Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al., (2012) 435 N.R. 188 (FCA)

• Judge: Sharlow, Trudel and Mainville, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: September 12, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2012), 435 N.R. 188 (FCA);2012 FCA 254

Gilead Sciences Can. Inc. v. Can. (2012), 435 N.R. 188 (FCA)

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Temp. Cite: [2012] N.R. TBEd. OC.014

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

(A-44-12; 2012 FCA 254; 2012 CAF 254)

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

Federal Court of Appeal

Sharlow, Trudel and Mainville, JJ.A.

October 9, 2012.

Summary:

Gilead Sciences Canada Inc. filed a New Drug Submission (NDS) seeking approval of a drug for the treatment of human immunodeficiency virus (HIV) infection. The NDS stated that the drug, known as Complera, contained the following medicinal ingredients: 1) tenofovir disoproxil fumarate (tenofovir), 2) emtricitabine, and 3) rilpivirine. Rilpivirine was one of a class of agents known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). A Notice of Compliance (NOC) was issued for Complera. Gilead submitted eight patents for listing on the patent register in relation to Complera, including Canadian Patent No. 2,512,475 (the '475 Patent). The '475 Patent contained claims combining the medicinal ingredients tenofovir and emtricitabine, together with a third unnamed antiviral agent selected from, amongst other classes of agents, NNRTIs. Rilpivirine was not mentioned in the '475 Patent claims. The Minister of Health refused to list the '475 Patent on the patent register as, in his view, it did not meet the requirements of s. 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations (the PM (NOC) Regulations). Gilead applied for judicial review.

The Federal Court, in a decision reported at 403 F.T.R. 86, accepted the Minister's position and dismissed the application. Gilead appealed.

The Federal Court of Appeal dismissed the appeal, but for reasons different than those expressed by the judge in dismissing the application for judicial review. The court concluded that the claims at issue in the '475 Patent were for a new combination of medicinal ingredients so that eligibility of the '475 Patent for listing depended upon the requirements of s. 4(2)(a) of the PM (NOC) Regulations, not s. 4(2)(b). However, the relevant claims in the '475 Patent did not meet the requirements of s. 4(2)(a) as they lacked strict product specificity with regard to the three medicinal ingredients listed in the NDS. The court therefore upheld the judge's conclusion that the patent claims failed the requirement for product specificity because they did not make specific reference to the medicinal ingredient rilpirivine, but only the broad class of compounds. However, the court did so under s. 4(2)(a) rather than s. 4(2)(b).

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Patented Medicines (Notice of Compliance) Regulations (the PM (NOC) Regulations) made product specificity between the patent claims and the Notice of Compliance (NOC) for the approved drug a key requirement for a patent to be considered eligible for listing on the patent register - The Federal Court of Appeal held that the wording of the PM (NOC) Regulations, as well as their object and purpose, suggested that the product specificity requirement set a high threshold of consistency - The wording of s. 4 of the PM (NOC) Regulations was consistent across the four subsections and required a high degree of specificity between the wording of the claim and the NOC - See paragraphs 33 to 45.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Gilead Sciences Canada Inc. filed a New Drug Submission (NDS) seeking approval of a drug for the treatment of human immunodeficiency virus (HIV) infection - The NDS stated that the drug, known as Complera, contained the following medicinal ingredients: 1) tenofovir disoproxil fumarate (tenofovir), 2) emtricitabine, and 3) rilpivirine - Rilpivirine was one of a class of agents known as non-nucleoside reverse transcriptase inhibitors (NNRTIs) - A Notice of Compliance (NOC) was issued for Complera - Gilead submitted Canadian Patent No. 2,512,475 (the '475 Patent) for listing on the patent register in relation to Complera - The '475 Patent contained claims combining the medicinal ingredients tenofovir and emtricitabine, together with a third unnamed antiviral agent selected from, amongst other classes of agents, NNRTIs - Rilpivirine was not mentioned in the '475 Patent claims - The Minister of Health refused to list the '475 Patent on the patent register as, in his view, it did not meet the requirements of s. 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations (the PM (NOC) Regulations) - Gilead applied for judicial review - The Federal Court judge accepted the Minister's position and dismissed the application - Gilead appealed - The Federal Court of Appeal dismissed the appeal, but for reasons different than those expressed by the judge in dismissing the application for judicial review - The court concluded that the claims at issue in the '475 Patent were for a new combination of medicinal ingredients so that eligibility of the '475 Patent for listing depended upon the requirements of s. 4(2)(a) of the PM (NOC) Regulations, not s. 4(2)(b) - However, the relevant claims in the '475 Patent did not meet the requirements of s. 4(2)(a) as they lacked strict product specificity with regard to the three medicinal ingredients listed in the NDS - The judge did not err in his reasoning under the product specificity analysis and his reasoning regarding product specificity was equally applicable under s. 4(2)(a) of the PM (NOC) Regulations - The court therefore upheld the judge's conclusion that the patent claims failed the requirement for product specificity because they did not make specific reference to the medicinal ingredient rilpirivine, but only the broad class of compounds - However, the court did so under s. 4(2)(a) rather than s. 4(2)(b).

Cases Noticed:

Dr. Q., Re, [2003] 1 S.C.R. 226; 302 N.R. 34; 179 B.C.A.C. 170; 295 W.A.C. 170; 2003 SCC 19, refd to. [para. 9].

Abbott Laboratories Ltd. v. Canada (Attorney General) et al., [2009] 3 F.C.R. 547; 382 N.R. 280; 2008 FCA 354, refd to. [para. 10].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 2011 FCA 132, appld. [para. 10].

Apotex Inc. v. Merck & Co. et al., [2010] 2 F.C.R. 389; 391 N.R. 336; 2009 FCA 187, refd to. [para. 28].

Nowegijick v. Minister of National Revenue et al., [1983] 1 S.C.R. 29; 46 N.R. 41, refd to. [para. 34].

Merck & Co. et al. v. Apotex Inc. (2006), 354 N.R. 51; 2006 FCA 323, refd to. [para. 34].

Statutes Noticed:

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

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

Counsel:

Jason C. Markwell and Amy E. Grenon, for the appellant;

Eric Peterson, for the respondents.

Solicitors of Record:

Norton Rose Canada LLP, Toronto, Ontario, for the appellant;

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

This appeal was heard on September 12, 2012, at Toronto, Ontario, before Sharlow, Trudel and Mainville, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered by Trudel, J.A., on October 9, 2012.