Date: 19990113
Docket: A-92-98 and A-93-98
CORAM: STONE J.A.
STRAYER J.A.
DÉCARY J.A.
BETWEEN:
HOFFMANN-LA ROCHE LIMITED and
SYNTEX PHARMACEUTICALS
INTERNATIONAL LIMITED
Appellants
(Applicants)
- and -
THE MINISTER OF NATIONAL
HEALTH AND WELFARE and
NOVOPHARM LIMITED
Respondents
(Respondents)
Heard at Toronto, Ontario, Wednesday, January 13, 1999
Judgment delivered from the Bench
at Toronto, Ontario on Wednesday, January 13, 1999
REASONS FOR JUDGMENT OF THE COURT BY: STRAYER J.A.
Date: 19990113
Dockets: A-92-98 and A-93-98
CORAM: STONE J.A.
STRAYER J.A.
DÉCARY J.A.
BETWEEN:
HOFFMANN-LA ROCHE LIMITED and
SYNTEX PHARMACEUTICALS
INTERNATIONAL LIMITED
Appellants
(Applicants)
- and -
THE MINISTER OF NATIONAL
HEALTH AND WELFARE and
NOVOPHARM LIMITED
Respondents
(Respondents)
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Toronto, Ontario on
Wednesday, January 13, 1999)
STRAYER J.A.:
[1] These two appeals, which were heard together, are from decisions of Jerome A.C.J. issued together on January 27, 1998 with one set of reasons.1 The two proceedings are identical except that A-92-98 relates to a proposed Notice of Compliance ("NOC") sought by the respondent Novopharm in respect of naproxen enteric coated 250 mg., 375 mg. and 500 mg. tablets, whereas A-93-98 pertains to a possible NOC sought by the respondent Novopharm in respect of naproxen 125 mg., 250 mg., 375 mg., and 500 mg. tablets.
[2] The appellants had filed patent lists in 1993 pertaining to the substance naproxen. The list included patents 1,124,735 ("735"), 1,131,660 ("660"), 1,135,717 ("717"), 1,186,318 ("318"), 1,186,319 ("319"), 1,199.646 ("646"), 1,207,338 ("338"), and 1,259,627 ("627").
[3] Novopharm filed notices of allegation in September 1996 in respect of the tablets in question in A-92-98, and in November 1996 in respect of the tablets in question in A-93-98. In both cases Novopharm alleged that the medicine naproxen itself is not claimed in any of the patents in the above-mentioned patent list.
[4] On November 13, 1996 the appellants commenced a proceeding for prohibition against the respondent Minister under section 6 of The Patented Medicines (Notice of Compliance) Regulations2 ("the Regulations") in respect of the tablets in issue in A-92-98, and on December 20, 1996 commenced a similar proceeding in respect of those in issue in A-93-98.
[5] When the two matters came on together for hearing before Jerome A.C.J. on November 14, 1997 the appellants advised the Court that they would not oppose the dismissal of their application in respect of patents 735, 318, 319, 646, 338, and 627. Of the remaining patents, namely 660 and 717, only claim 27 in each patent remained in issue. On January 27, 1998 the learned Associate Chief Justice found these claims to be in respect of "intermediates used in the process of making an active ingredient" but were not claims for the medicine itself. He stated his conclusions as follows:
| [2] I accept the submissions of the respondent that these claims are to intermediates used in the process of making an active ingredient for pharmaceutical use, then under the jurisprudence as found by this Court and by the Federal Court of Appeal and therefore binding on this Court, such claims are not claims for the medicine itself or its use. Furthermore these precise patents have already been considered by our Court, and not only do I agree with the following comments by my colleague Madame Justice Reed: |
| Many aspects of the issues originally raised in the present applications have been settled, at least, insofar as the Trial Division is concerned. This is the result of decisions such as: Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171 (F.C.T.D.); affirmed (1995), 60 C.P.R. (3d) 501 (F.C.A.) (process claims are not claims which contain a claim for the medicine itself); Eli Lilly and Co. v. Apotex Inc. (1995), 63 C.P.R. (3d) 245 (F.C.T.D.) (process claims for intermediate substances are not claims for the medicine itself); Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58; affirmed A-389-95, December 5, 1995 [reported 67 C.P.R. (3d) 25] (composition or formulation claims for the medicine itself). |
| The order of Madame Justice Reed was affirmed by the Federal Court of Appeal, (1996) 70 C.P.R. (3d) 1. At page 2 Stone J.A. cites the argument of the appellants in those proceedings, (i.e. the applicants in this proceeding) as follows: |
| "In paragraph 19 and 25 of their written argument, the Appellants make the following submissions: |
