COURT FILE NO.: 157/04; 162/04; 173/04 and 176/04

DATE: 20040402

ONTARIO

SUPERIOR COURT OF JUSTICE

DIVISIONAL COURT

B E T W E E N:

APOTEX INC.

Applicant

• and -

MINISTER OF HEALTH AND LONG-TERM CARE, ONTARIO LIEUTENANT GOVERNOR IN COUNCIL AND ATTORNEY GENERAL OF ONTARIO

Respondents

RHOXALPHARMA INC.

• and -

MINISTER OF HEALTH AND LONG-TERM CARE, & Others

PHARMASCIENCE INC.

• and -

MINISTER OF HEALTH AND LONG-TERM CARE, & Others

COBALT PHARMACEUTICALS INC.

• and -

MINISTER OF HEALTH AND LONG-TERM CARE, & Others

H.B. Radomski and J. Cosentino, for Apotex

Dennis W. Brown, Q.C. and James Kendik, for the Respondents

C. Hitchman and A. Browne, for Rhoxalpharma Inc. and Pharmascience Inc.

L. A. Thacker, for Cobalt

HEARD: April 2, 2004

O’DRISCOLL J.: (Orally)

1The applicants come to the Divisional Court under s.6(2) of the Judicial Review Procedure Act, R.S.O. 1990, c.J.1 (JRPA). The applicant points out that the matters complained of only came to their attention by viewing the Minister’s website on March 12, 2004, at which time, it is alleged, they found out that a competitor had obtained a “leg-up”, either with or without participation of the respondents.

2The applicants then went into high gear in order to get this motion before the Court today. Why, because on Tuesday next, April 6, 2004, the respondent Minister will release/publish a new schedule for the Formulary/CDI.

3As matters now stand, none of the applicants who are generic drug manufacturers will be on that new schedule with their proposed generic drugs listed in these applications. This, they advise will result in a competitor, Genpharm Inc., being off to a head start to the applicants’ detriment, an advantage never to be recovered because, it is conceded, that the first generic out-of-the-gate has a definite advantage.

4The respondents argue that “this is just another case about money.” Assuming that to be so, there is no place that these applicants can ever recoup their losses if the matter is resolved in their favour three or four months down the road.

5In the decision of the Federal Court of Appeal in Monsanto Canada Inc. v. Novopharm Ltd. [1996] F.C.J. No. 686, (F.C.A.), McGuigan J., said at para. [2]: that “the first generic drug onto the market will usually capture 60% of the general sales and that it would be impossible for the appellant ever to recoup this market share. The evidence of permanent loss of market to the appellant had to be taken into account by the motions judge and it was apparently not considered by him, either the rubic of the balance of convenience or under that of irreparable harm. It might be if the motions judge had taken this evidence into account, he would come to a different conclusion.” Granted, that deals with the RJR-MacDonald v. Canada (Attorney General) (1994), 1994 117 (SCC), 54 C.P.R. (3d) 114 (S.C.C.) and injunctions but it is a matter that has to be considered in this case as well.

6Besides the economic loss never to be recovered, there is, in my view, a more basic question, that is: whether the appellants have suffered something at the hands of the Government. In my view, that sets up irreparable harm at any time. In my view, s.6(2) of the JRPA has been, in the past, utilized in similar circumstances. I refer to the decision of Apotex Inc. v. Attorney General of Ontario (1984), 1984 1849 (ON SC), 47 O.R. (2d) 176, per Rosenberg J.

7I am satisfied that the prerequisites and requirements of s.6(2) of the JRPA have been met. The application for judicial review will continue.

O’DRISCOLL J.

Date of Reasons for Judgment: April 2, 2004

Date of Release: April 13, 2004

COURT FILE NO.: 157/04; 162/04; 173/04 and 176/04

DATE: 20040402

ONTARIO

SUPERIOR COURT OF JUSTICE

DIVISIONAL COURT