Date: 20030825
Docket: T-660-02
Citation: 2003 FC 981
Toronto, Ontario, August 25th, 2003
Present: The Honourable Madam Justice Layden-Stevenson
BETWEEN:
ASTRAZENECA CANADA INC.
Applicant
and
APOTEX INC., TAKEDA CHEMICAL INDUSTRIES, LTD.
and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] The respondent Apotex Inc. (Apotex) brings this motion to set aside the order of a prothonotary dated July 8, 2003 wherein its motion to strike paragraph 47 of the applicant's Memorandum of Fact and Law as well as Tabs 24 and 26 of Appendices A and B to the Memorandum of Fact and Law was dismissed. These are my reasons for dismissing the motion.
[2] The underlying application is one in which, pursuant to the Patented Medicines (Notice of Compliance) Regulations, AstraZeneca Canada Inc. (AstraZeneca) seeks an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Apotex with respect to Apo-Omeprazole tablets (10, 20, 40 mg.) until after the expiry of Canadian Patent 1,338,377 ('377 Patent). Reduced to its skeleton, the dispute is regarding whether the Apotex drug contains an inorganic salt stabilizing agent selected from potassium, sodium and aluminum salts.
[3] At issue, here, is the inclusion by AstraZeneca of two specific references in the "Authorities" section of the Appendices to its Memorandum of Fact and Law and its reliance on those references in support of paragraph 47 of its Memorandum of Fact and Law which states:
More particularly, Apotex' tablets contain sodium carboxymethycellulose and sodium croscarmellose which are sodium salts.
[4] The impugned references consist of page 308 from The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, 13th ed. (Tab 24) and page 160 from The Handbook of Pharmaceutical Excipients, 3rd ed. (Tab 26).
[5] On the motion before the prothonotary and on this motion, Apotex argued that AstraZeneca is relying on the references at Tabs 24 and 26 as evidentiary support and that to do so, it required leave of the court to file such "evidence". The prothonotary concluded that the court's intervention, at this stage of the proceeding, was not required and that the matter should be argued before and determined by the judge hearing the application on its merits.
[6] Discretionary orders of a prothonotary should not be disturbed on appeal unless they are clearly wrong, in the sense that the exercise of discretion by the prothonotary was based on a wrong principle or upon misapprehension of the facts, or they raise questions vital to the final issue of the case: Canada v. Aqua-Gem Investments Ltd. (1993), 2 F.C. 425 (C.A.). Apotex does not suggest that the motion deals with questions vital to the final issue of the case. Hence, it must establish that the prothonotary was clearly wrong.
[7] The first paragraph of the endorsement portion of his order leaves no doubt that the prothonotary fully appreciated the facts. Apotex contends that he erred in failing to address the principle issue on the motion, that is, whether the materials were evidence or authorities. While Apotex took the position that the references contained at Tabs 24 and 26 constituted evidence, AstraZeneca maintained that they were authoritative scientific chemical and pharmaceutical reference texts akin to dictionaries and that as such, the applications judge could take judicial notice of them. Although AstraZeneca cited no authority from this court in support of its position, it did refer to trade-mark and patent tribunal decisions as well as a decision of the Quebec Superior Court (R. v. Marushka (1981), 20 C.R. (3d) 168) wherein The Merck Index was considered to be a sufficiently recognized and authoritative work of reference in chemistry to permit judicial notice of matters contained in it. Relying on R. v. Chiouotti (1950), 96 C.C.C. 177 (B.C.C.A.) it noted that a pharmaceutical reference text such as theHandbook of Pharmaceutical Excipients had been recognized by the court. It was within this context that the prothonotary concluded that the dispute ought to be resolved by the applications judge.
[8] "Judicial notice" is defined in Sopinka and Lederman, The Law of Evidence in Canada, 2d ed. (Toronto: Butterworths, 1999) at p. 1055 as "the acceptance by a court or judicial tribunal, in a civil or criminal proceeding, without the requirement of proof, of the truth of a particular fact or state of affairs". The following excerpts are instructive:
Facts which are (a) so notorious as not to be the subject of dispute among reasonable persons, or (b) capable of immediate and accurate demonstration by resorting to readily accessible sources of indisputable accuracy, may be noticed by the court without proof of them by any party (p. 1055).
