[2000] 3 F.C. 360
A-772-98
(T-366-98)
AB Hassle, Astra AB and Astra Pharma Inc. (Appellants) (Applicants)
v.
The Minister of National Health and Welfare, Rhoxalpharma Inc. and Takeda Chemical Industries, Ltd. (Respondents) (Respondents)
Indexed as: AB Hassle v. Canada (Minister of National Health and Welfare) (C.A.)
Court of Appeal, Décary, Robertson and Evans JJ.A. —Ottawa, February 23 and March 7, 2000.
Patents — Practice — Appeal from order allowing appeal from Prothonotary’s order affidavit filed by generic drug manufacturer in NOC proceedings not confidential — Protective orders in NOC proceedings do not imperil principle of open justice — Issuance of protective order creating rebuttable presumption any information of type described in order subsequently filed will be kept confidential — Only in clearest cases, where obvious document not within terms of protective order should motion challenging confidential nature of document be granted — Once prima facie evidence document within class of documents contemplated by order, treated as confidential, heavy burden on challenging party to demonstrate otherwise — Information at issue prima facie within protective order — As Prothonotary applied improper test, Motions Judge right to interfere — Latter not applying test set out herein, but would have reached same conclusion had she had benefit of these reasons.
This was an appeal from an order allowing an appeal from an order of the prothonotary that certain documents were not confidential. The issue was whether certain affidavit evidence filed by RhoxalPharma, a generic drug manufacturer, under the Patented Medicines (Notice of Compliance) Regulations was confidential and therefore subject to a protective order issued earlier in these proceedings. RhoxalPharma was alleging that its proposed omeprazole tablets do not infringe the appellants’ patents so that a notice of compliance should issue.
Held, the appeal should be dismissed.
There is little, if any, public interest in knowing the specific content of drug processes and it cannot be seriously argued that issuing protective orders in NOC proceedings imperils the principle of open justice. The Court will always be willing to hear a third party challenge, whether or not provided for in the order.
Given that a protective order allows the parties to control by agreement which documents will be unavailable to the public, the appellants could neither explain what public interest they were protecting nor define the prejudice they would suffer given that the order grants them access to the information they claim should be accessible to all. Appeals such as this in NOC proceedings tend to be tactical manoeuvres rather than being motivated by a concern regarding the harm resulting from a document remaining confidential or a desire to secure a just determination of the proceeding on its merits.
The issuance of a protective order creates a rebuttable presumption that any information of the type described in the order which is subsequently filed will be kept confidential subject to the exceptions described in the order. At this stage of the proceedings, only in the clearest of cases, where it is obvious that the impugned document does not fall within the terms of the protective order, should a motion challenging the confidential nature of the document be granted. Once evidence is adduced that a document falls prima facie within the class of documents contemplated by the order and has been treated by the party as confidential, the burden lies with the challenging party to demonstrate that the document falls outside what was contemplated by the order. There are sound policy bases for this conclusion. The Court has a duty to deal with this type of summary application expeditiously. Counsel should be discouraged from using any possible occasion to make collateral attacks against a protective order. Further, the Court would be remiss in its duty if it did not summarily dismiss motions which are merely attempts to re-litigate protective orders.
As the information at issue was prima facie within the protective order, the burden was on the appellants to rebut the presumption of confidentiality. As the prothonotary applied an improper test, the Motions Judge had good reason to interfere. While the test she applied was not precisely the one set out herein, she made a careful review of the evidence and would have reached the same conclusion had she had the benefit of these reasons.
STATUTES AND REGULATIONS JUDICIALLY CONSIDERED
Federal Court Rules, 1998, SOR/98-106, r. 3.
Food and Drug Regulations, C.R.C., c. 870, s. C.08.001 (as am. by SOR/95-172, s. 4).
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(8) (as am. by SOR/98-166, s. 5).
CASES JUDICIALLY CONSIDERED
CONSIDERED:
AB Hassle v. Canada (Minister of National Health and Welfare) (1998), 81 C.P.R. (3d) 121 (F.C.T.D.); affd (1999), 87 C.P.R. (3d) 191 (F.C.A.); Apotex Inc. v. Canada (Attorney-General) (1993), 48 C.P.R. (3d) 296; 63 F.T.R. 197 (F.C.T.D.); Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329; 163 N.R. 183 (F.C.A.); Apotex Inc. v. Wellcome Foundation Ltd. (1993), 51 C.P.R. (3d) 305; 69 F.T.R. 161 (F.C.T.D.).
