Date: 19991216
Docket: A-563-97
(T-187-95)
| IN THE MATTER OF an application for an order pursuant to section 55.2(4) of the Patent Act and section 6 of the Patented Medicines (Notice of Complicance) Regulations |
CORAM: STRAYER J.A.
ROBERTSON J.A.
MALONE J.A.
B E T W E E N:
NOVOPHARM LIMITED and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Appellants
(Respondents)
" and "
ELI LILLY AND COMPANY and
ELI LILLY CANADA INC.
Respondents
(Applicants)
HEARD at Ottawa, Ontario on Wednesday, December 15, 1999
JUDGMENT delivered from the Bench at Ottawa, Ontario on December 15, 1999
REASONS FOR JUDGMENT BY: STRAYER J.A.
Date: 19991216
Docket: A-563-97
(T-187-95)
| IN THE MATTER OF an application for an order pursuant to section 55.2(4) of the Patent Act and section 6 of the Patented Medicines (Notice of Compliance) Regulations |
C O R A M: STRAYER J.A.
ROBERTSON J.A.
MALONE J.A.
B E T W E E N:
NOVOPHARM LIMITED and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Appellants
(Respondents)
" and "
ELI LILLY AND COMPANY and
ELI LILLY CANADA INC.
Respondents
(Applicants)
REASONS FOR JUDGMENT
(Delivered from the Bench at Ottawa, Ontario
on Wednesday, December 15, 1999)
STRAYER J.A.
The respondent ("Lilly") is the owner of Canadian Letters Patent 1,326,211 (the " '211 Patent") which was issued on January 18, 1994 and expires on January 18, 2011, in respect of its medicine vancomycin hydrochloride packaged in 10g, 1g and 500 mg vials for intravenous injection and for which Lilly had obtained notices of compliance (NOCs). By letter dated December 15, 1994 the appellant ("Novopharm") served the respondent Lilly with a notice of allegation that the '211 patent contains no claim for the medicine vancomycin hydrochloride itself and no claim for the use of the medicine. Therefore patent '211 would not be infringed by the making, use, or selling, of Novopharm's 10g, 1g and 500 mg strengths for intravenous injection. In response to that Notice of Allegation Lilly sought an order of prohibition.
The motions judge concluded that Lilly had failed to establish that the '211 Patent would be infringed if the Minister issued an NOC to Novopharm. At the same time, the motions judge concluded that the materials filed by Novopharm in its new drug submission ("NDS") relating to the 1g and 10g dosage forms were insufficient and, therefore, the Minister could only issue a NOC in respect of the 500 mg product. Specifically, the motions judge determined that "a reference of the medicine in one dosage on the new drug submission [was not] sufficient to comply with the regulations and protect the other dosage forms of the [drug]". Since the NDS filed by Novopharm contained detailed information only with respect to the 500 mg form, the motions judge held that the Minister could not determine the safety and efficiency of the 1g and 10g forms and issue a NOC for those sizes.
Accordingly, the motions judge made an order of prohibition in respect of the 1g and 10g product forms based on the insufficiency of the NDS in respect of these forms while dismissing the application in respect of the 500 mg form. Novopharm appeals the prohibition order granted below. While Lilly has not cross-appealed in respect of the dismissal of the prohibition order with respect to the 500 mg dosage, it argues that the motions judge erred in holding that the '211 Patent contains no claims to the medicine itself.
We are all of the view that the appeal should be allowed and the order of prohibition should be set aside. The special procedure for an application for prohibition under section 6 of the Patented Medicines (Notice of Compliance) Regulations1 ("the Regulations") is related to the protection of patent rights and should stand or fall on the validity of the second person's (here Novopharm's) allegations filed under paragraph 5(1)(b) of the Regulations. Those allegations all relate to possible infringement of the patents in the patent list filed by the first person (here, Lilly). It was not a proper use of this procedure to issue prohibition based on the alleged failure of Novopharm to make a proper NDS to the Minister, the making of such a submission under subsection 5(1) being a necessary step in the filing of a Notice of Allegations. Once the learned motions judge found, as he did, that there had been no adequate NDS by Novopharm he should have refused to issue a prohibition order as it was premature to do so. He should have assumed that the Minister would refuse to issue a NOC in the absence of a proper NDS and that no possible need would arise for a prohibition order until the NDS was completed. In this regard we respectfully adopt the views of another panel of this Court in the case of AB Hassle v. Minister of National Health and Welfare.2
While we will therefore allow the appeal we will do so without awarding costs. We recognize that the respondent was faced with a dilemma upon receipt of the Notice of Allegations, and that it is the apparent failure of the appellant to perfect its NDS prior to the motion being heard which led to these abortive court proceedings.
J.A.
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