Astrazeneca AB v. Apotex Inc., 2004 FC 71

Date: 20040116

Docket: T-2311-01

Citation: 2004 FC 71

Ottawa, Ontario, this 16th day of January, 2004

PRESENT:      THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE          

BETWEEN:

                                                             ASTRAZENECA AB and

ASTRAZENECA CANADA INC.

                                                                                                                                                      Applicants

                                                                              - and -

                                                                 APOTEX INC. and

THE MINISTER OF HEALTH

                                                                                                                                               Respondents

                                               REASONS FOR ORDER AND ORDER

O'KEEFE J.

[1]                 By motion, the applicants seek to set aside the order of Prothonotary Aronovitch dated August 5, 2003 which granted the respondent, Apotex, leave to file the affidavit of Dr. Bernard Sherman affirmed July 23, 2003. Appended as an exhibit to the Sherman affidavit was a revised product monograph filed with the Minister of Health in respect of Apotex' Apo-Omeprazole capsules.

Background

[2]                 The underlying proceeding was commenced by the applicants by notice of application dated December 31, 2001 in response to a Notice of Allegation ("NOA") dated November 16, 2001 served by the respondent, Apotex.

[3]                 The applicants, in the underlying proceeding, seek an order prohibiting the Minister from issuing a Notice of Compliance ("NOC") to Apotex in respect of Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration until the expiration of Canadian Patent No. 2,133,762 (the "'762 Patent").

[4]                 The '762 Patent relates to the use of omeprazole concomitantly with an antibiotic, and in particular, claims the use of omeprazole for increasing the bioavailability of antibacterial compounds including clarithromycin.

[5]                 Apotex' NOA asserts non-infringement of the '762 Patent on the following legal and factual basis:

The remaining claims relate only to use for increasing the bioavailability of an antibacterial compound.

Our product will not infringe because we are not seeking approval for such use and no such use will be included in our product monograph.

[6]                 The applicants filed their evidence on the merits on February 6, 2002.

[7]                 On March 8, 2002, Apotex served an affidavit of Dr. Sherman along with a notice of motion to dismiss the proceedings pursuant to subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133. Attached to Dr. Sherman's affidavit was excerpts of the original product monograph for Apo-Omeprazole. The March 8, 2002 Sherman affidavit was also put forward on the merits of the application by Apotex.

[8]                 Dr. Sherman stated at paragraphs 10 and 24 of his affidavit of March 8, 2002:

Prior to November 16, 2001, Apotex filed an Abbreviated New Drug Submission with the Minister for Apo-Omeprazole capsules containing omeprazole in 20mg strength for oral administration. As part of its submission, Apotex filed a draft Product Monograph which sets out, among other things, the uses to which Apo-Omeprazole may be put, as authorized by the Minister. The relevant portions of Apotex' Product Monograph are attached as Exhibit "B". The reason I have not included the entire Product Monograph herein is that it includes confidential Apotex data regarding Apo-Omeprazole which data is not relevant to this proceeding.

[. . .]

Claims 68 to 77 of the '762 Patent relate only to use for increasing the bioavailablity of an antibacterial compound. Apotex' Apo-Omeprzaole capsules will not infringe these claims as Apotex has not sought an approval for such and no such use will be included in its Product Monograph.

[9]                 The parties' witnesses were cross-examined during March and April 2002.

[10]            During cross-examination, Dr. Sherman stated that Apotex would not produce anything for pharmacists so long as the '762 Patent is in force, that mentioned the concomitant administration of antibiotics and Apo-Omeprazole.

[11]            By letter dated April 16, 2002, Apotex produced a more complete product monograph which contained the following reference to the concomitant administration of omeprazole and clarithromycin:

There is an increase in bioavailability (AUC) and half-life of omeprazole, and bioavailability (AUC) and C_max of clarithromycin during concomitant administration in healthy volunteers.

