Date: 20000825
Docket: A-767-98
(T-1742-95)
CORAM: ROTHSTEIN, J.A.
MCDONALD, J.A.
SHARLOW, J.A.
BETWEEN:
NU-PHARM INC.
Appellant
(Respondent)
- and -
HOFFMANN-LA ROCHE and SYNTEX
PHARMACEUTICALS INTERNATIONAL LIMITED
Respondents
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondent
(Respondent)
HEARD at Toronto, Ontario, on Thursday, August 24, and Friday, August 25, 2000
JUDGMENT delivered from the Bench at Toronto, Ontario, on Friday, August 25, 2000
| REASONS FOR JUDGMENT OF THE COURT BY: McDONALD J.A. |
Date: 20000825
Docket: A-767-98
(T-1742-95)
CORAM: ROTHSTEIN, J.A.
MCDONALD, J.A.
SHARLOW, J.A.
BETWEEN:
NU-PHARM INC.
Appellant
(Respondent)
- and -
HOFFMANN-LA ROCHE and SYNTEX
PHARMACEUTICALS INTERNATIONAL LIMITED
Respondents
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondent
(Respondent)
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Toronto, Ontario
on Friday, August 25, 2000)
McDONALD J.A.:
[1] This is an appeal and cross-appeal from a decision of Muldoon J. of the Federal Court Trial Division (1998), 85 C.P.R. (3d) 67, under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 in respect of the medicine flunisolide. The issues in the appeal are whether the respondents" (Syntex) patent 1288048 (the "048 patent") is invalid and, if valid, whether Nu-Pharm"s A-1 formulation for flunisolide nasal solution 0.025% infringes the 048 patent. The issue in the cross-appeal is whether the motions judge had the jurisdiction to deal with the Nu-Pharm A-2 formulation for flunisolide nasal solution 0.025%.
[2] Muldoon J. found the evidence tendered by Nu-Pharm insufficient to displace the statutory presumption of validity of the 048 patent under the Patent Act, R.S.C. 1985, c. P-4. He also prohibited the Minister from issuing a Notice of Compliance to Nu-Pharm in respect of its A-1 formulation of flunisolide. However, he dismissed the application to prohibit the Minister from issuing a Notice of Compliance to Nu-Pharm in respect of its A-2 formulation of flunisolide.
[3] Nu-Pharm challenges the motions judge"s approach to the presumption of validity under the Patent Act . In Bayer v. Canada (Minister of National Health and Welfare) [2000] F.C.J. No. 464 (QL) at para. 9, Sharlow J.A. stated:
| The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves on a balance of probabilities that the patent is invalid, the presumption is rebutted and is no longer relevant: Diversified Products Corp. v. Tye-Sil Corp. (1991), 35 C.P.R. (#d) 350 (F.C.A.) at 359. |
[4] Muldoon J."s finding that Nu-Pharm"s evidence was insufficient to displace the statutory presumption is a finding that, on a balance of probabilities, Nu-Pharm did not prove that the patent was invalid. We see no legal error in the approach of the learned judge.
[5] Nu-Pharm also challenges the motions judge"s assessment of the evidence in respect of invalidity. Nu-Pharm compares the 048 patent with previous patents for flunisolide. Although the 048 patent indicates that its novelty is that it is suitable for nasal administration of anti-inflammatory steroids without causing stinging, (as compared to prior formulations which caused stinging) Nu-Pharm says that the patent does not disclose novelty, that it is obvious and that its disclosures are insufficient.
[6] Nu-Pharm and Syntex both introduced expert affidavits and the experts were cross-examined at length. We see no reason why the motions judge was required to reject the evidence of the Syntex"s expert, or accept the evidence of Nu-Pharm"s expert. Nu-Pharm"s expert evidence on invalidity is cursory, consisting of a number of assertions by the expert. There is no detailed analysis. Indeed, our consideration of Nu-Pharm"s expert evidence is that it did not make a strong case for invalidity. From a review of the relevant patents and the evidence of the experts, we cannot say that the learned motions judge erred in concluding that the appellant"s evidence was insufficient to displace the statutory presumption of validity of the 048 patent.
[7] Counsel for Nu-Pharm attempted to demonstrate, by comparing the 048 patent with prior patents, that the 048 patent really did not disclose anything new or unobvious and that its disclosures were insufficient. However, Syntex"s expert addressed those issues as a person skilled in the art and concluded that the 048 patent did not suffer from the deficiencies alleged by Nu-Pharm"s counsel. On this basis, we are not prepared to interfere with the finding of the motions judge that the 048 patent is valid.
