Date: 19980702
Docket: A-223-98
CORAM: DENAULT J.A.
DÉCARY J.A.
LÉTOURNEAU J.A.
BETWEEN:
MERCK FROSST CANADA INC.,
- and -
MERCK & CO. INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH
- and -
APOTEX INC.,
Respondents
(Respondents)
Heard at Montreal (Quebec) on Friday, June 26, 1998.
Judgment delivered at Ottawa on July 2, 1998.
REASONS FOR JUDGMENT BY: DÉCARY J.A.
CONCURRED IN BY: DENAULT J.A.
LÉTOURNEAU J.A.
Date: 19980702
Docket: A-223-98
CORAM: DENAULT J.A.
DÉCARY J.A.
LÉTOURNEAU J.A.
BETWEEN:
MERCK FROSST CANADA INC.,
- and -
MERCK & CO. INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH
- and -
APOTEX INC.,
Respondents
(Respondents)
REASONS FOR JUDGMENT
DÉCARY J.A.
[1] This is yet another appeal pertaining to procedural matters under the Patented Medicines (Notice of Compliance) Regulations ("the Regulations"), this time with respect to amendments which came into force on March 12, 1998 (SOR/98-166).
[2] In April 1993, the appellants ("Merck") filed a Patent List in respect of their simvastatin tablets Canadian Patents Nos. 1,161,380 (the "380 Patent") and 1,199,322 (the "322 Patent").
[3] On January 26, 1998, the respondent Apotex Inc. ("Apotex"), served a Notice of Allegation ("the Notice") on Merck pursuant to paragraph 5(3)b) of the Regulations. Apotex alleged that the Merck Patents would not be infringed by its proposed formulation of simvastatin tablets.
[4] The Notice went on to allege that Patent 380 contained no claims for the medicine simvastatin or its use " since it related to a compound which constituted an intermediate step in the simvastatin process " and was thus improperly included in the Patent List. The Notice then alleged that Patent 380 only claimed this intermediate compound when produced by a specific process involving a specific microorganism, and Apotex would only obtain supplies of the intermediate compound when made by a different process involving a different microorganism. With respect to Patent 322, the Notice alleged that Apotex will not use or sell simvastatin made by any of the processes claimed in this patent.
[5] Apotex's Notice also informed Merck that the details of its process would be promptly disclosed once a suitable Protective Order or confidentiality agreement was in place.
[6] Merck and Apotex were unable to agree upon the terms of a confidentiality agreement.
[7] On March 13, 1998, Merck filed an application pursuant to subsection 6(1) of the Regulations seeking to prohibit the Minister from issuing a Notice of Compliance to Apotex. Merck's application was supported by five affidavits, as required by the Federal Court Rules applicable at the time.
[8] On March 19, 1998, Apotex brought a motion for a Protective Order and for an Order setting a schedule for the filing of affidavit evidence once the Protective Order was in place.
[9] Merck agreed to the terms of the Protective Order and only the scheduling motion went ahead before Mr. Justice Pinard. The Motions Judge accepted Apotex's proposed scheduling and made the following Order on March 26, 1998:
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2. an Order setting a schedule for the filing of Affidavit evidence as follows: |
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(a) applicants' evidence to be served and filed on the date that is on or before 45 days after receipt of Apotex' process to make simvastatin; |
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(b) respondents' evidence to be served and filed on a date that is on or before 30 days after the date prescribed by subparagraph (a) hereof; |
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[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 further explore 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. Second, Merck should not be forced to file its own affidavit evidence with respect to Apotex's process before Apotex files its own affidavit evidence. According to counsel, the presumption introduced in favour of the drug manufacturers when subsection 6(6) of the Regulations was added in 1998 changed the rules of the game and gave the manufacturers the right to have the last word in the filing of evidence.
[11] It will be useful at this stage to cite the relevant provisions of the Regulations:
| Patent List
[...]
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and wishes to compare that drug with, or make reference to, another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
[..]
| (i) the statement made by the first person pursuant to paragraph 4(2)(c) is false, |
| (ii) the patent has expired, |
| (iii) the patent is not valid, or |
| (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. |
[...]
(3) Where a person makes an allegation pursuant to paragraph (1)(b) or subsection (2) the person shall
| (a) provide a detailed statement of the legal and factual basis for the allegation; |
| (b) if the allegation is made under any of subparagraphs (1)(b)(i) to (iii), serve a notice of the allegation on the first person; |
| (c) if the allegation is made under subparagraph (1)(b)(iv), |
| (i) serve on the first person a notice of the allegation relating to the submission filed under subsection (1) at the time that the person files the submission or at any time thereafter, and |
| (ii) include in the notice of allegation a description of the dosage form, strength and route of administration of the drug in respect of which the submission has been filed; and |
| (d) serve proof of service of the information referred to in paragraph (b) or (c) on the Minister. |
Right of Action
6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraph 5(3)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.
