ViiV Healthcare ULC et al. v. Teva Canada Ltd. et al., (2014) 464 F.T.R. 66 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: September 04, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 464 F.T.R. 66 (FC);2014 FC 893

ViiV Healthcare ULC v. Teva Can. Ltd. (2014), 464 F.T.R. 66 (FC)

MLB headnote and full text

[French language version follows English language version]

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

.........................

Temp. Cite: [2014] F.T.R. TBEd. OC.019

ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group Limited (applicants) v. Teva Canada Limited and The Minister of Health (respondents)

(T-1517-13)

ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group Limited (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-333-14)

ViiV Healthcare ULC, ViiV Healthcare UK Limited and Glaxo Group Limited (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-335-14; 2014 FC 893; 2014 CF 893)

Indexed As: ViiV Healthcare ULC et al. v. Teva Canada Ltd. et al.

Federal Court

Hughes, J.

September 18, 2014.

Summary:

A Prothonotary, in two decisions for three proceedings, determined that Canadian Patent No. 2,289,753 (the '753 Patent) claiming but one medicinal ingredient, could not be listed under the Patented Medicines (Notice of Compliance) Regulations, where the underlying Notice of Compliance was directed to a fixed-dose combination of two or more medicines. ViiV Healthcare ULC and Glaxo were common "first person" applicants in all three proceedings; the Minister of Health was a common respondent. In the first proceeding, Teva Canada Ltd. was a respondent (see (2014), 452 F.T.R. 173). In the other two proceedings, Apotex Inc. was a respondent. The reference drug of ViiV in each case was a fixed-dose dual combination drug, called KIVEXA, which contained two medicinal ingredients. In the Apotex proceedings, the ViiV reference drug, called TRIZIVIR, contained three medicinal ingredients. In each case, the Prothonotary ordered that the '753 Patent be struck from the Patent Register. ViiV appealed.

