BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
Heard at Toronto, Ontario, on October 31, 2006.
Judgment delivered at Toronto, Ontario, on November 2, 2006.
REASONS FOR JUDGMENT BY: NADON J.A.
CONCURRED IN BY: LINDEN J.A.
EVANS J.A.
Date: 20061102
Docket: A-575-05
Citation: 2006 FCA 357
CORAM: LINDEN J.A.
NADON J.A.
EVANS J.A.
BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
NADON J.A.
[1] This is an appeal from a decision of Mr. Justice von Finckenstein of the Federal Court, dated October 27, 2005, which dismissed the Appellants’ application brought under the Patented Medicines (Notice of Compliance) Regulations, S.O.R/93-133 (“the Regulations”) for an order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to the Respondent, Apotex, in respect of its ramipril oral capsules of 1.25, 2.5, 5 and 10 mg until the expiration of Canadian patent 2,023,089 (the “089 patent “ or the “patent at issue”), which makes claim to the use of ramipril, inter alia, for the treatment of cardiac and vascular hypertrophy.
[2] In my view, this appeal cannot succeed.
[3] The issue raised by the appeal pertains to the construction of sub-paragraph 5(1)(b)(iv) of the regulations which reads as follows:
|
5.(1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, (b) allege that (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. |
5.(1) Lorsqu’une personne dépose ou déposé une demande d’avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d’un avis de conformité délivré à la première personne et à l’égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l’égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue : (b) soit une allégation portant que, selon le cas : (iv) aucune revendication pour le médicament en soi ni aucune revendication pour l’utilisation du médicament ne seraient contrefaites advenant l’utilisation, la fabrication, la construction ou la ente par elle de la drogue faisant l’objet de la demande d’avis de conformité. |
[4] More particularly, the issue is whether on a true construction of the provision, absent proof that Apotex, a second person under the Regulations, will infringe directly or indirectly the patent at issue, an NOC should issue. Put another way, does paragraph 5(1)(b)(iv) of the Regulations bar the Minister from issuing a NOC to a second person in circumstances where it is conceded that the mere sale of its drug product for the approved use, will lead to infringement of the patented use when patients, following prescriptions given to them by their physicians for use of the drug product for the patented use, will consume the drug for the patented use.
[5] The question before us was squarely addressed and dealt with by this court in Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 229, a decision rendered on June 21, 2006. That decision provides, in my view, a complete answer to the issue raised by this appeal.
[6] The Appellants argue that Pharmascience was wrongly decided and that we should rather follow a previous decision of the court, namely the “Genpharm” decision, Procter & Gamble Pharmaceutical Canada Inc. v. Canada (Minister of Health)(CA) [2003) 1FC402. In other words, the Appellants argue that by reason of conflicting decisions, it is open to this panel to decide which interpretation of paragraph 5 (1)(b)(iv) of the Regulations is the correct one.
[7] In my view, the Appellants’ submission must fail. Firstly, I cannot agree that we are faced with conflicting decisions on the point of law before us. That submission was likely well founded when the issue was argued before the Pharmascience panel but that is no longer the case.
[8] In my view, if there was a conflict between the Genpharm decision, on which the Appellants primarily rely, and another decision of this Court, namely AB Hassle v. Canada (Minister of National Health and Welfare), [2002] FCJ No.1533, 2002 FCA, 421, on which Apotex relies, and, I am prepared to accept that there was indeed a conflict, Pharmascience supra has resolved the conflict.
[9] Although Madam Justice Sharlow, who wrote the reasons in Pharascience for a unanimous court, was somewhat reluctant to conclude that these decisions offered conflicting interpretations of subparagraph 5(1)(b)(iv) of the Regulations, she nonetheless made it clear at paragraph 59 of her reasons that “There are statements in Genpharm that could be taken to support the broader interpretation of subparagraph 5(1)(b)(iv) proposed by Aventis…” (Aventis’ submission in Pharascience is indistinguishable from the submissions made in this Appeal by the Appellants).
[10] Sharlow J.A. continued and stated that although Genpharm was no doubt properly decided on its facts, paragraphs 45 to 50 thereof (on which the Appellants place great reliance) “do not reflect the correct interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations, and to that limited extent should be taken to have been reversed by AB Hassle”.
