Date: 19980703
Docket: T‑2274-93
IN THE MATTER OF an application for
an order of prohibition pursuant to section 55.2(4) of the Patent Act
and section 6 of the Patented Medicines (Notice of Compliance) Regulations
BETWEEN:
SCHERING
CANADA INC. and
SCHERING
CORPORATION
Applicants
-
and -
NU-PHARM
INC. and
THE
MINISTER OF HEALTH AND WELFARE
Respondents
REASONS
FOR ORDER
REED, J.:
[1] This is an
application, filed September 20, 1993, for an order of prohibition pursuant to
section 6(1) of the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, to prohibit the Minister from issuing a Notice of Compliance
("NOC") to Nu-Pharm under section C.08.004 of the Food and Drug
Regulations. The NOC in question relates to 10 mg tablets and 1 mg/ml oral
liquid syrup of a drug known as loratadine and 5 mg loratadine/120 mg
pseudoephedrine tablets. An order of prohibition is sought until after the expiration
of Canadian Letters Patent 1,160,230 ("_230_") and 1,272,480
("_480_").
[2] The
respondent, Nu-Pharm, has not filed any evidence to rebut the applicants'
evidence that the Notice of Allegation served by Nu-Pharm is not justified.
Nu-Pharm missed the deadline for doing so and Mr. Justice Rothstein denied its
application for an extension of time within which to file such evidence.
Nu-Pharm subsequently abandoned its appeal of that decision.
[3] On April
24, 1996, Nu-Pharm brought a motion to dismiss the within application or
permanently stay the application for judicial review. Alternately, it sought an
order allowing it to withdraw its Notice of Allegation and directing the
applicants to discontinue the within application. Nu-Pharm had withdrawn its
new drug submission to which the within application relates on February 22,
1996. This motion was adjourned sine die on April 29, 1996.
[4] The only
issue on the hearing of this application, then, is the appropriate disposition
of the application. The applicant argues that the appropriate disposition is
the issuance of an order of prohibition despite the fact that the new drug
submission to which it relates has been withdrawn and such order may to a
significant extent be purposeless.
[5] Counsel
for the respondent, on the other hand, argues that the appropriate disposition
is a dismissal of the application for mootness. He concedes that such dismissal
should be on terms that would preclude the respondent filing a (fresh) new drug
submission that is the same as that which was withdrawn. The exact terms of the
condition to be attached to such dismissal, however, was not a matter upon
which counsel could agree.
[6] I have
decided that even though the order may to some degree be pointless, since the
new drug submission to which it relates has been withdrawn, that I should
dispose of the within application by issuing the order the applicants request.
Two factors lead me to this conclusion: (1) the respondent earlier commenced a
motion for dismissal for mootness but that motion was not pursued; and (2) the
withdrawal of the new drug submission only occurred after the respondent had
missed the time limits for the filing of its evidence in this proceeding.
[7] An order
will issue accordingly.
Judge
OTTAWA,
ONTARIO
July
3, 1998