Date: 20030218
Docket: A-563-02
(T-1747-00)
Neutral citation: 2003 FCA 87
CORAM: STRAYER J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA INC.
Respondents
(Applicants)
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
STRAYER J.A.
[1] This is a motion brought by the appellants for the admission of new evidence on the appeal.
[2] The respondents AB Hassle, Astrazeneca AB and Astrazeneca Canada Inc. ("Astra") have an interest in Canadian patent 1,292,693 ("'693 patent"). On August 1, 2000 the appellant served on Astra a Notice of Allegation pursuant to section 5 of the Patented Medicines (Notice of Compliance) Regulations ("the Regulations") in respect of certain tablets it proposed to market. The Notice of Allegation alleged non-infringement by its tablet of the '693 patent. Astra sought prohibition of the issue of a Notice of Compliance. This application was heard on August 6 and 7, 2002 and was granted by Kelen J. on September 4, 2002. The appellant is appealing that decision.
[3] The appellant took the position at the hearing of the application for prohibition that its tablet would not infringe the '693 patent because that patent described a tablet containing omeprazole with a core, a subcoating and an exterior coating. These coatings are important in that they enable the tablet, which is taken for ulcers, to reach the intestine where they are required, without dissolving. in transit. The appellant asserted that the '693 patent called for a subcoat applied to the core in a separate process before the outer coating is applied. The appellant contended that its own version of the tablet, while having a subcoating, does not involve a separate application of that subcoat. Instead it contends that its subcoating is created in situ when the outer coating is applied to the core. However, at the hearing of the prohibition application an expert affidavit was submitted by Astra to the effect that the claims in patent '693 would include a formulation with a subcoat formed in situ.
[4] Within a month or two after Kelen J.'s order granting prohibition, a lawyer in a firm not representing the appellant in this matter discovered the existence of patent number 2,186,037 ("'037 patent") which had been published in August, 1996 and granted in April, 2002 to Astra AB (a predecessor of Astrazeneca AB). This patent also involves a formulation for an omeprazole tablet. It specifically describes a tablet with a subcoat formed in situ. This patent was not revealed by Astra in the proceedings before Kelen J. nor, according to the affidavit of the lawyer who subsequently discovered it in October, 2002, was it known to counsel for the appellant or to the responsible officers of their client, the appellant company.
[5] The appellant now seeks to have this patent put in as evidence, accompanied by the affidavit of Rick Tusi, the lawyer who discovered its existence. His affidavit attests to the facts already described and to the fact that he was informed by counsel for the appellant and the chairman of the appellant company that they had no knowledge of the '037 patent. In his affidavit he then describes the two patents and comes to the following conclusion.
As a result of all of the foregoing, it is clear that the purported invention of an omeprazole formulation, comprising a core material that contains omeprazole and an alkaline reacting compound, an enteric coating layer comprising an enteric coating polymer, and a water soluble separating layer that is formed in situ as a water soluble salt between the core material and the enteric coating layer by a reaction between the enteric coating polymer and the alkaline reacting compound, is the subject of the '037 Patent and, accordingly, was not, and could not have been, the subject of any invention disclosed and claimed in the Subject Patents.
[6] Thus the appellant contends that if the existence of the '037 patent had been known to the applications judge, he could not have considered the '639 patent to include within its scope a formulation involving a subcoating created in situ. This would follow automatically from the fact that, subsequent to the issue of the '693 patent which did not contain a specific reference to a subcoating formed in situ, there was issued the '037 patent which did. In its view, the fact that the second patent claimed a subcoating formed in situ would conclusively demonstrate that the first patent did not cover a tablet with a subcoating formed in situ.
[7] The test for the admission of new evidence on appeal was reiterated by the Supreme Court in Public School Boards' Association v. Alberta [2000] 1 SCR 44, para. 6 as follows:
(1) The evidence should generally not be admitted if, by due diligence, it could have been adduced at trial provided that this general principle will not be applied as strictly in a criminal case as in civil cases: see McMartin v. The Queen, [1964] S.C.R. 484.
(2) The evidence must be relevant in the sense that it bears upon a decisive or potentially decisive issue in the trial.
(3) The evidence must be credible in the sense that it is reasonably capable of belief, and
(4) It must be such that if believed it could reasonably, when taken with the other evidence adduced at trial, be expected to have affected the result.
[8] In the exercise of my discretion in this matter I have concluded that I should not make an order for the admission of this evidence.
