Federal Court Decisions

                                                                                                                                            Date: 20020226

                                                                                                                                       Docket: T-1898-01

                                                                                                               Neutral Citation: 2002 FCT 208

Ottawa, Ontario, this 26^th day of February, 2002

PRESENT:    THE HONOURABLE MR. JUSTICE PELLETIER

BETWEEN:

                                           BRISTOL-MYERS SQUIBB COMPANY and

                                           BRISTOL-MYERS SQUIBB CANADA INC.

                                                                                                                                                      Applicants

                                                                              - and -

                                       THE ATTORNEY GENERAL OF CANADA and

                                                BIOLYSE PHARMA CORPORATION

                                                                                                                                               Respondents

                                               REASONS FOR ORDER AND ORDER

[1]                 This motion raises a novel point as to the conduct of a judicial review of a decision of the Minister under the Patented Medicines (Notice of Compliance) Regulations, SOR/98-166, (NOC regs.). In response to a Direction to Attend which required the deponent to produce various documents, the Minister issued a certificate under s. 37 of the Canada Evidence Act. R.S.C. 1985, c. C-5 as amended by Statutes Canada 2001 c. 41. The purpose of this motion is to test that certificate.

[2]                 The applicant Bristol Myers Squibb is the holder of patent with respect to a medicine known as paclitaxel and had filed a patent list with respect to the product pursuant to the NOC regs. The respondent Biolyse Pharma Corporation ("Biolyse") filed a New Drug Submission for its medicine paclitaxel. The Minister determined that sections 5(1) and 5(1.1) of the NOC regs. did not apply to Biolyse's submission and therefore issued a Notice of Compliance without requiring Biolyse to prepare and serve a Notice of Allegation with respect to the applicant's patent.

[3]                 Upon becoming aware of the issuance Biolyse's NOC, the applicant commenced an application for judicial review of the Minister's decision. In its Notice of Application it sought production of "Biolyse Pharma Corporation's New Drug Submission for paclitaxel solution for injection at a strength of 6 mg/ml" (the New Drug Submission). Subsequently, the applicant issued a Direction to Attend to the Minister's representative in which she was directed to have the New Drug Submission and certain other documents in her possession when she attended for cross-examination on her affidavit. In response to the Direction to Attend, the Minister's representative issued a certificate under s. 37 of the Canada Evidence Act claiming the right to withhold production of the records on the basis of a specified public interest. The certificate states that production is objected to, in part, because of the absence of a protective order as to the documents in question and because Biolyse had not consented to the release of the information. The applicant then brought this motion seeking an order for production of the documents in question notwithstanding the issuance of the certificate.

[4]                 It is a matter of some significance that the application before the court is a judicial review of a decision to issue a Notice of Compliance. The issue is whether the Minister's determination that Biolyse's submission was not within subsections 5(1) or 5(1.1) of the NOC regs.can withstand judicial scrutiny. This is not, as is so often the case, an application for an order of prohibition as provided for in the NOC regs.

[5]                 Production of documents in the tribunal's possession in the course of applications for judicial review is governed by Rule 317 which provides as follows:

Since there is no provision for the filing of a tribunal record by the tribunal itself, (as there is in the case of the Federal Court Immigration Rules at Rule 17), Rule 317 is intended to put the applicant in the position where it can put the tribunal record before the Court by combining the records in its possession with those which it obtains from the tribunal. Document production precedes cross-examination on affidavits. Rule 308 provides that the time for completing the cross-examinations on the affidavits begins to run from the filing of the respondent's affidavits, or the expiry of the time limited for doing so.

[6]                 The types of documents required to be produced in response to a request under Rule 317 was considered by the Court of Appeal in 1185740 Ontario Ltd. v. M.N.R. [1999] F.C.J. No. 1432, where the following appears:

[5]      In Canada (Humans Right Commission) v. Pathak, [1995] 2 F.C. 455 (C.A.) this Court held that only documents which were actually before the Human Rights Commission in making its decision had to be produced. Other documents relied upon by the investigator did not have to be produced in the absence of evidence that the investigator had inaccurately summarized them. To much the same effect is the decision of this Court in Quebec Ports Terminals v. Canada (Labour Relations Board) 17 Admin. L.R. (2d) 16. I accept and follow these decisions.

[6]      The appellant has raised for the first time in this Court the point that both memoranda show on the final page the word "attachments" and the appellant seeks production of them. If there were attachments, these also would have been before the Minister. To the extent that there were any attachments, they should be produced.

[7]                 The cases relating to a wider duty of disclosure, such as Friends of the West Country Assn. v. Canada [1997] F.C.J. No. 557 must be read in the light of the Court of Appeal's decision in 1185740 Ontario Ltd., supra. In the former case, the judge decided that documents in the possession of the Minister and relevant to the issue must be produced whether or not they were before the decision maker. An appeal from that decision was dismissed for mootness with the qualification that the court took no position on the correctness of the decision appealed from. See [1997] F.C.J. No. 1362 (F.C.A.). In this case, it is clear that the respondent's New Drug Submission was before the Minister as it is the document which calls for a decision to be made.

[8]                 Were the decision to be made solely on the basis of Rule 317, I would have little difficulty in finding that the document requested must be produced, subject to an appropriate protective order being made to protect the Respondent's commercial confidential information.

[9]                 The Minister has asserted his right to exempt the material in his possession from production by issuing a certificate under section 37 of the Canada Evidence Act, the material parts of which are as follows:

[10]            The specific public interest invoked by the Minister can be found in the Certificate of Anne Elizabeth Bowes in which Ms. Bowes makes the following comments:

6. All of these documents, to which I have access, were prepared by or in relation to Biolyse Pharma Corporation ... I am not aware of any protective order having been issued by the Court in these proceedings. Nor am I aware that Biolyse Pharma Corporation has consented to the disclosure of these documents ...

