Date: 20001116
Docket: T-1768-00
OTTAWA, ONTARIO, THURSDAY, THE 16TH DAY OF NOVEMBER, 2000
PRESENT: THE HONOURABLE EDMOND P. BLANCHARD
BETWEEN:
BRISTOL-MYERS SQUIBB CANADA INC
Applicant
- and -
ATTORNEY GENERAL OF CANADA,
THE MINISTER OF HEALTH AND APOTEX INC.
Respondents
REASONS FOR ORDER AND ORDER
BLANCHARD J.:
[1] The applicant, Bristol-Myers Squibb Canada Inc., (hereinafter BMS), has brought a motion for an order pursuant to section 18.2 of the Federal Court Act, R.S.C. 1985, c. F-7, as amended, staying the decision of the Minister of Health to delist Canadian Patent 1,198,436, (hereinafter the `436 patent), pending the disposition of the application for judicial review.
[2] The Supreme Court of Canada has clearly established that the test for considering whether to grant a stay of proceedings is similar to that for an interlocutory injunction1. In other words, the applicant for the stay must satisfy a three stage test. In the case at bar, BMS had to establish that:
1) a serious issue be tried;
2) irreparable harm will occur;
3) the balance of convenience favours the grant of the stay.
Serious Issue to be Tried
[3] The threshold to establish if there is a serious issue is a rather low one2. Based on the facts before us, and since the Minister of Health initially allowed the Notice of compliance (hereinafter "NOC") to BMS, there is certainly a serious issue to be tried. BMS is submitting that the subsequent interpretation of the respondent, the Minister of Health, is contrary to Section 4 of Patented Medicines (Notice of Compliance) Regulations3 (hereinafter the regulatory scheme), and the case law as set out by McGillis J. in Apotex v. Canada4, in my view justifies the meeting of this threshold.
Irreparable Harm
[4] Having reviewed the written submissions of the applicant, BMS, and the respondent, Apotex Inc., and having considered the arguments presented before me, I am convinced that the applicant has met the requirements of the second stage of the test developed in the RJR Macdonald decision, namely that of irreparable harm.
[5] I distinguish Merck Frosst Canada Inc v. Apotex Inc.5 from the present case on the facts. On that occasion, the Federal Court of Appeal allowed an appeal, setting aside a decision granting a stay of proceedings. Merck Frosst Canada Inc. already had benefited from the regulatory provision of thirty (30) months. Further extensions were granted by the Trial Division which exceeded twelve (12) months. The Appeal Court made it very clear that the time limit provided for in the regulatory scheme was to be respected:
| A time limit for the legislative stay was fixed at 30 months, not just as one of many options for the parties but as a time limit which was to be respected unless altered by the Court for the sole reason authorized in subsection 7(5).6 |
[6] Indeed, the Supreme Court of Canada in dismissing an application for leave to appeal stated that based upon the facts of that case the applicant had not met any of the conditions required for a stay that are referred to in R.J.R. MacDonald decision:
| What might be termed a statutory stay of proceedings has been in effect for over 30 months. A further stay should not be lightly granted. I am not satisfied that the applicant has demonstrated that it will suffer irreparable harm if a stay is granted. None of its rights to seek an injunction or to claim damages will be curtailed by a stay. Indeed I am not satisfied that the applicant has met any of the conditions required for a stay that are referred to in R.J.R. MacDonald Inc. v. Canada (Attorney General), 1994] 1 S.C.R. 31. I would dismiss the application with costs7. (Emphasis added) |
[7] However, in the case at bar, BMS has been issued a NOC on February 7, 2000, the Minister of Health has maintained the patent on the Register, and extended it until November 17, 2000, date at which the matter of interim relief should be resolved. The `436 patent is still on the Register. All of this respecting the time limits provided for in the regulatory scheme.
[8] Hence, it is clear that the issue before us is not one of seeking a right outside or in addition to the regulatory scheme. The facts demonstrate that BMS is requiring a stay based on the RJR Macdonald decision and that they would suffer irreparable harm, since they would be deprived of the procedural benefit of the regulatory scheme.
[9] I accept the submission of counsel for the applicant, the present case is not based on private law but public law. Therefore the issue of quantification for damages is not relevant. The irreparable harm must be considered on the basis of its nature. The patent is currently on the Register, not allowing the stay would amount to deprive BMS of the procedural benefit of the regulatory scheme provided for by Parliament.
[10] I further accept the argument advanced by counsel for the applicant that if an application is ultimately allowed, and the Court considers that the `436 patent is properly listed, then the applicant would have been entitled to have continuous application of its rights under the Regulations. Furthermore, if a generic company were to obtain a NOC in the intervening period when there are
no patents on the patent list, then the application for judicial review would be rendered nugatory and that the applicant would have lost its rights to receive a notice of allegation under the Regulations and to proceed for an order of prohibition.
[11] The Federal Court of Appeal expressed concern in Merck Frosst v. Apotex that "...the Minister's authority to refuse a notice of compliance originally designed to protect the general health of Canadians, has been harnessed to protect the financial health of drug patentees"8. The Court further stated: "Whatever the public policy merits of this, it must be seen as an extraordinary means of providing interim protection to patentees by which a competitor can be blocked from marketing for 30 months..."9. In the case before me there is no factual evidence to support that the patentee is asking for anything more than the procedural benefit provided by the regulatory scheme.
