Abbott Laboratories Ltd. v. Canada (Minister of Health), 2005 FC 989

Date: 20050715

Docket: T-214-05

Citation: 2005 FC 989

Ottawa, Ontario, this 15^th day of July, 2005

PRESENT:    THE HONOURABLE MR. JUSTICE RUSSELL

BETWEEN:

ABBOTT LABORATORIES LIMITED

TAP PHARMACEUTICALS INC.

Applicants

and

THE MINISTER OF HEALTH, NOVOPHARM LIMITED

And TAKEDA PHARMACEUTICAL COMPANY LIMITED

Respondents

REASONS FOR ORDER AND ORDER

1.          THE APPEALS

[1]    Novopharm Limited ("Novopharm") and Abbott Laboratories Limited ("Abbott") are appealing from the orders of Prothonotary Milczynski dated May 6, 2005 ("First Order") and May 31, 2005 ("Second Order") (collectively, the "Orders"). The First Order provided for the issuance of the Second Order and contained Prothonotary Milczynski's reasons for the issuance of both Orders. The Second Order is a limited form of protective order, made pursuant to rule 151 of the Federal Court Rules, 1998.

[2]    It is Novopharm's position that the Orders are too narrow in their scope in that they fail to protect all of the documents which Novopharm has been ordered to produce pursuant to subsection 6(7) of the Patented medicines (Notice of Compliance) Regulations ("Regulations").

[3]    Novopharm says that the grounds for the Orders are clearly wrong. It seeks an appeal de novo and asks the Court to grant a more comprehensive protective order in the form provided in Novopharm's materials.

[4]    Abbott is appealing the Orders on the grounds that there was no evidence before Prothonotary Milczynski to support any of Novopharm's assertions of confidentiality and the limited form of protection contained in the Orders.

2.    BACKGROUND

The Application and the Protective Order Motion

[5]    On December 21, 2004, Novopharm served Abbott with a Notice of Allegation ("NOA") pursuant to section 5 of the Regulations.

[6]    The NOA was made in relation to Novopharm's Abbreviated New Drug Submission ("ANDS") for its proposed lansoprazole 15 mg and 30 mg delayed release capsules. The NOA contains allegations of non-infringement with respect to Canadian Patent Nos. 1,312,548 and 2,009,741.

[7]    In response to the NOA sent by Novopharm and pursuant to subsection 6 of the Regulations, Abbott commenced the within application on February 7, 2005.

[8]    By notice of motion dated March 22, 2005, Novopharm brought a motion ("Protective Order Motion") for a protective order, a schedule and an order that the application be specially managed. The Protective Order Motion was initially returnable on April 4, 2005 but was adjourned to April 11, 2005 when it was heard, in part, by Prothonotary Lafrenière. On April 11, 2005, Prothonotary Lafrenière ordered that the proceeding be specially managed and that the remainder of the Protective Order Motion be adjourned.

The Disclosure Order

[9]    By notice of motion dated April 18, 2005 ("Disclosure Motion"), Abbott sought an order requiring Novopharm to disclose to Abbott all of the relevant portions of its drug submission. The Disclosure Motion was granted on April 25, 2005 by Prothonotary Lafrenière and the resulting order ("Disclosure Order") was made on May 6, 2005.

[10]    The Disclosure Order was granted pursuant to the Court's authority under subsection 6 (7) of the Regulations. The Disclosure Order requires Novopharm to disclose to Abbott all relevant portions of its submission, including:

a)                   Excerpts from covering letters that refer to uses or indications;

b)                   Any correspondence pertaining to uses or indications;

c)                   Any Form 3011 or equivalent document;

d)                   All drafts of any proposed product monograph;

e)                   All drafts of any proposed labelling;

f)                     Any Form V or equivalent document;

g)                   Excerpts from any Clinical Study Reports or other documents:

i)                     that state a conclusion about any bioequivalence analysis but not the substance of that analysis or the data;

ii)                    that state a conclusion about any bioavailability analysis but not the substance of that analysis or the data;

iii)                  that state a conclusion about any pharmacodynamic analysis but not the substance of that analysis or the data; and

h)    All literature references made in Novopharm's submission.

The Orders Under Appeal

[11]    On May 2, 2005, the protective order portion of the Protective Order Motion was heard by Prothonotary Milczynski. Following the hearing, Prothonotary Milczynski made the First Order dated May 6, 2005.

[12]    Important passages of the reasons in the First Order are found at pages 6 and 9 and read as follows:

       In this case, I find that with limited exceptions, Novopharm has failed to discharge its onus. As discussed further below, the motion is granted only in part. An order respecting the confidentiality of only certain information shall issue, that being information regarding the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules non-medicinal ingredients.

       Novopharm has not established to my satisfaction that all of the material in the ANDS should be treated as confidential, the only exceptions being information about the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules' non-medicinal ingredients, exceptions that appeared to be acknowledged (if not conceded) by Abbott.

[13]    Following the reasons, paragraph 1 of the First Order provides as follows:

THIS COURT ORDERS that:

1.    The motion is granted in part:

(i)          a protective order consistent with these reasons shall issue, the terms of which shall be settled by the parties, on further teleconference with a hearing by the Court.

[14]    A further teleconference to settle the terms of the protective order arising out of the First Order took place on May 27, 2005. The Second Order then issued on May 31, 2005.

[15]    The critical paragraph of the Second Order is paragraph 5. It limits what can be protected as confidential information:

5.    The following information may be designated as Confidential Information:

(a)         Information regarding the specific formulation of Novopharm's lansoprazole 15 and 30 mg. delayed release capsules, which is the identity of the non-medicinal ingredients, and their form and/or amounts utilized (e.g. "standard", "strength" or "units"); and

(b)         Information or data regarding the comparative bioequivalence of Novopharm's lansoprazole 15 and 30 mg. delayed release capsules, but not the conclusions about any such information.

3.          EVIDENCE

Mr. David Windross

[16]                        Novopharm's evidence on the motion before Prothonotary Milczynski was provided by Mr. David Windross, an employee of Novopharm (VP, Government, Professional & Regulatory Affairs). He provided the following important information:

(a)                 The contents of Novopharm's ANDS are strictly confidential;

(b)                Novopharm would not want this information disclosed;

(c)                 Novopharm always treats this material as confidential;

(d)                Mr. Windross understands that Health Canada will not release the contents of an ANDS until after the product has gone to market;

(e)                 Until the product goes to market, Health Canada maintains the confidentiality of the entire contents of an ANDS;

(f)                  If a third party obtained anything in an ANDS, Novopharm's business interests could be severely and negatively affected;

(g)                 It is vital to keep all information in an ANDS confidential to prevent other pharmaceutical companies from using that information for their own purposes, for example, using Novopharm's formulation to produce their own version of the drug;

(h)                 While some of the contents of Novopharm's ANDS may be in the public domain, the manner in which this has been communicated, the precise content of each communication and the timing of those communications would be of great interest to Novopharm's competitors to gain a better understanding of Novopharm's approach to obtaining approval. This better understanding could help them prepare and seek approval for their own submissions;

(i)                   While documents such as the product monograph and product labelling are similar to the PREVACID equivalents [which are in the public domain], the differences are not public and those differences could help a competitor develop its own equivalent drug;

(j)                  While literature contained in an ANDS is not confidential, the list of references could reveal Novopharm's strategy for gaining approval for its product that would be recognized by Novopharm's competitors as having value.