REFERRED TO:
Merck Frosst Canada Inc. v. Canada (Minister of Health) (1998), 82 C.P.R. (3d) 417; 229 N.R. 33 (F.C.A.).
APPEAL from an order (AB Hassle v. Canada (Minister of National Health and Welfare) (1998), 83 C.P.R. (3d) 428; 161 F.T.R. 15 (F.C.T.D.)) allowing the appeal from an order of the prothonotary (AB Hassle v. Canada (Minister of National Health and Welfare) (1998), 83 C.P.R. (3d) 417 (F.C.T.D.)) as to whether affidavit evidence filed by a generic drug manufacturer was confidential and therefore subject to a protective order issued earlier in the notice of compliance proceedings. Appeal dismissed.
APPEARANCES:
J. Sheldon Hamilton and Yoon Kang for appellants (applicants).
Martin F. Sheehan for respondents (respondents).
SOLICITORS OF RECORD:
Smart & Biggar, Toronto, for appellants (applicants).
Martineau, Walker, Montréal, for respondents (respondents).
The following are the reasons for judgment rendered in English by
[1] Décary J.A.: This is an appeal from an order of Madam Justice Tremblay-Lamer (reported at (1998), 83 C.P.R. (3d) 428 (F.C.T.D.)) which allowed the appeal from an order of Prothonotary Morneau (reported at (1998), 83 C.P.R. (3d) 417 (F.C.T.D.)). The issue was whether certain affidavit evidence filed by the generic drug manufacturer RhoxalPharma Inc. (RhoxalPharma) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (NOC Regulations) was confidential and therefore subject to a protective order issued at an early stage of the proceedings by Mr. Justice Teitelbaum (reported at (1998), 81 C.P.R. (3d) 121 (F.C.T.D.); affd (1999), 87 C.P.R. (3d) 191 (F.C.A.)). As appears from the previous recital, this is the fifth time that the Federal Court of Canada is seized with matters pertaining to the confidentiality of documents in these proceedings. I might add some more background—that RhoxalPharma is alleging in a notice of allegation that its proposed omeprazole tablets do not infringe the appellants’ (Astra) patents so that a notice of compliance should issue.
[2] The relevant parts of the protective order are the following (Appeal Book, Vol. 1, at pp. 26-31) [reported as Appendix A at (1998), 83 C.P.R. (3d) 428 (F.C.T.D.), at pp. 437-440]:
2. Any document or thing, relating to the identity of RhoxalPharma’s supplier of omeprazole or the process, components and formulae by which RhoxalPharma’s omeprazole tablets are made, that is produced by any Party and any answer made by any Party relating thereto during or for the purpose of this proceeding, including any Examination and any Exhibit marked in this proceeding (hereinafter collectively referred to as the “Information”) may be subject to this Order.
…
9. In the absence of written permission from the Party disclosing any Confidential Information, the recipient of Confidential Information shall not disclose same to any one, except the Court staff, the following parties, companies or individuals and members and regular employees of the following firms:
(1) The Applicants in this proceeding and their related and affiliated companies and their counsel and within these, only the employees who need to know of the information;
(2) The Respondents in this proceeding and their related and affiliated companies and their counsel and within these, only the employees who need to know of the information;
(3) Up to three outside experts for each Party retained to assist the Party in the preparation and trial of this proceeding;
(4) The firms of Martineau Walker and Goudreau Gage Dubuc & Martineau Walker;
(5) The firm of Smart & Biggar;
(6) The Minister of National Health and Welfare;
(7) The Attorney General of Canada;
(8) The Department of Justice;
…
14. This Order shall not be construed:
(a) to prevent any individual or Party or its otherwise respective counsel from making use of information which was lawfully and without legal restriction in its possession prior to the date of this Order;
(b) to apply to information derived independently of disclosure hereunder;
(c) to apply to information which any individual or Party or its counsel lawfully and without legal restriction obtained from a person having the right to disclose such information;
(d) to prevent any individual or Party or its respective counsel to seek a determination or adjudication of the confidential character of any Challenged Information.