[12]            Apotex' motion to dismiss the proceedings was dismissed on July 17, 2002. The Prothonotary, in her decision, stated in part:

. . . Apotex makes the point that the evidence that will ultimately be placed before the Judge hearing the merits of the underlying application is already produced in the context of the present motion. That does not help Apotex, as there can be no determination of disputed facts in the context of a motion for summary dismissal.

[13]            The applicants' application record including its memorandum of fact and law was filed on August 13, 2002.

[14]            Apotex filed a motion on August 22, 2002 seeking leave to file the affidavit of Kenneth Brown, sworn August 19, 2002. The notice of motion stated at paragraphs 18 and 21:

In their voluminous Written Representations, the Applicants specifically made reference to the above noted portions of the Product Monograph and argued, therefore, that Apotex' Notice of Allegation and Dr. Sherman's evidence were contradicted by the Product Monograph itself. The Applicants advanced this position notwithstanding the clear fact that any references in the Product Monograph to "concomitant administration" or "increase in bioavailablity" were statements of scientific fact and were clearly directed to omeprazole generally and not to Apotex' Apo-Omeprazole capsules.

[. . .]

In response to the Applicants' submissions, Apotex' counsel explained that the particular references noted above pertain not to Apo-Omeprazole, but rather, to omeprazole generally, and further asserted that the noted references were required, in effect, as warnings to prospective readers of the Product Monograph so as to enable them to fully understand the pharmacology and pharmacokinetics of omeprazole.

[15]            Apotex was granted leave to file the Brown affidavit on November 13, 2002. The Brown affidavit basically stated that the reference in the Apotex product monograph for Apo-Omeprazole to increased bioavailability and concomitant administration are scientific statements required to be there by Health Canada and should, therefore, not be attributed to Apotex' brand.

[16]            The applicants sought to file the reply affidavit of Dr. Karen Burke, sworn December 11, 2002, in response to the Brown affidavit. Apotex opposed the applicants' motion. By order dated February 14, 2003, Prothonotary Aronovitch granted the applicants leave to file the Burke affidavit.

[17]            Mr. Justice O'Reilly dismissed the appeal of the order granting leave to file the Brown affidavit, a ruling that was upheld by the Court of Appeal on May 21, 2003.

[18]            By letter dated May 9, 2003, Apotex advised the applicants as follows:

The capsule product monograph previously produced to you has now been updated. Accordingly, we are enclosing herewith the most current version of Apotex capsule product monograph as submitted to the Minister by Apotex.

[19]            On June 16, 2003, Apotex filed and served its responding application record which contained the May 9, 2003 letter and the revised version of Apotex' product monograph for Apo-Omeprazole. The revised product monograph did not include the wording objected to by the applicants, i.e. the reference to increased bioavailability and concomitant use.

[20]            The applicants made a motion to strike the letter and the revised product monograph from Apotex' responding record. This motion was allowed on July 18, 2003.

[21]            On July 25, 2003, Apotex made a motion for leave to file as further evidence, an affidavit of Dr. Sherman, affirmed July 23, 2003, which appended Apotex' revised product monograph.

[22]            By order dated August 5, 2003, the Prothonotary granted Apotex leave to file the Sherman affidavit, affirmed July 23, 2003.

[23]            This is the appeal of that order.

Issue

[24]            Should the appeal of the Prothonotary's order be allowed?

Applicants' Arguments

[25]            The applicants submit that the Prothonotary erred in fact and law by granting leave to Apotex to file the Sherman affidavit which included a revised product monograph.

[26]            The applicants submit that the Prothonotary failed to make a determination of the relevance of the Sherman affidavit to Apotex' original litigation position and therefore proceeded on a wrong principle.

[27]            The applicants submit that the Prothontoary erred in law by applying the wrong test governing leave to file further evidence.

[28]            The applicants submit that Dr. Sherman's affidavit includes arguments on the merits which are not facts and thus, cannot be admitted as new evidence.