[17]     In response to the demonstrated reality that some of the ANDS material is public, Mr. Windross made a group of related arguments, listed under (h) above, that even if the substantive content of a document is public, there is confidence in things such as "the manner of communication with Health Canada, the timing of such communication, or any explanations, positions, or arguments presented to Health Canada" ("Context Information").

Dr. Albert Liston

[18]     Dr. Albert J. Liston is a Ph. D. scientist who worked at Health Canada for 30 years. He was the senior civil servant responsible for the operation of the branch of Health Canada that approves prescription drugs in Canada. From 1982 to 1984 he was the acting Assistant Deputy Minister of the Branch and from then until 1992 he was the Assistant Deputy Minister of Health for Canada responsible for the Health Protection Branch.

[19]     While at Health Canada, Dr. Liston was named Director under the Food and Drugs Act and Regulations, a statutory office responsible for managing and approving drug submissions for all drugs in Canada. Dr. Liston was, for the Health Protection Branch of the Ministry of Health, the person wielding the delegated authority of the Minister of Health, responsible for the Branch's compliance with federal freedom of information legislation. During his 30 years at Health Canada, Dr. Liston looked at a large number of drug submissions.

[20]     Dr. Liston has lectured on Ministry of Health confidentiality issues to masters students at Queen's University.

[21]       Dr. Liston explained that the Health Protection Branch treats the entire package of material in an ANDS as confidential until a submission is made public. This could occur, for example, following a NOC. Dr. Liston also explained that after a submission is made public, the Ministry responds to freedom of information requests by assessing what is and is not confidential in an ANDS.

[22]     The transcript of Dr. Liston's cross-examination was also before Prothonotary Milczynski and, based on that record, she preferred his evidence to that of Mr. Windross.

[23]     Dr. Liston provided the Court with three essential responses to Mr. Windross' arguments concerning Context Information:

(a)        In the ordinary case there is nothing confidential about any Context Information              in the specific documents that are in issue in this case;

(b)        While there may be an extraordinary case where the Context Information from                the specific documents in this case could be confidential, there is no evidence                that this is such an extraordinary case; and

(c)         Even if there were discernable Context Information from the specific documents              in this case, it is not the kind of information that would give competitors any                     "edge" or advantage relative to Novopharm or that would cause harm if                           disclosed.

Allegations of Harm

[24]       As explained by Mr. Windross, Novopharm takes the position that a significant reason for the confidential treatment of the materials, information and documentation in Novopharm's submission is that if a third party were to obtain this information, particularly a third party pharmaceutical company, Novopharm's business interests could be severely and negatively affected. Until Novopharm is able to take its lansoprazole delayed release capsules to market, Novopharm says it is vital that information relating to those capsules be kept strictly confidential so as not to allow other pharmaceutical companies to use Novopharm's formulation and other information to prepare and market their own generic lansoprazole delayed release capsules.

[25]       If no protective order is in place when Novopharm produces the material that has been ordered to be produced, Novopharm fears that Abbott might disclose that material to the public as part of the evidence filed with the Court. Any of Novopharm's competitors could then obtain such confidential information for their own purposes, thereby completely and permanently removing any confidentiality that information ever had, and giving Novopharm's competitors an unfair advantage.

[26]       Mr. Windross also gave evidence that he felt protecting the confidentiality of submissions is a cornerstone of the drug approval process and that allowing third parties to interfere with that protection would have a negative effect on the pharmaceutical industry as a whole.

4.          POINTS IN ISSUE

[27]     The Appeals raise the following issues:

(a)        Are the Orders clearly wrong, in the sense that the exercise of Prothonotary Milczynski's discretion was based upon a wrong principle or upon a misapprehension of the facts?

(b)        If so, upon a de novo review by this Court, is Novopharm entitled to a protective order in the form sought? This issue is composed of the following subsidiary issues:

(i)          should a protective order be granted as a result of the combined effect of the Disclosure Order, subsections 6 (7) and (8) of the Regulations and rules 151 and 152 of the Federal Court Rules, or

(ii)         in the alternative (or in any event) should a protective order be granted on the grounds that Novopharm has met the normal test for the issuance of such orders?

(c)         From Abbott's perspective, did Prothonotary Milczynski err by going beyond the evidentiary record and ordering that some information should be included in the Protective Order?

5.    SUBMISSIONS

Are the Orders Under Appeal Clearly Wrong?

Novopharm

[28]     The test on an appeal from the order of a prothonotary was recently confirmed and clarified by the Federal Court of Appeal in Merck & Co. v. Apotex Inc. (2003), 30 C.P.R. (4^th) 40 (F.C.A.), where it stated that:

Discretionary orders of prothonotaries ought not be disturbed on appeal to a judge unless:

a)                   The questions raised 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 the facts.

[29]         The parties agree that the questions raised are not vital to the final issue, but Novopharm submits that the Orders are clearly wrong, since the exercise of discretion by Prothonotary Milczynski was based upon:

                (a)           A wrong principle, in that she acted contrary to subsection 6(8) of the Regulations, which requires that a document produced under subsection 6 (7) of the Regulations be treated confidentially;

              (b)            A wrong principle and a misapprehension of the facts, in that she relied upon the unqualified and, therefore, inadmissible expert opinion evidence of Dr. Liston, which she preferred over the evidence of Mr. Windross; and

             (c)             A misapprehension of the facts, in that she found that Novopharm failed to meet the onus upon it of showing that the documents in issue are confidential and that harm to Novopharm could result from their public disclosure, despite the evidence of Mr. Windross and the lack of admissible evidence from Dr. Liston.

[30]       Based on various errors, Novopharm submits that the Orders are clearly wrong and that the Court should consider, de novo, the question of whether or not a protective order should issue in the form sought by Novopharm.

Abbott

[31]     Other than the discrete exception referred to in its own appeal, Abbott says that Prothonotary Milczynski exercised her discretion in a way that was entirely consistent with the Supreme Court of Canada's test in Sierra Club of Canada v. Canada (Minister of Finance), [2002] 2 S.C.R. 522, on when protective orders should be issued and how the underlying information should be assessed. Her findings of fact flow clearly from the evidence. There is no misapprehension of the facts identified in Novopharm's materials on this appeal; only a dissatisfaction with Prothonotary Milczynski's findings. As a result, Abbott submits that Novopharm's motion to appeal should be dismissed.

