Aventis Pharma Inc. v. Pharmascience, 2006 FCA 229

• Judge: Sexton, Sharlow and Malone, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: June 21, 2006
• Jurisdiction: Canada (Federal)
• Citations: 2006 FCA 229;(2006), 352 N.R. 99 (FCA)

Aventis Pharma Inc. v. Pharmascience (2006), 352 N.R. 99 (FCA)

MLB headnote and full text

Temp. Cite: [2006] N.R. TBEd. JL.014

Pharmascience Inc. (appellant/respondent) v. Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (respondents/applicants) and the Minister of Health and Schering Corporation (respondents/respondents)

(A-155-05; 2006 FCA 229)

Indexed As: Aventis Pharma Inc. et al. v. Pharmascience Inc. et al.

Federal Court of Appeal

Sexton, Sharlow and Malone, JJ.A.

June 21, 2006.

Summary:

Pharmascience Inc. sought a Notice of Com­pliance (NOC) to market capsules of ramipril for the treatment of hypertension. Aventis Pharm Inc. and Aventis Pharma Deutschland GmbH (Aventis) applied for a prohibition order to prevent the Minister from granting the NOC to Pharmascience. Scher­ing Corp., the owner of one of the rele­vant patents, was joined as a respondent and supported Aventis on the application.

The Federal Court, in a decision reported at 270 F.T.R. 187, allowed the prohibition application. Pharmascience appealed.

The Federal Court of Appeal dismissed the appeal.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Section 5(1)(b)(iv) of the Notice of Compliance (NOC) Regu­la­­tions stated that, in a non-infringement allega­tion, the generic drug producer must allege that "... no claim for the medicine itself and no claim for the use of the medi­cine would be infringed by the making, con­­structing, using or selling by that per­son of the drug for which the submission for the notice of compliance is filed." - Pharmasci­ence argued that the words "by that per­son" referred only to acts of Phar­mascience that would constitute infringe­ment of the patent in issue (including acts of Pharma­science that induced or procured infringe­ment by others) - Aventis argued that s. 5(1)(b)(iv) included any infringe­ment by anyone of the patent that resulted in any way from the issuance of a notice of com­pliance to Pharmascience - The Fed­eral Court of Appeal held that Pharma­science's interpretation was more consist­ent with the ordinary grammatical meaning of s. 5(1)(b)(iv) of the NOC Regulations, and with the legislative scheme and pur­pose - Section 55.2(4) of the Patent Act and, by extension, the NOC Regulations were intended to prevent patent infringe­ment by Pharmascience, not by patients - See para­graphs 29 to 61.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. no­tice of allegation) - Aventis held patent "'087" for the use of ramipril for the treat­ment of hypertension - It expired Novem­ber 4, 2002 - Aventis also held patent "'457" for the use of ramipril for cardiac in­sufficiency - The '457 patent issued De­cem­ber 13, 1988 was to expire in Decem­­ber 2005 - Schering held Patent "'206", a genus patent that included rami­pril - Al­though Schering's patent applica­tion was filed in October 1981, the patent did not issue until March 20, 2001 - Phar­ma­sci­ence sought a Notice of Compliance (NOC) to market ramipril for the treatment of hypertension - Aventis applied for a pro­hibition order - The Federal Court held that Pharmascience's Notice of Allegation was deficient because it stated only that it was not seeking approval for the treatment of cardiac insufficiency - It made no men­tion of how it would achieve that assertion (i.e., the steps it would take to limit mar­keting) - The Federal Court of Appeal held that the notice of allegation was adequate because it set out the grounds for the alle­ga­tion well enough to enable the person to whom it was addressed to make an in­formed decision about whether to com­mence prohibition proceedings - See para­graphs 22 to 28.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The Federal Court of Appeal stated that there are two senses in which a notice of allegation may be said to be "inadequate" or "insufficient" - First, the words may be used to describe a judi­cial determination as to whether the person to whom the notice of allegation has suffi­cient information to determine whether to seek a prohibition order - Second, they were sometimes used to describe a situ­a­tion where a non-infringement allegation was not justified because it failed to ad­dress a relevant patent claim, or because it was not capable of establishing non-in­fringement (for example, where it was based on an incorrect construction of a patent claim) - The court held that a notice of allegation could not be found to be in­ade­quate or insufficient in that secondary sense without addressing the allegation on the merits - See paragraphs 23 and 24.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - At issue on an appeal was whether a trial judge erred in determining that a notice of allegation was inadequate -The Federal Court of Appeal held that the adequacy of a notice of allegation was a question of mixed law and fact - The stan­dard of review was palpable and over­riding error, except to the extent that a question of law could be extricated from the judge's deter­mination, in which case that question of law had to be determined correctly - See paragraphs 15 to 21.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court of Appeal discussed the doc­trine of double patenting - The court stated that "'Double patenting' refers to certain judge made rules that have been devised to prevent the 'evergreening' of patents. Ever­greening is the undue exten­sion of the statutory monopoly in a par­ticular patent by means of a series of patents with obvi­ous or uninventive addi­tions ... The juris­prudence has so far ident­ified two cate­gories of double patenting. In the first cate­gory, 'same invention patent­ing', two patents are the same or have an identical or conterminous claim. The sec­ond category, 'obviousness double patent­ing', is some­what broader. In obviousness double pat­enting, the claims of the patents are not identical or conterminous, but the later patent has claims that are not patentably distinct from the other patent, or involve no novelty or ingenuity.'" - See paragraphs 66 and 67.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Fed­eral Court of Appeal discussed the doc­trine of double patenting - The court stated that "'Double patenting' refers to certain judge made rules that have been devised to pre­vent the 'evergreening' of patents. Ever­greening is the undue exten­sion of the statutory monopoly in a par­ticular patent by means of a series of patents with obvi­ous or uninventive addi­tions ... Although it is difficult at this point to envisage a case involving more than one inventor that is or should be vulnerable to a claim of double patenting, I see no rea­son to foreclose such a possibility. In my view the doctrine of double patenting, as a set of judge made rules, should be left to evolve on a case by case basis." - See paragraphs 66 and 73.

