Novartis Pharmaceuticals Canada Inc. v. Canada (Attorney General) et al., (2012) 415 F.T.R. 5 (FC)

• Judge: Martineau, J.
• Court: Federal Court (Canada)
• Case Date: Wednesday June 20, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2012), 415 F.T.R. 5 (FC);2012 FC 836

Novartis Pharmaceuticals v. Can. (A.G.) (2012), 415 F.T.R. 5 (FC)

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[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

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Temp. Cite: [2012] F.T.R. TBEd. JL.021

Novartis Pharmaceuticals Canada Inc. (applicant) v. Attorney General of Canada and Minister of Health (respondents)

(T-1679-11; 2012 FC 836; 2012 CF 836)

Indexed As: Novartis Pharmaceuticals Canada Inc. v. Canada (Attorney General) et al.

Federal Court

Martineau, J.

June 29, 2012.

Summary:

Novartis Pharmaceuticals Canada Inc. made a new drug submission for a respiratory antibiotic (Tobi Podhaler) and applied to have its '819 patent listed in respect of Tobi Podhaler on the basis that it contained claims for the formulation that contained the medicinal ingredient (Patented Medicines (Notice of Compliance) Regulations, s. 4(2)(b)), a claim for the dosage form (s. 4(2)(c)) and a claim for the use of the medicinal ingredient (s. 4(2)(d)) for which approval had been sought in the new drug submission. Novartis obtained a notice of compliance. The Office of Patented Medicines and Liaison (OPML) refused to list the '819 patent where the approved formulation of Tobi Podhaler, containing tobramycin as its only medicinal ingredient, was not contained in any of the '819 patent claims within the meaning of s. 4(2)(b) because it was not explicitly named therein. Absent an approved formulation containing the medicinal ingredient, the OPML concluded that the product specificity requirements under ss. 4(2)(c) and 4(2)(d) were not satisfied. Novartis applied for judicial review, asserting that, inter alia, the OPML erred by interpreting s. 4(2) as requiring patent claims to explicitly mention the medicinal ingredient(s) of the related drug product in order to be eligible for listing.

The Federal Court dismissed the application.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Novartis Pharmaceuticals Canada Inc. made a new drug submission for a respiratory antibiotic (Tobi Podhaler) and applied to have its '819 patent listed in respect of Tobi Podhaler on the basis that it contained claims for the formulation that contained the medicinal ingredient (Patented Medicines (Notice of Compliance) Regulations, s. 4(2)(b)), a claim for the dosage form (s. 4(2)(c)) and a claim for the use of the medicinal ingredient (s. 4(2)(d)) for which approval had been sought in the new drug submission - Novartis obtained a notice of compliance - The Office of Patented Medicines and Liaison (OPML) refused to list the '819 patent where the approved formulation of Tobi Podhaler, containing tobramycin as its only medicinal ingredient, was not contained in any of the '819 patent claims within the meaning of s. 4(2)(b) because it was not explicitly named therein - Absent an approved formulation containing the medicinal ingredient, the OPML concluded that the product specificity requirements under ss. 4(2)(c) and 4(2)(d) were not satisfied - Novartis applied for judicial review, asserting that the OPML erred by not applying a purposive construction with a person skilled in the art having been involved or consulted before making its decision - The Federal Court rejected the assertion - The OPML was not required to seek expert opinion and there was no presumption that its failure to do so affected the correctness of its construction of the patent claims - See paragraph 43.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Novartis Pharmaceuticals Canada Inc. made a new drug submission for a respiratory antibiotic (Tobi Podhaler) and applied to have its '819 patent listed in respect of Tobi Podhaler on the basis that it contained claims for the formulation that contained the medicinal ingredient (Patented Medicines (Notice of Compliance) Regulations, s. 4(2)(b)), a claim for the dosage form (s. 4(2)(c)) and a claim for the use of the medicinal ingredient (s. 4(2)(d)) for which approval had been sought in the new drug submission - Novartis obtained a notice of compliance - The Office of Patented Medicines and Liaison (OPML) refused to list the patent where the approved formulation of Tobi Podhaler, containing tobramycin as its only medicinal ingredient, was not contained in any of the patent claims within the meaning of s. 4(2)(b) because it was not explicitly named therein - Absent an approved formulation containing the medicinal ingredient, the OPML concluded that the product specificity requirements under ss. 4(2)(c) and 4(2)(d) were not satisfied - Novartis applied for judicial review, asserting that the OPML erred by interpreting s. 4(2) as requiring patent claims to explicitly mention the medicinal ingredient(s) of the related drug product in order to be eligible for listing - OPML, according to Novartis, should have construed the patent with reference to the common knowledge of the ordinary skilled worker in the art and that tobramycin was included in a number of claims as a medicinal ingredient by virtue of the reference to "antibiotic" and that was sufficient for s. 4(2)(b) - The Federal Court affirmed the OPML's decision - A rather high threshold of specificity was required for a patent to be eligible for listing under s. 4(2)(b) - It was not sufficient that the approved medicinal ingredient be, as a matter of scientific fact, within a more or less large class of active agents that the patent claimed - The OPML reasonably concluded that none of the claims contained the approved medicinal ingredient tobramycin - That conclusion was determinative of the case.