[32]       However, having applied the correct test for a protective order and reached conclusions on the evidence that were certainly available to her, Abbott argues that Prothonotary Milczynski erred when she went beyond the evidentiary record and, on the basis of a concession from counsel in argument, ordered that some information would be included in the Protective Order after all. Abbott says that this dramatic departure from her findings of fact and the law was an improper attempt to cure Novopharm's fundamentally empty evidence and protect information that she perceived might have been proven confidential had Novopharm not been wedded to its blanket protective order theory.

[33]     Based on her clear finding that "[t]here were simply assertions [from Novopharm] that everything in the documents and information was confidential" There was no evidence substantiating these assertions, only speculation," Abbott submits that Prothonotary Milczynski had no basis upon which to order any material to be included in a Protective Order.

Is Novopharm Entitled to a Protective Order in the Form Sought?

i)           Should the order be granted as a result of the combined effect of the Disclosure Order, subsections 6(7) and (8) of the Regulations and Rules 151 and 152 of the Federal Court Rules?

Novopharm

[34]       Novopharm argues that subsection 6(8) of the Regulations requires that any portion of a submission ordered to be produced pursuant to subsection 6(7) shall be treated confidentially. All of the portions of Novopharm's submission that will be disclosed in this proceeding were ordered to be produced pursuant to subsection 6(7).

[35]     Novopharm points out that the relationship between subsections 6(7) and 6(8) of the Regulations, and the requirement that anything disclosed under subsection 6(7) be treated confidentially, were imposed deliberately by the legislature. These subsections were added to the Regulations by amendment in 1998. The Regulatory Impact Analysis Statement for the amendment explains that the addition of subsection 6(7) was made to improve the Regulations by explicitly providing for disclosure from a generic manufacturer's drug submission. The quid pro quo for this extraordinary disclosure by a generic manufacturer to its brand-name opponent was that the materials should be treated confidentially.

[36]       Novopharm's position is that material to be filed in a Federal Court proceeding is required by law to be treated confidentially (as in the case of materials ordered to be produced pursuant to subsection 6(7) of the Regulations) and that the provisions of Rule 152 of the Federal Courts Rules apply, unless otherwise ordered by the Court. Like subsection 6(8) of the Regulations, the language of Rule 152 is mandatory, unless the Court specifically orders otherwise. Novopharm points out that Prothonotary Milczynski does not refer to, or consider the effect of Rule 152, anywhere in the Orders.

[37]     Novopharm argues that Rule 152(2) mandates a strict regime for the protection of the confidentiality of materials that is similar in its restrictiveness to a "Counsel's Eyes Only" protective order.

[38]     In conjunction with the strict regime mandated by Rule 152, Rule 151 of the Federal Courts Rules provides the Court with specific authority to issue protective orders to ensure that confidential materials are treated confidentially both before and after filing, while also allowing for those materials to be provided to individuals other than the solicitors of record in appropriate circumstances. However, before issuing a protective order under Rule 151(2) the Court "must be satisfied that the material should be treated as confidential."

[39]     In the First Order, Prothonotary Milczynski's conclusion was that "An order respecting the confidentiality of only certain information shall issue, that being information regarding the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules' non-medicinal ingredients." This conclusion determined the scope of paragraph 5 of the Second Order. The basis for this conclusion was that "Novopharm has not established to my satisfaction that all of the material in the ANDS should be treated as confidential." In Novopharm's submission, Prothonotary Milczynski was clearly wrong when she granted a protective order, in the form of the Second Order, that did not include within its scope at least the materials ordered to be produced under the Disclosure Order. The relationship between subsections 6(7) and 6(8) of the Regulations and, in particular, the mandatory language of subsection 6(8), requires that these materials must be treated confidentially. As such, Novopharm says that subsection 6(8) should, on its own, have been sufficient to satisfy Prothonotary Milczynski that those materials had to be treated as confidential and protected by a protective order.

[40]     Novopharm further argues that Prothonotary Milczynski made her decision based upon a wrong principle because Rule 151 includes only one mandatory requirement for the issuance of a protective order: the Court must be satisfied that the material "should be treated as confidential." In Rule 152, the legislature set out specific restrictions on material to be filed that "is required by law to be treated confidentially." These conditions, says Novopharm, are satisfied by the mandatory language of subsection 6(8) of the Regulation, which requires that materials produced under subsection 6(7) be treated confidentially.

[41]       Instead of applying these legislative imperatives with respect to how the documents ordered to be disclosed should be treated, Novopharm says that Prothonotary Milczynski misdirected herself by focusing on the evidence regarding the confidentiality of the underlying information in the documents. This was wrong because it is the documents themselves, not just the information within the documents, that has been ordered to be produced. It is also in direct conflict with the requirements of the Regulations and the Federal Courts Rules, 1998.

[42]     Novopharm urges that the Orders be amended and that a protective order should issue that at least protects the confidentiality of any documents from Novopharm's submission that were ordered to be produced pursuant to the Disclosure Order.

Abbott

[43]       Abbott says that, knowing that the motion for a Protective Order was pending, Prothonotary Lafrenière specifically ordered that the Disclosure Order was "without prejudice to or adjudication upon any matter which is subject of a motion for a Protective Order."

[44]     Novopharm argues that Prothonotary Lafrenière inadvertently decided the Protective Order motion by ordering disclosure under subsection 6(7) of the Regulations. Novopharm claims that such a Disclosure Order automatically justifies a Protective Order. Abbott submits that such a rule would be entirely contrary to Sierra Club, which requires that any breach of the open court rule, with the corresponding breach of the right to freedom of expression protected by section 2(b) of the Charter, be specifically justified by close scrutiny of the information that a party seeks to exclude from the public record.

[45]       Abbott says that subsection 6(8) deals with the obligation of a party receiving information pursuant to subsection 6(7) to treat it confidentially. It does not indicate whether documents will be accessible to the public when filed in Court. Abbott argues that the subsection merely creates an obligation of confidence akin to an implied undertaking which prevents the recipient of the compelled information from disclosing it. It does not create a general public policy that every piece of paper in a submission is confidential.

[46]     Also, Abbott feels that the existence of subsection 6(8) suggests that there is not, at common law, a confidence in each and every piece of paper within each and every submission received by the Minister of Health. This remedial provision does not deem the material confidential, but requires a recipient to treat it as confidential. This is more consistent, Abbott says, with the conclusion that there is no general or over-arching confidence in every piece of paper. It does not support Novopharm's assertion that all of the contents of every submission necessarily meet the requirements of "confidentiality" articulated by the Supreme Court of Canada in Sierra Club.

