Smithkline Beecham Inc. v. Apotex Inc., docket T-2230-97

Date: 19981218

Docket: T-2230-97

T-2660-96

BETWEEN:

     SMITHKLINE BEECHAM INC.

     and BEECHAM GROUP p.l.c.

     Applicants

     - and -

     APOTEX INC. and

     THE MINISTER OF HEALTH

     Respondents

     REASONS FOR JUDGMENT

DUBÉ J :

[1]      The target for this volley of appeals and cross-appeals by both parties is this concise decision of Associate Senior Prothonotary Giles dated November 23, 1998:

ORDER

Upon motion dated the 6th day of November 1998 on behalf of the Respondent, Apotex Inc. ("Apotex") for:

1.      An Order shortening the thirty month period prescribed by subsection 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations ("the Regulations") by a period of six months.

2.      Such further and other relief as this Honourable Court may deem just.

IT IS HEREBY ORDERED THAT:

The 30 month period be shortened by one month, costs fixed at $2,500.00 to the Respondents in the cause for this and file T-2660-96.

[2]      Paragraph 7(1)(e) above referred to provides as follows:

7. (1) The Minister shall not issue a notice of compliance to a second person before the latest of

...

(e) subject to subsections (2), (3) and (4), the expiration of 30 months after the receipt of proof of the making of any application referred to in subsection 6(1), and

[3]      The respondent Apotex attacks the order on the ground that the period ought to have been reduced by at least four and half months, whereas the applicants claim that the period ought not to have been reduced at all. Under the Notice of Compliance Regulations where the patentee [the applicants] files suit within the 45-day period prescribed, the granting of a Notice of Compliance ("NOC") to the generic drug maker [Apotex] may be delayed up to 30 months pending resolution of the lawsuit. However, under subsection 7(5) of the Regulations, a court may shorten or extend the period of 30 months "where the court finds that a party to the application failed to reasonably cooperate in expediting the application". The subsection reads:

7(5) A court may shorten or extend the time limit referred to in paragraph (1)(e) in respect of an application where the court has not yet made an order pursuant to subsection 6(1) in respect of that application and where the court finds that a party to the application failed to reasonably cooperate in expediting the application.

[4]      At the hearing of these appeals, both parties unleashed the traditional arsenal of arguments to the effect that the other party is guilty of lack of cooperation. Apotex accuses the applicants of procrastination, mainly because of the four and half month delay in producing affiants for cross-examination. On the other hand, the applicants charge Apotex with treachery for having negotiated and consented to a new schedule without ever indicating to them that it intended to file a motion to shorten the statutory deadline. Moreover, according to the applicants, Apotex refused to answer proper questions and asked many inappropriate questions during the course of the cross-examinations.

[5]      The Associate Senior Prothonotary did not release written reasons for his order, but he undoubtedly had the benefit of the same arguments I heard. Thus, I must assume that he considered them all before coming to his decision.

[6]      The test to be applied on appeals of a prothonotary's decision under the former Rule 336(5), now Rule 51(1), has been defined by the Federal Court of Appeal in Canada v. Aqua-Gem Investments Ltd.¹: the appellant must show that the prothonotary's decision was clearly wrong in the sense that it was based on a wrong principle or misapprehension of facts, or it raises questions vital to the final issue of the case.

[7]      Obviously, there has been a degree of dilatoriness on both sides. The Associate Senior Prothonotary had the discretion under subsection 7(5) of the Regulations to shorten or extend the time limit where he found that a party to the application failed to reasonably cooperate in expediting the application. He also had the discretion to assess the degree of extension or limitation of the time limit.

[8]      He decided to shorten the period by one month. It is not for this Court, on appeal, to impose its own appreciation of the situation. In these circumstances, I cannot find that the Associate Senior Prothonotary was clearly wrong or misapprehended the fact as both parties were guilty of some degree of dilatoriness and lack of cooperation. Moreover, I cannot find that such a minor limitation of one month out of 30 months would vitally prejudice any of the parties.

[9]      The jurisprudence has repeatedly warned the parties involved that the procedure under these Regulations must be carried out expeditiously by all parties². They cannot anticipate the protection of the Court from the consequences of their own procrastination.

[10]      Consequently, all the appeals and cross-appeals are dismissed and each party will bear its own costs.

OTTAWA, Ontario

December 18, 1998

    

     Judge

__________________

     ¹      [1993] 2 F.C. 425.

     ²      Bayer AG v. Canada (Minister of National Health & Welfare) (1993), 51 C.P.R. (3d) 329 (C.A.); Merck Frosst v. Minister of National Health & Welfare (1994), 55 C.P.R. (3d) 302 (C.A.) and Pharmacia Inc. v. Minister of National Health & Welfare (1994), 58 C.P.R. (3d) 209 (C.A.).