7. ...To that end, no manufacturer may market a new drug in Canada without first satisfying the minister, by providing specified information that the drug is safe effective and of high quality.

8. This determination cannot be made unless the Minister is confident that the information being provided by the manufacturer is absolutely complete and accurate. To encourage completeness and accuracy, and as is made known to the drug manufacturing industry, the Minister treats as entirely confidential all information received from, or prepared internally in relation to a manufacturer in furtherance of its application for drug approval. Otherwise there is a danger that a manufacturer who fears disclosure of its trade secrets to a competitor may be less than fully forthcoming or may choose not to seek to market its drug in Canada at all.

9. Like the Minister, this court has recognized that the perceived confidentiality of information is a cornerstone of the regulatory scheme, and that for this system to function effectively, the confidential nature of the relationship ought to be honoured and maintained to the extent possible. To ensure that such confidentiality is maintained, this court has also endorsed the use protective orders in related litigation.

10. In light of the above, pursuant to section 37 of the Canada Evidence Act, I object to the disclosure of these documents and of the information contained in them. It should not be disclosed on the ground that its disclosure would be contrary to the public interest as described above.

[11]            The specified public interest claimed by the Minister's representative is the confidence of drug manufacturers that their proprietary commercially confidential information will not be made public to their detriment. On the specific facts of this case, this includes the interest of Biolyse in seeing that its confidential information is protected. Section 37(4.1) requires the Court to consider whether disclosure of the information would encroach upon the specified public interest.

[12]            The public interest advanced by disclosure is the public interest in the lawful administration of the NOC regs. which is tested by an application for judicial review. The disclosure required by the judicial review application is not public disclosure, notwithstanding the public interest in open justice, but sufficient disclosure to ensure the proper administration of justice.   

[13]            There are two aspects to disclosure. The first is the Court's interest in having the full record before it when hearing the application for judicial review. Courts are deeply inimical to the notion of making decisions on an inadequate factual record. In theory, this interest would be satisfied by disclosing the New Drug Submission to the Court only. The second is the applicant's interest in having access to the record to assist it in demonstrating that the Minister's decision was in error. This is a partisan interest, but in an adversarial system a partisan interest is not only legitimate but necessary. The challenge is to provide sufficient disclosure to allow the adversarial system to function without thereby prejudicing Biolyse's legitimate commercial interests in confidentiality. In the past, the courts have managed this through protective orders which allow disclosure to counsel and selected experts who are bound by the order to refrain from disclosing to the applicant the content of the disclosed document.

[14]            And so, it is my view, the lawful administration of the NOC regs. and the requirements of the administration of justice justify an encroachment upon the specified interests identified in the certificate.

[15]            The next issue is the extent of any limitation on disclosure required by subsection 37(5). It is clear that a protective order is required. The parties have had discussions about a protective order but have been unable to agree in the face of the section 37 certificate. Given that I have found that disclosure is required, it is likely that agreement can be reached between reasonable and experienced counsel. But before leaving the matter to counsel, I wish to raise a point which was touched upon during argument.

[16]            The applicant is proceeding on the basis that the documents in issue are those described in the Direction to Attend served upon the Minister's delegate. Rule 317 provides that disclosure is obtained by making a demand upon the tribunal. If an objection is to be taken, it is to be made within the parameters of Rule 318. While Rule 91, which deals with the content of a Direction to Attend, is in Part 3 of the Rules and is said to apply to all proceedings, Rule 317 is specific to Applications. While it can be said that these Rules are not in pari materia in that one deals with production of documents by the tribunal, and the other deals with production of documents by a witness to be cross-examined, they can be made to overlap as they did here. A perceived defect in production pursuant to Rule 317 was sought to be corrected by invoking Rule 91. Each Rule must be read so as to leave room for the application of the other.

[17]            In my view, Rule 317, which is the rule of narrower application, governs production of documents by a tribunal. A demand is made of the tribunal and if the tribunal objects, it can do so following the procedure in Rule 318. A Direction to Attend issued under Rule 91 can be used to compel the deponent of an affidavit on the part of the tribunal to produce at the cross examination those documents referred to in the demand under Rule 317 for which an objection to production has not been upheld. But, in the case of a deponent on behalf of the tribunal, it is not appropriate to use Rule 91 to expand the scope of the demand for production beyond what has been demanded under Rule 317. It is clear that production under Rule 317 is circumscribed in a way that a demand under Rule 91 is not. For example, Rule 94 limits objections to production to claims of privilege which is a narrower ground that is available under Rule 318. See    Canadian Arctic Resources Committee Inc. v. Diavik Diamond Mines Inc. [2000] F.C.J. No. 910 (Prothonotary Hargrave).

[18]            The result is that the only document whose production would be properly before the Court is the document whose production was demanded in the Notice of Application. I will adjourn this motion for the parties to attempt to negotiate a protective order acceptable to all with respect to that document on the understanding that if agreement cannot be reached the matter is to be brought back before me.

                                                                            ORDER

THIS COURT ORDERS that:

1.         The applicant is entitled to production of Biolyse Pharma Corporation's New Drug Submission once a suitable protective order is in place; and

2.         This matter is adjourned with leave to have the matter brought back before me if the parties are unable to agree on the terms of a protective order within 15 days of the date of this order.

                                                                                                                                    "J. D. Denis Pelletier"                

                                                                                                                                                               Judge