15. Nothing in this Order shall foreclose or limit any Party:
(a) from asserting that any Information designated as “Confidential” pursuant to this Order is, in fact, not confidential;
…
16. Any Party may waive in writing all or any part of his or its right under this Order and shall have the right to apply to the Court for any modification or variation of the strictures on disclosure imposed by this Order as applied to any specific item or items of designated Confidential Information or to determine the confidentiality of Challenged Information.
17. In the event of a challenge to the confidentiality of designated Confidential Information, the Party asserting confidentiality shall have the burden of proving on a balance of probabilities that the information is, in fact, confidential.
18. In the event of a challenge to the confidentiality of designated Confidential Information, Confidential Information shall not include information which:
(a) is or was public knowledge or part of any public record, or which becomes public knowledge or part of any public record by means not in violation of the provisions of this Order or of the law;
(b) is or was acquired lawfully from a person not a Party to this action in circumstances not governed by an obligation of confidence;
(c) is or was already known to the receiving Party, affiliates, its counsel or experts; or
(d) is or was independently developed by the receiving Party, its counsel or experts.
19. The terms and conditions of use of Confidential Information and the maintenance of the confidentiality thereof during any hearing of this proceeding shall be matters in the discretion of the Court.
[3] Protective orders with respect to methods or processes of manufacture of pharmaceutical drugs are routinely sought early in NOC Regulations proceedings and, it is fair to say, are generally granted subject to certain conditions. There are obvious reasons why this is so.
[4] First, whether one looks at it from the perspective of a brand name pharmaceutical manufacturer or from that of a generic drug manufacturer, the perceived confidentiality of information is a cornerstone of the regulatory scheme set out in the Food and Drug Regulations, C.R.C., c. 870, s. C.08.001 [as am. by SOR/95-172, s. 4] and in the Patented Medicines (Notice of Compliance) Regulations:
The perceived confidentiality of information flowing from a drug manufacturer to the Department of National Health and Welfare is a cornerstone of the system pertaining to the processing of new drug submissions and the issuance of notices of compliance. For this system to function effectively, the confidential nature of the relationship ought to be honoured and maintained to the extent possible…. [My emphasis.] [Apotex Inc. v. Canada (Attorney-General) (1993), 48 C.P.R. (3d) 296 (F.C.T.D.), at p. 305, McGillis J.]
Section 5(3)(a) of the Regulations requires that the applicant for the NOC provide a detailed statement of the basis in fact and law for his statement of allegation. It seems intended that the patentee be fully aware of the grounds on which the applicant says issuance of a NOC will not lead to an infringement of the patent before the patentee decides whether or not to apply to a court for a determination. Such disclosure would define the issues at a very early stage. If that is the purpose, it confirms the intention that the proceedings be expeditiously conducted …. An applicant for a NOC alleging a different process cannot be expected to make full disclosure without a protective order. Confidentiality cannot be assured until there is a proceeding in court. [My emphasis.] [Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.), at pp. 337-338, Mahoney J.A. See, also, Merck Frosst Canada Inc. v. Canada (Minister of Health) (1998), 82 C.P.R. (3d) 417 (F.C.A.), at p. 421].
[5] I note in this regard that the Regulations were amended in 1998 (SOR/98-166) and now expressly state, in subsection 6(8), that “[a] document produced under subsection (7)”—i.e. any portion of the submission for a notice of compliance filed by the second person relevant to the disposition of the issues in the proceedings—“shall be treated confidentially”.
[6] Second, in endorsing the principle that confidential orders can issue in these types of proceedings and in crafting their terms on an ad hoc basis so as to restrict their application to what was strictly necessary in any given case, the courts have carefully attempted to strike a balance between the need for public scrutiny of the court process and, to use the words of MacKay J. in Apotex Inc. v. Wellcome Foundation Ltd. (1993), 51 C.P.R. (3d) 305 (F.C.T.D.), at pages 309-310, “the interests of justice between the parties, including the bona fide commercial and proprietary interests of parties to litigation”.
[7] Let us not be naïve. There is little, if any, public interest in knowing the specific content of drug processes and no one can seriously argue that the issuance of protective orders of the type at issue in NOC proceedings imperils the principle of open justice. The parties themselves may challenge the true confidentiality of specific documents by the very terms of the orders and the Court will always be prepared to hear challenge by a third party, whether or not the terms of the order so provide.