The Federal Court dismissed the appeals. The Prothonotary's decisions were correct. The Court also determined that another claim of the same patent directed to a formulation containing one named medicinal ingredient, and another medicinal ingredient to be selected from a group of medicinal ingredients, also did not support a listing.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court considered the scheme of the Patented Medicines (Notice of Compliance) Regulations, respecting the listing of a patent in relation to a new drug submission - The subject matter listing requirements pertinent to the patent at issue on this appeal were set out in ss. 4(2)(a) and 4(2)(b) of the Regulations - See paragraphs 38 to 46.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court considered a number of decisions of the Court and the Federal Court of Appeal dealing with the propriety of the listing of certain patents under the Patented Medicines (Notice of Compliance) (NOC) Regulations as amended in 2006 - Having regard to those decisions, the Court stated that "Thus, in Bayer and Gilead a patent claiming only one medicinal ingredient could not be listed where the relevant NOC was directed to a combination of that one medicinal ingredient and other medicinal ingredients, arguably, to produce a different effect than if the drugs were administered separately." - See paragraphs 47 to 49.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Section 4(2) of the Patented Medicines (Notice of Compliance) (NOC) Regulations set out the applicable patent listing eligibility requirements - The Federal Court set out the following principles respecting the interpretation of s. 4(2) - "There is no sound reason to adopt different legislative requirements of product specificity for the various subparagraphs of subsection 4(2) ...; absent precise and specific matching between what the patent claims and the product/use/ dosage forms for which the NOC has been granted to the first person, the Minister cannot properly list the patent ...; a claim for a formulation means a claim that includes both medicinal and non-medicinal ingredients. A claim directed to medicinal ingredients, without claiming also non-medicinal ingredients, does not qualify for listing as a formulation under subsection 4(2)(b) ...; where a patent claims only one medicinal ingredient, it cannot be listed as against an NOC obtained for two (or more) medicinal ingredients, at least where '... a drug with one medicinal ingredient will have a different effect from a drug where two medicinal ingredients are combined to achieve the desired effect' ... ." - See paragraph 48.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The "first person" applicant/appellant ("ViiV") argued that policy considerations favoured listing patents claiming a single medicinal ingredient where the drug in question contained that medicinal ingredient plus at least one more; the so-called fixed-dose combination (FDC) - ViiV argued that to exclude patents like its Canadian Patent No. 2,289,7 53 ('753 patent) from listing under the Notice of Compliance (NOC) Regulations would deter innovation, and that the rebalancing made by the 2006 amendments to the Regulations should not be interpreted so as to exclude FDC products - The Federal Court rejected the arguments - "Trial Courts should be loathe to embark on 'policy' interpretations of legislation without a clear and substantial reason to do so. Second, I reject ViiV's arguments because the 2006 amendments to the NOC Regulations have endeavoured to strike a balance between the interests of the various parties. ... Finally, I reject ViiV's arguments respecting policy, because I find that the Federal Court of Appeal has already interpreted subsection 4(2)(a) and (b) of the NOC Regulations and, given that interpretation, the '753 patent does not qualify for listing. " - See paragraphs 50 to 69.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - A Prothonotary determined that a patent claiming but one medicinal ingredient could not be listed by the Minister of Health under the Patented Medicines (Notice of Compliance) Regulations, where the underlying Notice of Compliance (NOC) was directed to a fixed-dose combination of two or more medicines - The Prothonotary reviewed, in particular, the decision of the Federal Court of Appeal in Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012) - On appeal, the "first person" appellant argued that the Federal Court of Appeal in Gilead dealt with s. 4(2)(a) of the NOC Regulations only in obiter, and that the decision of Russell, J., in Bayer Inc. v. Canada (Minister of Health) et al. (2009), should be followed in determining the meaning and effect of that section - The Federal Court disagreed - In Gilead, the Federal Court of Appeal clearly stated in its conclusion that it was dealing with s. 4(2)(a) - "Gilead is amply clear; a high threshold of specificity between what is claimed in the patent and the NOC is required. A patent claiming only one medicinal ingredient cannot be listed in respect of an NOC containing two or more medicinal ingredients." - The distinction with respect to ss. 4(2)(a) and (b) by Russell, J., was not endorsed by the Federal Court of Appeal in Bayer - See paragraphs 70 to 77.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court raised and addressed the issue of whether fixed-dose compositions were unique, so as to be able to be listed under s. 4(2)(a) of the Notice of Compliance (NOC) Regulations - "Logic would dictate that, if two separate tablets, each containing a single medicinal ingredient, were to be placed in a single envelope suitable for swallowing, then, while the envelope contained two medicines, each remained discrete. Thus, it could be argued, the envelope still contained a discrete - or single - medicinal ingredient. ... I find that this argument cannot prevail. First, in law, Gilead [Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012)] is amply clear. There is a 'high threshold' of consistency; every medicine in the envelope must be claimed. ... Second, the evidence in the record is ambiguous as to whether we have two separate medicines functioning independently, or whether they somehow interact and are synergistic. ... In my view, it is not productive when considering the listing requirements of subsection 4(2) of the NOC Regulations to consider synergy or not. The decision of the Federal Court of Appeal in Gilead is sufficiently clear. A patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients." - See paragraphs 78 to 89.

Food and Drug Control - Topic 1114

Drugs - New drugs - Delisting of patent - The overall issue was whether a Prothonotary erred in finding that Canadian Patent No. 2,289,753 (the '753 patent) was not eligible for listing under the Notice of Compliance (NOC) Regulations in respect of the appellant's KIVEXA or TRIZIVIR products - The question dealt with by the Prothonotary was whether s. 4(2)(a) of the NOC Regulations allowed a person to list on the Patent Register in respect of a Fixed Dose Combination (FDC) product, a patent containing a claim to a compound that corresponded to one of two medicinal ingredients of an FDC - The Federal Court held that the Prothonotary was correct - The Court also addressed the issue of whether claim 32 of the '753 patent met the product specificity requirements under s. 4(2)(b) of the NOC Regulations, and concluded that for the purpose of s. 4(2)(b), product specificity required listing in the claim all of the medicinal ingredients included in the formulation contained in the approved FDC, and not just in the patent description - See paragraphs 90 to 96.