[47]     Similarly, Novopharm argues that Rule 152 automatically leads to a Protective Order. Abbott says this is clearly wrong. Like subsection 6(8) of the Regulations, Rule 152 simply sets out a mechanism for the treatment of documents that are confidential. It cannot take away the Court's duty to examine necessity, and other aspects of the Sierra Club test, before it specifically orders that information and documents will be excluded from the public record under a Protective Order.

            (ii)        Should a protective order be granted on the grounds that Novopharm has             met the normal test for the issuance of such orders?

            Novopharm

[48]     In addition to the combined effect of the Disclosure Order, subsections 6(7) and (8) of the Regulations and Rules 151 and 152 of the Federal Court Rules, Novopharm says that a comprehensive protective order should be granted on the grounds that Novopharm has met the normal test for the issuance of such orders in accordance with the Supreme Court of Canada's decision in Sierra Club.

[49]       Novopharm submits that Prothonotary Milczynski was clearly wrong when she preferred the unqualified and inadmissible expert opinion evidence of Dr. Liston over the direct fact evidence of Mr. Windross.

[50]     In particular, Novopharm says that Prothonotary Milczynski was clearly wrong when she accepted the evidence of Dr. Liston with respect to the effect of an NOA on the confidentiality of documents in the possession of Health Canada. This evidence was to the effect that, in Dr. Liston's opinion, the delivery of an NOA "... breaches or contravenes the concept of confidentiality." Dr. Liston does not speak for Health Canada (which he admitted) and ceased working for Health Canada before the Regulations came into force (and therefore before the first NOA was ever served.) His evidence is in direct contrast to that of Mr. Windross, who clearly stated that Health Canada keeps materials in an ANDS confidential until a product goes to market, which is well after the delivery of an NOA and after the issuance of an NOC.

[51]     Novopharm also says that Prothonotary Milczynski was also clearly wrong in holding that Mr. Windross' evidence was general, vague and speculative in comparison with that of Dr. Liston. In fact, Novopharm alleges it was Dr. Liston who speculated on what might or might not be in Novopharm's ANDS. Mr. Windross, on the other hand, gave detailed and specific evidence about the confidentiality of the documents in question and the harm that would be suffered by Novopharm if those documents were made public.

[52]       Furthermore, Novopharm reiterates that the evidence of Dr. Liston and the analysis of Prothonotary Milczynski incorrectly focus on the information within the documents, rather than the documents themselves. As explained by Mr. Windross in his evidence, which Novopharm says was misapprehended by Prothonotary Milczynski, the focus of the inquiry should be on the documents themselves and the context in which the information within those documents can be found. Novopharm says this is the relevant inquiry, as it is the documents that must be produced, not simply the information contained in them. In failing to consider and apply Mr. Windross' evidence, and in preferring the approach of Dr. Liston, Novopharm says that Prothonotary Milczynski made her decision based upon a wrong principle, misapprehended the evidence, and was clearly wrong.

[53]       It is Novopharm's position that had Prothonotary Milczynski not based her decision upon a wrong principle and misapprehended the evidence of Mr. Windross and Dr. Liston, she would have come to the conclusion that the test for a protective order was met in this case.

[54]       In particular, Novopharm says that Prothonotary Milczynski should not have dismissed the effect of the overarching principle of confidentiality with respect to drug submissions. As a result of this principle, and in accordance with the legislative mandate of subsection 6(8) of the Regulations, protective orders are routinely sought and generally granted in proceedings under the Regulations. As the Federal Court of Appeal stated in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 5 C.P.R. (4^th) 149 (F.C.A.) ("AB Hassle"):

      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.

[55]       Novopharm also asks the Court to note that AB Hassle, like the case at bar and every other case commenced under the Regulations, was commenced subsequent to the filing of an NOA. In contrast to Prothonotary Milczynski's conclusion concerning the effect of an NOA, the Federal Court of Appeal found that the confidential nature of the relationship between generic manufacturers and Health Canada was sufficient to support a protective order, notwithstanding the delivery of an NOA.

[56]       As noted by the Federal Court of Appeal in AB Hassle, protective orders in cases under the Regulations do not prevent the parties to the application from having access to the materials in issue, only the public. According to the Federal Court of Appeal, 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 (emphasis added).

AB Hassle, at p. 154

[57]       In the case at bar, Novopharm says that no evidence was filed by Abbott to suggest that there is any public interest whatsoever in requiring Novopharm to produce its materials without the protection of a protective order.

[58]       In fact, Novopharm notes that the test for protective orders in cases under the Regulations focuses on the belief of the moving party as to the confidentiality of the information and the likelihood that its non-confidential release could cause harm to its interests. The question of whether there is a public interest in the information's disclosure is not the primary focus of the inquiry. The Federal Court of Appeal in AB Hassle and the Supreme Court of Canada in Sierra Club have already noted that there is a "relatively small public interest at stake" in cases under the Regulations.

[59]       In this case, Novopharm submits that the test for the issuance of a protective order has been met. The evidence shows that Novopharm has a subjective belief that the information is confidential and that its interests would be harmed by its disclosure. The evidence also shows that the information has been treated as confidential and that Novopharm's belief that its interests could be harmed by the disclosure is reasonable. By choosing not to challenge Mr. Windross' evidence on cross-examination and by only filing the evidence of an individual (Dr. Liston) who cannot speak for Health Canada, has never worked in the generic drug industry and is not an expert in the confidentiality of documents, Novopharm says that Abbott did not adduce any meaningful evidence to contradict the clear and convincing evidence of Mr. Windross.

[60]       Novopharm is also of the view that the position of Abbott and the evidence of Dr. Liston are in direct opposition to the analysis in a recent decision of this Court involving the confidentiality of drug submissions under the Access to Information Act. In Merck Frosst Canada & Co. v. Canada (Minister of Health) (2004), 33 C.P.R. (4^th) 211 (F.C.) ("Merck Frosst"), this Court stated:

       Basing myself on AB Hassle, supra, I have no hesitation in finding that the information when submitted was confidential, was always treated by Merck Frosst as confidential, and that Merck Frosst has a legitimate expectation that the information would be kept in confidence by Health Canada.

       Some of that information appears to be currently in the public domain. However ... the question is not really whether or not there is information in the public domain concerning SINGULAR J , the question is whether the information as presented by Merck Frosst is in the public domain. If that information in the form presented "comme telle"> (as such) is not in the public domain, confidentiality has not, in my opinion, been lost. ...

       What is important here is the context in which the information is situated within the records held by the government.

     Merck Frosst, at pp. 227-228.

