Allergan Inc. et al. v. Canada (Minister of Health) et al., (2011) 400 F.T.R. 164 (FC)

• Judge: Crampton, J.
• Court: Federal Court (Canada)
• Case Date: November 17, 2011
• Jurisdiction: Canada (Federal)
• Citations: (2011), 400 F.T.R. 164 (FC);2011 FC 1316

Allergan Inc. v. Can. (2011), 400 F.T.R. 164 (FC)

MLB headnote and full text

Temp. Cite: [2011] F.T.R. TBEd. NO.052

Allergan Inc., Allergan Sales Inc. and Allergan Inc. (applicants) v. The Minister of Health and Sandoz Canada Inc. (respondents)

(T-154-10; 2011 FC 1316)

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

Federal Court

Crampton, J.

November 17, 2011.

Summary:

The applicants (Allergan) sought an order pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Sandoz Canada Inc. until the expiry of two patents that Allergan owned, namely, Canadian Patent No. 2,440,764 ('764 patent) and Canadian Patent No. 2,225,626 ('626 patent). If issued, the NOC would permit Sandoz to market a generic version of a drug which combined two active ingredients, brimonidine tartrate (0.2%) (brimonidine) and timolol maleate (0.5%) (timolol), used in the treatment of glaucoma. Allergan currently marketed the branded version of that drug under the name "COMBIGAN". In support of its NOC, Sandoz filed an abbreviated new drug submission with the Minister in which it compared its drug (the generic drug) to COMBIGAN. Sandoz then sent a Notice of Allegation (NOA) to Allergan, putting the validity of the patents in issue. Sandoz alleged that the '764 patent was obvious as to the priority date and therefore invalid, that the Product Monograph of the generic drug would not induce infringement of any of the claims in the '626 patent, that the generic drug would not infringe any of the claims in the '626 patent and the '626 patent was invalid for inutility.

The Federal Court held that Allergan's '764 patent was not void for obviousness, and therefore, the prohibition order would be issued respecting that patent. The court stated that given that the '764 patent was issued more recently than the '626 patent, it was not strictly necessary to consider Sandoz's allegations made in respect of the '626 patent. Any determinations that might be made in respect of the latter patent could not affect the period of time during which Sandoz would be unable to market the generic drug, due to the conclusion the court reached in respect of the '764 patent. The court, however, in case it was wrong in its conclusion that the subject matter of the '764 patent was not obvious, also assessed the issues raised in respect of the '626 patent. In that regard, the issue of inducement of infringement was determinative, because the '626 patent was a use patent, which could not be directly infringed by Sandoz. The court concluded that Allergan had not met its burden on that issue (i.e., Sandoz's allegation that it would not induce infringement of the '626 patent was justified). In the event that its conclusion on the inducement issue was overturned, the court proceeded to address the various other allegations that Sandoz made in support of its position that the generic drug would not infringe the '626 patent and that the '626 patent was invalid. The court concluded that Allergan had demonstrated, on a balance of probabilities, that Sandoz's allegations with respect to the invalidity of either patent were not justified. In the result, the court determined that this application would be allowed and a prohibition order issued with respect to the '764 patent but dismissed with respect to the '626 patent.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court set out the test for assessing obviousness - See paragraph 37.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Allergan marked a drug, COMBIGAN, under patent '764 - The patent claims described a fixed combination of brimonidine (0.2%) and timolol (0.5%) in a pharmaceutically acceptable carrier containing BAK (0.001% to 0.01%) (the Composition) and the use of the Composition for the topical treatment of glaucoma and ocular hypertension - Sandoz sought a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations so it could market a generic version of the drug - In its Notice of Allegation (NOA), Sandoz alleged that the '764 patent was invalid for obviousness - At issue was whether Sandoz's allegation was justified - The Federal Court held that Allergan met its burden of establishing, on a balance of probabilities, that Sandoz's allegation that the '764 patent was invalid on the ground of obviousness was not justified - See paragraphs 34 to 127.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Allergan owned patent '626 respecting a combination drug used to treat glaucoma (COMBIGAN) - Sandoz, a generic drug manufacturer, sought a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations so it could market a generic version of the drug - Sandoz claimed the '626 patent was invalid for inutility on the basis that the claims covered non-useful subject matter; and the utility of that subject matter could not be soundly predicted as of the priority and filing dates - The Federal Court opined that Allergan had met its burden of demonstrating, on a balance of probabilities, that the allegation respecting invalidity for inutility was not justified - The court opined that Sandoz was precluded from raising the sound prediction issue because it did not raise the matter in its Notice of Allegation, and in any event Sandoz's allegation was not justified - See paragraphs 193 to 226.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court stated that the components of the doctrine of sound prediction were: a factual basis for the prediction; at the filing date of the patent application, the inventor had to have had an articulable and sound line of reasoning from which the desired result could be inferred from the factual basis; and there had to be proper disclosure - See paragraph 216.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 2890

Infringement of patent - Acts constituting an infringement - Inducing infringement - The Federal Court stated that to establish infringement of a use claim by inducement it was necessary to establish: "i. an act of infringement was completed by a direct infringer; ii. the infringement was influenced by the inducing party to the point that, without that influence, the infringement would not have taken place; and iii. the inducing party knew that its influence would result in the completion of the act of infringement" - See paragraph 15.

