OTTAWA, ONTARIO, December 8, 2006
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
and
NOVOPHARM LIMITED and THE MINISTER
OF HEALTH
ORDER AND REASONS FOR ORDER
[1] The Applicants have brought a motion within the context of this Notice of Compliance proceeding requesting that I recuse myself from hearing a forthcoming motion brought by the Respondent to dismiss these proceedings and from any other involvement in these proceedings. For the Reasons that follow, I have determined that I will not recuse myself.
[2] These are Notice of Compliance (NOC) proceedings. In accordance with the Patented Medicines (Notice of Compliance) Regulations, such proceedings are to be made by way of application, to proceed in a summary fashion, and to be concluded within twenty-four (24) months from when they are instituted. This seemingly simple model has not proven successful in practice. The issues include those of patent validity and infringement which are complex issues, particularly in the field of drugs and medicines, requiring sophisticated expert evidence. The stakes are usually very high. An innovator drug company may find that a successful generic has entered the market eroding substantially the market position and profitability of the innovator. More than one generic may enter the market, the order in which they enter and the marketing strength of the generic may be critical. It is not unusual to find that millions of dollars may be at stake and that every single day that a generic is prevented from entering the market can be critical to each of the innovator and the generic.
[3] As a result, NOC proceedings in this Court are usually hotly contested, many procedural motions and issues arise, tactics and strategy abound. Both the innovator and the generic instigate and participate in such matters. So much is at stake. If, at the end of the day, the innovator is successful, the generic is prevented from marketing the product at issue. If the generic is successful, it may enter the market but be subject to possible patent infringement actions respecting the same or other patents. Res judicata does not apply in such actions so that the result of the NOC proceedings cannot be applied to the patent infringement action. The Regulations provide a further tool to the generic to sue the innovator for damages if it can be shown that the innovator, in some improper way, used the NOC proceedings to delay entry by the generic into the market.
[4] Here we have a motion by the innovator, that I recuse myself on the basis of alleged reasonable apprehension of bias. One hesitates to, in effect, judge oneself, but that appears to be the process. The judge in question decides if it is appropriate that he or she be recused. The test for recusal is not in issue, it is that set out in the recent decision of the Supreme Court of Canada in Wewaykum Indian Band v. Canada, [2003] 2 S.C.R. 259 at paragraph 60 of the decision of the Court:
60 In Canadian law, one standard has now emerged as the criterion for disqualification. The criterion, as expressed by de Grandpré J. in Committee for Justice and Liberty v. National Energy Board, supra, at p. 394, is the reasonable apprehension of bias: [page289]
... the apprehension of bias must be a reasonable one, held by reasonable and right minded persons, applying themselves to the question and obtaining thereon the required information. In the words of the Court of Appeal, that test is "what would an informed person, viewing the matter realistically and practically -- and having thought the matter through -- conclude. Would he think that it is more likely than not that [the decision-maker], whether consciously or unconsciously, would not decide fairly."
[5] There is no question of actual bias, the issue is that of reasonable apprehension of bias. The Applicants have fairly stated their position in paragraphs 35 and 36 of their Memorandum:
35. In the present case, Sanofi-Aventis does not suggest that there is actual bias, but rather, suggests that there is a reasonable apprehension of bias. Certainly, the personal integrity of Justice Hughes is not at issue.
36. The question is whether, having regard to the totality of the circumstances, confidence in the integrity of the administration of justice would be undermined if Justice Hughes decides the present motion. The test is whether reasonable, right-minded and properly informed persons would think that Justice Hughes, whether consciously or unconsciously, would not decide the motion fairly.
[6] At this stage, it is appropriate to review these proceedings and other proceedings.
