Biovail Corp. v. Canada (Minister of National Health and Welfare)

Biovail Corp. v. Canada (Minister of National Health and Welfare) Court (s) Database Federal Court of Appeal Decisions Date 2003-10-31 Neutral citation 2003 FCA 406 File numbers A-637-02 Decision Content Date: 20031031 Docket: A-637-02 Citation: 2003 FCA 406 CORAM: Décary J.A. Létourneau J.A. Nadon J.A. BETWEEN: BIOVAIL CORPORATION and GALEPHAR P.R. INC. Appellants and THE MINISTER OF NATIONAL HEALTH AND WELFARE and RHOXALPHARMA INC. Respondents Heard at Ottawa, Ontario, on October 7, 2003. Judgment delivered at Ottawa, Ontario, on October 31, 2003. REASONS FOR JUDGMENT BY: NADON J.A. CONCURRED IN BY: DÉCARY J.A. LÉTOURNEAU J.A. Date: 20031031 Docket: A-637-02 Citation: 2003 FCA 406 CORAM: Décary J.A. Létourneau J.A. Nadon J.A. BETWEEN: BIOVAIL CORPORATION and GALEPHAR P.R. INC. Appellants and THE MINISTER OF NATIONAL HEALTH AND WELFARE and RHOXALPHARMA INC. Respondents REASONS FOR JUDGMENT [1] This appeal from a decision of Noël J. of the Federal Court, 2002 FCT 1143, November 5, 2002, which dismissed the appellants' motion for an order reversing a decision of Prothonotary Roger Lafrenière dated August 27, 2002, raises an issue with respect to the interpretation of subsection 6(7) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"). [2] Although the relevant facts were thoroughly reviewed by Noël J. in his decision, a brief summary thereof will be helpful to a proper understanding of the appeal. [3] The appellant Biovail Corporation ("Biovail") is the exclusive licensee of Canadian patent 2,111,085 entitled "Extended-Release Form of Dilitiazem" relating to the drug dilitiazem (the "'085 Patent"). Following receipt of a Notice of Allegation ("NOA") from the respondent RhoxalPharma Inc. ("Rhoxal") dated January 31, 2002, in which Rhoxal asserted that the process by which it would manufacture capsules of 120mg, 180mg, 240mg, 300mg and 360mg of dilitiazem hydrochloride would not infringe the '085 Patent, Biovail commenced proceedings under the Regulations on March 19, 2002, to prohibit the Minister of National Health and Welfare (the "Minister") from issuing a Notice of Compliance ("NOC") to Rhoxal with respect to its dilitiazem hydrochloride capsules until the expiration of the '085 Patent. [4] Before going any further, I should mention that the Rhoxal's NOA dated January 31, 2002, was the second NOA sent to Biovail. In effect, on July 24, 2001, Rhoxal had provided Biovail with a first NOA which led Biovail to initiate proceedings on September 12, 2001, to prohibit the Minister from issuing a NOC to Rhoxal in connexion with its dilitiazem hydrochloride capsules until the expiration of the '085 Patent. However, on September 24, 2001, Rhoxal withdrew its NOA and, as a result, Biovail's proceedings were abandoned. [5] On April 8, 2002, at Rhoxal's request, the Federal Court issued a Protective Order with respect to the documents which Rhoxal might have to disclose to Biovail during the course of the proceedings. [6] On April 18, 2002, Rhoxal provided to Biovail documents containing the detailed formulation, the description of the manufacturing process and the summary flow chart of the process used to make its capsules. These documents form part of Rhoxal's Abbreviated New Drug Submission ("ANDS") filed with the Minister in support of its application for a NOC concerning its dilitiazem hydrochloride capsules. [7] On April 30, 2002, counsel for Biovail acknowledged receipt of the above documents and confirmed that they had been received, subject to the Protective Order of April 8, 2002. [8] On May 2, 2002, Biovail filed its evidence on the merits of its application for a Prohibition Order, namely the affidavits of Maria Susana Diaz and Dina Khairo, both sworn on May 1, 2002. [9] On May 30, 2002, counsel for Biovail sent the following letter to counsel for Rhoxal: Thank you for the signed Consent which we received on May 8, 2002. We acknowledge receipt of a general description of the ingredient list and manufacturing instructions for the RhoxalPharma capsule enclosed with your letter of April 18, 2002. We expect to receive as part of the affidavit evidence that you will be filing, more detailed documents disclosing the formulation and composition, and manufacturing and processing instructions for the RhoxalPharma capsule. You will note that paragraph 2 of the Protective Order of April 8, 2002 specifically refers to "the formulation of composition of ... dilitiazem capsules, the process by which RhoxalPharma's dilitiazem capsules are made or the identity of RhoxalPharma's supplier of dilitiazem capsules...". Thus, as the Protective Order contemplates the disclosure of this information, we would like to receive it as part of your evidence. We also expect to see, as part of your client's evidence, the relevant parts of the abbreviated new drug submission (ANDS), the contents of which are also specifically referred to in paragraph 2 of the Protective Order. As we previously advised you, we are prepared to extend the same courtesy