AstraZeneca Canada Inc. et al. v. Apotex Inc. et al., 2010 FC 714

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: June 30, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 714;(2010), 376 F.T.R. 17 (FC)

AstraZeneca Can. Inc. v. Apotex Inc. (2010), 376 F.T.R. 17 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. AU.005

AstraZeneca Canada Inc. and AstraZeneca Aktiebolag (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-371-08; 2010 FC 714)

Indexed As: AstraZeneca Canada Inc. et al. v. Apotex Inc. et al.

Federal Court

Hughes, J.

June 30, 2010.

Summary:

AstraZeneca Canada Inc. and AstraZeneca Aktiebolag applied under the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the respondent Minister of Health from issuing a Notice of Compliance to the other respondent, Apotex Inc., for 20 and 40 mg esomeprazole magnesium tablets until after the expiry of Canadian Patent No. 2,139,653 (the '653 patent). The overriding issue was whether the allegations made by Apotex in its Notice of Allegation that claim 8 of the '653 patent was invalid, were justified within the meaning of s. 6(2) of the Regulations.

The Federal Court dismissed the application. The court found that the allegations that claim 8 was invalid for lack of sound prediction as to utility and for obviousness, were justified. The allegation as to anticipation was not justified.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - A generic drug company alleged that claim 8 of the subject patent was invalid - The Federal Court first addressed the proper construction of claim 8, rewritten as: "8. A salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater" - At issue was the meaning of "having an optical purity of 99.8% or greater" - One of two different ways of expressing optical purity of a sample of an enantiomeric compound was to express optical purity in absolute terms; the other way was to express purity in terms of the excess of one enantiomer over the other, enantiomeric excess or (ee) - The innovators of the patent argued that throughout the description of the patent, whenever a percentage figure was given for optical purity, it was always expressed as (ee) - The generic drug company argued that absolute purity must have been intended when (ee) was omitted in the claims - The Federal Court agreed with the innovators' interpretation that 99.8% should be read as meaning optical purity expressed in terms of (ee) - A person skilled in the art would wish to read the claim in an "informed and purposive" way, looking at the whole of the disclosure and the claims - See paragraphs 66 to 70.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - At issue was the validity of claim 8 of the subject patent, namely, "8. A salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater" - There was nothing respecting utility expressly stated - The Federal Court, in determining whether a promise of utility was implicit in claim 8, and what was that promise, noted that claim 8 was not directed to a new compound; it was directed to a previously known compound having a particular purity; and that no particular use of that compound was expressed in the claim - "Where there is a new compound, utility does not need to be included in the claim, so long as it is described in the descriptive portion of the patent ... Where there is a new use for an old compound, that new use must be set out in the claims ... [T]hus, so far as claim construction is concerned, we have only a known compound having a particular purity claimed" - The issue of utility arose later in considering sound prediction and utility - See paragraphs 71 to 76, 81.

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - The Federal Court discussed the burden of proof in respect of allegations as to invalidity by a generic in a Notice of Allegation served in the context of the Patented Medicines (Notice of Compliance) Regulations - See paragraphs 77 to 79.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - At issue was the validity of claim 8 of the subject patent, namely, "8. A salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater" - The background to what the patent described as its invention included the following: omeprazole, including its salts, was a well known "blockbuster" drug useful in the treatment of gastric acid related conditions; it was known that omeprazole was racemic and comprised two enantiomers; and at least two known successful attempts at separating omeprazole into its enantiomers had been published, including the Erlandsson article -The Federal Court was satisfied, on the evidence, that a purity of 95.6% for esomeprazole had been reported has having been achieved by Erlandsson, and that the technique could have been used to increase that purity to 99.8% (ee) if desired, given that the product would be used as a pharmaceutical - Accordingly, the allegation that claim 8 of the patent was obvious, was justified - There was the means and motivation to make an enantiomer of high purity such as 99.8% - See paragraphs 134 to 137.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - German patent application DE 40 35 455 A1 (DE '455) was made available to the public more than one year before the priority date of the application for the patent at issue here, and more than two years before the filing date of the Canadian application for the patent - The question was, given that DE '455 described a process for separating the enantiomers of omeprazole (and salts) into "optically pure" fractions, did the description "enable" what was claimed in claim 8, namely, a purity of 99.8% (ee) or greater - On some occasions, that purity would reach 99.8% (ee); on other occasions, a lower purity was achieved, or "nothing worth the trouble of testing" was achieved - The Federal Court, given the evidence, found no enablement such as would support the allegation of anticipation - To practice DE '455 would at best only occasionally result in a product with the purity level stipulated in claim 8 - See paragraphs 95 to 125.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - Claim 8 of the subject patent was for the salts of esomerprazole having a certain high level of purity - The utility promised by the patent was "improved therapeutic profile such as a lower degree of interindividual variation", made possible by "high stability towards racemisation" - The Federal Court found that the allegation that claim 8 was invalid for lack of sound prediction for insufficient support as to utility, was justified - "The facts of the present case do not show that as of the priority date, May 1993, or even the Canadian filing date, May 1994, that the inventors had either a factual basis for a prediction that esomeprazole salt of a particular purity would have the utility indicated in the patent, nor did they have an articulable and sound line of reasoning for referring such a result. Clearly, there was no proper disclosure in the patent in that respect" - See paragraphs 82 to 94.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See second Patents of Invention - Topic 1032 and Patents of Invention - Topic 1724 ].

