Date: 20021108
Docket: A-622-01
(T-1266-99)
Neutral citation: 2002 FCA 440
CORAM: STRAYER J.A.
EVANS J.A.
PELLETIER J.A.
BETWEEN:
NOVARTIS A.G. and NOVARTIS PARMACEUTICALS CANADA INC.
Appellants
(Applicants)
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
(Respondents)
MOTION DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES
JUDGMENT delivered at Ottawa, Ontario, Friday, November 8, 2002
REASONS FOR JUDGMENT BY: STRAYER J.A.
CONCURRED IN BY: EVANS J.A.
PELLETIER J.A.
Date: 20021112
Docket: A-622-01
(T-1266-99)
Neutral citation: 2002 FCA 440
CORAM: STRAYER J.A.
EVANS J.A.
PELLETIER J.A.
BETWEEN:
NOVARTIS A.G. and NOVARTIS PHARMACEUTICALS CANADA INC.
Appellants
(Applicants)
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
(Respondents)
REASONS FOR JUDGMENT
STRAYER J.A.
Introduction
[1] This is a motion in writing by the respondent Apotex Inc. to have an appeal from a decision of Blais J. of October 18, 2001 dismissed for mootness.
Facts
[2] The appellants ("Novartis") are the owners of patent 1,332,150 (the "150 Patent") which was included on a patent list filed by them with the Minister of Health under subsection 4(1) of the Patented Medicines (Notice of Compliance) Regulations ("the Regulations").
[3] On May 28, 1999, the respondent Apotex Inc. ("Apotex") sent a Notice of Allegation pursuant to subsection 5(1) of the Regulations alleging that certain claims of the 150 patent are invalid. On July 13, 1999 Novartis filed in the Federal Court Trial Division an application for prohibition to prevent the Minister of Health from issuing to Apotex a Notice of Compliance "in connection with its version of the drug cyclosporine" until after the expiration of patent 150.
[4] This matter was ultimately heard by Blais J. of the Trial Division who on October 18, 2001 dismissed the application for prohibition on the grounds, inter alia, that a number of specified claims in the 150 patent were invalid because they were anticipated, obvious, or overly broad. Novartis filed a notice of appeal from the decision of Blais J. on October 23, 2001. On July 18, 2002 the Minister of Health issued to Apotex an NOC in connection with one form of dosage of cyclosporine, namely a 100 mg/ml oral solution.
[5] The appeal is set down for hearing by this Court on November 27, 2002. In the meantime, however Apotex has made this application in writing for a judgment dismissing the appeal on the grounds that it is moot, the NOC having been issued in the meantime.
[6] In support of its position, Apotex relies on three decisions of this Court: Merck Frosst Canada Inc. et al v. Apotex et al ((1999), 240 N.R. 195); Pfizer Canada Inc. v. Apotex Inc. et al ((2001) 11 C.P.R.4th 245); and Novartis Pharmaceuticals Canada Inc. et al v. Rhoxalpharma Inc. et al ((2001) 16 C.P.R.4th 188). In each of these cases a judge had refused prohibition sought under section 6 of the Regulations but, before the appeal could be heard, an NOC was issued. In each case, this Court held the appeal to be moot and dismissed it.
[7] Novartis seeks to distinguish these cases on the basis that each involved findings of non-infringement of the owner's patent, but not invalidity. It argues that, in the present case, Apotex has obtained a Notice of Compliance with respect to only one form and dosage of cyclosporine. If, however, it should subsequently decide to seek an NOC in respect of other forms and dosages, it could rely on the finding by Blais J. of invalidity of the patent claims that might otherwise prevent it from getting an NOC. For this reason, Novartis argues that the decision of Blais J. has ongoing implications for the issue of future NOC's related to other forms of cyclosporine; the correctness of the Blais decision is therefore not moot, but may have a direct bearing on the future ability of Apotex to obtain other NOCs.
Analysis
[8] I would first make two observations about the position of Novartis. I am not satisfied that there is the clear cut distinction between findings of non-infringement and findings of invalidity for these purposes. It is true that the three decisions of this Court relied on by Apotex appear to have involved issues of non-infringement. However, if Novartis is correct in attaching some kind of res judicata quality to dismissals of applications for prohibition under the Regulations, then the original "second person" who obtained a dismissal on grounds of non-infringement could equally rely on that dismissal in a later notice of allegation in respect of some different but similar dosage or form that it could argue to be non-infringing, by analogy to the product in question in the first prohibition proceedings. Indeed, in the Rhoxalpharma case which the Novartis characterizes as involving non-infringement, it made essentially the same submission against mootness as it makes in the present case involving invalidity. Nevertheless, this Court dismissed the appeal for mootness (see Apotex' reply on this motion pages 17-21).
