Date: 19990526
Docket: A-99-98
CORAM: DÉCARY J.A.
ROBERTSON J.A.
ROTHSTEIN J.A.
BETWEEN:
NOVOPHARM LIMITED and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Appellants
(Respondents)
- and -
GLAXO GROUP LIMITED and
GLAXO WELLCOME INC.
Respondents
(Applicants)
Heard at Ottawa (Ontario) on Wednesday, May 26, 1999.
Judgment delivered from the Bench on Wednesday, May 26, 1999.
REASONS FOR JUDGMENT
OF THE COURT DELIVERED BY: DÉCARY J.A.
Date: 19990526
Docket: A-99-98
CORAM: DÉCARY J.A.
ROBERTSON J.A.
ROTHSTEIN J.A.
BETWEEN:
NOVOPHARM LIMITED and
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Appellants
(Respondents)
- and -
GLAXO GROUP LIMITED and
GLAXO WELLCOME INC.
Respondents
(Applicants)
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Ottawa (Ontario)
on Wednesday, May 26, 1999)
DÉCARY J.A.
[1] On February 9, 19981, Madame justice Tremblay-Lamer found that the respondents ("Glaxo") could not rely on the Patented Medicines (Notice of Compliance) Regulations2 ("the Regulations") to prohibit the Minister of National Health and Welfare ("the Minister") from issuing a notice of compliance ("NOC") to the appellant Novopharm in respect of beclomethasone dipropriorate inhaler (50 micrograms and 250 micrograms/dose). She was of the view that the two Canadian Letters Patent 1,236,746 and 1,272,917 on which Glaxo relied disclosed claims for mechanical devices commonly known as inhalers which are not "medicine" within the meaning of the Regulations.
[2] Having found Novopharm's allegation justified, the trial judge dismissed the motion for prohibition sought by Glaxo against the Minister. She went on, however, to decide that the Minister could not issue the NOC "until all appeals have been exhausted or all appeal periods have expired".
[3] The Minister (file A-91-98) and Novopharm (file A-99-98) appealed from the latter part of the judgment and Glaxo (file A-137-98) cross-appealed from the earlier part. The appeals and cross-appeal were consolidated in file A-99-98 and files A-91-98 and A-137-98 were closed.
[4] Prior to the hearing of the appeal, Glaxo conceded (presumably on the basis of the recent decisions of this Court in Hoffmann-La Roche et al. v. Novopharm et al3) "for purposes of this appeal only that Glaxo accepts that, in the event that the Court of Appeal dismisses the appeal by Glaxo on the substantive issue, the proceeding will then be "finally dismissed" as that term is used in the Regulations".
[5] While the Court would have preferred a more outright concession, the fact is that the issue has been resolved by the decisions of this Court previously referred to and that the appeal by Novopharm and by the Minister, should the cross-appeal be dismissed, cannot but be allowed.
[6] With respect to the substantive issue raised by Glaxo in its cross-appeal, we share the view of the trial judge that the patents at issue, being patents for devices by which medicaments can be administered to or by patients rather than patents for the substance being administered, are not a "medicine" within the meaning of the Regulations.
[7] The appeal by the Minister will be allowed without costs.
[8] The appeal by Novopharm will be allowed with costs.
[9] The cross-appeal by Glaxo will be dismissed with costs in favour of Novopharm.
"Robert Décary"
| J.A. |
1 Glaxo Group Ltd. et al. v. Novopharm Ltd. et al. (1998), 144 F.T.R. 252.
2 SOR/93-133.
3 (13 January 1999), A-92-98 and A-93-98, and A-286-98 and A-287-98 (F.C.A.).