| 19. In view of this Court's decision in Deprenyl ... (where this Court held that process claims were not covered by the Regulations) and in Eli Lilly and Co. ... (where this Court held that claims for an intermediate were not covered by the Regulations), and the fact that the 660, 717, 627 and 338 patents contain only claims to process and intermediates, the Appellants will not oppose the dismissal of the appeal as regards these patents, without prejudice to any rights of appeal. ..." (emphasis added). |
| [3] As I not only agree with both decisions, but I am bound by them and I have not been persuaded that the facts in the case at bar are sufficiently [sic] to warrant the relief sought, the application for prohibition is dismissed on the ground that the claims of the '660 and '717 patents are claims to intermediates and are not claims for the medicine itself nor claims for the use of the medicine. |
[6] At the hearing of these prohibition applications, the appellant also asked the motions judge to interpret the term "finally dismissed" in subsection 7(4) of the regulations. The relevant provisions are:
| 7. (1) The Minister shall not issue a notice of compliance to a second person before the latest of |
| ... |
| (e) subject to subsection (2), (3) and (4), the expiration of 30 months after the receipt of proof of the making of any application referred to in subsection 6(1), |
| ... |
| (4) Paragraph (1)(e) ceases to apply in respect of an application referred to in subsection 6(1) if the application is withdrawn or is finally dismissed by the court. |
Although this matter had not been mentioned in their notices of motion, the appellants sought some kind of declaration by the court that the stay provided by section 7 of the Regulations should continue until all possible appeals had been exhausted. In their view, until that happened, their applications for prohibition could not be considered to be "finally dismissed".
[7] The Associate Chief Justice did not grant such relief: in fact he made no mention of this request in his reasons when he dismissed the applications for prohibition.
[8] The appellants in the present appeals contend that the Associate Chief Justice erred by not finding that there was a claim for the medicine itself, i.e. naproxen, in claims 27 of patents 660 and 717, and by refusing to declare the continuation of the stay under section 7 of the Regulations.
A Claim for the Medicine Itself
[9] The appellants essentially argue in respect of this issue that the motions judge either made a wrong finding of fact or that he erred in law in considering himself bound by the decision of the Court of Appeal in Hoffmann-La Roche Ltd. v. Canada (Minister of Health and Welfare)3.
[10] To deal with the second question first, this Court in the earlier Hoffmann-La Roche case just cited noted that this same appellant in that case had conceded in its written argument that, inter alia, the claims in patents 660 and 717 contain only claims to processes and intermediates and for this reason it consented to its appeal being dismissed as regards those patents. Such appeals were accordingly dismissed. But the appellants in the present case say that the Associate Chief Justice erred in saying that he was bound by that decision. They argue that the principles of res judicata and issue estoppel do not apply where the parties are different. In the earlier case it was Apotex Inc. which was the party in adverse interest to the appellant, not the present respondent Novopharm. Stare decisis, they say, is irrelevant because it applies only to settled points of law whereas the proper interpretation of a patent claim is a mixed question of law and fact.
[11] We find it unnecessary to deal with this question. The Associate Chief Justice in paragraph [2] of his reasons (supra) began by saying he accepted the respondent's argument that "these claims are to intermediates used in the process of making an active ingredient for pharmaceutical use..." It is true that he went on to state that he was bound by the earlier Hoffmann-La Roche decision in this Court, but he also said that he agreed with it and that he had
| not been persuaded that the facts in the case at bar are sufficiently [sic] to warrant the relief sought...4 |
He thus concluded that the claims of the 660 and 717 patents are claims to intermediates or processes and not claims for the medicine itself.
