Date: 20050125
Docket: T-388-04
Ottawa, Ontario, this 25th day of January, 2005
Present: THE HONOURABLE MR. JUSTICE von FINCKENSTEIN
BETWEEN:
APOTEX INC.
Applicant
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR ORDER AND ORDER
[1] This is an appeal from a decision of Prothonotary Tabib dated September 15, 2004, denying an application by AstraZeneca Canada Inc. ("AstraZeneca") to be allowed access to certain documents that are subject to a confidentiality order of this Court.
[2] In the underlying proceeding, commenced on February 23, 2004, Apotex Inc ("Apotex") seeks an order requiring the Minister of Health (the "Minister") to state a Canadian Reference Product ("CRP") on the Notice of Compliance ("NOC") that was issued for Apo-Omeprazole. The dispute between Apotex and the Minister relates to the proper evaluation and interpretation of the testing data submitted by Apotex to the Minister, pursuant to the Food and Drug Act Regulations ("FDA Regulations"). Apotex did not name AstraZeneca as a party to the underlying proceeding. On the consent of the parties, a protective order was issued on April 21, 2004.
[3] AstraZeneca, which is not a party to this proceeding either, suspects that the CRP is its drug Losec. It sought an order from this Court on June 7, 2004, seeking to access and copy all of the documents and confidential information that have been filed under the protective order by Apotex and the Crown respondents. The documents and information relate to Apotex's regulatory submission to the Minister for approval of Apo-Omeprazole capsules 20mg. On September 15, 2004, Prothonotary Tabib dismissed AstraZeneca's motion to vary the protective order.
Decision of the Prothonotary
[4] Prothonotary Tabib noted that Reed J. stated in Apotex Inc. v. Attorney General of Canada et al. (1986), 10 C.P.R. (3d) 310, at page 312, that "something more than an argument based on the general principle of the public nature of court proceedings must be given as a reason for altering the original order - some changed circumstances, or compelling reason not directly considered when the order was given."
[5] Prothonotary Tabib reviewed the compelling reasons that were asserted by AstraZeneca. The first reason was that there was a compelling public interest in the proceeding that would justify the variation of the protective order. Prothonotary Tabib rejected this argument, noting that the allegations set out in the Notice of Application are expressly limited to the Minister's dealings with Apotex. She accordingly held that there is no issue raising a wider public interest, aside from the general interest in having open court proceedings. She relied on Apotex Inc, supra, in holding that this interest was not sufficiently compelling to justify varying the protective order.
[6] AstraZeneca's second argument was that the issues in the underlying proceeding could involve facts relevant to the term "marketed". Prothonotary Tabib noted that counsel for AstraZeneca had abandoned this argument at the hearing of the motion. Prothonotary Tabib also stated, in obiter, that even if the proceeding did raise an issue as to the meaning of "marketed", that would not be sufficient to justify AstraZeneca's intervention . The inclusion of that issue in the proceeding would create nothing more than a "jurisprudential" interest, which the Court has held is not sufficient to justify a motion for leave to intervene. (See Canadian Union of Public Employees (Airline Division) v. Canadian Airlines International Ltd., [2000] F.C.J. No. 220 (C.A.)(QL))
[7] Prothonotary Tabib then considered AstraZeneca's argument that its economic interests will be directly affected by the issues raised in the present proceeding. She acknowledged that there is likely to be a significant economic impact, but stated that "the fact that AstraZeneca's economic interests may be affected by the issuance of a Notice of Compliance referring to its brand name product does not give AstraZeneca any interest whatsoever in the process and procedure contemplated in the Food and Drug Regulations for identifying and designating that reference product or in any application concerned solely with the Food and Drug Regulations."
[8] Finally, Prothonotary Tabib considered AstraZeneca's argument that since it had been criticized in the past for seeking leave to intervene without being able to demonstrate an interest, and had not been able to do so due to the relevant facts being inaccessible by reason of confidentiality orders, it was only "fair, justifiable and minimally intrusive" to allow it to see the confidential material so that it could then determine whether there were any grounds to intervene. According to Prothonotary Tabib, this "convoluted" argument has no "logical or common sense basis". She further stated that "there is no unfairness, inherent or otherwise, in preventing a stranger to litigation to invade the confidential information protected by a duly issued confidentiality order without requiring that third party to establish a direct interest in the litigation".