[8] Given that for all practical purposes a protective order allows the parties to control by agreement which documents will be unavailable to the public, counsel for the appellants was at a loss to explain what public interest his clients were protecting in the instant case. He was also at a loss to define the prejudice suffered by his clients since the order at issue grants them access to the information they now claim should be accessible to all. Indeed, experience suggests that appeals of this kind in notice of compliance proceedings have more to do with tactical manoeuvres than with concerns about any harm that may result from keeping a document confidential or with meeting the objective of rule 3 of the Rules of this Court [Federal Court Rules, 1998, SOR/98-106], i.e. “to secure the just, most expeditious and least expensive determination of every proceeding on its merits”. In an ideal world, counsel would agree to the terms of the confidential order and then abide by it.
[9] Protective orders issued at the beginning of the proceedings prior to the filing of evidence are by necessity drafted in general terms. As I have already pointed out, they are meant to allow the parties to move on and the Court to dispose of the application as expeditiously as it can. The judge who issues the order does so after having balanced the interest of the public and that of the parties. The test to be applied at that first stage with respect to confidentiality is that described by this Court in the very appeal from Mr. Justice Teitelbaum’s order [(1999), 87 C.P.R. (3d) 191 (F.C.A.), at page 192]:
… a confidentiality order may be issued on the basis of a subjective but reasonably held belief….
I pause here to observe that neither the Prothonotary nor the Motions Judge had the benefit of that concise definition of the applicable test when they each made their decision.
[10] Once a protective order has issued, it would be counter-productive if parties, who have no other choice but to file sensitive evidence and do so with a relatively secure judicial guarantee of confidentiality, were to live with the constant fear of facing routine attacks by adverse parties. The seeking and obtaining of a protective order would be a futile exercise if, whenever a document is filed under such order, the party invoking the order were routinely forced to start from scratch, face a burden similar to or more onerous than the one it has already overcome and reargue the very arguments that were accepted or dismissed by the judge issuing the order.
[11] In my view, the issuance of a protective order in circumstances such as the present creates a presumption that any information of the type described in the order which is subsequently filed will be kept confidential subject to the exceptions described in the order, such as those found in paragraphs 14 and 18 of the protective order at issue. The presumption is, of course, rebuttable but—and this is the test to be applied at this stage of the proceedings—it is only in the clearest of cases, where it is obvious that the impugned document does not fall within the terms of the protective order, that a motion challenging the confidential nature of the document should be granted. Once evidence is put forward to the effect that a document falls prima facie within the class of documents contemplated by the order and has been treated by the party as confidential—in this case, the class is described in paragraph 2 of the protective order—the burden, and it is a heavy one, lies with the challenging party to demonstrate that the document falls outside what was contemplated by the order or is not of a kind which the judge could have had in mind when he or she issued the order.
[12] There are sound policy bases for this conclusion. The Court, as has so often been said (see, for example, Bayer, supra, at page 337), has a clear duty to deal with this type of summary application expeditiously. Counsel should be discouraged from using any possible occasion to make what amounts in reality to collateral attacks against a protective order. Further, the Court would be remiss in its duty if it did not summarily dismiss motions which are merely attempts to get around or re-litigate protective orders.
[13] I appreciate that the test which this Court now sets out is somewhat at odds with that set out by Teitelbaum J. in paragraph 17 of the protective order granted in this case. However, I doubt whether the terms of the protective order could, on a question which is after all a question of law, tie the hands of the judge eventually seized with a motion challenging the confidential nature of a particular document.
[14] In the case at bar, the information at issue—the list of the ingredients of the proposed omeprazole tablets and expert evidence bearing on the distinctions between these proposed tablets and those disclosed in the Astra patents—relates prima facie to “the process, components and formulae by which RhoxalPharma’s omeprazole tablets are made” (see paragraph 2 of the protective order). The burden was therefore on the appellants to rebut the presumption of confidentiality that attached to this information.
[15] The Prothonotary having applied an improper test, the Motions Judge had good reason to interfere. While the test she applied was not precisely the one set out in these reasons, we are satisfied that she made a careful review of the evidence and that she would have reached the same conclusion had she had the benefit of these reasons.
[16] The appeal should be dismissed with costs to the respondent RhoxalPharma Inc. here and in both instances below.
Robertson J.A.: I agree.
Evans J.A.: I agree.