[61]       At page 8 of the First Order, Prothonotary Milczynski distinguishes Merck Frosst, stating that it was decided under a different statutory regime; one that "did contemplate the expectation of the parties and information to be taken in its entirety and in context." But Novopharm says that this determination highlights the wrong principle upon which her decision was based, as the expectations of the parties and the context in which the information is presented are directly relevant to the test for a protective order in cases under the Regulations.

[62]       Further, Prothonotary Milczynski rejects Merck Frosst as being decided under the Access to Information regime. She does this, however, immediately after accepting the evidence of Dr. Liston, who readily admits that his only experience with respect to the confidentiality of documents arises out of the Access to Information regime. Novopharm says that if Merck Frosst is irrelevant, then so too is the evidence of Dr. Liston.

[63]       In Novopharm's submission, rather than being "of little assistance," the reasoning in Merck Frosst is both helpful and applicable to the case at bar. Abbott already knows everything that is public about PREVACID; it is Abbott's product. What Abbott wants disclosed are the specific documents submitted by Novopharm to Health Canada and the context in which the information within those documents was provided. That is the very information that is relevant to this case, is most confidential and would cause the most damage to Novopharm if it were made public.

[64]       The evidence of Mr. Windross is that Novopharm's business interests could be severely and negatively affected if excerpts from Novopharm's submission were publicly disclosed and thereby obtained by another generic pharmaceutical company. There is substantial evidence before this Court, says Novopharm, both from Mr. Windross and Mr. Mason, that these documents would be of interest and useful to Novopharm's competitors in developing their own products to compete with Novopharm or to interfere in the approval of Novopharm's product. Novopharm proposes, therefore, that it is completely reasonable to believe that in the highly competitive generic drug industry, what is useful to its competitors would be detrimental to Novopharm.

[65]       Accordingly, in Novopharm's submission, it has met the test for the issuance of a protective order in this case that would protect the confidentiality of all of the documents ordered to be disclosed by the Disclosure Order. Novopharm requests that the Orders be amended and a protective order issue in the form attached to its Notice of Motion.

            Abbott

[66]     Abbott says that the requirements of Sierra Club are not satisfied in this case. According to Sierra Club, a Protective Order should only be granted when:                     

(a)    It is necessary to prevent a serious risk to an important interest, including a commercial interest, in the context of litigation "; and

(b)    The salutary effects of the Order, including the effects on the right of civil litigants to a fair trial, outweigh its deleterious effects, including the effects on the right to free expression, which in this context includes the public interest in open and accessible court proceedings.

[67]     Justice Iacobucci, in Sierra Club, explained at paras. 53 56 what is required to satisfy the burden on the "commercial interest" part of the test:

      In order to qualify as an "important commercial interest," the interest in question cannot merely be specific to the party requesting the order; the interest must be one which can be expressed in terms of a public interest in confidentiality. For example, a private company could not argue simply that the existence of a particular contract should not be made public because to do so would cause the company to lose business, thus harming its commercial interests. if there is no general principle at stake, there can be no "important commercial interest" for the purposes of this test. Or, in the words of Binnie J. in F.N. (Re), [2000] 1 S.C.R. 880, 2000 SCC 35">2000 SCC 35, at para. 10, the open court rule only yields "where the public interest in confidentiality outweighs the public interest in openness" (emphasis added [by Iacobucci J.]).

       In addition to the above requirement, courts must be cautious in determining what constitutes an "important commercial interest." It must be remembered that a confidentiality order involves an infringement on freedom of expression takes place under the second branch of the test, courts must be alive to the fundamental importance of the open court rule. See generally Muldoon J. in Eli Lilly and Co. v. Novopharm ltd. (1994), 56 C.P.R. (3d) 437 (F.C.T.D.), at p. 439.

[68]     Russell J. observed in A.C. v. Canada, [2003] F.C.J. No. 1861 (F.C.T.D.) at paras. 18 - 19, that there is a "heavy onus" to obtain a Confidentiality Order. The case must be "clearly established" and more than merely "speculative." The applicant must establish a "real and substantial" risk of harm that is "well-grounded in the evidence" and it is insufficient for the witnesses to rely on "bare statements assertions" (sic), as Novopharm did before Prothonotary Milczynski.

[69]     Abbott points out that, in the present case, Prothonotary Milczynski explicitly applied the Sierra Club test and found that Novopharm did not satisfy the heavy onus because Novopharm failed to:

(a)   Identify the information for which protection was sought;

(b)   Demonstrate a legally relevant interest specific to Novopharm in the alleged confidentiality of that information;

(c)   Demonstrate a public interest related to Novopharm's alleged specific interest that would justify the blanket protective order it sought; or

(d)   Prove any specific harm to any legally relevant interest if information were not excluded from the public record of the proceedings of the Court.

[70]     Abbott concludes that Novopharm has not identified any way in which Prothonotary Milczynski either misstated the appropriate test or misapplied it. She correctly followed Sierra Club and, on that analysis, Novopharm failed to meet its burden. Again, this is hardly surprising given the high level of scrutiny required to be conducted by the Court and the fact that Mr. Windross did not even attest to having read the Novopharm ANDS, but merely asserted, in general, that all of the contents of any ANDS are always confidential.

                  Did Prothonotary Milczynski err by going beyond the evidentiary record and          order that some information be included in the Protective Order?

Abbott

[71]       Abbott says that Prothonotary Milczynski's reasons correctly follow Sierra Club, and her findings flow naturally from the evidence, until the very last paragraph:

       Novopharm has not established to my satisfaction that all of the material in the ANDS should be treated as confidential, the only exceptions being information about the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules' non-medicinal ingredients, exceptions that appeared to be acknowledged (if not conceded) by the Applicants.

[72]       Abbott argues that, in this final paragraph, Prothonotary Milczynski made the error of including information in the Protective Order without evidence to justify it. She had already concluded that "[t]here were simply assertions [from Novopharm] that everything in the documents and information was confidential There was no evidence substantiating these assertions, only speculation."

[73]       Hence, Abbott takes the position that it was not open to Prothonotary Milczynski to attempt to convert a concession made by counsel in argument into the foundation for including a small segment of information in a Protective Order.

[74]       Sierra Club requires that the risk of harm that Novopharm had to prove must be well grounded in the evidence.

[75]       Since there was no evidence to substantiate Novopharm's assertions that everything in the documents and information was confidential, Abbott says there was no evidence that any risk attached to disclosure of any such documents, and therefore there was no basis upon which to order any documents be included in a Protective Order.

Novopharm

[76]       Because Abbott chose not to appeal the May 6^th Order, Novopharm says that the scope of Abbott's appeal is very limited: Abbott's appeal can only address the question of whether the Protective Order is consistent with the May 6^th Order. The larger question of whether a protective order should have been granted is not properly the subject matter of Abbott's appeal.