[7] Prior to the institution of these proceedings the Respondent, Novopharm, sent a letter, called a Notice of Allegation under the Regulations, stating that it intended to obtain permission to market a drug containing ramipril in Canada. Novopharm alleged that certain patents, which for brevity I will call the ‘089, the ‘948, the ‘549 and the ‘387 patents would not be infringed if Novopharm were to market its drug in Canada. Novopharm further alleged that two of these patents, the ‘549 and the ‘387 were, in addition, invalid. As a result, the Applicants instituted these proceedings stating that such allegations were not justified.
[8] Sanofi-Aventis has also been engaged in other NOC proceedings in this Court respecting many of the same patents. In Aventis Pharma Inc. v. Pharmascience Inc., 2006 FC 898, this Court held that Aventis (a predecessor of Sanofi-Aventis) had not proven that Pharmascience’s allegation of non-infringement was not justified in respect of the ‘948 patent. In other words, Sanofi-Aventis failed to show infringement by the generic Pharmascience of the ‘948 patent. In Aventis Pharma Ltd. v. Apotex Inc. 2005 FC 1461, affirmed by the Federal Court of Appeal on November 2, 2006, 2006 FCA 357, it was held that Sanofi-Aventis had failed to show infringement by the generic Apotex of the ‘089 patent.
[9] Waiting in the wings are two further NOC proceedings involving yet another generic Laboratoire Riva Inc. In these proceedings one of the issues is whether Sanofi-Aventis can prove whether Riva’s allegation of non-infringement of a number of patents, among them the ‘089 and the ‘948 patents which were previously the subject of decisions of this Court respecting other generics, Pharmascience and Apotex is justified.
[10] With respect to the two Riva proceedings, I acted as solicitor of record for a time for Riva and signed one of the Notices of Allegation. I took no active part in respect of the examinations of Sanofi-Aventis’ witnesses. A year and a half has passed since I was sworn in as a judge of this Court.
[11] The common thread, if any, between Riva and this current Novopharm proceeding, is the same as that in the decided cases of this Court respecting Pharmascience and Apotex namely, has the allegation of the particular generic in question that it would not infringe the ‘089 or ‘948 patent been shown not to be justified?
[12] It is important to note that there is, in respect of the forthcoming motion, which is among the matters from which I am asked to recuse myself, no issue as to validity of any patent. Patent validity can, in some circumstances, be in rem proceedings. This however, is only in an ordinary patent action where the Court may in fact impeach a patent or some of its claims in a judgment that is in rem and effective against the patent itself and not just the parties.
[13] Infringement on the other hand requires a factual examination as to what the alleged infringer does or says it will do. This is a determination of fact to be made upon the evidence as determined by the Court in each case. That determination of fact is then applied to the claims of the patent at issue, as construed by the Court, to determine if an allegation of non-infringement is justified.
[14] The question of infringement, therefore, is a mixed question of fact (what the alleged infringer does or will do) and the law (construction of the claim) see Whirlpool Corp. v. Camco Inc. [2000] 2 S.C.R. 1067 at para.67.
[15] The claim at issue of the ‘089 Patent has previously been considered by the Federal Court in the Apotex case, supra, at paragraph 25 of the reasons as being a claim for use of ramipril in treating Hypertrophy. That construction was undisputed. The judgment was affirmed on appeal.
[16] In Pharmascience, supra, the Federal Court has previously construed the ‘948 Patent at paragraph 3 of the Reasons as the use of ramipril in combination with a calcium antagonist to prevent and treat pneumonia. Again this construction was undisputed.
[17] I have read the Memorandum of Argument filed by Sanofi-Aventis in respect of the forthcoming motion to dismiss and note at paragraph 23 that the construction of the claims of the ‘089 and ‘948 Patents urged there is not inconsistent with the finding of this Court, in those prior Apotex and Pharmascience decisions. I also note that Sanofi-Aventis in that Memorandum, argues, in paragraphs such as 60 and 92, that findings as to infringement are “fact-intensive” and that each case is to be considered separately.
