Date: 20040608
Docket: T-371-03
Toronto, Ontario, June 8th, 2004
Present: The Honourable Mr. Justice von Finckenstein
BETWEEN:
FOURNIER PHARMA INC & LABORATOIRES FOURNIERS S.A.
(Applicants)
and
THE MINISTER OF HEALTH & CIPHER PHARMACEUTICALS LIMITED
(Respondents)
REASONS FOR ORDER AND ORDER
[1] This is an appeal from an Order of Prothonotary Lafrenière dated May 12th 2004. The facts that led to Prothonotary Lafrenière's decision, briefly set out, are as follows.
[2] The Respondent, Cipher Pharmaceutical ("Cipher"), served a Notice of Allegation
("NOA"), dated January 16th, 2003, on the applicant, Laboratoires Fournier S.A. ("Fournier"). In its NOA, Cipher alleged that the making, using or selling of its capsules did not infringe Canadian Patent 2,219,475, which is owned by Fournier. Cipher indicated that its process and formulation for the capsules was set out in US Patent No. 5,545,628.
[3] Fournier commenced this application under the NOC Regulations on March 5th, 2003, seeking a Prohibition Order blocking the Minister of Health from issuing a Notice of Compliance to Cipher for its capsules.
[4] On March 27th, 2003, Cipher provided Fournier with a copy of its batch records indicating the formulation and manufacturing process for its Cipher capsules and a copy of its proposed product monograph (the "Cipher documents"). The Cipher documents formed part of Cipher's Abbreviated New Drug Submission ("ANDS") which was filed with the Minister of Health in support of an NOC for its Cipher capsules. No request was made at this time by Fournier for other portions of Cipher's ANDS nor for samples of the Cipher capsules.
[5] On May 12th, 2003, Fournier served and filed its evidence on the merits of its application for a Prohibition Order, namely the affidavits of Dr. H. Goldberg and Graham Jobson.
[6] On June 26th, 2003, Cipher served and filed its evidence on the merits resisting Fournier's application for a Prohibition Order, namely the affidavits of Dr. I. W. French and Dr. Rhodes.
[7] On August 19th, 2003 the Court granted Fournier an opportunity to file a narrow reply affidavit of Dr. Goldberg, which was filed on August 27th, 2003.
[8] Counsel for Fournier conducted cross-examinations on the corporate representative of Cipher, Dr. French, on November 13th, 2003. Fournier did not request samples of Cipher capsules from Dr. French.
[9] Counsel for Fournier conducted cross-examinations on Cipher's expert affiant, Dr. Rhodes, on November 25th and 26th, 2003. During the cross-examination, it emerged that Dr. Rhodes had, in connection with proceedings in the US, obtained two Cipher capsules and conducted organoleptic tests (tests by means of every human sense including smell) of those two tablets.
[10] Counsel for Fournier requested that Dr. Rhodes produce the samples of Cipher capsules in his possession. Counsel for Cipher, Shonagh McVean, took the request under advisement.
[11] By correspondence dated January 8th, 2004, Ms. McVean declined Fournier's request for samples. The reasons for the refusal were:
- these samples were obtained in respect of US proceedings, long after Dr. Rhodes had given his affidavit in these proceedings;
- Cipher does not rely on Dr. Rhodes' examination for these proceedings;
- no test other than visual inspection had been performed on these capsules;
- Fournier did not ask for samples in its NOA, nor had Fournier brought a motion under s. 6(7) of the NOC Regulations for production of the samples.
[12] There has been no prior request for Cipher capsules by Fournier nor has Fournier ever brought a motion for production of Cipher's NDS in Order to ascertain if samples were provided to the Minister.
[13] Fournier brought a motion for production of the samples referred to by Dr. Goldberg on March 31st, 2004 before Prothonotary Lafrenière.
[14] In its motion Fournier asked for an Order:
Requiring the Cipher's expert Rhodes to re-attend cross-examination on his affidavit sworn on June 26, 2003 and to produce samples of the proposed fenofibrate product manufactured by the Cipher;
Permitting the Fournier to conduct testing on the samples requested to be produced; and, in the alternative;
Permitting Fournier to deliver additional evidence of testing results of a different fenofibrate product under Rule 312 of the Federal Court Rules, 1998 (the "Rules");
In the alternative, an Order extending the time for filing Fournier's record until June 11, 2004.