to you kindly extended to us in consenting to an extension of time in filing your evidence. [10] On July 2, 2002, Rhoxal filed its evidence consisting of two affidavits of Dr. Norman Weiner, the first on the issue of the invalidity of the '085 Patent, and the second on the issue of non-infringement. [11] On July 9, 2002, Biovail filed a Notice of Motion seeking the production of all relevant portions of Rhoxal's ANDS and the new drug application of Andrax, Rhoxal's alleged supplier, filed in the United States of America. Biovail also sought leave to file reply evidence to the evidence of Dr. Weiner. [12] In support of its motion, Biovail relied on the affidavits of Ms. Khairo and Diaz, filed as its evidence on the merits, and on the affidavit of Nicholas Whalen, a student-at-law, sworn on July 9, 2002, and that of Heather Watts, one of Biovail's attorneys, sworn on August 23, 2002. [13] Biovail's motion was argued on August 26, 2002, before Prothonotary Lafrenière who, on August 26, 2002, dismissed the motion. The Prothonotary's Reasons were issued on September 19, 2002. [14] In dismissing Biovail's motion, Prothonotary Lafrenière concluded that Biovail had failed to demonstrate that the disclosure sought was "required and important" and that the disclosure already made by Rhoxal was inadequate. The Prothonotary further held that Biovail had not brought its motion in a timely manner. In his view, Biovail ought to have made its request for production under subsection 6(7) prior to the filing of its evidence. Hence, he dismissed Biovail's motion. [15] As a result, Biovail brought a motion under Rule 51 of the Federal Court Rules, 1998, for an order reversing Prothonotary Lafrenière's decision. With respect to that part of Biovail's motion seeking disclosure of portions of Andrax's United States New Drug Submission, Noël J. concluded that the issue was moot, by reason of paragraph 5 of the affidavit of Len Arseneault, dated August 22, 2002, whereby Mr. Arseneault, Rhoxal's Director of Research and Regulatory Affairs, stated that Rhoxal did not have a copy of Andrax's New Drug Submission and that Andrax was not a party under Rhoxal's control. There is no appeal from that part of Noël J.'s Order. [16] With respect to that part of Biovail's motion seeking leave to file reply evidence to the evidence of Dr. Weiner, Noël J. referred the matter back to the Prothonotary. There is also no appeal from that part of Noël J.'s Order. [17] After reviewing the relevant facts, the Prothonotary's decision, subsection 6(7) of the Regulations and the relevant case law, Noël J. indicated what, in his view, an applicant had to show in order to obtain disclosure under subsection 6(7): that his request for disclosure is timely, that the information already in hand is not sufficient to allow him to properly address the issues under litigation and that the sought-after information is relevant to the issues before the Court. [18] Noël J. then went on to apply the above requirements to the motion before him. Firstly, he found no justification for Biovail's delay in seeking disclosure of the material sought, i.e. why the motion was not filed prior to Biovail adducing its evidence on the merits. Secondly, he was not satisfied that the disclosure already made by Rhoxal was insufficient so as to allow Biovail to properly respond. Thirdly, the learned Judge was not satisfied that the material sought by Biovail was relevant to the issues under litigation. [19] As a result, Noël J. concluded that Prothonotary Lafrenière's decision was based on the evidence before him and that he had properly exercised his discretion. Consequently, Biovail's motion under Rule 51 was dismissed. Hence, the present appeal. [20] The issue before us is whether Noël J. erred in dismissing Biovail's appeal from Prothonotary Lafrenière's decision. We are only concerned with the dismissal of Biovail's motion for production of all relevant portions of Rhoxal's ANDS. [21] In challenging Noël J.'s decision, Biovail makes a number of submissions. It argues that Noël J. failed to apply the correct legal test with respect to the application of subsection 6(7) when he formulated a three-pronged test at paragraph 40 of his Reasons, where he states: [40] In order to be able to justify the application of subsection 6(7) of the Regulations, a party must convince the Court on three matters: a) That the request for disclosure is done in a timely manner; and b) That the information already provided is not sufficient to deal with the issues at stake; and c) That the disclosure of the required information is necessary because it is relevant to the disposition of the issues in the proceeding. Biovail submits that not only is there no authority to support the first prong of the test, but that the second and third prongs were specifically rejected by this Court in Novartis AG et al. v. Abbott Laboratories Ltd. et al. (2000), 7 C.P.R. (4th) 264 at 269-272 (F.C.A.). [22] Biovail also argues that the learned Judge erred in finding that the words "at any time", found in subsection 6(7), should be interpreted as requiring a first person to bring its motion for production of a ANDS "without delay". Biovail submits that subsection 6(7) has previously been interpreted in a manner consistent with the framework for statutory interpretation outlined by the Supreme Court of Canada in Rizzo v. Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 at 40-41, as well as the March 12, 1998 Regulatory Impact Analysis Statement accompanying the amendments to the Regulations. Biovail says that a proper construction of the words "at any time", as well as the 30-day window provided by the Federal Court Rules, 1998, allowed it to be within the time period permitted by subsection 6(7). [23] Biovail further submits that Noël J. erred in finding that the evidence before the Prothonotary did not deal specifically with the relevancy requirement of subsection 6(7). It argues that the affidavits of Ms. Diaz and Ms. Khairo clearly address the relevance of Rhoxal's ANDS to the proceedings. Biovail also says that in dismissing its argument that Rhoxal should have produced the ingredient list and manufacturing instructions under oath, rather than in a letter produced for settlement purposes, the Motions Judge erred, since documents provided for settlement purposes are privileged and, therefore, cannot be used for the purpose of preparing its evidence-in-chief. [24] Rhoxal argues that Noël J. made no palpable and overriding error in dismissing Biovail's motion for the production of its ANDS. It submits that it had already provided Biovail with the relevant extracts of its ANDS, that these extracts were not disclosed as part of settlement discussions and that it had no obligation to produce these documents under oath. Finally, Rhoxal says that Biovail has not met the test for disclosure under subsection 6(7), since no evidence was adduced with respect to the relevancy of the information sought. [25] For the reasons that follow, I am of the view that this appeal should be dismissed. [26] I begin by reproducing subsection 6(7) of the Regulations, which reads as follows: 6. (7) On motion of a first person, the court may, at any time during a proceeding, (a) order a second person to produce any portion of the submission for a NOC filed by the second person relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and (b) order the Minister to verify that any portion produced corresponds fully to the information in the submission. 6. (7) Sur requête de la première personne, le tribunal peut, au cours de l'instance, a) ordonner à la seconde personne de produire les extraits pertinents de la demande d'avis de conformité qu'elle a déposée et lui enjoindre de produire sans délai tout changement apporté à ces extraits au cours de l'instance; b) enjoindre au Ministre de vérifier que les extraits produits correspondent fidèlement aux renseignements figurant dans la demande d'avis de conformité. [27] In Novartis AG, supra, this Court was called upon to provide guidance with respect to the interpretation of subsection 6(7). Therein, the first person, Novartis, sought disclosure of information contained in the second person's Abbreviated New Drug Submission ("ANDS") which formed part of the application sent to the Minister for a NOC. In allowing only partial disclosure of the second person's ANDS, the motions judge held that Novartis had not adduced "compelling evidence" demonstrating the necessity of ordering the disclosure of the material sought. [28] In appeal, Novartis argued that the Motions Judge had erred by imposing upon it a test for disclosure which could not be justified on the basis of the wording of the subsection. Rather, according to Novartis, the only test for disclosure under the subsection was the relevancy of the material sought. [29] Mr. Justice Rothstein, writing for the Court, could not agree with Novartis' submission that relevancy was the only test under the subsection. In his view, Novartis was mistaken in arguing that the proper interpretation of the subsection led to the imposition of an obligation similar to that imposed on parties to produce documents and information in normal civil litigation, in which context the establishment of relevancy gives rise to an obligation to produce documents and answer questions. Rather, in Mr. Justice Rothstein's opinion, relevancy under subsection 6(7) is simply a condition allowing the Court to exercise its discretion. Thus, if the information sought is relevant, the Court may order its production. [30] Mr. Justice Rothstein then indicated that although the subsection did not provide any criteria limiting or guiding the Court with respect to the discretion to be exercised, the nature and context of the proceedings under the Regulations did provide some guidance as to the manner in which the Court should exercise its discretion. [31] Rothstein J.A. was satisfied that the March 12, 1998 Amendments to the Regulations (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/98-166), and the accompanying Regulatory Impact Analysis Statement