AstraZeneca's objective
[9] AstraZeneca is now appealing the decision of Prothonotary Tabib. AstraZeneca's reasons for seeking the original motion to vary the protective order and proceeding with this appeal are clearly stated: 1) so that AstraZeneca can find out "what this case is all about"; 2) so that AstraZeneca can "possibly" seek an order allowing it to participate in the proceeding in some capacity; and 3) to participate in the proceeding if an order so providing is granted.
Standard of Review
[10] Both sides agree that the relevant law for appeals of a Prothonotary is laid down in Canada v. Aqua Gem Investments Ltd, [1993] 2 F.C. 425 as reformulated in Merck & Co. v. Apotex Inc., [2004] 2 F.C.R. 459, namely:
discretionary orders of prothonotaries ought not be disturbed unless
(a) the questions raised are vital to the final issue of the case, or
(b) the orders are clearly wrong as based upon wrong principle or misapprehension of facts.
Vitality
[11] AstraZeneca argues that it requires access to the confidential documents since this is the only way that it can fashion an application for party or intervener status. Otherwise, it will be gone from these proceedings. Thus, this issue is vital to the proceedings.
[12] In my view, AstraZeneca's position on this point cannot succeed. The facts of this case make it clear that AstraZeneca is a "stranger" to the present proceeding and its subject matter. It is not a party to the proceedings and it does not even know if the CRP in issue is Losec. The matter is purely a dispute between the Minister and Apotex regarding the terms of the NOC, i.e. an issue regarding health and safety, not patents. Furthermore, even if AstraZeneca were a proper party, variation of the terms of a protective order would not fundamentally affect the "prosecution, consideration or determination" of the issues in the proceeding. It would merely affect the access that is to be granted to AstraZeneca regarding the materials placed before the Court.
[13] In support of its position, AstraZeneca quotes Socan v Landmark Cinemas (2004), 30 C.P.R. (4th) 257, at paras. 13-14, where the Court states:
At para. 22 of her decision, the judge concluded that "The matter of joinder of parties and amendment of pleadings here does not raise a question vital to the final disposition of the case." Consequently, she ruled that she could not exercise the Prothonotary's discretion de novo. With respect, I believe the learned judge erred in so concluding.
It is not always easy to distinguish between amendments to pleadings that are said to be routine amendments and amendments that raise a question that is vital to the final resolution of the case. In the present instance, the amendment sought to add, as new defendants, persons whose participation in the proceedings "is necessary to ensure that all matters may be effectually and completely be determined by the court": se Rule 104 of the Federal Court Rules, 1998 SOR/98-106. I have no hesitation in concluding that the amendment raises a question vital to the final resolution of the case. Accordingly, the judge should have exercised the Prothonotary's discretion de novo. I am, therefore, left with the duty to exercise de novo that discretion: see Merck & Co. v. Apotex Inc., supra, para. 28.
[14] However, as can be seen from the above quote, that case involved the request by a plaintiff to add additional defendants. While that may be vital to a case, I fail to see how that logic applies to allowing access to a confidential document to a "stranger" who, by its own admission, wants to know what the case is all about. Thus, the first leg of the test from Merck, supra, is not met.
Alleged Errors
[15] AstraZeneca also argued at the hearing that the Prothonotary committed two errors:
a) she interpreted too narrowly the expression "compelling reasons" as used in Apotex Inc, supra; and
b) she made an error when she stated in obiter:
Even if it had been demonstrated to me that the issue of factual or legal meaning of the word 'marketed' had been at issue in these proceedings, I would still not have found sufficient interest in AstraZeneca to view that information for the purpose of determining whether to intervene in this application. Any interpretation of the word 'marketed' herein would occur in relation to the Food and Drug Regulations only, because that is the only regulation at issue in these proceedings.
In AstraZeneca's view, this is an error as the word "marketed" is also used in s. 5 of thePatended Medicines (Notice of Compliance) Regulation SOR/93-133 ("NOC Regulations").