There are some facts which, although not immediately within the judge's knowledge, are indisputable and can be ascertained from sources to which it is proper for the judge to refer. These may include texts, dictionaries, almanacs and other reference works, previous case reports, certificates from various officials and statements from various officials and statements from witnesses in the case (p. 1058).
The cases, however, are in conflict as to the extent to which, if at all, facts of nature and scientific facts, which are capable of accurate demonstration from reliable sources, can be noticed (p. 1059).
Before taking judicial notice, a judge should give counsel an opportunity to lead evidence and/or make argument as to the appropriateness of judicial notice of the particular fact in question (p. 1067).
[9] All applications, including proceedings under the Regulations, are to proceed expeditiously and interlocutory motions, such as motions to strike, are inconsistent with the object of the rules governing applications: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 58 C.P.R. (3d) 209 (F.C.A.). It is for the judge hearing the application on its merits to determine the relevance, weight and admissibility of any material filed by the parties: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1995), 58 C.P.R. (3d) 245 (F.C.T.D.); Hoffmann-LaRoche Ltd. v. Canada (Minister of Health and Welfare) (1996), 70 C.P.R. (3d) 26 (F.C.T.D.); AB Hassle v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 489 (F.C.T.D.).
[10] In my view, Canadian Tire Corp. v. P.S. Part Source Inc. (2001), 11 C.P.R. (4th) 386 (F.C.A.) and AstraZeneca Canada Inc. v. Apotex Inc., Court File No. T-2311-01, Endorsement dated July 13, 2003 (F.C.T.D.) are not determinative, as suggested by Apotex, because they relate to circumstances where the court was concerned with material that was indisputably evidence. There was no issue in relation to the doctrine of judicial notice.
[11] The references included at Tabs 24 and 26 of AstraZeneca's "authorities" will, ultimately, be determined to be properly or improperly included in its Appendices. As I see it, the question that I must answer is who should make that determination - the prothonotary, the motions judge or the judge assigned to hear the matter on the merits? In my view, it would be presumptuous for me, as a motions judge, to make such a determination. My reading of the prothonotary's order leads me to conclude that he was of the same mind.
[12] The prothonotary's conclusion was not clearly wrong with respect to the references included at Tabs 24 and 26. Regarding paragraph 47 of AstraZeneca's Memorandum of Fact and Law, the impugned sentence is argument. While Apotex may properly request that the applications judge disregard it, it cannot succeed in having it struck at this stage of the proceeding.
[13] The motion is dismissed with costs. Apotex will have 7 days from the date of this order within which to serve and file its Memorandum of Fact and Law.
ORDER
THIS COURT ORDERS that the motion is dismissed with costs.
The respondent Apotex will have 7 days from the date of this order within which to serve and file its Memorandum of Fact and Law.
"Carolyn Layden-Stevenson"
J.F.C.
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-660-02
STYLE OF CAUSE: ASTRAZENECA CANADA INC.
Applicant
and
APOTEX INC., TAKEDA CHEMICAL INDUSTRIES, LTD. and THE MINISTER OF HEALTH
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: AUGUST 11, 2003
REASONS FOR ORDER
AND ORDER BY: LAYDEN-STEVENSON J.
DATED: AUGUST 25, 2003
APPEARANCES: Mr. Gunars Gaikus
For the Applicant
Mr. Andrew Brodkin
For the Respondents
SOLICITORS OF RECORD: Smart & Biggar
Barristers and Solicitors
Toronto, Ontario
For the Applicants
Goodmans LLP
Barristers and Solicitors
Toronto, Ontario
For the Respondents
FEDERAL COURT OF CANADA
Date: 20030825
Docket: T-660-02
BETWEEN:
ASTRAZENECA CANADA INC.
Applicant
and
APOTEX INC., TAKEDA CHEMICAL INDUSTRIES, LTD. and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
AND ORDER