Date: 20000407
Docket: A-518-98
CORAM: LÉTOURNEAU J.A.
ROTHSTEIN J.A.
SHARLOW J.A.
BETWEEN:
BAYER INC. and BAYER AG
Appellant
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and APOTEX INC.
Respondents
(Respondents)
REVISED REASONS FOR JUDGMENT
SHARLOW J.A.
[1] This appeal was dismissed on March 2, 2000 for reasons that were delivered orally. We were and remain of the view that there is no error in the reasons or decision of the Motions Judge that would warrant our intervention.
[2] Several issues were raised on the appeal. One was whether or not the element of inventive ingenuity is essential for patents based on a divisional application. We determined that it was, based on the decision of the Supreme Court of Canada in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R.9 (S.C.C.). That was sufficient to dismiss the appeal.
[3] In the reasons delivered orally, we commented on the burden of proof. Counsel for the Respondent Apotex had not been permitted to speak to this issue at the hearing and for that reason he requested an opportunity to make a written submission. We agreed, and gave the same opportunity to counsel for the Appellants.
[4] Having reviewed those submissions, we remain of the view that the Motions Judge correctly applied the relevant principles relating to the burden of proof. However, we think it appropriate to comment more fully on that issue.
[5] An application for a prohibition order under the Patent Medicines (Notice of Compliance) Regulations is like any other application for judicial review in the sense that the applicant has the burden of establishing its entitlement to the order sought. Bayer, in other words, had the burden of proving that the allegation of invalidity made by the Apotex was not justified. The Motions Judge said as much in paragraph 15 of his reasons:
| The substantive issue in this application is whether Bayer has discharged its burden in establishing that the Apotex allegation of invalidity is not justified. |
[6] In seeking to discharge its burden of proving the allegation to be unjustified, Bayer relied on the statutory presumption of the validity of its patent. Because that presumption exists, it may be said that Apotex, as the party responding to the application for a prohibition order, has a burden of proof in this sense: if Apotex had adduced no evidence that was capable of establishing the invalidity of the patent, Bayer could have succeeded on the basis of the statutory presumption alone. As the Motions Judge correctly said at paragraph 15:
| A statutory presumption, for example, may assist Bayer and "have the effect of displacing the burden of proof". |
[7] The quotation is from Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), where Hugessen J.A. said at 319:
| As I understand the scheme of the [Patent Medicines (Notice of Compliance) Regulations], it is the party moving under s. 6, in this case Merck, which, as the initiator of the proceedings, has the carriage of the litigation and bears the initial burden of proof. That burden, as it seems to me, is a difficult one since it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would allow the Minister to issue a notice of compliance. There may, of course, be some presumptions (such as for example the statutory presumption of validity of a patent ) [...] which may help the moving party and have the effect of displacing the burden of proof. |
[8] However, in this case Apotex did adduce evidence, in the form of an affidavit, that the Motions Judge correctly accepted as going to the question of validity.
[9] 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. (3d) 350 (F.C.A.) at 359.
[10] The Motions Judge understood and correctly applied this approach. That is clear from paragraph 36 of his reasons:
| In conclusion, the statutory presumption of a patent"s validity applies "in the absence of any evidence to the contrary." In this case, the limited evidence of the parties and Bayer"s acknowledgement establish that the composition claims disclose no inventive ingenuity over and above that of the compound claims. This evidence, when assessed in light of Farbwerke Hoechst , is sufficient to rebut the presumption of validity in section 43 of the Patent Act, at least for the purpose of this summary proceeding. |
[11] For these reasons, the appeal was dismissed with costs.
Karen R. Sharlow
J.A.
"I agree
Gilles Létourneau"
"I agree
Marshall Rothstein