Balance of Convenience
[12] As the facts demonstrate, the `436 patent is already listed on the Register and the Minister of Health agreed, at least until today, that the status quo be maintained until the issue for interim relief is resolved. I am therefore satisfied that the balance of convenience favours the applicant. Moreover, the respondent, Apotex is fully protected by the regulatory scheme which provides under section 8 as follows:
8. (1) If an application made under subsection 6(1) is withdrawn or discontinued by the first person or is dismissed by the court hearing the application or if an order preventing the Minister from issuing a notice of compliance, made pursuant to that subsection, is reversed on appeal, the first person is liable to the second person for any loss suffered during the period
8. (1) Si la demande présentée aux termes du paragraphe 6(1) est retirée ou fait l'objet d'un désistement par la première personne ou est rejetée par le tribunal qui en est saisi, ou si l'ordonnance interdisant au ministre de délivrer un avis de conformité, rendue aux termes de ce paragraphe, est annulée lors d'un appel, la première personne est responsable envers la seconde personne de toute perte
subie au cours de la période :
(a) beginning on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations, unless the court is satisfied on the evidence that another date is more appropriate; and
a) débutant à la date, attestée par le ministre, à laquelle un avis de conformité aurait été délivré en l'absence du présent règlement, sauf si le tribunal estime d'après la preuve qu'une autre date est plus appropriée;
(b) ending on the date of the withdrawal, the discontinuance, the dismissal or the reversal.
b) se terminant à la date du retrait, du désistement ou du rejet de la demande ou de l'annulation de l'ordonnance.
(2) A second person may, by action against a first person, apply to the court for an order requiring the first person to compensate the second person for the loss referred to in subsection (1).
(2) La seconde personne peut, par voie d'action contre la première personne, demander au tribunal de rendre une ordonnance enjoignant à cette dernière de lui verser une indemnité pour la perte visée au paragraphe (1).
(3) The court may make an order under this section without regard to whether the first person has commenced an action for the infringement of a patent that is the subject matter of the application.
(3) Le tribunal peut rendre une ordonnance aux termes du présent article sans tenir compte du fait que la première personne a institué ou non une action pour contrefaçon du brevet visé par la demande.
(4) The court may make such order for relief by way of damages or profits as the circumstances require in respect of any loss referred to in subsection (1).
(4) Le tribunal peut rendre l'ordonnance qu'il juge indiquée pour accorder réparation par recouvrement de dommages-intérêts ou de profits à l'égard de la
perte visée au paragraphe (1).
(5) In assessing the amount of compensation the court shall take into account all matters that it considers relevant to the assessment of the amount, including any conduct of the first or second person which contributed to delay the disposition of the application under subsection 6(1). SOR/98-166, ss. 8, 9.
(5) Pour déterminer le montant de l'indemnité à accorder, le tribunal tient compte des facteurs qu'il juge pertinents à cette fin, y compris, le cas échéant, la conduite de la première personne ou de la seconde personne qui a contribué à retarder le règlement de la demande visée au paragraphe 6(1). DORS/98-166, art. 8 et 9.
[13] Based upon an analysis of the record, I am convinced that the applicant, BMS, is determined to act promptly, since it was in constant communication with the respondent, the Minister of Health, as demonstrated in the November 7, 2000, correspondence:
| As I indicated in our telephone conversation yesterday, based on the information received from you on October 30, November 1 and November 3, 2000 we will be proceeding, with dispatch, to bring a motion for interim relief. (...) As I indicated yesterday, it is our position that this matter should be heard and resolved as soon as possible (...).10 |
[14] For these reasons, the appeal brought by the applicant, BMS, before me is allowed, staying the Minister of Health's decision to remove the `436 patent, pending the final disposition of the application for judicial review.
ORDER
THIS COURT ORDERS that:
| 1. the Minister of Health's decision to remove from the patent register the Canadian Patent 1,198,436, (`436 patent), be stayed, pending the final disposition of the application for judicial review under section 18.1 of the Federal Court Act, and the Patented Medicines (Notice of Compliance) Regulations. |
| 2. Costs to the applicant. |
"Edmond P. Blanchard"
Judge
__________________
1 RJR-Macdonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311 at pp. 332-333.
2 Copello v. Canada (Minister of Foreign Affairs) (1998), 152 F.T.R. 110 at 111 (T.D.).
3 SOR/93-133, filed March 12/93; gazetted March 24/93.
4 Apotex v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271.
5 Merck Frosst Canada Inc. v. Apotex Inc. (1997), 72 C.P.R. (3d) 170.
6 Supra, note 5 at p. 178
7 Merck Frosst Canada Inc. and Merck & Co. Inc. v. Apotex Inc. and the Minister of National Health & Welfare Supreme Court of Canada March 12, 1997 Court File No. 25812.
8 Supra, note 5 at p. 175.
9 Ibid.
10 Applicant's motion record, exhibit 26 at p. 141.