[29]            The applicants submit that although the revised product monograph may qualify as a fact, it is not referred to in the NOA as part of the detailed factual basis for the allegation of non-infringement. Apotex produced and defended the original product monograph which it said was the subject of its allegation of non-infringement. The applicants state that Apotex is limited to its original position including the legal and factual basis detailed in its NOA.

[30]            The applicants submit that the Prothonotary erred by failing to recognize that Apotex is estopped from relying on the revised product monograph as Apotex had previously represented to the Court that the reference to increased biovavailablity and concomitant use were required to be in the original product monograph. The applicants argue that Apotex cannot now be permitted to adopt a contrary position.

Apotex' Arguments

[31]            Apotex submits that the standard of review to be applied to the appeal of the Prothonotary's decision is that as outlined in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 at 454 (C.A.). Apotex also submits that case management prothonotaries, , must be given latitude to manage cases and that their exercise of discretion should only be interfered with "in the clearest case of a misuse of judicial discretion" (see Microfibres Inc. v. Annabel Canada Inc. (2001), 16 C.P.R. (4th) 12 at 15 - 17 (F.C.T.D.)).

[32]            Apotex submits that while the applicants boldly state that the Prothonotary was clearly wrong, they do not address the proper test, namely, whether the Prothonotary's exercise of discretion was judicial. Apotex states that the Prothonotary exercised her discretion not only judicially, but correctly.

[33]            Apotex submits that after the Prothonotary properly considered each element of the test for filing additional evidence, she correctly determined that the Sherman affidavit was relevant to the matters at issue, that it would provide assistance to the hearing judge and that filing it would serve the interests of justice. Apotex relies on Rules 3, 8, 312 and 84(2) of the Federal Court Rules, 1998, S.O.R./98-106 in support of its position.

[34]            Apotex submits that its NOA speaks to what its product monograph "will" mention and that the product monograph referred to in the NOA is the revised product monograph, i.e. the final product monograph that will be in effect when the product is approved.

[35]            Apotex argues that it is not taking a different position by submitting the revised product monograph. After stating the references to "increases in bioavailability" and "concomitant administration" were entirely irrelevant to the uses for which Apo-Omeprazole approval was sought and were scientific statements required to be included, Apotex deleted the references so as to remove any doubt regarding the product's claimed uses. Apotex submits there is nothing inconsistent in the stance it has taken during this proceeding and that the applicant's arguments regarding altered litigation strategy are without merit.

[36]            Apotex also submits that it is in the interests of justice that the proceeding be conducted on the basis of the most complete and up-to-date evidentiary record, which includes the revised product monograph now on file with the Minister.

Analysis and Decision

Standard of Review

[37]            The standard of review to be applied to a prothonotary's decision is stated in Aqua-Gem, supra. MacGuigan J.A. stated at pages 462 to 464:

I also agree with the Chief Justice in part as to the standard of review to be applied by a motions judge to a discretionary decision of a prothonotary. Following in particular Lord Wright in Evans v. Bartlam, [1937] A.C. 473 (H.L.) at page 484, and Lacourciere J.A. in Stoicevski v. Casement (1983), 43 O.R. (2d) 436 (Div. Ct.), discretionary orders of prothonotaries ought not to be disturbed on appeal to a judge unless:

(a)             they are clearly wrong, in the sense that the exercise of discretion by the prothonotary was based upon a wrong principle or upon a misapprehension of the facts, or

(b)            they raise questions vital to the final issue of the case.

Where such discretionary orders are clearly wrong in that the prothonotary has fallen into error of law (a concept in which I include a discretion based upon a wrong principle or upon a misapprehension of the facts), or where they raise questions vital to the final issue of the case, a judge ought to exercise his own discretion de novo.

