Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al.

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Supreme Court (Canada)
• Judge: McLachlin, C.J.C., Major, Bastarache, Binnie, LeBel, Deschamps, Fish, Abella and Charron, JJ.
• Citation: (2005), 334 N.R. 55 (SCC),2005 SCC 26,EYB 2005-90541,[2005] SCJ No 26 (QL),[2005] ACS no 26,[2005] 1 SCR 533,334 NR 55,JE 2005-996,253 DLR (4th) 1,[2005] CarswellNat 1261,139 ACWS (3d) 552,39 CPR (4th) 449
• Date: 05 November 2004

Bristol-Myers v. Can. (A.G.) (2005), 334 N.R. 55 (SCC)

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: [2005] N.R. TBEd. MY.031

Biolyse Pharma Corporation (appellant) v. Bristol-Myers Squibb Company, Bristol-Myers Squibb Canada Inc., and the Attorney General of Canada (respondents) and Canadian Generic Pharmaceutical Association, Pfizer Canada Inc. (intervenors)

(29823; 2005 SCC 26; 2005 CSC 26)

Indexed As: Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al.

Supreme Court of Canada

McLachlin, C.J.C., Major, Bastarache, Binnie, LeBel, Deschamps, Fish, Abella and Charron, JJ.

May 19, 2005.

Summary:

A cancer-fighting medicine (paclitaxel) was discovered by the National Cancer Institute in the United States and was given to the pub­lic domain. Bristol-Myers Squibb Com­pany and Bristol-Myers Squibb Canada Inc. (col­lectively BMS) had three patents related to the formulation and method of administra­tion of paclitaxel marketed under the name Taxol. Biolyse submitted a New Drug Sub­mis­sion (NDS) for its paclitaxel for injec­tion. Since Biolyse's drug had a different botanical source of paclitaxel than BMS's Taxol, and Biolyse made claims for new and different uses, Health Canada had recom­mended that Biolyse submit a NDS rather than an Abbreviated New Drug Submission. The Minister of Health issued a Notice of Compliance (NOC) to Biolyse. BMS applied to quash the NOC. BMS argued that s. 5 of the Patented Medicines (Notice of Compli­ance) Regulations was engaged and the Min­ister therefore erred in failing to require that Biolyse serve a Notice of Allegation on BMS.

The Federal Court of Canada, Trial Divi­sion, in a decision reported at 224 F.T.R. 236, allowed the application and quashed the NOC issued to Biolyse. The court held that Biolyse had not compared its drug to another drug for the purpose of demonstrating bio­equivalence and s. 5(1) of the NOC Regula­tions did not apply. However, the court held that s. 5(1.1) of the NOC Regulations was engaged and the Minister erred in failing to require Biolyse to serve a Notice of Allega­tion on BMS. Biolyse appealed, arguing that s. 5(1.1) of the NOC Regulations did not apply to its NDS.

The Federal Court of Appeal, in a decision re­ported at 303 N.R. 63, dismissed the ap­peal. Biolyse appealed, arguing that s. 5(1.1) of the NOC Regulations should not be con­strued to apply to a NDS for an innova­tor drug.

The Supreme Court of Canada, Bastarache, Major and Charron, JJ.A., dissenting, al­lowed Biolyse's appeal. The court held that "submission" in s. 5(1.1) did not include a NDS for an innovator drug. Neither s. 5(1) nor s. 5(1.1) of the NOC Regulations was en­gaged and the NOC issued to Biolyse should not have been quashed.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - [See both Food and Drug Control - Topic 1109 ].

Food and Drug Control - Topic 1108

Drugs - New drugs - Notice of compliance - Judicial review - The Minister of Health issued a Notice of Compliance (NOC) to Bio­lyse in respect of its paclitaxel for injection - An application to quash the NOC was allowed and the decision was af­firmed on appeal - Biolyse appealed - At issue on the appeal was the interpretation of s. 5(1.1) of the Patented Medicines (Notice of Compliance) Regulations - The Supreme Court of Canada held that on the question of the interpretation of s. 5(1.1), the Minister's opinion was not entitled to deference and the standard of review on the point was correctness - See paragraph 36.