[15] In his Order of May 12th, 2004, Prothonotary Lafrenière denied the motion, basically on the basis of two reasons: I) relevancy - Cipher was not relying on the examination of these samples by Dr. Rhodes, and ii) inexcusable delay by Fournier in asking for these samples; referring to his reasons in file T-1878-02 and T-766-03.
Analysis
[16] The standard for review on appeals from the orders of Protonotaries is well established. In Merck & Co. v. Apotex Inc. (2003), 315 N.R. 175, reformulating the test in Canada v. Aqua-Gem Investments Ltd. (1993), 149 N.R. 273, Décary J.A. stated at para.19:
Discretionary orders of Protonotaries ought not to be disturbed on appeal to a judge unless:
a) the questions in the motion are vital to the final issue of the case, or
b) the orders 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 facts.
[17] In the present case, I fail to see how the production of the samples in issue is relevant to Fournier's case. The samples in issue relate to another proceeding in the US and not to the proceedings before this court. No reference to samples was made in either Fournier's or Cipher's pleadings. No samples, including the samples in issue, were referred to in Dr. Rhodes' affidavit. Dr. Rhodes did not examine the samples for the purpose of these proceedings. The examination of the samples consisted of an organoleptic test, which is defined as a test by means of every human sense including smell, ie. the samples were not tested for their chemical composition or characteristics. And lastly, Cipher is not relying on Dr. Rhodes' examinations of the samples for these proceedings.
[18] Not being relevant, these samples, logically, can also not be vital to the proceedings. Vital questions were defined by MacGuigan J. in Canada v. Aqua-Gem Investments Ltd., supra. at para. 97 as "questions vital to the final issue of the case, i.e. to its final resolution." The samples at issue in this case do not meet this definition.
[19] Counsel for Fournier relied on my earlier decision in A.B. Hassle v. Apotex, [2004] F.C. 762. That decision can readily be distinguished from this case for the following reasons:
- The previous decision of Kelen J. in [2002] FCT 931 had made it clear that testing of samples would provide the best and probably conclusive evidence
- From the outset of the new proceedings, it was clear that testing evidence would be pivotal to the proceedings
- AstraZeneca from the beginning had sought samples
- The affidavit of Apotex's lead scientist referred to the testing of samples
- There was an inexcusable delay of over 8 months before Apotex produced the samples, so as to allow testing by AstraZeneca.
[20] On the basis of those facts, I found that Prothonotary Lafrenière had erred in not taking into account the interest of the court and in failing to ensure that the best and probably the most conclusive evidence available was brought before the court, rather than being excluded due to the delaying tactics of the litigants. None of these factors are present in this case. The samples are simply not relevant to the proceedings and Prothonotary Lafrenière was correct in dismissing the motion on that basis.
[21] Given that the samples were not relevant to the proceedings, i.e. not vital, there is no need for me to address the issue of undue delay which was raised by Fournier. I hasten to add, however, that (without ruling on the merits of the point) I saw nothing in the pleadings or submissions that would lead me to doubt the correctness of Prothonotary Lafrenière's decision on that point.
[22] Accordingly, the appeal will not be allowed.
THIS COURT ORDERS that
1. The appeal from the Order of Prothonotary Lafrenière dated May 12th, 2004 is hereby dismissed.
2. The Respondent shall have their costs in this motion.
"K. von Finckenstein"
J.F.C.
FEDERAL COURT
Names of Counsel and Solicitors of Record
DOCKET: T-371-03
STYLE OF CAUSE: FOURNIER PHARMA INC & LABORATOIRES FOURNIERS
S.A.
(Applicants)
and
THE MINISTER OF HEALTH & CIPHER PHARMACEUTICALS LIMITED
(Respondents)
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: JUNE 7, 2004
REASONS FOR ORDER
AND ORDER BY: von FINCKENSTEIN J.
APPEARANCES BY:
Mr. David M. Reive
Mr. Denis Sloan
FOR THE APPLICANT
Ms. Shonagh Mcvean
Mr. Joseph Briante
FOR THE RESPONDENT
SOLICITORS OF RECORD:
Dimock Stratton Clarizio LLP
Toronto, Ontario
FOR THE APPLICANT
Gilbert's LLP
Toronto, Ontario
FOR THE RESPONDENT
FEDERAL COURT
Date: 20040608
Docket: T-371-03
BETWEEN:
FOURNIER PHARMA INC & LABORATOIRES FOURNIERS S.A.
(Applicants)
and
THE MINISTER OF HEALTH & CIPHER PHARMACEUTICALS LIMITED
(Respondents)
REASONS FOR ORDER AND ORDER