[77]       Novopharm also argues that the Protective Order is fully consistent with both the May 6^th Order and Prothonotary Milczynski's reasons for decision and, for this reason, Abbott's appeal must fail.

[78]       Abbott bases its position on what it calls a "discrete error." Abbott says that Prothonotary Milczynski first concluded that there was "no evidence" substantiating Novopharm's assertions that everything in the relevant documents and information was confidential, and then went on to protect certain documents and information notwithstanding this purported lack of evidence.

[79]       However, contrary to Abbott's assertions, Novopharm points out that Prothonotary Milczynski specifically found that there was evidence to support the inclusion of certain documents and information in the Protective Order. At page 9 of her May 6^th Order, Prothonotary Milczynski states as follows:

      Novopharm has not established to my satisfaction that all of the material in the ANDS should be treated as confidential, the only exceptions being information about the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules'non-medicinal ingredients, exceptions that appeared to be acknowledged (if not conceded) by the Applicants. (emphasis added)

[80]       Elsewhere in the May 6^th Order, Prothonotary Milczynski specifically finds that Novopharm has met its evidentiary onus with respect to certain information. At page 6 of the May 6^th Order, she writes:

       In this case, I find that with limited exceptions, Novopharm has failed to discharge its onus. As discussed further below, the motion is granted only in part. An order respecting the confidentiality of only certain information shall issue, that being information regarding the comparative bioequivalence of Novopharm's lansoprazole 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules non-medicinal ingredients. (emphasis added)

[81]       It is Novopharm's position that the evidentiary record not only supports the Protective Order as issued, but that is supports the broader form of protective order sought in Novopharm's original motion.

[82]       It was the evidence of Mr. Windross, that Form 3011, one of the documents found in Novopharm's ANDS and ordered to be produced in this case, contains strictly confidential information concerning the non-medicinal ingredients used in Novopharm's formulation. At paragraph 13 of his affidavit, sworn April 14, 2005, Mr. Windross stated that:

       ... sections of the Form 3011 such as the related submission information, the proposed shelf life, the non-medicinal ingredients and the proposed indication/use sections all contain information that is strictly confidential to Novopharm, has never been public and would not be provided by Novopharm to anyone but Health Canada without the protection of its confidentiality.. (emphasis added)

[83]       Novopharm also argues that Dr. Liston, the witness for Abbott, acknowledged in his evidence that this information could be confidential. After describing the general attributes of a Form 3011, Dr. Liston states:

26. Apart from the non-medicinal ingredients, this document is in no way confidential, nor does it contain any confidential information. The non-medicinal ingredients are discussed below.

...

45. There can certainly be cases in which the list of the inactive ingredients in a tablet or capsule could amount to confidential or proprietary information. It may be that the list of ingredients is a complicated or sophisticated selection of materials that cannot easily be reproduced and that has value to the person who develops the "formulation." (emphasis added)

[84]       With respect to Novopharm's product monograph and its description of the non-medicinal ingredients in Novopharm's formulation, Mr. Windross stated as follows:

15. It is true that Novopharm's proposed Product Monograph for its lansoprazole delayed-release capsules is similar to the PREVACID Product Monograph in many respects. It is, however, the differences between Novopharm's proposed Product Monograph and the PREVACID Product Monograph that are relevant to the issues in this case. Those differences are not public. They have been kept strictly confidential by Novopharm and will remain confidential until Novopharm's product goes to market. This is, in part, because the differences could help a competitor understand and copy Novopharm's strategy for gaining approval for its lansoprazole product before the expiry of the patents at issue in this case.

16. If Novopharm's proposed Product Monograph were made public, Novopharm's competitors would not only have all the details of Novopharm's product, including its formulation and bioequivalence information, but would also be able to base their own proposed Product Monographs on Novopharm's. While this is a fact of life for both brand-name and generic companies once their product goes to market (as the Product Monograph is released to the public at that time), it would be very prejudicial to Novopharm for it to be publicly available before that time.

[85]       In providing his opinion that the Novopharm product monograph could not contain anything different from the corresponding PREVACID product monograph, Dr. Liston was careful to exclude information concerning bioequivalence and non-medicinal ingredients. At paragraph 28 of his affidavit, he stated as follows:

       Apart from the comparative bioequivalence, however presented, and list of non-medicinal ingredients, Novopharm's Product Monograph cannot contain any substantive information that differs from the corresponding information in the PREVACID7 Product Monograph ... (emphasis added)

[86]       In Novopharm's submission, there was sufficient evidence before Prothonotary Milczynski for her to conclude that Novopharm's formulation and bioequivalence information were confidential and ought to be protected by the Protective Order. Certainly, she was not clearly wrong or acting on a misapprehension of the facts when she did so.

6.          ANALYSIS

The Test

[87]       As both sides point out, the applicable standard of review of a discretionary order of a prothonotary is that it ought not to be disturbed on appeal by a judge unless:

(a)        The questions raised 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                                 

          the facts.

[88]       This is the principle clearly established by the Federal Court of Appeal in Canada v. Aqua-Gem Investment Ltd., [1993] 2 F.C. 425 (F.C.A.), and recently confirmed by the Federal Court of Appeal in Merck & Co. v. Apotex Inc. (2004) 30 C.P.R. (4^th) 40 at para. 19, (F.C.A.).

[89]       In the present case, the Protective Order Motion does not raise issues that are vital to the final issue of the case, so the Court is being asked to intervene and set aside the decision of Prothonotary Milczynski on the basis that it is clearly wrong because it is either based upon a wrong principle and/or upon a misapprehension of the facts.

Subsection 6(8) of the Regulations

[90]       Novopharm's initial position is that the decision is clearly wrong because it disregards the combined effect of subsections 6(7) and 6(8) of the Regulations and Rules 151 and 152 of the Federal Courts Rules, 1998.

[91]       In essence, Novopharm says that the mandatory language of subsection 6(8) of the Regulations ("A document produced under subsection (7) shall be treated confidentially") requires that the materials that Prothonotary Lafrenière ordered produced under subsection 6(7) be treated confidentially. Prothonotary Milczynski should have used subsection 6(8) on its own as the basis for a Protective Order that would have covered all of the materials produced under subsection 6(7), and the fact that she did not do so means that her decision was clearly wrong.

[92]       The difficulty with this position is that Rule 151 under which the Protective Order was sought makes it clear that such orders are discretionary in that "the Court may order that materials to be filed shall be treated as confidential," and the jurisprudence related to Rule 151 stipulates a range of factors which the Court must consider in deciding whether to exercise that discretion. In fact, the relevant jurisprudence is referred to and applied by Prothonotary Milczynski in her decision.