left not doubt that the Governor-in-Council intended, by the enactment of subsection 6(7), fuller disclosure than what had previously been ordered by the Court. In this regard, at paragraph 16 of his Reasons, he referred to the following excerpt in the Regulatory Impact Analysis Statement: Other changes are designed to reduce unnecessary litigation and streamline the litigation process: specifying the circumstances in which parties can be awarded damages and factors that may be taken into account in calculating damages; specifying some of the circumstances in which costs may be awarded; ensuring the products-specific patent list; expressly confirming the authority of the Minister of Health to audit patent lists; placing the burden of proof on manufacturers seeking to produce a generic version of a drug covered by a product-by-process patent; permitting the court to order disclosure portions of a generic manufacturer's Notice of Compliance submission if it is relevant to resolving the issues by the court (the information must be treated confidentially); requiring more specificity with a Notice of Allegation ... [32] Rothstein J.A. then went on, citing the decisions of McGillis J. in SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999), 3 C.P.R. (4th) 22 (F.C.T.D.) and Pelletier J. (as he then was) in Proctor & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health) (2000), 7 C.P.R. (4th) 116 (F.C.T.D.), to opine that certain factors would constitute appropriate considerations for the exercise of discretion under subsection 6(7), namely, whether disclosure of the material sought was required and important, and whether the disclosure in the NOA was insufficient or inadequate. Mr. Justice Rothstein, however, made it clear that the above considerations were only examples of what could constitute relevant considerations in the exercise of discretion under subsection 6(7). [33] As I have already indicated, Biovail argues that Noël J. erred in concluding that notwithstanding the words "at any time" found in subsection 6(7), a first person had to bring a motion for production "without delay". It takes the position that Noël J. erred in concluding that the timeliness of the application was an appropriate consideration. I have no hesitation in stating that the timeliness of an application is a consideration which a judge may take into account in deciding whether he or she should order production under subsection 6(7). Although the subsection provides that the Court may order production "at any time during a proceeding, ...", it does not follow, as Biovail suggests, that the delay in which the motion is made cannot be a relevant consideration. Once satisfied that the documents sought are relevant, a judge may consider a number of factors in deciding whether he or she ought to order production, one of these factors being, in my view, whether the application was brought in a timely manner. To hold otherwise would, in my respectful view, make no sense. [34] In view of the conclusion which I have reached in regard to the relevancy of the documents sought, as will shortly appear from my Reasons, we need not decide whether, in the present instance, Biovail's application was brought in a timely manner. [35] I now turn to the question of whether the material sought by Biovail is relevant to the issues in these proceedings. Noël J., at paragraph 47 of his Reasons, concluded that Biovail had not adduced any evidence showing the relevancy of the material sought. The Prothonotary also appears to have been of that view. Based on the material in the record before him, I cannot but agree with Noël J. that Biovail has failed to demonstrate the relevancy of the documents sought. It has not adduced any evidence to show that portions of Rhoxal's ANDS, other than those already disclosed, are relevant to the issues in this litigation. Counsel for Biovail asserted in writing and orally before us that other portions of Rhoxal's ANDS were relevant, but those assertions can only be characterized, in my view, as bald assertions. There is nothing linking these assertions to the evidence. It may well be that there are indeed other relevant portions of Rhoxal ANDS which have not been provided to Biovail, but the burden was on Biovail to convince the Court that that was the case. In my view, Biovail has failed in that endeavour. [36] In support of the motion which has given rise to this appeal, Biovail relies primarily on the affidavit of Dina Khairo sworn May 1, 2002. Specifically, at paragraph 56 of its Memorandum of Fact and Law, Biovail lists the reasons found in Ms. Khairo's affidavit which support its arguments relating to the relevancy of the material sought: 56. The affidavit of Ms. Dina Khairo, sworn May 1, 2002, listed numerous reasons why the NDS of RhoxalPharma was relevant, required and important in the proceedings, including: a) the need to address inconsistent allegations made by RhoxalPharma with regard to its formulation (para. 33); b) the need to address inconsistent allegations made by RhoxalPharma with regard to its supplier (para. 36-37); c) the fact that if the allegations made by RhoxalPharma in NOA #2 with regard to its formulations are accepted, RhoxalPharma has effectively admitted its infringement of claims 36 and 37 of the '085 Patent (paras. 