Cases Noticed:

Bayer Inc. v. Canada (Minister of Health) et al. (2009), 358 F.T.R. 20; 2009 FC 1171, affd. (2010), 405 N.R. 248; 86 C.P.R.(4th) 81; 2010 FCA 161, refd to. [para. 18].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 2011 FCA 132, refd to. [para. 19].

GlaxoSmithKline Inc. v. Canada (Attorney General) et al. (2005), 334 N.R. 324; 2005 FCA 197, refd to. [para. 34].

Janssen-Ortho Inc. v. Canada (Attorney General), [2007] F.T.R. Uned. 471; 2007 FC 729, refd to. [para. 34].

Biovail Corp. v. Canada (Minister of National Health and Welfare) (2005), 279 F.T.R. 18; 2005 FC 1135, refd to. [para. 34].

Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012), 403 F.T.R. 86; 2012 FC 2, refd to. [para. 37].

Abbott Laboratories Ltd. v. Canada (Attorney General) et al. (2008), 382 N.R. 280; 2008 FCA 354, refd to. [para. 40].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 2009 FCA 35, refd to. [para. 40].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 S.C.C. 67, refd to. [para. 41].

New Brunswick (Board of Management) v. Dunsmuir, [2008] 1 S.C.R. 190; 372 N.R. 1; 329 N.B.R.(2d) 1; 844 A.P.R. 1; 2008 SCC 9, refd to. [para. 41].

Alliance Pipeline Ltd. v. Smith, [2011] 1 S.C.R. 160; 412 N.R. 66; 2011 SCC 7, refd to. [para. 41].

Alberta Teachers' Association v. Information and Privacy Commissioner (Alta.) et al., [2011] 3 S.C.R. 654; 424 N.R. 70; 519 A.R. 1; 539 W.A.C. 1; 2011 SCC 61, refd to. [para. 41].

Hoffmann-LaRoche Ltd. v. Mayne Pharma (Canada) Inc. et al., [2005] F.T.R. Uned. A41; 2005 FC 814, refd to. [para. 43].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 312 F.T.R. 100; 2007 FC 446, refd to. [para. 43].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 44].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 4(2)(b), sect. 4(2)(c) [para. 14].

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

Counsel:

Arthur Renaud and Marc Richard, for the applicant;

John L. Syme and Leah Garvin, for the respondents.

Solicitors of Record:

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

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents.

This application was heard at Ottawa, Ontario, on June 20, 2012, by Martineau, J., of the Federal Court, who delivered the following reasons for judgment on June 29, 2012.