Cases Noticed:

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 7].

AB Hassle et al. v. Apotex Inc. et al. (2002), 223 F.T.R. 43; 2002 FCT 931, refd to. [para. 7].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al., [2002] 3 F.C. 221; 213 F.T.R. 161; 2001 FCT 1264, refd to. [para. 7].

AstraZeneca Canada Inc. v. Apotex Inc. et al. - see AstraZeneca AB et al. v. Apotex Inc. et al.

AstraZeneca AB et al. v. Apotex Inc. et al. (2004), 248 F.T.R. 1; 2004 FC 313, refd to. [para. 7].

AB Hassle et al. v. Apotex Inc. et al., [2003] F.T.R. Uned. 741; 2003 FCT 771, refd to. [para. 7].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 7].

AB Hassle et al. v. Apotex Inc. et al. (2003), 249 F.T.R. 1; 2004 FC 379, refd to. [para. 7].

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

AB Hassle et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 30; 2005 FC 234, refd to. [para.7].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 2007 FC 688, refd to. [para. 7].

AB Hassle et al. v. Genpharm Inc. et al. (2004), 329 N.R. 374; 2004 FCA 413, refd to. [para. 8].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al., [2000] F.T.R. Uned. 833 (T.D.), refd to. [para. 8].

AB Hassle et al. v. Rhoxalpharma Inc. et al. (2002), 222 F.T.R. 48; 2002 FCT 780, refd to. [para. 8].

P.S. Partsource Inc. v. Canadian Tire Corp. (2001), 267 N.R. 135; 2001 FCA 8, refd to. [para. 26].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 61 C.P.R.(4th) 305; 2007 FC 971, refd to. [para. 26].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 85 C.P.R.(4th) 321; 2010 FC 510, refd to. [para. 39].

Whirlpool Corp. et al. v. Camco Inc. et al. (1997), 134 F.T.R. 161; 76 C.P.R.(3d) 150 (T.D.), affd. (1999), 236 N.R. 330; 85 C.P.R.(3d) 129 (F.C.A.), affd. [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 40].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 67 C.P.R.(4th) 94 (F.C.), refd to. [para. 40].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd. (1981), 35 N.R. 390; 56 C.P.R.(2d) 145 (S.C.C.), refd to. [para. 72].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 73].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541, refd to. [para. 74].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 69 C.P.R.(4th) 191; 2008 FC 11, refd to. [para. 77].

Merck & Co. et al. v. Apotex Inc. (1995), 180 N.R. 373; 60 C.P.R.(3d) 356 (F.C.A.), refd to. [para. 90].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 92].

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. 104].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, refd to. [para. 122].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 124].

Authors and Works Noticed:

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (3rd Ed. 2009), pp. 269-270, 283- 291 [para. 27].

Counsel:

Gunars A. Gaikis, Yoon Kang and Tracey Stott, for the applicants;

Andrew Brodkin and Richard Naiberg, for the respondent, Apotex Inc.;

No one appearing for the respondent, Minister of Health.

Solicitors of Record:

Smart & Biggar; Toronto, Ontario, for the applicants;

Goodman, LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

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

This application was heard at Toronto, Ontario, on June 1-3, 2010, before Hughes, J., of the Federal Court, who delivered the following reasons for judgment and judgment, dated June 30, 2010.