[8] As to the question of infringement, Nu-Pharm says that its Notice of Allegation contains the allegation that its product will not infringe the 048 patent because it will not be substantially non-stinging, and in the absence of evidence to the contrary, this allegation must be accepted as a fact. Although Syntex"s expert deposed that Nu-Pharm"s A-1 formulation fit "literally within the scope of Claim 1 of the 048 patent", Nu-Pharm says that this evidence must be discounted because the A-1 formulation was alleged by Nu-Pharm not to be substantially non-stinging, that Syntex"s expert admitted that stinging was a subjective question and that testing was required to refute the allegation and that she had not conducted any test of the A-1 formulation.
[9] Claim 1 of the 048 patent provides:
| A substantially non-stinging aqueous anti-inflammatory steroid formulation suitable for intranasal administration, which formulation comprises: an anti-inflammatory steroid in an amount between about 0.01% and about 0.05% (w/v); propylene glycol in an amount between about 2% and about 10% (w/v); PEG 400 in an amount between about 10% and about 25% (w/v); polysorbate 20 in an about between about 1% and about 4% (w/v); and water. |
[10] As we read this claim, it describes a formulation consisting of ingredients in specified ranges of quantities of each. The formulation is described as being a substantially non-stinging aqueous anti-inflammatory steroid formulation. However, the non-stinging reference is not disjunctive in relation to the balance of the claim. In other words, it is not a separate requirement to be met to prove infringement in addition to proving the similarity of the compositions of the A-1 and the 048 patent formulations. The evidence that the Nu-Pharm A-1 formulation fits within Syntex"s 048 formulation is sufficient to conclude that it infringes Syntex"s patent.
[11] Although the learned motions judge made no express finding of infringement by Nu-Pharm"s A-1 formulation, he prohibited the Minister from issuing a Notice of Compliance for it. In dismissing the prohibition application in respect of Nu-Pharm"s A-2 formulation, he based his conclusion on the difference between the A-2 and the 048 formulations. We think the obvious inference is that the motions judge granted prohibition in respect of the A-1 formulation because of its similarity to the 048 formulation. There was an evidentiary basis for such a conclusion and this Court will not interfere with it.
[12] With respect to the cross-appeal, we are not persuaded that there is anything in the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 that would preclude a Notice of Allegation from including alternative formulations of the same drug. Nor are we persuaded that there is an evidentiary basis for concluding that the motions judge lacked the jurisdiction to deal with the application before him insofar as it related to the A-2 formulation of flunisolide nasal solution 0.025%.
[13] The appeal and cross-appeal will each be dismissed.
"F.J. McDonald"
J.A.
Toronto, Ontario
August 25, 2000
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
| COURT NO: A-767-98 (T-1742-95) |
| STYLE OF CAUSE: NU-PHARM INC. |
Appellant
(Respondent)
- and -
HOFFMANN-LA ROCHE and Syntex
PHARMACEUTICALS INTERNATIONAL LIMITED
Respondents
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH
AND WELFARE
Respondent
(Respondent)
| DATES OF HEARING: THURSDAY, AUGUST 24, AND |
FRIDAY, AUGUST 25, 2000
| PLACE OF HEARING: TORONTO, ONTARIO |
REASONS FOR JUDGMENT OF
| THE COURT BY: McDONALD J.A. |
Delivered at Toronto, Ontario on Friday, August 25, 2000
| APPEARANCES BY: Mr. Mr. H. B. Radomski |
| For the Appellant |
(Respondent)
Mr. Gunars Gaikis
For the Respondents
(Applicants)
No appearance
For the Respondent
(Respondent)
| SOLICITORS OF RECORD: GOODMAN & GOODMAN |
Barristers and Solicitors
2400-250 Yonge Street West, box 24
Toronto, Ontario
M5B 2M6
| For the Appellant |
| (Respondent) |
SMART & BIGGAR
Barristers & Solicitors
438 University Avenue
Suite 1500, Box 111
Toronto, Ontario
M5G 2K8
For the Respondents
(Applicants)
Morris Rosenberg
Deputy Attorney General of Canada
For the Respondent
(Respondent)
FEDERAL COURT OF CANADA
Date: 20000825
Docket: A-767-98
(T-1742-95)
BETWEEN:
NU-PHARM INC. Appellant
(Respondent)
- and -
HOFFMANN-LA ROCHE and Syntex
PHARMACEUTICALS INTERNATIONAL LIMITED
Respondents
(Applicants)
| - and - |
THE MINISTER OF NATIONAL HEALTH
AND WELFARE
Respondent
(Respondent)
| REASONS FOR JUDGMENT |