38-43); and (d) the failure on the part of RhoxalPharma to provide samples upon which Biovail could conduct tests to confirm or deny the allegations made in NOA #2 (paras. 14-19, 34). [37] Unfortunately for Biovail, I fail to see how Ms. Khairo's affidavit supports its motion for disclosure of additional portions of Rhoxal's ANDS. Ms. Khairo's affidavit was offered as part of Biovail's evidence and, thus does not purport to address the issue of relevancy under subsection 6(7). The obvious purpose of Ms. Khairo's affidavit is to show that Rhoxal's NOA is deficient, i.e. that it contains numerous inconsistent allegations with regard to its capsule formulation and its supplier. The affidavit also attempts to show that Rhoxal may have admitted, in its NOA, that its capsule formulation infringes the '085 Patent. It cannot be said, however, that Ms. Khairo's affidavit demonstrates why other portions of Rhoxal's ANDS are relevant and thus, ought to be disclosed to Biovail. [38] When Ms. Khairo's affidavit was filed, Biovail had by then received documentary information with respect to the detailed formulation, the description of the manufacturing process and the summary flowchart of the process used by Rhoxal to make its capsules, these documents all forming part of Rhoxal's ANDS. Nowhere in her affidavit does Ms. Khairo indicate or take the position that the material received is incomplete or insufficient, or that she requires additional information in order to complete or supplement her affidavit. In other words, she does not take the position that there exist other portions of Rhoxal's ANDS that are relevant. She makes no attempt to speak to or demonstrate the relevancy of other portions of Rhoxal's ANDS. She simply attempts to make the case that the Court should make the Order prohibiting the Minister from issuing an NOC to Rhoxal on the ground that Rhoxal has not shown that its process would not infringe the '085 Patent. [39] I therefore conclude on this point that Noël J. made no error when he held that Biovail had not met its burden of proof in regard to the relevancy of the material sought. Although this conclusion is sufficient to dispose of the appeal, I will nonetheless address two other issues raised by Biovail. [40] Firstly, Biovail argues that it was prevented from using or referring to the ingredient list and manufacturing instructions because it had received this information in the context of settlement discussions. On April 18, 2002, counsel for Rhoxal wrote to counsel for Biovail in the following terms (Appeal Book, Vol. III, p.369): Further to your telephone call with M. Leclerc and pursuant to your request, please find enclosed the ingredient list and manufacturing instructions for the RhoxalPharma capsules referred to in the Notice of Allegation of January 31, 2002. These documents are subject to the Confidential Order dated April 8, 2002. We also confirm our consent to a fifteen (15) day extension on your evidence filing deadline. We await to hear from you regarding settlement potential for this matter. [41] On April 30, 2002, counsel for Biovail wrote to counsel for Rhoxal, acknowledging receipt of the material sent. The first paragraph of the letter reads as follows (Appeal Book, Vol. III, p. 373): Thank you for your letter of April 18, 2002, enclosing the ingredient list and manufacturing instructions for the RhoxalPharma capsules. I confirm that we have received this subject to the Confidentiality Order of April 8, 2002. [42] The above letters make it clear, in my view, that the only restriction regarding the use of the documents sent to Biovail is the April 8, 2002, Confidentiality Order. Under that Order, it was open to Biovail to use the information received from Rhoxal, subject to the following terms (see p. 3 of the Order, p.328 of Vol. II of Appeal Book): Each of the persons to whom Confidential Information is disclosed pursuant to the terms of this Order shall: (a) not disclose said Confidential Information to anyone except others permitted to see it pursuant to this Order; and (b) not use said Confidential Information for any purpose except for the purpose of this litigation [emphasis added]; (c) take reasonable precautions as to the storage, custody and use of the Confidential Information to prevent the unauthorized or inadvertent disclose of any Confidential Information. [43] The letters of April 18 and April 30, 2002, and the Protective Order of April 8, 2002, leave me in no doubt that nothing prevented Biovail from using in these proceedings the information provided to it by Rhoxal on April 18, 2002. There is nothing in the exchange of correspondence to support Biovail's argument that it was prevented from using the material by reason of settlement discussions. [44] Secondly, Biovail argues that although