Words and Phrases

By that person - The Federal Court of Ap­peal interpreted the meaning of this phrase as found in s. 5(1)(b)(iv) of the Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regula­tions, SOR/93-133 - See paragraphs 55 to 60.

Cases Noticed:

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) et al. (1996), 109 F.T.R. 148; 66 C.P.R.(3d) 169 (T.D.), refd to. [para. 11].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Wel­fare) et al. (1999), 167 F.T.R. 111 (T.D.), refd to. [para. 12].

AB Hassle et al. v. Apotex Inc. (2006), 350 N.R. 219; 2006 FCA 51, refd to. [para. 15].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 2005 FCA 270, refd to. [para. 15].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 15].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 329 N.R. 152; 2004 FCA 398, refd to. [para. 15].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 211 D.L.R.(4th) 577; 2002 SCC 33, refd to. [para. 19].

H.L. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 401; 333 N.R. 1; 262 Sask.R. 1; 347 W.A.C. 1; 2005 SCC 25, refd to. [para. 19].

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; 160 D.L.R.(4th) 193, refd to. [para. 19].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, consd. [para. 20].

Apotex Inc. and Novopharm Ltd. v. Well­come Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, consd. [para. 20].

Harvard College v. Commissioner of Pat­ents, [2002] 4 S.C.R. 45; 296 N.R. 1, 2002 SCC 76, refd to. [para. 20].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 25].

Beloit Canada Ltd. v. Valmet Oy (1988), 82 N.R. 235; 20 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 35].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 1 F.C. 402; 291 N.R. 339 (F.C.A.), affing. (2001), 213 F.T.R. 101; 2001 FCT 1151 (T.D.), application for leave to appeal dismissed (2003), 326 N.R. 398 (S.C.C.), refd to. [para. 36].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2002), 298 N.R. 323; 2002 FCA 421, consd. [para. 37].

AstraZeneca AB et al. v. Apotex Inc. et al. (2006), 285 F.T.R. 258; 2006 FC 7, refd to. [para. 38].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1461, refd to. [para. 38].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 2005 FC 1421, refd to. [para. 38].

Axcan Pharma Inc. v. Pharmascience Inc. et al. (2005), 280 F.T.R. 283; 2005 FC 1231, refd to. [para. 38].

Lundbeck (H.) A/S et al. v. Canada (Min­ister of Health) et al., [2003] F.T.R. Uned. 943; 2003 FC 1334, refd to. [para. 38].

Lundbeck (H.) A/S v. Canada (Minister of Health) (2003), 240 F.T.R. 57; 2003 FC 1145, refd to. [para. 38].

AB Hassle et al. v. Apotex Inc. et al. (2004), 249 F.T.R. 1; 2004 FC 379, refd to. [para. 38].

AstraZeneca AB et al. v. Apotex Inc. et al. (2004), 248 F.T.R. 1; 2004 FC 313, appeal dismissed as moot, [2004] N.R. Uned. 93 (F.C.A.); leave to appeal dis­missed (2005), 336 N.R. 399 (S.C.C.), refd to. [para. 38].

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. [para. 47].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, refd to. [para. 49].

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. 67].

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R. 9, refd to. [para. 69].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regu­lations, SOR/93-133, sect. 5(1)(b)(iv) [para. 55].

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

Authors and Works Noticed:

Driedger, Elmer A., Construction of Stat­utes (2nd Ed. 1983), pp. 87, 247 [para. 49].

Counsel:

Donald H. MacOdrum, Mark Mitchell and A. David Morrow, for the appellant/re­spondent, for the respondents/applicants, Sanofi-Aventis;

Anthony Creber, for the respondent/respon­dent, Schering.

Solicitors of Record:

Lang Michener LLP, Toronto, Ontario, for the appellant/respondent;

Smart & Biggar, Toronto, Ontario, for the respondents/applicants, Sanofi-Aventis;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the respondent/respondent, Schering.

This appeal was heard at Montreal, Que­bec, on June 6 and 7, 2006, by Sexton, Shar­low and Malone, JJ.A., of the Federal Court of Appeal. Sharlow, J.A., delivered the fol­low­ing decision for the court on June 21, 2006.