[...]
(6) For the purposes of an application referred to in subsection (1), where a second person has made an allegation under subparagraph 5(1)(b)(iv) in respect of a patent and where that patent was granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.
[...]
|
Liste de brevets
[...]
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et souhaite en faire la comparaison, ou faire renvoi, à une autre drogue qui a été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue:
[...]
| b) soit une déclaration portant que, selon le cas: |
| (i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse, |
| (ii) le brevet est expiré, |
| (iii) le brevet n'est pas valide, |
| (iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. |
[...]
(3) Lorsqu'une personne fait une allégation visée à l'alinéa (1)b) ou au paragraphe (2), elle doit:
| a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde; |
| b) si l'allégation est faite aux termes de l'un des sous-alinéas (1)b)(i) à (iii), signifier un avis de l'allégation à la première personne; |
| c) si l'allégation est faite aux termes du sous-alinéa (1)b)(iv): |
| (i) signifier à la première personne un avis d'allégation relative à la demande déposée selon le paragraphe (1), au moment où elle dépose la demande ou par la suite, |
| (ii) insérer dans l'avis d'allégation une description de la forme posologique, de la concentration et de la voie d'administration de la drogue visée par la demande; |
| d) signifier au ministre une preuve de la signification effectuée conformément aux alinéas b) ou c). |
Droits d'action
6. (1) La première personne peut, dans les 45 jours après avoir reçu signification d'un avis d'allégation aux termes des alinéas 5(3)b) ou c), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer un avis de conformité avant l'expiration du brevet visé par l'allégation.
[...]
(6) Aux fins de la demande visée au paragraphe (1), lorsque la seconde personne a fait une allégation aux termes du sous-alinéa 5(1)b)(iv) à l'égard d'un brevet et que ce brevet a été accordé pour le médicament en soi préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes, la drogue que la seconde personne projette de produire est, en l'absence d'une preuve contraire, réputée préparée ou produite selon ces modes ou procédés.
[...]
|
[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.
[14] Merck's second argument is that the Scheduling Order "will largely negate the effect of the presumption introduced by the legislator in Section 6(6), as it is contemplated that Merck will file affidavits analyzing Apotex's process." (Appellants' memorandum of fact and law, para. 58 at 19). According to counsel, in para. 59,
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Apotex emerges with a marked procedural advantage, in that: |
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(i) it would appear that Apotex may rely on any details of its process filed in Court by Merck in Merck's further affidavits, to attempt to rebut the presumption; |
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(ii) Apotex may shield itself from cross-examination by not producing this information as evidence in affidavit form; |
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(iii) Rather than bringing comprehensive evidence before the Court to respond to the presumption, Apotex may carefully sculpt its responding affidavits to consider only certain points raised by Merck and thereby further shield many areas from cross-examination. |
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[15] This "marked procedural advantage" is premised on the possibility that Apotex may decide not to file its process, thereby depriving Merck of the opportunity to cross-examine Apotex on its process. It is also premised on the belief that Apotex, because it has an onus, should go first or, if Merck were to go first, then Merck should be entitled to a right of reply. Since the new Rules of the Federal Court (which came into force on April 25, 1998) only allow an applicant to file additional affidavits or a supplementary record "with leave of the Court" (rule 312), an applicant is at risk of not having the opportunity to reply to the affidavit evidence of the respondent. That risk did not exist under the old Rules where an applicant had the right to file a supplementary application record within ten days from being served with the respondent's application record (rule 1608).
[16] With respect, I do not share the apocalyptic view of counsel as to the impact of the impugned order on Merck's rights.
[17] First, Merck could have decided not to complete its record with additional affidavits. Second, whatever Merck does, Apotex's process cannot make its way into the evidence unless Apotex itself files it as part of its application record, thereby opening the door to cross-examination of the deponent of its affidavits; in the very unlikely event that Apotex decides not to file its process in its application record, it may have a hard time convincing the court that it has rebutted the presumption in favour of Merck. Third, it is highly improbable that if the cross-examination of the deponent of Apotex's affidavits reveals any new information of relevance, a judge would deny a motion by Merck under new Rule 312 for leave to file an additional record. Proceedings under the Regulations are not cat and mouse games. Fourth, the introduction of the presumption (whatever its real impact on the proceedings, an issue I need not address here) in the Regulations is irrelevant to the sequence of events prescribed by the Rules of the Court: it is at the end of the day, when all the evidence has been gathered under the Rules, that a judge will decide whether or not the presumption has been rebutted. Fifth, the presumption applies whether the evidence is confidential or not and, where confidential, whether confidentiality was agreed to by the parties or ordered by the Court.
[18] The appeal should be dismissed with costs.
"Robert Décary"
J.A.
"I agree.
Pierre Denault"
"I agree.
Gilles Létourneau J.A."
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