Patents of Invention - Topic 2890

Infringement of patent - Acts constituting an infringement - Inducing infringement - Allergan owned patent '626 respecting a combination drug used to treat glaucoma (COMBIGAN) - Sandoz, a generic drug manufacturer, sought a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations so it could market a generic version of the drug - Sandoz then sent a Notice of Allegation (NOA) to Allergan claiming that the Product Monograph (PM) of the generic drug would not induce infringement of any of the claims in the '626 patent - Allergan claimed that the proposed indications in Sandoz's PM would induce physicians, pharmacists and or patients to infringe the claims of the patent - The Federal Court opined that Allergan had not met its burden on this issue (i.e., Sandoz's allegation that it would not induce infringement of the '626 patent was justified) - See paragraphs 128 to 172.

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - Allergan owned patent '626 respecting a combination drug used to treat glaucoma (COMBIGAN) - Sandoz, a generic drug manufacturer, sought a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations so it could market a generic version of the drug - Sandoz then sent a Notice of Allegation (NOA) to Allergan claiming that its generic drug would not infringe the claims of the '626 patent - The Federal Court opined that Allergan had demonstrated, on a balance of probabilities, that Sandoz's allegation of non-infringement of the '626 patent was not justified - See paragraphs 172 to 192.

Cases Noticed:

Allergan Inc. v. Barr Laboratories Inc., [2011] U.S. Dist. Lexis 101778 (D. Del.), refd to. [para. 32].

Syntex LLC v. Apotex Inc., [2006] W.L. 1530101 (N.D. Cal.), refd. to. [para. 32].

Roche Palo Alto et al. v. Apotex Inc. et al. (2007), 526 F Supp 2d 985 (N.D. Cal.), refd to. [para. 32].

Pfizer Can. Inc. v. Canada (Minister of Health) et al. (2009), 360 F.T.R. 200; 2009 FC 1294, refd to. [para. 32].

Sanofi-Aventis Can. v. ratiopharm Inc. (2010), 367 F.T.R. 307; 2010 FC 230, refd to. [para. 32].

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. 34].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 37].

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. 47].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 51].

Laboratoires Servier et al. v. Apotex Inc. et al. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 52].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 54].

Merck & Co. et al. v. Canada (Minister of Health) et al. (2010), 375 F.T.R. 121; 2010 FC 1042, refd to. [para. 56].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, affd. (2010), 408 N.R. 166; 2010 FCA 242, refd to. [para. 69].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 72].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541, refd to. [para. 80].

Calgon Carbon Corp. v. North Bay (City) et al. (2005), 344 N.R. 224; 2005 FCA 410, refd to. [para. 80].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 82].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 82].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 2009 FC 320, refd to. [para. 90].

Schering-Plough Can. v. Pharmascience (2009), 360 F.T.R. 109; 2009 FC 1128, refd to. [para. 110].

Abbott Laboratories Ltd. et al. v. Canada (Minister of Health) et al. (2007), 367 N.R. 120; 2007 FCA 251, refd to. [para. 133].

Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.), refd to. [para. 138].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, refd to. [para. 139].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 140].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al., [2002] 3 F.C. 221; 213 F.T.R. 161 (T.D.), refd to. [para. 145].

Solvay Pharma Inc. et al. v. Apotex Inc. et al. (2008), 323 F.T.R. 1; 2008 FC 308, refd to. [para. 145].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al. (2007), 366 N.R. 231; 2007 FCA 167, refd to. [para. 145].

Dableh v. Ontario Hydro (1996), 199 N.R. 57; 68 C.P.R.(3d) 129 (F.C.A.), refd to. [para. 146].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2006), 354 N.R. 383; 2006 FCA 357, refd to. [para. 147].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 2005 FC 1421, refd to. [para. 147].

Sanofi-Aventis Canada Inc. et al. v. Laboratoire Riva Inc. et al. (2008), 331 F.T.R. 259; 2008 FC 291, refd to. [para. 147].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 281 F.T.R. 233; 2005 FC 1381, refd to. [para. 157].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6; 2003 FC 1443, refd to. [para. 157].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1461, refd to. [para. 167].

Goodridge et al. v. Pfizer Canada Inc. et al., [2010] O.T.C. 1095; 2010 ONSC 1095, refd to. [para. 169].

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, dist. [para. 174].

Merck & Co. et al. v. Apotex Inc. et al. (2010), 381 F.T.R. 162; 2010 FC 1265, refd to. [para. 220].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 6(1) [para. 1].

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

Authors and Works Noticed:

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005) (Looseleaf), c. 5, p. 166.4 [para. 90].

Counsel:

Andrew J. Reddon, Steven G. Mason and Steven Tanner, for the applicants;

David Rieve, Angela Furlanetto and Ryan Evans, for the respondent, Samdoz Canada Inc.

Solicitors of Record:

Andrew J. Reddon, Steven G. Mason and Steven Tanner, for the applicants;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health;

David Rieve, Angela Furlanetto and Ryan Evans, for the respondent, Sandoz Canada Inc.

This application was heard at Toronto, Ontario, on October 17-20, 2011, before Crampton, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on November 17, 2011.