Date: 20031222
Docket: A-400-03
Citation: 2003 FCA 487
CORAM: ROTHSTEIN J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
- and -
ASTRAZENECA CANADA INC.
Respondent
(Applicant)
- and-
TAKEDA CHEMICAL INDUSTRIES LTD.
and THE MINISTER OF HEALTH
Respondents
(Respondents)
Heard at Ottawa, Ontario, on December 10, 2003.
Judgment delivered at Ottawa, Ontario, on December 22, 2003.
REASONS FOR JUDGMENT BY: MALONE, J.A.
CONCURRED IN BY: ROTHSTEIN, J.A.
SHARLOW, J.A.
Date: 20031222
Docket: A-400-03
Citation: 2003 FCA 487
CORAM: ROTHSTEIN J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
- and -
ASTRAZENECA CANADA INC.
Respondent
(Applicant)
- and-
TAKEDA CHEMICAL INDUSTRIES LTD.
and THE MINISTER OF HEALTH
Respondents
(Respondents)
REASONS FOR JUDGMENT
[1] This is an appeal by Apotex from an interlocutory order of the Federal Court dated August 25, 2003, made in an application by Astrazeneca under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-122. In the application, Astrazeneca is seeking to prohibit the Minister of Health from issuing a notice of compliance to Apotex for Apo-Omeprazole tablets until the expiry of Canadian Patent 1,338,377 ('377 Patent). The hearing of the application is scheduled for February 17-18, 2004.
[2] The order dismissed an appeal from a Prothonotary, who in turn had dismissed the motion of Apotex to strike the following statement from paragraph 47 of Astrazeneca's memorandum of fact and law:
|
More particularly, Apotex' tablets contain sodium carboxymethylcellulose and sodium croscarmellulose which are sodium salts. |
and also to strike from the book of authorities submitted by Astrazeneca excerpts from two reference works cited in support of that statement. The Judge's reasons are reported as Astrazeneca Canada Inc. v. Apotex Inc., [2003] F.C.J. 1254.
[3] There is no debate about the standard of review to be applied by this Court, and no suggestion that the Judge below erred in the standard of review she applied to the decision of the Prothonotary. The issue on appeal is whether the Judge and the Prothonotary both misconstrued the question they were called upon to determine. Both of them approached the issue as relating solely to the admissibility of evidence, which led them to defer the motion to strike to the Judge who will hear the application for prohibition.
[4] The application was commenced as a result of a notice of allegation that Apotex sent to Astrazeneca which states, among other things, that its proposed product will not infringe the '377 Patent. The '377 Patent refers to certain compositions, including a basic inorganic salt. One of the grounds of the application for prohibition is the assertion by Astrazeneca that there would be infringement because the tablets to be produced by Apotex would contain a sodium salt.
[5] In its response to the application of Astrazeneca, Apotex filed the affidavit of Dr. Bernard Sherman. He was cross-examined. The cross-examinations apparently have left a debate as to whether or not Dr. Sherman admitted that the Apotex tablets would contain a sodium salt. That issue will be for the Judge who hears the application.
[6] On May 26, 2002, Astrazeneca's Application Record was filed, with a memorandum of law that included paragraph 47, quoted above. That paragraph has three supporting citations. The first is Apotex's formulation documents which list the ingredients. The second and third are pages 308 and 454 from The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, 13th ed. and page 160 from The Handbook of Pharmaceutical Excipients, 3rd ed. Copies of those pages are included in Astrazeneca's book of authorities.
[7] None of the affidavits submitted by Astrazeneca made the statement that appears in paragraph 47, or referred to the two excerpts (which I refer to as the "Reference Materials").
[8] Apotex brought a motion to strike paragraph 47 and the Reference Materials on the basis that there was no evidence to support the statement. Apotex also argued that the Reference Materials had not been properly admitted as evidence and therefore could not support the statement, and that Astrazeneca was improperly attempting to enter evidence under the guise of authorities.
[9] The Reference Materials are not "authorities" in the classic sense. Generally, "authorities" are statutes, jurisprudence and other legal writings that set out or explain laws or legal principles. In oral argument, counsel for Astrazeneca acknowledged that the purpose for introducing the Reference Materials at this late date was to "shore up" or "nail down" what Astrazeneca asserts is a factual admission made by Dr. Sherman during cross-examination that the tablets will contain a sodium, potassium or aluminum salt. This can only mean that its real value is as evidence to prove a key fact relating to a controversial issue between the parties.