Food and Drug Control - Topic 1109

Drugs - New drugs - Notice of compliance - New drug submissions - A cancer-fight­ing medicine (paclitaxel) was discovered by the National Cancer Institute in the United States and was given to the public domain - Bristol-Myers Squibb (BMS) had patents related to the formulation and method of administration of paclitaxel, marketed under the name Taxol - Biolyse submitted a New Drug Submission (NDS) for its paclitaxel drug - Since Biolyse's drug had a different botanical source of paclitaxel than BMS's Taxol, and Biolyse made claims for new and different uses, Health Canada had recommended that Bio­lyse submit a NDS rather than an Ab­brevi­ated New Drug Submission - The Minister of Health issued a Notice of Compliance (NOC) to Biolyse - A motions judge quashed the NOC, holding that s. 5(1.1) of the Patented Medicines (Notice of Compli­ance) Regulations was engaged and the Min­ister therefore erred in failing to re­quire Biolyse to serve a Notice of Allega­tion on BMS - The Supreme Court of Can­ada held that s. 5(1.1) was not engaged and the NOC should not have been quashed - The court rejected BMS's argu­ment that "submission" in s. 5(1.1) in­cluded a NDS for an innovator drug - The court stated, inter alia, that "An inter­preta­tion of the NOC Regulations that confers on BMS a monopoly merely by demon­strat­ing the presence of a public domain medicine like paclitaxel in its product provides no value to the public in ex­change for the monopoly BMS seeks. When the NOC Regulations are considered in their proper context, and in particular in light of the wording of s. 55.2(4) of the Patent Act that authorized them, the NOC Regulations do not have the sweeping eff­ect contended for by BMS" - See para­graph 4.

Food and Drug Control - Topic 1109

Drugs - New drugs - Notice of compliance - New drug submissions - A cancer-fight­ing medicine (paclitaxel) was discovered by the National Cancer Institute in the United States and was given to the public domain - Bristol-Myers Squibb (BMS) had patents related to the formulation and method of administration of paclitaxel marketed under the name Taxol - Biolyse submitted a New Drug Submission (NDS) for its paclitaxel drug - Since Biolyse's drug had a different botanical source of paclitaxel than BMS's Taxol, and Biolyse made claims for new and different uses, Health Canada had recommended that Bio­lyse submit a NDS rather than an Ab­brevi­ated New Drug Submission - The Minister issued a Notice of Compliance (NOC) to Biolyse - A motions judge quashed the NOC, holding that s. 5(1.1) of the Patented Medicines (Notice of Compli­ance) Regula­tions was engaged and the Minister there­fore erred in failing to require Biolyse to serve a Notice of Alle­gation on BMS - The Supreme Court of Canada held that s. 5(1.1) was not engaged and the NOC should not have been quashed - The court stated, inter alia, that "s. 5(1.1) does not apply to innovative drugs. It should be con­fined to applications for generic copies of patented drugs in the circumstances con­templated by the regula­tor, i.e. where a manufacturer makes a submission for a NOC for a drug which contains a medicine that it purports to copy from another gen­eric but in fact copies from the innovator company that has filed the patent list" - See paragraph 69.

Cases Noticed:

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. 1].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 1].

Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc., [1994] 1 F.C. 742; 162 N.R. 177 (F.C.A.), affd. [1994] 3 S.C.R. 1100; 176 N.R. 1, refd to. [para. 6].

Imperial Chemical Industries plc v. Novo­pharm Ltd. (1991), 126 N.R. 377; 35 C.P.R.(3d) 137 (F.C.A.), refd to. [para. 8].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Wel­fare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299, refd to. [para. 24].

Rizzo and Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, appld. [paras. 37, 96].

Bell ExpressVu Limited Partnership v. Rex et al., [2002] 2 S.C.R. 559; 287 N.R. 248; 166 B.C.A.C. 1; 271 W.A.C. 1; 2002 SCC 42, appld. [paras. 43, 96].

Francis v. Baker, [1999] 3 S.C.R. 250; 246 N.R. 45; 125 O.A.C. 201, refd to. [paras. 47, 97].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 52].

Bristol-Myers Squibb Canada Inc. v. Can­ada (Attorney General) et al. (2001), 199 F.T.R. 142; 10 C.P.R.(4th) 318 (T.D.), affd. (2002), 288 N.R. 24; 16 C.P.R.(4th) 425; 2002 FCA 32, refd to. [paras. 58, 112].