[93]       Prothonotary Milczynski was obviously aware of the import of subsection 6(8) of the Regulations because she refers to it and discusses it before applying the Sierra Club test under Rule 151:

       Subsection 6(8) of the Regulations further provides that any documents produced pursuant to subsection 6(7), "shall be treated confidentially," meaning that as between the parties, the documents and information from the ANDS that have been ordered to be produced for the purposes of the litigation shall not be, and shall not be caused to be, disclosed.

[94]       In other words, Prothonotary Milczynski reconciles the mandatory wording of Regulation 6(8) with the discretionary nature of Rule 151 by saying that subsection 6(8) imposes confidentiality "between the parties" but does not deem materials produced pursuant to subsection 6(7) to be confidential for the purpose of a motion under Rule 151.

[95]       I cannot say that such an approach is clearly wrong. Subsection 6(8) is only applicable to a "document produced under subsection 6(7)" and subsection 6(7) provides a discretionary means for the Court to order, on motion by a "first person" (in this case the Applicants), that a "second person" (in this case Novopharm) produce portions of the NOC submission relevant to the disposition of the issues in the proceedings. If this is done, the recipient of a document produced as part of that process must treat the document confidentially. This does not mean that the document is deemed to be confidential for other purposes and other stages of the proceedings. In coming to Court for an order under Rule 151, Novopharm acted in accordance with Prothonotary Milczynski's reading of the effect of subsection 6(8). If subsection 6(7) deemed a document to be confidential for all purposes, then Rule 152 would apply automatically and there would be no need for a discretionary decision under Rule 151.

[96]       What appears at first glance to be a conflict between the mandatory language of subsection 6(8) and the discretionary language of Rule 151 is resolved on closer scrutiny. Subsection 6(7) provides the means for disclosure, and subsection 6(8) decrees that any documents so produced will be treated as confidential, until such time as the confidentiality of the material is established, in accordance with Rule 151, either as a matter of legislative fiat or Court order. In the context of the present case Novopharm could not establish confidentiality under a legislative provision and so had to proceed by way of Rule 151 to seek a Court Order in accordance with the governing jurisprudence.

[97]       In my view, then, Prothonotary Milczynski was correct to go beyond subsection 6(8) of the Regulations and to consider the motion for a Protective Order in accordance with Rule 151 and the relevant jurisprudence.

The Normal Test

[98]       Novopharm's second line of argument is that the documents disclosed under the Disclosure Order in accordance with subsection 6(7) of the Regulations should be held as confidential under a Protective Order because Novopharm was able to satisfy the grounds for such an order under Rule 151 and Prothonotary Milczynski was clearly wrong to hold otherwise.

[99]       In my view, Prothonotary Milczynski correctly refers to the Sierra Club test in her decision and appropriately sets out the factors that need to be satisfied before a protective order should issue. Her conclusion is that, "with limited exceptions," Novopharm failed to discharge the onus that the jurisprudence demands.

[100]    This conclusion is justified by Prothonotary Milczynski in her view of the evidence:

       In this case, I accept Novopharm's argument that there is a public interest in protecting the propriety and commercially sensitive information of generic drug manufacturers and the information that they may disclose in proceedings under the Regulations. This interest does not, however, give rise to a blanket confidentiality order. Other than providing a list of the information ordered to be disclosed from the ANDS pursuant to subsection 6(7) of the Regulations, however, Novopharm did not provide the Court with evidence relating what the information or documents were, and why in every case they ought to be confidential and kept from public access. The evidence was general and vague, and indeed, some of the information sought to be made subject to a confidentiality order appeared to be already accessible and available in the public domain. There were simply assertions that everything in the documents and information was confidential because Novopharm regarded them as confidential, and because the context of their submission and this proceeding required they be kept secret in their entirety so as not go give competitors any unfair advantage. There was no evidence substantiating these assertions, only speculation. In this respect, I prefer the Applicants' evidence, namely the two affidavits of Dr. Bert Liston, a former Assistant Deputy Minister of Health for Canada responsible for the Health Protection Branch, and in particular, the following point: that where an ANDS has been submitted, the mere fact of its filing is confidential, consequently confidentiality is appropriately applied to the entire content of the submission until a notice of allegation of allegation has been filed. Thus the "public giving" of the notice of allegation negates the blanket confidentiality thereafter, the concealment of material from the ANDS should be made only in the public interest and where the material is truly confidential.

      The decision of this Court in Merck Frosst Canada & Co. v. Canada (Minister of Health) (2004), 33 C.P.R. (4^th) 211 (F.C.) is of little assistance. In that case, a different statutory regime was under consideration, one that did contemplate the expectation of the parties and information to be taken in its entirety and in context.

[101]    Novopharm says that these conclusions on the evidence are clearly wrong for a variety of reasons:

(a)        Dr. Liston never dealt with an ANDS in the context of the Regulations during his time at Health Canada, which ended in 1992. He may know the general form of submission but he has no knowledge of the actual contents of Novopharm's submission;

(b)        Dr. Liston admitted on cross-examination that he did not regard himself as an expert in the area of confidentiality of documents;

(c)         Most of Dr. Liston's evidence is purported expert opinion evidence regarding what information might be in Novopharm's submission and whether the material would be confidential. Dr. Liston was not qualified as an expert in accordance with the principles established in R. v. Mohan, [1994] 2 S.C.R. 9 at p. 20 so that the expert opinion portions of his evidence are just not admissible;

(d)        There is no evidence before the Court from Health Canada to rectify the deficiencies in Dr. Liston's evidence or to challenge the evidence of Mr. Windross;

(e)        Prothonotary Milczynski was clearly wrong to prefer the unqualified and inadmissible expert opinion evidence of Dr. Liston over the direct fact evidence of Mr. Windross;

(f)          Prothonotary Milczynski was also clearly wrong in holding that Mr. Windross' evidence was general and vague and speculative in comparison with the evidence of Dr. Liston;

(g)        The evidence of Dr. Liston and the analysis of Prothonotary Milczynski incorrectly focus on the information within the documents, rather than the documents themselves.

[102]    What appears to have troubled Prothonotary Milczynski about Novopharm's approach to the Protective Order is that Novopharm failed to elaborate or specify the type of information for which it sought protection and relied instead upon general assertions that all of the material in an ANDS is necessarily confidential. In fact, it would appear that Mr. Windross did not attest to having reviewed the Novopharm ANDS. He appears to assert that, because an ANDS is always confidential, all of the Novopharm ANDS is confidential.