Cases Noticed:

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [paras. 11, 34, 54].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 71 C.P.R.(4th) 389; 2009 FCA 35, refd to. [paras. 11, 46, 47].

Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012), 435 N.R. 188; 2012 FCA 254, refd to. [paras. 27, 47].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 31].

Parke, Davis & Co. v. Fine Chemicals of Canada Ltd., [1959] S.C.R. 219; 17 D.L.R.(2d) 153, refd to. [para. 33].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2009), 354 F.T.R. 280; 78 C.P.R.(4th) 428; 2009 FC 1165, refd to. [para. 35].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 93 C.P.R.(4th) 186; 2011 FCA 132, refd to. [paras. 37, 47].

Abbott Laboratories Ltd. et al. v. Canada (Attorney General) et al. (2008), 380 N.R. 287; 68 C.P.R.(4th) 445; 2008 FCA 244, refd to. [para. 47].

Bayer Inc. v. Canada (Minister of Health) et al. (2009), 358 F.T.R. 20; 79 C.P.R.(4th) 1; 2009 FC 1171, affd. (2010), 405 N.R. 248; 86 C.P.R.(4th) 81; 2010 FCA 161, refd to. [para. 47].

Novartis Pharmaceuticals Canada Inc. v. Canada (Attorney General) et al. (2012), 415 F.T.R. 5; 104 C.P.R.(4th) 107; 2012 FC 836, refd to. [para. 47].

Eli Lilly Canada Inc. v. Canada (Attorney General) et al. (2014), 448 F.T.R. 160; 238 A.C.W.S.(3d) 446; 2014 FC 152, refd to. [para. 47].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2003] 4 F.C. 505; 303 N.R. 63; 24 C.P.R.(4th) 417 (F.C.A.), refd to. [para. 54].

R. v. Russel (W.I.), [2013] 3 S.C.R. 3; 447 N.R. 111; 308 O.A.C. 347; 2013 SCC 43, refd to. [para. 66].

Ontario v. Criminal Lawyers' Association of Ontario - see R. v. Russel.

R. v. Henry (D.B.) et al., [2005] 3 S.C.R. 609; 342 N.R. 259; 376 A.R. 1; 360 W.A.C. 1; 219 B.C.A.C. 1; 361 W.A.C. 1; 2005 SCC 76, refd to. [para. 75].

R. v. Prokofiew (E.) (2010), 264 O.A.C. 174; 100 O.R.(3d) 401; 2010 ONCA 423, affd. [2012] 2 S.C.R. 639; 435 N.R. 1; 296 O.A.C. 1; 2012 SCC 49, refd to. [para. 75].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 2 [para. 44]; sect. 4(2)(a), sect. 4(2)(b) [para. 43].

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

Authors and Works Noticed:

Rothstein, Marshall, Advocacy in Intellectual Property Litigation in the Supreme Court of Canada (2014), 262 Intellectual Property Journal 145, p. 146 [para. 61].

Counsel:

Patrick Kierans, Louisa Pontrelli and Christopher Guerreiro, for the applicants, ViiV Healthcare ULC et al.;

Eric Peterson, for the respondent, Minister of Health;

David Aitken and Scott Beeser, for the respondent, Teva Canada Ltd.;

Ben Hackett and Jaro Mazzola, for the respondent, Apotex Inc.

Solicitors of Record:

Norton Rose Fulbright Canada LLP, Toronto, Ontario, for the applicants ViiV Healthcare ULC et al;

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health;

Aitken Klee LLP, Ottawa, Ontario, for the respondent, Teva Canada Ltd.;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.

These motions, by way of an appeal, were heard on September 4, 2014, at Toronto, Ontario, before Hughes, J., of the Federal Court, who delivered the following judgment and reasons, dated September 18, 2014.