[9] I believe that the fundamental principles applicable are those stated in the reasons of Isaac J.A. in the Pfizer case, as approved and followed by another panel of this Court in the Rhoxalpharma case less than one year ago. The basic principle is that the extraordinary procedures provided by the Regulations are for the public law purpose of enabling the Trial Division to prevent a public officer from issuing a Notice of Compliance, designed for the protection of the public's health, if the patentee can show that the patents, as referred to by a generic company in its notice of allegation seeking a Notice of Compliance, are owned by the applicant "first person" and that the relevant claims are not invalid and would be infringed. This is a finding of the Court for the limited purpose of deciding whether or not the Minister can issue a Notice of Compliance: no one could suppose that this is a scheme designed for res judicata determinations of the scope or validity of patents. As Isaac J.A. said at 253-54 of the Pfizer case:
[25] It should be noticed that a decision by this Court that the appeals are moot does not mean that the appellants are without remedies. They may commence actions for infringement if so advised and the facts warrant. This Court has been very clear on the fact that s. 6 proceedings are not adjudicative of the rights of the patentee. In Merck Frosst Canada, supra, at 319, Hugessen J.A. rejected the notion that prohibition proceedings could be assimilated to an action of any kind:
The proceedings are not an action and their object is solely to prohibit the issuance of a notice of compliance under the Food and Drug Regulations. Manifestly, they do not constitute "an action for infringement of a patent" . . .
In these circumstances, it is idle to suggest that any decision that this Court makes in these appeals could be used to attack collaterally a judgment in an infringement action.
As Isaac J.A. also pointed out in Pfizer at 252, by subsection 7(4) of the Regulations the period of automatic stay of the issue of an NOC expires when, inter alia, the application for prohibition is "dismissed by the court". This has been interpreted by this Court to mean "dismissed by the Trial Division", given the special and self-contained scheme of the Regulations. (Hoffman-LaRoche Ltd. v. Canada (1996), 70 C.P.R. (3d) 206). It does not mean "dismissed by the Federal Court of Appeal".
[10] In terms of the Regulations, the appellant has sought its remedy under section 6 to stop the Minister from issuing a Notice of Compliance. That remedy was denied by the Trial Division and the Notice of Compliance has been issued. This Court held in both the Merck Frosst and Pfizer cases referred to above that, once the prohibition proceedings are dismissed by the Trial Division, the Minister is entitled to issue this particular NOC. As stated by Isaac J.A. in Pfizer (page 254) "This lawful administrative action taken by the Minister under the Regulations has rendered the appeals moot". As he also pointed out in the above quotation, this does not preclude the appellant from other possible remedies available to it under the general law of intellectual property.
Disposition
[11] I would therefore allow the motion to dismiss the appeal on grounds of mootness and issue judgment accordingly with costs, including costs of this motion, to the respondents.
(s) "B.L. Strayer"
J.A.
I agree
"John M. Evans" J.A.
I agree
"J. Denis Pelletier" J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-622-01
STYLE OF CAUSE: Novartis A.G. and Novartis Pharmaceuticals Canada Inc. v. Apotex Inc. and The Minister of Health
MOTION DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES
REASONS FOR JUDGMENT OF THE HONOURABLE MR. JUSTICE STRAYER
CONCURRED IN BY: The Honourable Mr. Justice Evans
The Honourable Mr. Justice Pelletier
DATED: November 8, 2002
WRITTEN REPRESENTATIONS BY:
Mr. Anthony G. Creber
FOR THE APPELLANTS
Mr. Andrew R. Brodkin
Ms. Nathalie Butterfield
FOR THE RESPONDENT, APOTEX INC.
SOLICITORS OF RECORD:
Gowling Lafleur Henderson LLP
Ottawa, Ontario
FOR THE APPELLANTS
Goodmans LLP
Toronto, Ontario
FOR THE RESPONDENT, APOTEX INC.
Mr. Morris Rosenberg
Deputy Attorney General of Canada
FOR THE RESPONDENT, MINISTER OF HEALTH