[9] First, I am not persuaded by the affidavit of Mr. Tuzi that the existence of the '037 patent could not have been ascertained by reasonable diligence on the part of the appellant or its counsel prior to the hearing of the prohibition application. The patent was first published in 1996 and the appellant's Notice of Allegation was sent on August 1, 2000. The '037 patent is for a drug which the appellant was preparing to sell and for which it was seeking a Notice of Compliance. Since it was obvious that there was a potential dispute over the scope of patent '693 it is surprising that the appellant would not have researched diligently for any patent that might throw light on the construction of patent '693. In this respect the appellant's argument is self-defeating: it now asserts the vital importance of this piece of evidence to the proper interpretation of patent '693 but explains that the possibility of the existence of '037 was not something that one would normally search for in preparing argument as to the construction of the earlier patent for tablets of the same drug. Moreover, I do not find the evidence sufficiently clear and persuasive as to the due diligence of the appellant company or its counsel. There is no direct evidence from either of these sources but only hearsay evidence of a lawyer not engaged in this litigation as to the reasonableness of their efforts or lack of effort to find this evidence prior to the hearing of the prohibition application.
[10] It will be noted in the first point of the test stated by the Supreme Court (supra) in Public School Boards' Association, the due diligence test should be applied more strictly in civil cases and I find that due diligence has not been adequately proven here.
[11] That portion of the proposed new evidence consisting of the '037 patent would be potentially relevant and its text "capable of belief". I do not believe, however, that the patent as such, merely as explained by a lawyer, could be reasonably expected to affect the result. The appellant relied strongly on a decision of this Court in Abbott Laboratories, Ltd. et al v. Nu-Pharm Inc. (1998) 83 CPR(3d) 441. In that case two patents which had issued subsequent to the patent being construed were held to have relevance to the interpretation of the earlier patent. That was not a case of admission of new evidence. The existence of the later patents had been dealt with in the original evidence before the applications judge. They were put into evidence by Nu-Pharm Inc. and Abbott's three experts were cross-examined on them. That is not the case here and in my view a panel of this Court receiving this proposed new evidence would not find it very helpful in the absence of any expert analysis of either the '037 patent or of the '693 patent viewed again in the light of the existence of '037. Further, it should be noted that in Abbott this Court did not say that the later patents were determinative of the matter but simply that they raised a prima facie case when introduced at to the hearing of the application, so that the burden of proof was placed on Abbott, the applicant, to show that notwithstanding the later patents which involved a process similar to Nu-Pharm's, the earlier patent which was the subject of the Notice of Allegation was nevertheless wide enough to cover Nu-Pharm's process as well. This Court simply determined that in these circumstances the applications judge had erred in continuing to place the burden of proof on Nu-Pharm. In the present case the burden of proof is not in issue.
[12] Further it is important to note the grounds on which the applications judge granted prohibition in the present case. He did so on the basis that the appellant's letter of August 1, 2000 did not comply with the regulations and therefore did not constitute a Notice of Allegation. He so concluded because the Notice did not provide sufficient facts about the formulation of the new drug so that the applicants could determine whether the generic's tablets have an "inert subcoating", nor did it provide the legal basis upon which Apotex was subsequently to argue at the hearing that the subcoating claimed in patent '693 was restricted to a subcoating as applied by the process described therein, that is by a separate step of applying the subcoating to the core of the tablet. It seems clear that the proposed new evidence could not make up for the deficiencies of the original Notice of Allegation and unless the Court of Appeal is disposed to reverse the applications judge on that point the appeal cannot succeed. It would only be potentially relevant if this Court begins by finding the Notice of Allegation to have been valid. Only then would the Court be able to consider any new evidence with respect to the construction of patent '693.
Disposition
[13] For these reasons I am dismissing with costs the motion for the introduction of new evidence on appeal.
(s) "B.L. Strayer"
J.A.
FEDERAL COURT OF APPEAL
Names of Counsel and Solicitors of Record
DOCKET: A-563-02
STYLE OF CAUSE: Apotex Inc. v. AB Hassle, Astrazeneca AB et al.
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: Tuesday, January 28, 2003
REASONS FOR ORDER BY: Strayer J.A.
DATED: Tuesday, February 18, 2003
APPEARANCES:
H. B. Radomski & Andrew Brodkin FOR THE APPELLANT
Gunars A. Gaikis & J. Sheldon Hamilton FOR THE RESPONDENTS
SOLICITORS OF RECORD:
H.B. Radomski/Andrew Brodkin/Ildiko Mehes
GOODMANS LLP
Toronto, Ontario
FOR THE APPELLANTS
Gunars A. Gaikis/J. Sheldon Hamilton
SMART & BIGGAR
Toronto, Ontario
Eric Peterson
Department of Justice
Toronto, Ontario For the Respondents