[10] Normally, a reference work would be attached as an exhibit to an affidavit given by a deponent who attests to his scientific credentials, asserts the relevance and authenticity of the work and confirms its accuracy based on his expert opinion; all subject to cross-examination in the normal way. It is then for the trier of fact to decide the relevance, admissibility and weight of the work. In this case, however, the procedure adopted by Astrazeneca will result in the trier of fact being presented with evidence that is unsupported by any affidavit or oral testimony and that is untested by cross-examination.
[11] The Judge below accepted the argument of counsel for Astrazeneca that the Reference Materials are a permitted source of information with respect to a fact of which a Court may properly take judicial notice. Judicial notice can be taken of facts unproven by any party but that are so notorious as to be beyond reasonable dispute, or that are capable of immediate and accurate demonstration by reference to readily accessible sources of indisputable accuracy, such as texts, dictionaries, almanacs and other reference works (see Sopinka and Lederman, The Law of Evidence in Canada, 2 ed. (Toronto: Butterworths, 1999) at page 1058). However, in the case of a disputed fact, especially one that is of critical importance to a case, such references must be used with care.
[12] In my view, the principles to be applied in this case are the same as those that were applied in Canadian Tire Corp v. P.S. Part Source Inc.(2001), 11 C.P.R. (4th) 386 (F.C.A.). That case involved trade-mark expungement proceedings, which are determined on affidavit evidence. One party sought to strike evidence that was hearsay. This Court acknowledged that an interlocutory motion to strike evidence usually will fail because the matter is best left to the trier of fact. However, an exception may be made, and was made in that case, because it was demonstrated that the evidence was hearsay that went to a controversial issue, and that the other party would be prejudiced by leaving the matter for disposition by the trier of fact.
[13] In this case, the prejudice to Apotex is obvious. If the determination of the admissibility of this evidence is deferred to the Judge hearing the application for prohibition, Apotex will attend the hearing not knowing whether the evidence will be included in the record and not being able to respond to or cross-examine upon this evidence. If the motion to strike is not allowed, the result is tantamount to permitting a party to adduce evidence to impugn the credibility or reliability of a witness without confronting the witness with that evidence or giving the witness an opportunity to explain: see Browne v. Dunn (1893), 6 R. 67 (H.L.) .
[14] I see no relevant distinction between this case and Pfizer Co. Ltd. v. Deputy Minister of National Revenue for Customs and Excise, [1977] 1 S.C.R. 456 (which was not brought to the attention of the Judge or the Prothonotary in this case). There, two reference works were referred to and relied on by the Tariff Board in a decision. These works were not put in evidence or referred to at the hearing. Writing for a unanimous panel, Pigeon J. stated at page 15 as follows (my emphasis):
|
In my view, the objection is well-founded. While the Board is authorized by statute to obtain information otherwise than under the sanction of an oath or affirmation... this does not authorize it to depart from the rules of natural justice. It is clearly contrary to those rules to rely on information obtained after the hearing was complete without disclosing it to the parties and giving them an opportunity to meet it. |
[15] I conclude that the orders of the Prothonotary and the Judge were based on a misapprehension of the facts which led to an error of law. In my analysis, the Reference Materials are evidence and there is no basis to conclude otherwise. With respect to the doctrine of judicial notice, there is no basis to support the conclusion that this Court can take judicial notice of these materials in the circumstances of this case.
[16] I hasten to add that there may well be instances where scientific reference materials may properly be the subject of the doctrine of judicial notice. However, the factual underpinnings surrounding this appeal do not support that conclusion here.
[17] The appeal should be allowed, and the orders of the Motions Judge dated August 25th, 2003 and the Prothonotary dated July 8th, 2003 should be set aside. An order should issue striking the Reference Materials from Astrazeneca's Book of Authorities and the impugned sentence from its factum. Apotex should have its costs throughout.
"B. Malone"
J.A.
"I agree
Marshall Rothstein
J.A."
"I agree
Karen Sharlow
J.A."
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-400-03
APPEAL FROM A JUDGMENT OR AN ORDER OF THE FEDERAL COURT OF CANADA DATED AUGUST 25, 2003, FEDERAL COURT OF CANADA FILE NO.
T-660-02
STYLE OF CAUSE: APOTEX INC. v. ASTRAZENECA CANADA INC. ET AL.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: December 10, 2003
REASONS FOR JUDGMENT BY: Malone J.A.
CONCURRED IN BY: Rothstein J.A.
Sharlow J.A.
DATED: December 22, 2003
APPEARANCES:
Mr. Andrew R. Brodkin for the Appellant
Ms. Julie Perrin
Mr. Gunars A. Gaikis for the Respondent, Astrazeneca
Canada Inc.
SOLICITORS OF RECORD:
Goodmans LLP for the Appellant
Toronto, Ontario
Smart & Biggar for the Respondent, Astrazeneca
Toronto, Ontario Canada Inc.