[103]    This meant that Novopharm did not satisfy the onus imposed in the Sierra Club test in various ways:

(a)   Other than the exceptions identified by Prothonotary Milczynski, no specific information or material was identified as requiring protection. Novopharm merely relied upon a blanket assertion that all of its documents were confidential. This was obviously not supportable because some of those documents contained information that was already in the public domain;

(b)   Because there was no specificity, Novopharm was unable to demonstrate a legally relevant interest in the confidentiality of the materials, and thus was unable to identify a corresponding public interest that would justify the blanket order which it sought;

(c)   The lack of specificity also meant that Novopharm was unable to make out a convincing case for ensuing harm and chose to rely instead upon a general and speculative assertion that disclosure of any of the documents would give competitors an unfair advantage.

[104]    Novopharm now seeks to overcome these difficulties by saying that Prothonotary Milczynski focussed on "information" when she should have focussed on "documents." Once again, Novopharm wishes to assert the primacy of subsection 6(8) of the Regulations. But the Sierra Club test does not take this approach. Prothonotary Milczynski was focussed upon applying the Sierra Club test, which she did. I cannot say, then, that she was clearly wrong in this regard.

[105]    As regards the evidentiary issues raised by Novopharm, it has to be said that the whole evidentiary record on both sides is less than satisfactory. This is primarily because Health Canada has not participated in this motion and has not provided direct evidence of what happens to documents and information that are submitted as part of the ANDS process.

[106]    This being said, Prothonotary Milczynski's decision makes it clear that the reason why she is of the view that, "with limited exceptions, Novopharm has failed to discharge its onus" is because Novopharm has not provided sufficient evidence to satisfy the Sierra Club test and other related jurisprudence. Assertions are made, but mere assertions are not enough: "There is no evidence substantiating these assertions, only speculation."

[107]    So any shortcomings in the evidence of Dr. Liston do not necessarily assist Novopharm to overcome this fundamental issue that assertions are not enough.

[108]    It is true that Prothonotary Milczynski does go on to say that she prefers Abbott's evidence, but she only emphasises one issue in this regard: where an ANDS if filed, the "mere fact of its filing is confidential, consequently confidentiality is appropriately applied to the entire content of the submission until a notice of allegation of allegation (sic) has been filed."

[109]    The significance of this fact is merely to point out that blanket confidentiality for the material in an ANDS cannot be sustained indefinitely. And whether, as Dr. Liston says, the notice of allegation negates the blanket confidentiality, or whether this occurs at some other time or in some other way, there will come a point when the public interest requires that material will only be held in confidence if it is truly confidential in accordance with the usual test.

[110]    The point is that Novopharm cannot rely upon the blanket confidentiality of subsection 6(8) in a context where the true confidentiality of the subsection 6(7) disclosure is being put to the test. If it wants protection for its documents and information under Rule 151 it has to go beyond blanket assertions of confidentiality and speculation and show the Court which documents are truly confidential in accordance with the governing jurisprudence.

[111]    So, in my view, attacking the evidence of Dr. Liston in this motion does not overcome the difficulty that Novopharm has in showing that Prothonotary Milczynski's decision was clearly wrong when it came to assessing Mr. Windross' evidence, and concluding that what he had to say did not discharge the onus upon Novopharm that Sierra Club demands.

[112]    Dr. Liston's point was that there could be situations where the "Context Information" contained in specific documents might be confidential, but there was nothing to suggest that such was the case in this instance. My reading of Mr. Windross' evidence, is that, apart from his general assertions about the confidentiality of the whole package of documents disclosed, he did not identify specific "Context Information" that was, in fact, confidential and relate this to a specific harm that disclosure would cause.

[113]    Novopharm's, and Mr. Windross', approach to this matter was based upon the premise that subsection 6(8) of the Regulations provides a statutory mandate for the blanket protection of documents and information disclosed under subsection 6(7). Mr. Windross' evidence and his general assertions are geared to this approach. But once it is concluded that subsection 6(8) does not provide such blanket mandatory coverage, and that the normal Sierra Club test has to be satisfied, the shortcomings of such an approach become immediately evident.

[114]    It was these shortcomings that Prothonotary Milczynski identified in Mr. Windross' evidence. In doing so, and in concluding that the onus had not been met by Novopharm, the Court cannot say that she was clearly wrong.

[115]    In order to satisfy the Sierra Club test, Novopharm was required to identify and elaborate the documents and information that required protection. Rather than providing such elaboration, Novopharm chose to assert that everything in an ANDS is necessarily confidential. Prothonotary Milczynski rejected this approach on a Rule 151 motion, and I believe she was correct to do so.

[116]    The importance of Dr. Liston's evidence for Prothonotary Milczynski's decision was that he was able to speak to the contents of an ANDS and the general policies of the Ministry. The only point that Prothonotary Milczynski singles out is the one which supports the position that blanket confidentiality comes to an end at some time. Whatever the shortcomings of the evidence (and both sides had difficulty in presenting direct evidence on point) I do not believe they undermine the fundamental decision that Prothonotary Milczynski made to the effect that the onus was on Novopharm to satisfy the Sierra Club test and Novopharm's own evidence, given by Mr. Windross, was not enough to do this.

Cases Cited By Novopharm

[117]    I do not believe that the cases cited by Novopharm assist in overcoming the problems inherent in its approach to satisfying the Sierra Club test.

[118]    I believe Prothonotary Milczynski was correct to point out that a different statutory regime was in play in the case of Merck Frosst Canada, and one that brought up other considerations.

[119]    Similarly, the general wording relied upon in AB Hassle has to read in terms of the specific facts of that case which dealt with "certain affidavit evidence" and not the extent to which the contents of an ANDS should be included in a Protective Order, which is the case in the present appeals.

[120]    Prothonotary Milczynski was correct, in my opinion, to concentrate upon the test as stated in Sierra Club and its particular application to the facts of this case.

Abbott's Appeal

[121]    I believe Abbott is just wrong in its assertion that Prothonotary Milczynski "made the error of including information in the Protective Order without evidence to justify it."

[122]    Her decision makes it clear that she does not, as Abbott asserts, "attempt to convert a concession made by counsel in argument into the foundation for including a small segment of information in a Protective Order."

[123]    Prothonotary Milczynski makes a specific finding on the evidence that there are "limited" exceptions where Novopharm has discharged the onus, and her reference to the acknowledgment of counsel in the final paragraph is not the basis for the finding that "Novopharm has not established to my satisfaction that all the materials in the ANDS should be treated as confidential, the only exceptions being information about the comparative bioequivalence of Novopharm's 15 mg and 30 mg delayed-release capsules, and the specific formulation of the capsules' non-medicinal ingredients ."

[124]    My review of the evidence of Mr. Windross indicates that he did provide sufficient specificity to support these conclusions, and this was not questioned in any material way by Dr. Liston .

[125]    Prothonotary Milczynski was not clearly wrong in this regard.

ORDER

THIS COURT ORDERS that

1.                   Both Appeals are dismissed

2.                   No order shall be made as to costs.

"James Russell"