Ferring Inc. v. Canada (Attorney General) et al. (2003), 310 N.R. 186; 26 C.P.R.(4th) 155; 2003 FCA 274, refd to. [paras. 58, 112].

Toba Pharma Inc. v. Canada (Attorney Gen­eral) et al. (2002), 227 F.T.R. 261; 21 C.P.R.(4th) 232; 2002 FCTD 927, refd to. [paras. 58, 112].

AstraZeneca Canada Inc. v. Canada (Min­ister of Health) (2004), 253 F.T.R. 195; 36 C.P.R.(4th) 58; 2004 FC 736, refd to. [paras. 58, 112].

Nu-Pharm Inc. v. Canada (Attorney Gen­eral) et al., [1999] 1 F.C. 620; 159 F.T.R. 68 (T.D.), refd to. [para. 62].

Merck & Co. et al. v. Canada (Attorney General) et al. (1999), 176 F.T.R. 21 (T.D.), affd. (2000), 254 N.R. 68; 5 C.P.R.(4th) 138 (F.C.A.), leave to appeal denied, [2000] 1 S.C.R. xvii; 259 N.R. 196, refd to. [paras. 62, 80].

Nu-Pharm Inc. v. Canada (Attorney Gen­eral) et al. (1998), 224 N.R. 386; 80 C.P.R.(3d) 74 (F.C.A.), refd to. [para. 80].

Syntex (U.S.A.) L.L.C. et al. v. Canada (Minister of Health) et al. (2002), 292 N.R. 147; 20 C.P.R.(4th) 29 (F.C.A.), refd to. [para. 80].

Canadian Pacific Ltd. v. Matsqui Indian Band et al., [1995] 1 S.C.R. 3; 177 N.R. 325; 122 D.L.R.(4th) 129, refd to. [para. 82].

Pushpanathan v. Canada (Minister of Citi­zenship and Immigration), [1998] 1 S.C.R. 982, addendum [1998] 1 S.C.R. 1222; 226 N.R. 201, refd to. [para. 85].

Pfizer Canada Inc. v. Canada (Minister of National Health and Welfare) et al. (1986), 12 C.P.R.(3d) 438 (F.C.A.), refd to. [para. 87].

Reference Re Section 7 of the Patented Medicines (Notice of Compliance) Regu­lations - see Merck & Co. et al. v. Canada (Minister of Health) et al.

Merck & Co. et al. v. Canada (Minister of Health) et al. (1999), 249 N.R. 110; 3 C.P.R.(4th) 77 (F.C.A.), refd to. [para. 87].

Eli Lilly Canada Inc. v. Canada (Minister of Health) (2003), 23 C.P.R.(4th) 289 (F.C.A.), refd to. [para. 88].

Novopharm Ltd. v. Canada (Minister of National Health and Welfare), [1998] 3 F.C. 50; 149 F.T.R. 63 (T.D.), refd to. [para. 90].

H.L. v. Canada (Attorney General) et al. (2005), 333 N.R. 1; 2005 SCC 25, refd to. [para. 96].

Marche et al. v. Halifax Insurance Co. (2005), 330 N.R. 115; 230 N.S.R.(2d) 333; 729 A.P.R. 333; 2005 SCC 6, refd to. [para. 96].

Harvard College v. Commissioner of Pat­ents, [2002] 4 S.C.R. 45; 296 N.R. 1; 2002 SCC 76, refd to. [para. 96].

Chieu v. Canada (Minister of Citizenship and Immigration), [2002] 1 S.C.R. 84; 280 N.R. 268; 2002 SCC 3, refd to. [para. 96].

United Taxi Drivers' Fellowship of South­ern Alberta et al. v. Calgary (City), [2004] 1 S.C.R. 485; 318 N.R. 170; 346 A.R. 4; 320 W.A.C. 4; 2004 SCC 19, refd to. [para. 102].

Spar Aerospace Ltd. v. American Mobile Satellite Corp. et al., [2002] 4 S.C.R. 205; 297 N.R. 83; 2002 SCC 78, refd to. [para. 102].

R. v. McDonald (A.P.) et al. (2002), 209 N.S.R.(2d) 283; 656 A.P.R. 283 (C.A.), refd to. [para. 102].

Canadian Pacific Air Lines v. Canadian Air Lines Pilots Association, [1993] 3 S.C.R. 724; 160 N.R. 321, refd to. [para. 105].