Rhoxal was not obliged to produce affidavit evidence to support its NOA, it should nonetheless be ordered to produce its ANDS under oath because the disclosure was made in the context of settlement discussions. At paragraphs 52, 53 and 54 of its Memorandum, Biovail explains its position as follows: 52. While it is clear that RhoxalPharma is not obliged to file affidavit evidence in support of the allegations that it has made, this does not mean that it cannot attempt to rely on the document it has given Biovail, by ignoring the rules and legal principles governing such production. Since RhoxalPharma has produced its alleged formula in the context of settlement discussions, it should not now be permitted to escape its obligations under the Regulations, by claiming it has already produced such documents when that production does not permit their use in the proceedings. 53. In addition, the documents produced are not under oath, and are not adducible in evidence by RhoxalPharma. Biovail cannot be compelled to make out RhoxalPharma's case by putting these documents in its own evidence. 54. While Biovail indeed bears the burden of proof, under section 6 of the Regulations, for disproving the allegations contained in NOA #2, it cannot do so if it must respond to an admittedly incomplete and inadequate NOA. [45] If Biovail's point is that there was a duty upon Rhoxal to produce the sought-after material by way of affidavit, Biovail then is clearly mistaken. That point was unequivocally decided by this Court in Merck Frosst Canada Inc. v. Canada (Minister of Health) (1998), 82 C.P.R. (3d) 417. At paragraphs 10, 12 and 13 of his Reasons, Mr. Justice Décary, writing for the Court, says: [10] Merck objects to the Order on the following grounds. First, Apotex should not be allowed to disclose its process to Merck without supporting the disclosure with an affidavit. According to counsel, Merck has a right to explore further the meaning and effect of Apotex's process through cross-examination of the deponent of the affidavit prior to deciding whether or not to file additional evidence ... [12] Merck's first argument confuses, in my view, disclosure of evidence and filing of evidence. The Motions Judge's Order in effect merely allows Apotex to disclose its process to Merck now that a Protective Order is in place. It puts the parties in the very position they would have been in had they reached an agreement on the confidentiality issue prior to the institution by Merck of its application. The disclosure in effect completes the Notice of Allegation which a generic company is required by subsection 5(3) to serve on the manufacturer and which must contain pursuant to paragraph 5(3)(a) "a detailed statement of the legal and factual basis for the allegation". Apotex could obviously not include its process in the Notice without first obtaining a Protective Order. Once the Protective Order is obtained, the process is disclosed as part of the Notice and there being no requirement that a Notice be supported by affidavit, I fail to see why an affidavit should be required to support the disclosure of the process. [13] That is not to say, of course, that the process has been filed in the proceedings brought by Merck under subsection 6(1). It has, yet, merely been disclosed. The disclosure allows Merck to either realize that its objection is ill-founded and withdraw its application or, in the event it chooses to proceed with its application, to complete its affidavit evidence. It bears repeating that Merck, as the moving party in proceedings under subsection 6(1), has the initial evidentiary burden. Had the process been disclosed to it from the start, Merck would have had the opportunity to file affidavit evidence with actual knowledge of what the process was. That opportunity is now given back to Merck, with a time limit of 45 days which is precisely that which it would have had if Apotex's process had been disclosed as part of the Notice of Allegation. [Emphasis added] [46] For these reasons, I would dismiss Biovail's appeal with costs. "M. Nadon" J.A. "I agree. Robert Décary J.A." "I agree. Gilles Létourneau J.A." FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-637-02 APPEAL FROM AN ORDER OF THE FEDERAL COURT OF CANADA DATED NOVEMBER 5, 2002, NO. T-472-02. STYLE OF CAUSE: BIOVAIL CORPORATION and GALEPHAR P.R. INC. v. THE MINISTER OF NATIONAL HEALTH AND WELFARE and RHOXALPHARMA INC. PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: October 7, 2003 REASONS FOR JUDGMENT: NADON J.A. CONCURRED IN BY: DÉCARY J.A. LÉTOURNEAU J.A. DATED: October 31, 2003 APPEARANCES: Mr. Douglas N. Deeth Ms. Heather E. A. Watts FOR THE APPELLANTS Ms. Marie Lafleur Ms. Julie Desrosiers FOR THE RESPONDENT (RHOXALPHARMA INC.) SOLICITORS OF RECORD: DEETH WILLIAMS WALL LLP Toronto, Ontario FOR THE APPELLANTS FASKEN MARTINEAU DUMOULIN LLP Montréal (Québec) FOR THE RESPONDENT (RHOXALPHARMA INC.) Mr. Morris Rosenberg FOR THE RESPONDENT Deputy Attorney General of Canada (THE MINISTER OF NATIONAL Ottawa, Ontario HEALTH AND WELFARE)