In Canada v. "Jala Godavari" (The) (1991), 40 C.P.R. (3d) 127 (F.C.A.), this Court in an obiter dictum stated the rule the other way around, seeking to emphasize the necessity for the exercise of the Judge's discretion de novo, in contradistinction to the view that was at that time gaining acceptance in the Trial Division that the prothonotary's discretion should be followed unless he had committed error of law. Jala Godavari should not, I think, be read as meaning that the prothonotary's discretion should never be respected, but rather that it is subject to an overriding discretion by a judge where the question involved is vital to the final issue of the case. (Error of law is, of course, always a reason for intervention by a judge, and is not in any way in controversy).

Now, in the case at bar, what kind of interlocutory order was in question? The appellant urged this Court to follow Stoicevski, but was unable to explain in argument why the prothonotary's decision here was not on a question vital to the final issue of the case. The formulations both of Lord Wright and Lacourciere J.A. underline the contrast between "routine matters of pleading" (Lord Wright) and "a routine amendment to a pleading" (Lacourciere J.A.) [italics added] and questions vital to the final issue of the case, i.e., to its final resolution.

The question before the prothonotary in the case at bar can be considered interlocutory only because the prothonotary decided it in favour of the appellant. If he had decided it for the respondent, it would itself have been a final decision of the case: A-G of Canada v. S.F. Enterprises Inc. et al. (1990), 90 DTC 6195 (F.C.A.) at pages 6197-6198; Ainsworth v. Bickersteth et al., [1947] O.R. 525 (C.A.). It seems to me that a decision which can thus be either interlocutory or final depending on how it is decided, even if interlocutory because of the result, must nevertheless be considered vital to the final resolution of the case. Another way of putting the matter would be to say that for the test as to relevance to the final issue of the case, the issue to be decided should be looked to before the question is answered by the prothonotary, whereas that as to whether it is interlocutory or final (which is purely a pro forma matter) should be put after the prothonotary's decision. Any other approach, it seems to me, would reduce the more substantial question of "vital to the issue of the case" to the merely procedural issue of interlocutory or final, and preserve all interlocutory rulings from attack (except in relation to errors of law).

The issue decided by the Prothonotary in this case was whether to grant Apotex leave to file the affidavit of Dr. Sherman which appended a revised product monograph that differed from the original product monograph referenced in Apotex' NOA. Apotex had defended the original product monograph by obtaining an order for leave to file the affidavit evidence of Kenneth Brown and defending the applicants' appeals of that order to both the Federal Court Trial Division (as it was then called) and the Federal Court of Appeal. Since the Prothonotary's decision does not raise questions vital to the final issue of this case, I am of the view that I should exercise my discretion de novo only if the Prothonotary was clearly wrong, in the sense of being based upon a wrong principle or upon a misapprehension of the facts.

[38]            Rules 3, 8, 51(1), 84(1) and 312 of the Federal Court Rules, 1998 read as follows:

[39]            Lemieux J., of this Court, discussed the factors to be considered when applying Rule 84(2) in Salton Appliances (1985) Corp. v. Salton Inc. (2000), 4 C.P.R. (4th) 491 (F.C.T.D.), at page 497:

I am satisfied Rule 84(2), read in its context and against the history of the former Rules, is designed to deal with matters that arise during cross-examination for which there is a need to address by way of further affidavit with leave of the Court.

The cases decided by this Court and by the Ontario Courts recognize that relevancy of the proposed affidavit, absence of prejudice to the opposing party, assistance to the Court, and the overall interest of justice are relevant factors to be taken into account in deciding whether leave to file a further affidavit should be granted. (See Hiram Walker Consumers Home Ltd. v. Consumers Distributing Company et al., [1981] F.C.J. No. 813, court file T-4539-80; Gingras v. Canadian Security and Intelligence Service et al. (1987), 19 C.P.R. (3d) 283; Bayer AG et al. v. Canada (Minister of Health & Welfare) et al. (1994), 83 F.T.R. 318, Eli Lilly et al. v. Apotex Inc. et al. (1997), 144 F.T.R. 189.