[18] Thus the findings that I will be asked to make in the present proceeding, particularly on the forthcoming motion, to the extent that there would be any commonality with Riva, would be fact intensive findings unique to each circumstance for each generic.
[19] While Courts have often been circumspect when issues as to possible bias arise and have as a matter of expediency, assigned a different Judge to hear a matter when even the merest suggestion as to apprehension of bias arise, that is a matter of expediency only and does not establish jurisprudential precedent. In this case, the Applicants’ only raised the suggestion of a bias issue by letter sent to the Court in the middle of the afternoon of the day before several motions were due to be heard by me, having been set down for hearing several weeks previously.
[20] Turning to the jurisprudence, the Arsenault-Cameron v. PEI case in the Supreme Court of Canada, reported at [1999] 3 S.C.R. 851 is instructive. The court states at paragraph 2 that:
“The test for apprehension of bias takes into account the presumption of impartiality. A real likelihood of bias must be demonstrated.”
[21] In Samson Indian Nation and Band v. Canada, [1998] 3 F.C. 3, Justice Teitelbaum of this Court at paragraph 73 to 75 reminds the reader as to the solemnity of the judicial oath and the impartiality that it brings with it.
[22] In Wewaykum, supra, the Supreme Court at paragraph 59 of its decision invokes one of its earlier decisions in Bertram stating that the law should not carelessly evoke the possibility of bias in a Judge. As set out earlier in these Reasons in quoting from paragraph 60 of Wewaykum, there must be a “reasonable” apprehension of bias held by “reasonable and right minded persons.” One does not view such matters through the mind of a cynical, capricious, excessively suspicious, paranoid or perfectionist person as MacKinnon ACJO stated at page 679 of Re Currie (1984), 14 D.L.R. (4th) 651 (Ont CA).
[23] Here the position of Sanofi-Aventis as to the alleged “reasonable” apprehension of bias is that somehow I would make findings in this case on the facts and in law that might benefit a former client at the time when I was practicing law, which former client has pending cases involving two of the same patents. As I have already pointed out, factual findings as to infringement are case specific, and there is no controversy as to construction of the claim. Such allegations are more like those recited by MacKinnon ACJO than those of a reasonable person.
[24] Judges should be allowed to do their job free from unreasonable allegations of bias. They have taken an oath to execute their powers and trusts duly and faithfully. Lawyers practicing before the Courts have their own duties to their client and the Court. Lawyers should be encouraged, at the appropriate time, to put that career behind them and assume new duties as a Judge serving the public duly and faithfully. As the Supreme Court stated in Arsenault-Cameron, supra at paragraph 4 in referring to a decision of the Constitutional Court of South Africa: “No recusal application could be founded on a relationship of advocate unless the advocacy was regarding the case to be heard”.
[25] The motion for recusal is dismissed with costs.
ORDER
FOR THE REASONS ABOVE:
1. The motion is dismissed; and
2. The Respondent is entitled to its costs of the motion.
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1979-05
STYLE OF CAUSE: Sanofi-Aventis Canada Inc. et al.
v. Novopharm Limited et al.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: December 7, 2006
ORDER and REASONS
FOR ORDER: HUGHES, J.
DATED: December 8, 2006
APPEARANCES:
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Gunars A. Gaikis J. Sheldon Hamilton Mark G. Biernacki |
FOR THE APPLICANTS |
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Jonathan Stainsby Mark Edward Davis Neil Fineberg |
FOR THE RESPONDENT, NOVOPHARM LIMITED |
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No One Appearing |
FOR THE RESONDENT, THE MINISTER OF HEALTH |
SOLICITORS OF RECORD:
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Smart & Biggar Toronto, Ontario |
FOR THE APPLICANTS |
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Heenan Blaikie LLP Toronto, Ontario |
FOR THE RESPONDENT, NOVOPHARM LIMITED |
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John H. Sims, Q.C. Deputy Attorney General of Canada |
FOR THE RESPONDENT, THE MINISTER OF HEALTH |