. [para. 33].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 2009 FC 137, refd to. [para. 34].

Parke-Davis Division v. Canada (Minister of Health) - see Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al.

Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 2 F.C. 514; 296 N.R. 279; 2002 FCA 454, refd to. [para. 35].

Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al., [2002] 1 F.C. 517; 210 F.T.R. 265 (T.D.), refd to. [para. 37].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299, refd to. [para. 43].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 132 F.T.R. 60 (T.D.), consd. [para. 46].

Glaxo Wellcome Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 134 F.T.R. 220; 75 C.P.R.(3d) 129 (T.D.), consd. [para. 47].

Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc., [1994] 1 F.C. 742; 162 N.R. 177 (F.C.A.), affd. [1994] 3 S.C.R. 1100; 176 N.R. 1, consd. [para. 50].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55, refd to. [para. 53].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 53].

Counsel:

Edward Hore and Kevin Zive, for the appellant;

Steve Mason, Andrew J. Reddon and David Tait, for the respondents.

Solicitors of Record:

Hazzard & Hore, Toronto, Ontario, for the appellant;

McCarthy Tetrault LLP, Toronto, Ontario, for the respondents.

This appeal and cross-appeal were heard at Toronto, Ontario, on May 27, 2010, by Noël, Dawson and Trudel, JJ.A., of the Federal Court of Appeal. Dawson, J.A., delivered the following judgment and reasons for judgment of the Court of Appeal, dated June 22, 2010.