As I view the law on the point in this Court there is the additional requirement as to the non-availability of the material in the proposed affidavit prior to cross-examination; a supplementary affidavit cannot be a substitute for putting available information to a deponent on cross-examination. A further affidavit is not designed to repair answers which cross-examining counsel wishes he did not get. Moreover, normally, parties are obliged to disclose all available information before cross-examination so as to avoid splitting the evidence.

This Court has held that the same factors discussed in Salton Appliances, supra, apply to the filing of additional affidavits pursuant to Rule 312 (see Marshall v. Canada (Solicitor General) (2002), 216 F.T.R. 85, 2002 FCT 168).

Is it in the Interests of Justice to Allow the Filing of the Supplementary Sherman Affidavit?

[40]            As can be seen from this history of the matter (outlined at paragraphs 1 to 22 of these reasons), Apotex was relying on the original product monograph until it sent the revised product monograph to the applicants by letter dated May 9, 2003. By that point in the proceeding, the parties had filed their affidavits, carried out cross-examinations and the applicants had filed both their application record and their memorandum of fact and law on the basis of the original product monograph. In fact, Apotex obtained leave to file the affidavit of Kenneth Brown which stated that the original product monograph's references to increased bioavailability and concomitant use were scientific information required to be included by Health Canada. At this late stage of the application, Apotex was still supporting its use of the original product monograph. It should also be noted that during the applicants' appeals of Apotex being granted leave to file the Brown affidavit, the original product monograph was the product monograph put before the Courts.

[41]            I cannot accept that it is in the interests of justice to allow a party to proceed this far into an application and then to change its litigation approach. Applications for prohibition under section 6 of the Regulations are meant to be dealt with in an expeditious manner (see A.B. Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.) at paragraph 27). It was only after the cross-examination of Mr. Brown on his affidavit and the cross-examination of Dr. Burke on her reply affidavit that Apotex decided to put forward the revised product monograph.

[42]            I am therefore of the view that the Prothonotary was clearly wrong in her decision, since Apotex has not met the requirements for leave being granted to file the supplementary affidavit of Dr. Sherman. It is not in the overall interests of justice that leave be granted to file this affidavit due to Apotex' approach of using the original product monograph and supporting it (as outlined in paragraph 41 of this decision) until just before the hearing date.

[43]            As Apotex has not met at least one of the requirements for obtaining leave to file the further affidavit, I need not discuss the other requirements for granting leave or the other arguments raised by the applicants on this appeal.

[44]            I am satisfied that the Prothonotary, by granting leave, exercised her discretion based upon a wrong principle thus causing her decision to be clearly wrong.

[45]            The motion of the applicants is allowed and the decision of the Prothonotary is set aside.

[46]            The applicants shall have their costs of the motion.

ORDER

[47]            IT IS ORDERED that:

1.          The motion of the applicants is allowed.

2.          The applicants shall have their costs of the motion.

                                                                                   "John A. O'Keefe"             

J.F.C.                    

Ottawa, Ontario

January 16, 2004

                                       FEDERAL COURT

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                   T-2311-01

STYLE OF CAUSE: ASTRAZENECA AB and

ASTRAZENECA CANADA INC.

Applicants

and

APOTEX INC. and

THE MINISTER OF HEALTH

Respondents

PLACE OF HEARING:                                   Toronto, Ontario

DATE OF HEARING:                                     November 3 to 5, 2003

REASONS FOR ORDER AND ORDER: O'Keefe J.

DATED:                      January 16, 2004

APPEARANCES:

                                     Gunars Gaikis

Yoon Kang

For the Applicants

H. B. Radomski

Andrew Brodkin

Ildiko Mehes

For the Respondent,

Apotex Inc.

Rick Woyiwada

For the Respondent,

Minister of Health

SOLICITORS OF RECORD:

                                     SMART & BIGGAR

Toronto, Ontario

For the Applicants

GOODMANS LLP

Toronto, Ontario

For the Respondent,

Apotex Inc.

Morris Rosenberg

Deputy Attorney General of Canada

For the Respondent,

Minister of Health