Apotex Inc. v. Canada (Minister of Health) et al. (1999), 165 F.T.R. 42; 87 C.P.R.(3d) 271 (T.D.), refd to. [para. 111].

GlaxoSmithKline Inc. v. Canada (Attorney General) et al. (2004), 264 F.T.R. 162; 2004 FC 1302, refd to. [para. 113].

Gerber Garment Technology Inc. v. Lectra Systems Ltd., [1997] R.P.C. 443 (Eng. C.A.), refd to. [para. 134].

Merck Frosst Canada Inc. v. Canada (Min­ister of National Health and Welfare) (1998), 84 C.P.R.(3d) 492 (F.C.T.D.), affd. (2000), 259 N.R. 88; 8 C.P.R.(4th) 48 (F.C.A.), refd to. [para. 140].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Wel­fare) et al. (1995), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 140].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Wel­fare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299, refd to. [para. 140].

Merck Frosst Canada Inc. et al. v. Apotex Inc. (1997), 208 N.R. 388; 72 C.P.R.(3d) 170 (F.C.A.), refd to. [para. 141].

Willick v. Willick, [1994] 3 S.C.R. 670; 173 N.R. 321; 125 Sask.R. 81; 81 W.A.C. 81, refd to. [para. 150].

R. v. Ulybel Enterprises Ltd., [2001] 2 S.C.R. 867; 275 N.R. 201; 206 Nfld. & P.E.I.R. 304; 618 A.P.R. 304; 2001 SCC 56, refd to. [para. 154].

R.J.R.-MacDonald Inc. v. Canada (Attor­ney General) - see RJR-MacDonald Inc. et Imperial Tobacco Ltd. v. Canada (Procureur général).

RJR-MacDonald Inc. et Imperial Tobacco Ltd. v. Canada (Procureur général), [1994] 1 S.C.R. 311; 164 N.R. 1; 60 Q.A.C. 241, refd to. [para. 157].

Friesen v. Minister of National Revenue, [1995] 3 S.C.R. 103; 186 N.R. 243, refd to. [para. 157].

Bayer Inc. v. Canada (Attorney General) et al. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), refd to. [para. 157].

Eli Lilly & Co. et al. v. Novopharm Ltd. et al., [1998] 2 S.C.R. 129; 227 N.R. 201, refd to. [para. 161].

R. v. McIntosh (B.B.), [1995] 1 S.C.R. 686; 178 N.R. 161; 79 O.A.C. 81, refd to. [para. 174].

R. v. Hinchey (M.F.) and Hinchey (B.A.), [1996] 3 S.C.R. 1128; 205 N.R. 161; 147 Nfld. & P.E.I.R. 1; 459 A.P.R. 1, refd to. [para. 175].

R. v. Proulx (J.K.D.), [2000] 1 S.C.R. 61; 249 N.R. 201; 142 Man.R.(2d) 161; 212 W.A.C. 161; 2000 SCC 5, refd to. [para. 178].

Degelder Construction Co. v. Dancorp De­vel­opments Ltd. et al., [1998] 3 S.C.R. 90; 231 N.R. 122; 113 B.C.A.C. 1; 184 W.A.C. 1, refd to. [para. 178].

Zeitel and Henning v. Ellscheid et al., [1994] 2 S.C.R. 142; 165 N.R. 214; 71 O.A.C. 134, refd to. [para. 182].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al. (1994), 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 186].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) - see Bull (David) Laboraties (Canada) Inc. v. Pharmacia Inc. et al.

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 55.2(1), sect. 55.2(4), sect. 55.2(5) [para. 33].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regu­lations, SOR/93-133, sect. 5(1), sect. 5(1.1) [para. 33].

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

Authors and Works Noticed:

Barrigar, Robert H., Canadian Patent Act Annotated (2nd Ed.) (2004 Loose­leaf Update), p. PA-232.1 [para. 139].

Côté, Pierre-André, Interpretation of Legis­lation in Canada (3rd Ed. 2000), pp. 24, 25 [para. 97]; 308 [para. 128].