[16] With respect to the first "error", AstraZeneca does not dispute that the Prothonotary used the correct test when considering the application. As stated by Reed, J. in Apotex, supra, at paras 6 and 7:
It is argued that as a matter of general principle I should grant access to the sealed file. Scoteet v. Scoteet, [1913] A.C. 417 (H.L.) especially at p. 431; Samuel Moore & Co. v. Commissioner of Patents (1979), 45 C.P.R. (2d) 185110 D.L.R. (3d) 35,[1980] 2 F.C. 350, and Smith Kline & French Canada Ltd. v. Frank W. Horner, Inc. (1982),70 C.P.R. (2d) 128 (F.C.T.D.) are cited. It is argued that it is a matter of fundamental public order that proceedings be public and that while there are some exceptions they do not pertain in this case.
I do not consider this argument to be a sufficient ground for altering the original order sealing the court file. When that order was made the general principle would have been considered. The Associate Chief Justice found it appropriate on the basis of the representations made to him by the parties at that time to provide an exception to that general principle and to seal the file. I do not think the phrase in the Associate Chief Justice's order "until further ordered by this Court" contemplates a reopening of the file on the ground now sought by Pfizer. Something more than an argument based on the general principle of the public nature of court proceedings must be given as a reason for altering the original order -- some changed circumstances, or compelling reason not directly considered when the order was given. (Underlining added)
[17] AstraZeneca, however, argues that "compelling interest" was interpreted too narrowly by the Prothonotary since this is not the same as "direct interest". "Direct interest" is the test used when adding a party. In AstraZeneca's view, the Prothonotary applied this test instead of the "compelling interest" test. AstraZeneca believes that the dramatic economic impact that a change of the terms of the NOC may have on it qualifies as a "compelling interest".
[18] The Prothonotary, when rejecting the notion that "economic interest" should qualify as a "compelling interest", did indeed allude to Apotex v. Canada (Attorney General), [2001] F.C.J No. 1049 (T.D.)(QL), a case involving the same party and the same drug as in this appeal, and where AstraZeneca was denied participation as either a party or as an intervener. However, her rationale for rejecting the economic interest point was not based on the lack of direct interest. It concerned the lack of any type of nexus between AstraZeneca's economic interest and the proceedings under the FDA regulations. As she stated:
However, the fact that AstraZeneca's economic interests may be affected by the issuance of a Notice of Compliance referring to its brand name product does not give AstraZeneca any interest whatsoever in the process and procedure contemplated in the Food and Drug Regulations for identifying and designating that reference product or in any application concerned solely with the Food and Drug Regulations.
[19] The observation made by the Prothonotary was certainly correct. AstraZeneca has not demonstrated in any way how its economic interest has any bearing on or relevance to the proceedings between Apotex and the Minister. I am quite prepared to accept that a compelling interest can amount to something less than a direct interest, however it must have a legal component. If mere economic interest qualified, any competitor of Apotex's could move to be allowed access to the protected confidential information. This would render the order useless.
[20] With respect to the second "error", AstraZeneca is correct that the word "marketed" is used in both the NOC regulations and the FDA regulations. Both before Prothonotary Tabib and at this hearing, counsel for AstraZeneca confirmed that the affidavits and materials in Apotex's motion record conclusively established that the proceedings between Apotex and the Minister do not involve facts relevant to the term "marketed" and its interpretation.
[21] Given the fact that the word "marketed" is not in issue, and the Prothonotary's observation was obiter and had no effect on her decision, this is an immaterial point. It does not meet the "error" requirement of the second leg of the test from Merck, supra.
Conclusion
[22] Accordingly, AstraZeneca has not met the requirements of Merck, supra, necessary for me to undertake a de novo review of the Prothonotary's decision. Consequently, this appeal cannot succeed.
ORDER
THIS COURT ORDERS that this appeal be dismissed, with costs of this motion in favour of Apotex Inc.
Judge
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-388-04
STYLE OF CAUSE: APOTEX.INC. v. THE MINISTER OF HEALTH AND
THE ATTORNEY GENERAL OF CANADA
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: January 18th, 2005
REASONS FOR ORDER : The Honourable Mr. Justice von Finckenstein
APPEARANCES:
Ms. Julie Rosenthal FOR APPLICANT
Mr. John R. Morrissey and
Ms. Denise Lacombe FOR NON - PARTY
SOLICITORS OF RECORD:
Goodmans LLP
Toronto, Ontario FOR APPLICANT
Smart & Biggar
Toronto, Ontario FOR NON-PARTY