[12] We think it sufficient to conclude that in our view the learned motions judge was entitled to so find, and was correct in so finding, on the evidence before him. It is the applicant for prohibition under these Regulations which has the onus of proving that the respondent's notice of allegations is not justified5. In the circumstances of this case, the appellants had the onus of proving that these claims were in respect of the medicine itself, namely the medicine which was the subject of the two notices of allegations concerning various tablet forms of the substance naproxen. In our view the appellants clearly did not meet that onus. They contented themselves with putting in as evidence the text of the two patents. It is certainly not apparent on the face of these patents that claim 27 in each one claims the medicine itself. The appellants provided no expert evidence to demonstrate to the motions judge that such was the case and they have brought to our attention nothing in the proceeding which should have led the motions judge to this conclusion.
[13] This being so, we can see no reviewable error in the decisions by the Associate Chief Justice to dismiss both applications for prohibition.
The Meaning of "finally dismissed"
[14] We turn to the question as to whether the motions judge should have declared that the stay established by the Regulations should continue "until all appeals from this Court's judgment have been exhausted." While an argument was made to this end before the judge, he did not refer to it in his reasons or order. Similarly he dismissed without reasons an application on this ground for reconsideration of his first order. Whether he thereby intended to reject the argument or not, we believe the argument itself was misplaced when raised before him. The respondents object that this issue was not identified in the originating notices of motion by which proceedings were launched for prohibition pursuant to the Regulations. In our view it would not have been proper for such relief to be sought in those originating notices of motion because no such relief is contemplated in the Regulations. It is the Regulations which provide this procedure for seeking prohibition to block the issue of Notices of Compliance and the appellants specifically invoked those Regulations in their originating notices. It is the Regulations, not the Court, which create the automatic stay and which provide the conditions for its termination. The special power of the court under subsection 7(5) to shorten or extend the stay where a party fails "to reasonably cooperate" was not invoked here. Thus the court had no direct authority to extend the stay as the appellants might prefer. Nor did it have any authority while acting under the Regulations to issue a declaration as to the proper interpretation of the words "finally dismissed" in subsection 7(4). Such a remedy is nowhere authorized in the Regulations. The proper remedy would be one sought under section 18.1 of the Federal Court Act, a remedy which indeed the appellants have since pursued in other proceedings also now before the Court.
Disposition
[15] Therefore these appeals should be dismissed with costs.
"B.L. Strayer"
J.A.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKETS: A-92-98 and A-93-98
| STYLE OF CAUSE: HOFFMANN-LA ROCHE LIMITED and |
SYNTEX PHARMACEUTICALS
INTERNATIONAL LIMITED
| Appellant |
(Applicants)
- and -
| THE MINISTER OF NATIONAL |
HEALTH AND WELFARE and
NOVOPHARM LIMITED
| Respondents |
(Respondents)
DATE OF HEARING: WEDNESDAY, JANUARY 13, 1999
PLACE OF HEARING: TORONTO, ONTARIO
REASONS FOR JUDGMENT BY: STRAYER J.A.
Delivered at Toronto, Ontario
on Wednesday, January 13, 1999
APPEARANCES: Mr. Sheldon Hamilton
Ms. Geneviève Prevost
| For the Appellants |
Mr. Donald Plumley, Q.C.
Mr. Mark Mitchell
For the Respondent
Novopharm
Mr. F.B. (Rick) Woyiwada
For the Respondent
Minister
| SOLICITORS OF RECORD: Smart & Biggar |
Barristers & Solicitors
438 University Avenue
Suite 1500
Toronto, Ontario
M5G 2K8
| For the Appellant |
Lang Mitchener
Barristers & Solicitors
BCE Place, P.O. Box 747, Suite 2500
181 Bay Street,
Toronto, Ontario
M5J 2T7
For the Respondent
Novopharm
Morris Rosenberg
Deputy Attorney General
of Canada
For the Respondent
Minister
| FEDERAL COURT OF APPEAL |
| Date: 19990113 |
| Dockets: A-92-98 and A-93-98 |
| BETWEEN: |
| HOFFMANN-LA ROCHE LIMITED and |
| SYNTEX PHARMACEUTICALS |
| INTERNATIONAL LIMITED |
| Appellants |
| (Applicants) |
| - and - |
| THE MINISTER OF NATIONAL |
| HEALTH AND WELFARE and |
| NOVOPHARM LIMITED |
| Respondents |
| (Respondents) |
| REASONS FOR JUDGMENT |
| OF THE COURT |
__________________
5 Merck Frosst v. Canada (1994) 55 C.P.R. (3d) 302 at 319 (F.C.A.).