[11] Hence, the question is whether it is now open to us to reverse Pharmascience, supra. In my view, we cannot reverse.
[12] In Miller v. Canada (Attorney General) 2002 FCA 370 this Court held that a prior decision would not be overturned unless it could be shown that it was manifestly wrong, “in the sense that the Court overlooked a relevant statutory provision, or a case that ought to have been followed” (para 10 of Rothstein, J.A.’s reasons in Miller).
[13] The Appellants have failed to persuade me that Pharmascience is “manifestly wrong” and they did not submit that there was a basis for distinguishing it.
[14] Although this is sufficient, on the facts of the case, to dispose of the appeal in favour of Apotex, I would add, for the reasons expressed by Sharlow J.A. in Pharmascience, supra, that the Appellants, a first person under the Regulations, cannot succeed on their Application for an order of prohibition unless they can show that Apotex, a second person under the Regulations, will infringe the 089 patent in making, constructing, using or selling its apo-ramipril, the drug in respect of which it is seeking the issuance of an NOC for the treatment of hypertension.
[15] In particular, I agree fully with the following remarks made by Sharlow, J.A. at paragraph 57 of her reasons in Pharascience:
In my view, the interpretation proposed by Pharmascience [the second person] is more consistent with the ordinary grammatical meaning of subparagraph 5(1)(b)(iv) of the NOC Regulations, and is also more consistent with the legislative scheme and purpose. Subsection 55.2(4) of the Patent Act and by extension the NOC Regulations are intended to prevent patent infringement by Pharmascience, not by patients.
[16] The Appellants have adduced evidence that if Apo-ramipril is allowed on the market as a result of the issuance of a NOC by the Minister, physicians will prescribe it for the treatment of hypertrophy, pharmacists will dispense it for that use and patients will consume it for the treatment of hypertrophy.
[17] However, the mere sale by Apotex of its Apro-ramipril for the treatment of hypertension, ie the use for which a NOC will be issued, cannot possibly constitute infringement by Apotex of the patent at issue.
[18] To constitute an indirect infringement of the patent by Apotex there must be, in the words of Sexton J.A. in AB Hassle “something more” than sale. The “something more” is conduct that would make Apotex liable in an action for infringement including procuring or inducing others to infringe. There is no evidence here of such conduct on the part of Apotex.
[19] In that regard, the words of Sexton J.A. in paragraph 57 of his reasons in AB Hassle, supra are entirely apposite and I make them mine:
Thus Apotex cannot be prevented from obtaining a NOC solely on the basis that it will sell omeprazole. If it were otherwise, then serious policy issues would arise. If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result,
would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost.
I note that this view of the matter was also clearly expressed by Sharlow J.A. at paragraph 58 of her reasons in Pharascience.
[20] Consequently, I come to the conclusion that von Finckenstein J.A. did not err in dismissing the Appellants’ application for an order of prohibition.
[21] I would therefore dismiss the Appeal with costs.
“M. Nadon”
“I agree
A.M. Linden”
“I agree
John M. Evans”
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-575-05
STYLE OF CAUSE: SANOFI-AVENTIS CANADA INC.
ET AL
Appellants
and
APOTEX INC. ET AL
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: OCTOBER 31, 2006
REASONS FOR JUDGMENT: NADON J.A.
CONCURRED IN BY: LINDEN J.A.
EVANS J.A.
APPEARANCES BY:
Mr. Gunars A. Gaikis FOR THE APPELLANTS
Ms. Yoon Kang FOR THE APPELLANTS
Mr. Andrew R. Brodkin FOR THE RESPONDENT, APOTEX INC.
Mr. John H. Simpson FOR THE RESPONDENT, APOTEX INC.
SOLICITORS OF RECORD:
SMART & BIGGAR
Barristers & Solicitors
Toronto, Ontario FOR THE APPELLANTS
GOODMANS LLP
Barristers & Solicitors
Toronto, Ontario FOR THE RESPONDENT, APOTEX INC
John H. Sims, Q.C. FOR THE RESPONDENT, THE MINISTER
Deputy Attorney General of Canada OF HEALTH