Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al., 2012 FC 2

• Judge: Mosley, J.
• Court: Federal Court (Canada)
• Case Date: Tuesday November 08, 2011
• Jurisdiction: Canada (Federal)
• Citations: 2012 FC 2;(2012), 403 F.T.R. 86 (FC)

Gilead Sciences Can. Inc. v. Can. (2012), 403 F.T.R. 86 (FC)

MLB headnote and full text

Temp. Cite: [2012] F.T.R. TBEd. MY.019

Gilead Sciences Canada, Inc. (applicant) v. The Minister of Health and the Attorney General of Canada (respondents)

(T-235-11; 2012 FC 2)

Indexed As: Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al.

Federal Court

Mosley, J.

January 3, 2012.

Summary:

The applicant applied for judicial review of a decision of the Minister of Health which refused to list Canadian Patent 2,512,475 on the Patent Register in relation to a new drug submission.

The Federal Court dismissed the application.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicant filed a New Drug Submission (NDS) with respect to a pharmaceutical product for the treatment of human immunodeficiency virus (HIV) infection - The submission was for the approval of tablets (now marketed under the name "Complera") formulated with three medicinal ingredients: (1) tenofovir disoproxil fumarate (tenofovir); (2) emtricitabine; and (3) rilpivirine - Rilpivirine came within the class of agents known as non-nucleoside reverse transcriptase inhibitors (NNRTIs) - The Minister of Health refused to list Canadian Patent 2,512,475 (the '475 Patent) on the Patent Register in relation to the NDS - The ground provided was that the patent referenced NNRTIs as a class without specifying rilpivirine - The applicant applied for judicial review - The parties agreed that Complera contained the medicinal ingredients tenofovir, emtricitabine and rilpivirine and that rilpivirine was within the class of NNRTIs referenced in the claims of the '475 Patent - The controversy arose because the claims did not specifically reference rilpivirine as a medicinal ingredient in the formulations to treat infection which the patent addressed - The Federal Court dismissed the application - The court construed the relevant claims of the '475 Patent as combinations and formulations of two medicinal ingredients plus a third one of the NNRTI class that could possibly include, but was not specifically rilpivirine - The patent was properly considered for listing under s. 4(2)(b) rather than s. 4(2)(a) of the Patented Medicines (Notice of Compliance) Regulations as containing formulation rather than combination claims - On a plain and ordinary reading of s. 4(2)(b), all of the ingredients in the NDS had to be found in the formulation in the claim - Here, the claimed formulation and the approved formulation did not match precisely and the requirement of product specificity was not met - The Minister correctly construed the relevant '475 Patent claims as formulations and correctly interpreted s. 4(2)(b) of the Regulations as requiring strict product specificity with regards to the formulation - The '475 Patent did not meet the specifics of the NDS - The Minister reasonably concluded that the '475 Patent was not eligible for listing.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - The Federal Court stated that when reviewing a decision of the Minister of Health on patent listing, the court had to first construe the claims - The Minister's understanding of the patent was reviewable for correctness - With respect to the question of whether the medicinal ingredient or formulation approved by the Notice of Compliance was that claimed by the patent, the Minister's understanding of the legal principles including the interpretation of the Patented Medicines (Notice of Compliance) Regulations was reviewable for correctness - The Minister's application of those principles to the facts of the new drug submission was reviewable for reasonableness - See paragraphs 16 to 17.

Cases Noticed:

Abbott Laboratories Ltd. v. Canada (Attorney General) et al. (2008), 382 N.R. 280; 2008 FCA 354, refd to. [para. 12].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 2009 FCA 35, refd to. [para. 12].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 2011 FCA 132, refd to. [para. 12].

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. 19].

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. 20].

Procter & Gamble Co. v. Beecham Canada Ltd. and Calgon Interamerican Corp. (1982), 40 N.R. 313; 61 C.P.R.(2d) 1 (F.C.A.), refd to. [para. 20].

Reliance Electric Industrial Co. et al. v. Northern Telecom Ltd. (1993), 60 F.T.R. 208; 47 C.P.R.(3d) 55 (T.D.), refd to. [para. 20].

Hoffmann-LaRoche Ltd. v. Mayne Pharma (Canada) Inc. et al., [2005] F.T.R. Uned. A41; 41 C.P.R.(4th) 505; 2005 FC 814, refd to. [para. 20].

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. 29].

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. 41].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 2, sect. 4(2) [para. 15].

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

Authors and Works Noticed:

Canadian Intellectual Property Office, Manual of Patent Office Practice (2009), c. 11, ྷ 11.07 [para. 40].

Counsel:

Jason Markwell and Amy Grenon, for the applicant;

Eric Peterson, for the respondents.

Solicitors of Record:

Jason Markwell, Amy Grenon, Norton Rose LLP, Toronto, Ontario, for the applicant;

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

This application was heard on November 8, 2011, at Toronto, Ontario, before Mosley, J., of the Federal Court, who delivered the following decision on January 3, 2012.