Eli Lilly Canada Inc. v. Canada (Attorney General) et al., (2015) 475 N.R. 299 (FCA)

• Judge: Nadon, Dawson and Boivin, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: April 22, 2015
• Jurisdiction: Canada (Federal)
• Citations: (2015), 475 N.R. 299 (FCA);2015 FCA 166

Eli Lilly Can. Inc. v. Can. (A.G.) (2015), 475 N.R. 299 (FCA)

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Temp. Cite: [2015] N.R. TBEd. AU.004

Eli Lilly Canada Inc. (appellant) v. Attorney General of Canada and Minister of Health (respondents)

(A-146-14; 2015 FCA 166; 2015 CAF 166)

Indexed As: Eli Lilly Canada Inc. v. Canada (Attorney General) et al.

Federal Court of Appeal

Nadon, Dawson and Boivin, JJ.A.

July 17, 2015.

Summary:

The Minister of Health refused to list Eli Lilly Canada Inc.'s Canadian Patent No. 2,379,329 on the patent register maintained under the Patented Medicines (Notice of Compliance) Regulations against Eli Lilly's product Trifexis identified as New Drug Submission No. 141 509. Eli Lilly applied for judicial review.

The Federal Court, in a decision reported at (2014), 448 F.T.R. 160, dismissed the application. Eli Lilly appealed.

The Federal Court of Appeal allowed the appeal with costs. The court set aside the Federal Court's decision, allowed Eli Lilly's judicial review application with costs and returned the matter to the Minister for reconsideration in the light of the court's reasons.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Minister of Health refused to list Canadian Patent No. 2,379,329 (the '329 Patent) on the patent register against Eli Lilly's product Trifexis identified as New Drug Submission No. 141 509 - The Minister had issued a Notice of Compliance (NOC) in respect of NDS 141 509 for a precise formulation containing two medicinal ingredients, namely spinosad and milbemycin oxime - The Minister found that the '329 Patent did not contain a claim for the formulation containing both spinosad and milbemycin oxime, but rather that it contained claims for a formulation containing spinosad alone - In the Minister's opinion, although milbemycins were mentioned in the '329 Patent as compounds which could be combined with spinosad, the patent did not meet the requirements of s. 4(2)(b) of the Patented Medcines (Notice of Compliance) Regulations which required that the patent make a claim to the formulation containing the medicinal ingredients found in the NOC-approved drug - Eli Lilly applied for judicial review - The Federal Court dismissed the application - The judge held that the claims of the '329 Patent included not only spinosad as the active ingredient, but other active ingredients such as milbemycin oxime - The judge therefore found that the Minister erred in her construction of the patent - However, the judge then turned to the third prong of the test in Abbott Laboratories v. Canada (Attorney General) (2008 FC) for determining the eligibility of a patent for listing on the register - The judge held that she was bound to follow Gilead Sciences Canada Inc. v. Canada (Minister of Health) (2012 FCA) - In her view, reference in the '329 Patent to milbemycins was not sufficiently specific so as to allow her to find that its claims matched the formulation found in Trifexis - As a result, she concluded that the Minister's decision to refuse to list the '329 Patent on the register was reasonable notwithstanding that the Minister erred in construing the claims of the patent - Eli Lilly appealed - The Federal Court of Appeal allowed the appeal - The judge erred in respect of the third prong of the Abbott test - More particularly, she misunderstood the requirements of s. 4(2)(b) of the Regulations - The decisions in Gilead (FC and FCA) were distinguishable - The patent at issue in those decisions did not claim the three medicinal ingredients found in the NOC-approved drug product - The judge appeared to have understood Gilead FCA to require her to find the words milbemycin oxime in the '329 Patent's claims and that, failing the appearance of those words, the '329 Patent did not claim the formulation which had been approved by the issuance of the NOC - However, the question at the third step of the Abbott test was not whether the words milbemycin oxime appeared in the claims of the '329 Patent, but whether the claims of the '329 Patent claimed milbemycin oxime as a medicinal ingredient in the formulation set out in the patent - The third prong of the Abbott test was met - The '329 Patent claimed a formulation of two medicinal ingredients, spinosad and milbemycin oxime - See paragraphs 44 to 108.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - Section 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations provided that a patent was eligible for listing on the Register if it claimed a formulation of medicinal ingredients which had been approved by the Minister by reason of the issuance of a Notice of Compliance (NOC) - The test in Abbott Laboratories v. Canada (Attorney General) (2008 FC) set out the questions which the court had to resolve in order to determine if the requirements of s. 4(2) had been met - The Minister of Health refused to list Eli Lilly Canada Inc.'s Canadian Patent No. 2,379,329 (the '329 Patent) on the patent register against Eli Lilly's product Trifexis identified as New Drug Submission No. 141 509 on the grounds that the '329 Patent did not contain a claim for the two compounds found in Eli Lilly's drug product - Eli Lilly applied for judicial review - The Federal Court dismissed the application - Eli Lilly appealed - The Federal Court of Appeal stated that "The third prong of the Abbott test, i.e. whether the formulation claimed in the '329 Patent is the formulation found in Trifexis in respect of which a NOC has been issued by the Minister, is subject to two standards. Firstly, the interpretation of paragraph 4(2)(b) of the Regulations must be reviewed on a standard of correctness. Secondly, the determination of whether the formulation claimed in the '329 Patent is the formulation which has been approved by the Minister through the issuance of a NOC stands to be decided on a standard of reasonableness as it requires the application of paragraph 4(2)(b) of the Regulations to the specific facts of the case" - See paragraph 47.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See Food and Drug Control - Topic 1109.1 ].

Cases Noticed:

Abbott Laboratories Ltd. v. Canada (Attorney General) et al. (2008), 329 F.T.R. 190; 67 C.P.R.(4th) 51; 2008 FC 700, appld. [para. 23].

Abbott Laboratories Ltd. v. Canada (Attorney General) et al., [2009] 3 F.C.R. 547; 382 N.R. 280; 2008 FCA 354, appld. [paras. 23, 100].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 2009 FCA 35, refd to. [para. 23].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 2011 FCA 132, refd to. [para. 23].

Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012), 435 N.R. 188; 2012 FCA 254, dist. [paras. 23, 100].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [paras. 29, 107].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 29].

Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012), 403 F.T.R. 86; 2012 FC 2, dist. [para. 40].

Telfer v. Canada Revenue Agency (2009), 386 N.R. 212; 2009 FCA 23, refd to. [para. 45].

Agraira v. Canada (Minister of Public Safety and Emergency Preparedness) et al. (2013), 446 N.R. 65; 2013 SCC 36, refd to. [para. 45].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 53].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2008] 1 F.C.R. 672; 12 F.T.R. 100; 2007 FC 446, refd to. [para. 59].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 2 [para. 20]; sect. 4(2) [para. 19].

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

Counsel:

Jay Zakaib, Jennifer Wilkie and Kelly McClellan, for the appellant;

Eric Peterson, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the appellant;

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents.

This appeal was heard on April 22, 2015, at Toronto, Ontario, before Nadon, Dawson and Boivin, JJ.A., of the Federal Court of Appeal. The judgment of the Court of Appeal was delivered on July 17, 2015, including the following opinions:

Nadon, J.A. (Boivin, J.A., concurring) - see paragraphs 1 to 99;

Dawson, J.A. - see paragraphs 100 to 108.