Date: 19980528
Docket: T-1713-95
BETWEEN:
PFIZER CANADA INC. and
PFIZER CORPORATION
Applicants
- and -
NU-PHARM INC. and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondents
REASONS FOR ORDER
RICHARD J.:
[1] By notice of motion dated May 14, 1998, the applicants (the moving parties) seek an order for:
| 1. Leave to file the Affidavit of Barbara Gallagher dated May 14, 1998; |
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| 2. In the alternative, an Order pursuant to Rule 317 of the Federal Court Rules requiring the Minister to file a certified copy of the chemistry and manufacturing portion of Nu-Pharm"s New Drug Submission and in particular sections 2.1.1; 2.1.2 and 2.1.3 which set out the source and synthetic process for the manufacture of the bulk fluconazole in Nu-Pharm"s New Drug Submission; |
| 3. Directions relating to the filing of a supplementary application record with respect to the additional material. |
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[2] The grounds for this motion are:
| 1. An issue in this proceeding is whether Nu-Pharm"s New Drug Submission ("NDS") contains the process which is the subject matter of the Notice of Allegation. |
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| 2. At the time of preparing the Applicants" application record, the Applicants included as item 15 in the Application Record a certified copy of Nu-Pharm"s NDS which had been made available in other court proceedings (T-1352-93). The contents of this document indicated that the only synthetic process before the Minister was the "acetate process" and not the process which was the subject matter of the present Notice of Allegation. |
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| 3. At the time of the inclusion in the Applicants" Record, Nu-Pharm"s NDS was publicly available. |
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| 4. By Reason of the Order of Giles A.S.P. as upheld by McGillis J. it now appears that the registry improperly made these documents available to the public. |
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| 5. Pfizer relied upon the public availability of this document and, therefore, did not bring a motion to compel production under Rule 317 (then Rule 1612) of the Federal Court Rules from the Minister of Health ("Minister"). |
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| 6. Furthermore, by an affidavit that was just recently made available, the Minister has admitted that the only process in Nu-Pharm"s NDS is the acetate process, namely, the process which is already subject to an order of prohibition of Mr. Justice Richard. |
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| 7. The proposed evidence that is being sought leave to be introduced is highly relevant to the issue of what process is indeed before the Minister and whether this proceeding is moot. |
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| 8. The recent admissions by the Minister as to the contents of the NDS were not previously available to Pfizer as the Minister never filed an affidavit in this proceeding and, furthermore, Nu-Pharm never provided a witness who had knowledge as to the contents of its NDS. |
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| 9. The Applicants rely on Rules 312, 313 and 317 of the Federal Court Rules. |
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[3] The respondent Minister takes no position with respect to whether leave to file an additional affidavit should be granted. However, the Minister submits that no order should be made pursuant to Rule 317 and that part of the motion should be dismissed.
[4] The respondent, Nu-Pharm Inc., opposes the motion, but requests an opportunity to file a supplementary record containing responding material if any of the relief is granted.
[5] The applicants" amended originating notice of motion for the purpose of obtaining an order in accordance with subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulation was filed in this court on August 1, 1996.
[6] The hearing of the application for prohibition is set down for three days during the week of June 22, 1998.
[7] That part of the motion which seeks an order pursuant to Rule 317 is dismissed. As was stated by the Federal Court of Appeal in Eli Lilly and Co. v. Nu-Pharm Inc., (1996) 69 C.P.R. (3d) 1 at page 20, the required information was not accessible through the predecessor to this rule (Rules 1612 and 1613) as it refers to material before a federal board and not the Minister"s file, when no decision of the Minister is the subject of judicial review. I further note that subsection 6(7) of the amended Regulation (SOR/98-166) does not apply to this proceeding.
[8] The purpose of seeking to introduce the affidavit of Barbara Gallagher dated May 14, 1998, is to introduce into the record an affidavit of another person in another court proceeding. That affidavit is marked as Exhibit "F" to Barbara Gallagher"s affidavit and was sworn by Jayne Baik on May 8, 1998.
[9] Jayne Baik is a Technical Information Officer in the Submission and Information Policy Division, Therapeutic Products Directorate, Health Protection Branch, Department of Health.
[10] The affidavit of Jayne Baik was filed by the Minister in Court File No. T-429-98 where Apotex Inc. has commenced a judicial review proceeding in the nature of mandamus to compel the Minister to issue a notice of compliance for fluconazole, the same drug as in these proceedings.
[11] The affidavit refers to the Nu-Pharm New Drug Submission by reason of it being cross-referenced by Apotex Inc. in its application for a notice of compliance for fluconazole.
[12] The question addressed in the affidavit is whether Nu-Pharm complied with the Food and Drug Regulations or Health Canada"s "Changes to Marketed New Drugs" policy when it purported on June 27, 1996, to submit an alternative manufacturing process to the acetate process, that was subsequently identified as the olefin process. It concludes that the New Drug Submission has not been amended to include the olefin process referred to in the letter, at this time.
[13] The notice of allegation in this proceeding relies on the olefin process. The acetate process but not the olefin process is currently subject to a prohibition order.
[14] The moving parties claim that the proposed evidence they seek to introduce, the affidavit of Jayne Baik, is highly relevant to the issue of what process is indeed before the Minister and whether the prohibition proceeding is moot.
[15] The recent admissions by the Minister as to the contents of the NDS were not previously available to Pfizer as the Minister never filed an affidavit in this proceeding and Nu-Pharm never provided a witness who had knowledge as to the contents of its NDS.
[16] The respondent, Nu-Pharm, submits that it will have no opportunity to cross-examine Jayne Baik and that the moving parties have not explained the full delay in bringing this motion and have failed to establish the relevance of the evidence sought to be introduced.
[17] There was no suggestion that Jayne Baik was not trustworthy but rather that her evidence had to be understood in its context.
[18] The lack of the opportunity to cross-examine Jayne Baik is a factor that the motions judge can consider in deciding what weight to give to her evidence. Also, I am giving the respondent, Nu-Pharm Inc., the opportunity to file and serve responding material1.
[19] I find, in the circumstances, that the moving parties have given an acceptable explanation for the delay in seeking to introduce this evidence.
[20] Having regard to the arguments of both counsel concerning the relevance of the new evidence, I conclude that it is in the interest of justice, and would not cause serious prejudice, to grant the moving parties leave to file the first affidavit of Barbara Gallagher with Exhibit "F", being the affidavit of Jayne Baik, only attached to it.
[21] The applicants" supplementary record with the additional material is to be filed and served no later than May 31, 1998.
[22] The respondent, Nu-Pharm Inc., may file and serve a supplementary record containing responding material on or before June 8, 1998.
__________________________
Judge
Ottawa, Ontario
May 28, 1998
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1 I drew counsel"s attention to Rule 316 of the Federal Court Rules, 1998, which provides that, on motion, the Court may, in special circumstances, authorize a witness to testify in court in relation to an issue of fact raised in an application. Although no subpoena may be issued without leave of the Court to compel the attendance of a witness at a hearing other than a trial or a reference under Rule 153, such leave may be granted on an ex parte motion under Rule 41(5). Counsel did not pursue this avenue.
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