Driedger, Elmer E., Construction of Stat­utes (2nd Ed. 1983), pp. 86 [para. 182]; 87 [para. 95]; 94 [para. 117]; 247 [paras. 38, 97].

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 163 [para. 133].

Garland, Steven B. and Want, Jeremy E., The Canadian Patent System: An Appro­priate Balance Between the Rights of the Public and the Patentee (1999), 16 C.I.P.R. 43, generally [para. 133]; pp. 43, 44 [para. 189].

Grenier, François M., and Lemay, Cath­er­ine, Le règlement sur les médica­ments brevetés (avis des conformité) (2003), 20 C.I.P.R. 51, p. 57 [para. 184].

Henderson, Gordon F., Patent Law of Can­ada (1994), p. 10 [para. 189].

Hore, Edward, The Notice of Compliance Regulations Under the Patent Act: The First Two Years (1995), 12 C.I.P.R. 207, pp. 208 [paras. 135, 140]; 209 to 211 [para. 142].

Hughes, Roger T., and Woodley, John H., Patents (1984) (2004 Loose­leaf Update) (Issue 60), pp. 381-17 [para. 148]; 381-18, 381-19 [para. 142].

Kernochan, John M., Statutory Interpreta­tion: An Outline of Method (1976), 3 Dal. L.J. 333, pp. 348, 349 [para. 44].

Orlhac, Thierry, The New Canadian Phar­maceutical Compulsory Licensing Provi­sions or How to Jump Out of the Frying Pan and Into the Fire (1990), 6 C.I.P.R. 279, generally [para. 8].

Smith, Margaret, Patent Protection for Pharmaceutical Products (1993), gen­erally [para. 73].

Smith, Margaret, Patent Protection for Pharmaceutical Products in Canada - Chronology of Significant Events (March 30, 2000), generally [para. 160].

Sullivan, Ruth, Sullivan and Driedger on the Construction of Statutes (4th Ed. 2002), pp. 2 [para. 94]; 21 [para. 105]; 218 [para. 154]; 260, 261 [paras 125, 154]; 262 [para. 125]; 282 [para. 99]; 284 [para. 128]; 285 [para. 150]; 471, 472 [paras. 154, 179]; 499, 500 [para. 156].

Takach, George Francis, Patents: A Cana­dian Compendium of Law and Practice (1993), p. 119 [para. 8].

Wilcox, Peter R., and Ripley, Daphne C., The Patented Medicines (Notice of Com­pliance) Regulations (2000), 16 C.I.P.R. 429, p. 433 [para. 184].

World Trade Organization, Report of the Panel on Canada - Patent Protection of Pharmaceutical Products, Complaint by the European Communities and their member States (March 17, 2000), Doc. WT/DS114/R, gen­erally [paras. 47, 134].

Counsel:

Andrew J. Roman, for the appellant;

Anthony G. Creber and Patrick S. Smith, for the respondents, Bristol-Myers Squibb Company and Bristol-Myers Squibb Canada Inc;

No one appeared for the respondent, the Attorney General of Canada;

Written submission only by Edward Hore, for the intervener, the Canadian Generic Pharmaceutical Association;

John Terry and Conor McCourt, for the intervener, Pfizer Canada Inc.

Solicitors of Record:

Miller Thomson, Toronto, Ontario, for the appellant.

Gowling Lafleur Henderson, Ottawa, Ontario, for the respondents, Bristol-My­ers Squibb Company and Bristol-Myers Squibb Canada Inc.

Attorney General of Canada, Ottawa, Ontario, for the respondent, the Attorney General of Canada.

Hazzard & Hore, Toronto, Ontario, for the intervener, the Canadian Generic Phar­maceutical Association.

Torys, Toronto, Ontario, for the intervener, Pfizer Canada Inc.

This appeal was heard on November 5, 2004, before McLachlin, C.J.C., Major, Bastarache, Binnie, LeBel, Deschamps, Fish, Abella and Charron, JJ., of the Supreme Court of Canada. The judgment of the Supreme Court of Canada was delivered in both official languages on May 19, 2005, including the following opinions:

Binnie, J. (McLachlin, C.J.C., LeBel, Deschamps, Fish and Abella, JJ., con­curring) - see paragraphs 1 to 71;

Bastarache, J., dissenting (Major and Charron, concurring) - see paragraphs 72 to 193.