Applicant
and
THE ATTORNEY GENERAL OF CANADA
AND APOTEX INC.
REASONS FOR ORDER
HARRINGTON J.
[1] The underlying application in this case is for a judicial review of a decision of the Minister of Health with respect to two Canadian patents. Novopharm, whose business is affected by a similar decision pertaining to the same patents, has sought to intervene. I dismissed that motion but ordered that the judicial review of two similar applications be heard on the merits immediately following this one. These are my reasons.
BACKGROUND
[2] An interlocutory order of Mr. Justice von Finckenstein has already made it to the Court of Appeal. There is no better way to outline the facts than to draw upon the decision of Madam Justice Sharlow of the Court of Appeal (Apotex Inc. v. Sanofi-Aventis Canada Inc., 2007 FCA 7) , which decision is presently the subject of an application for leave to appeal in the Supreme Court.
[3] In short, Sanofi makes and sells a drug by the name of Altace. The medical ingredient is ramipril. A number of patents in respect of Altace are listed on the Register maintained by the Minister under the Patented Medicines (Notice of Compliance) Regulations. There are two patents relevant to this application for judicial review: Canadian patent numbers 2,382,387 (‘387) and 2,382,549 (‘549). Both were listed following a submission by Sanofi in November 2003.
[4] Apotex filed an abbreviated new drug submission alleging that its proposed ramipril product, Apo-ramipril, is the bioequivalent of Altace. This submission was filed before Sanofi filed its submission which led to the addition of the ‘387 and ‘549 patents to the Register.
[5] Apparently the Minister was satisfied some time ago that Apo-ramipril is bioequivalent to Altace and that a notice of compliance (NOC) to that effect should issue, subject to the requirements of the Regulations. Sanofi commenced an application in this Court (T-87-06) for an order prohibiting the Minister from issuing the NOC. It was thought that those proceedings served as a statutory stay for up to two years in accordance with subsection 7(1)(e) of the Regulations.
[6] However, the Minister has apparently taken a new approach to his administration of the Regulations in light of the decision by the Supreme Court of Canada last November in AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49. As per the headnote:
Under the Patented Medicines (Notice of Compliance) Regulations (“NOC Regulations”), a generic manufacturer who is not prepared to await the expiry of what are alleged to be the relevant patents, must challenge their validity or applicability to its proposed product (s. 5). The challenge is to be embodied in a notice of allegation. The innovator drug company may then apply for an order prohibiting the issuance of the NOC based on the relevance, validity and applicability of the listed patents (s. 7). The application for prohibition triggers a 24‑month statutory freeze on the issuance of a NOC. In this case, the Minister was entitled to issue the NOC to Apotex on the basis of Apotex’s abbreviated new drug submission without subjecting it to the 24‑month statutory freeze in respect of the after‑issued patents. The NOC Regulations are concerned only with patents relevant to the innovator product actually copied and not with subsequently issued and listed patents from which a generic manufacturer could not receive a benefit. [paras. 3,14,28,31]
[7] The Minister has concluded that Apotex’s comparison was based on Altace as it was before ‘549 and ‘387 were added to the Patent Register, and that it did not make use of the changes claimed therein. He therefore issued Apotex a NOC, notwithstanding the proceedings pending in this Court.
[8] Sanofi sought a stay of the operation of the NOC which stay was granted by Mr. Justice von Finckenstein, 2006 FC 1559. However, his order was overturned on appeal by Madam Justice Sharlow. An application to the Supreme Court to stay Madam Justice Sharlow’s stay was dismissed, but the Court ordered that Sanofi’s application for leave to appeal be expedited.
[9] Suffice it to say that the Minister’s decision to administer the Regulations in a new way is of considerable importance and carries with it grave consequences.
[10] Mr. Justice von Finckenstein had ordered that the hearing of this application on the merits be expedited. It is hoped to be heard next month.
[11] Novopharm has also sought a NOC from the Minister of Health with respect to its generic version of ramipril. Like Apotex, it has been relieved by the Minister of having to deal with the same two patents. However, it still has to deal with another two and so has not yet obtained a NOC. Nevertheless, it faces a similar prohibition application by Sanofi in docket T-2188-06 with respect to patents ‘387 and ‘549.
[12] Another application, T-2189-06, is similar in that it is directed by Sanofi against the Minister with respect to the same NOC which was issued to Apotex. It may possibly be overcome by these proceedings.
INTERVENER STATUS
[13] In determining whether intervener status should be granted pursuant to Rule 109 of the Federal Courts Rules, the Court should take into account several factors. In Canadian Union of Public Employees (Airline Division) v. Canadian Airlines International Ltd., [2000] F.C.J. No. 220 (QL), 95 A.C.W.S. (3d) 249, the Court of Appeal set out six. I do not read the decision as requiring that all six factors be met, or that other factors need not to be taken into consideration. They are:
a. Is the proposed intervener directly affected by the outcome?
b. Does there exist a justiceable issue and a veritable public interest?
c. Are there other reasonable or efficient means to submit the questions to the Court?
d. Is the position of the proposed intervener adequately defended by one of the parties to the case?
e. Are the interests of justice better served by the intervention?
f. Can the Court hear and decide the case on the merits without the proposed intervener?
[14] Sanofi makes the allegation that both Apotex and Novopharm benefited from the two patents in question. That is an issue of fact, and may well differ in each application. The Minister is perfectly able to defend his position, as is Apotex. The case can be decided without Novopharm’s help. Furthermore, the Court has already expressed the desire that the hearing on the merits be expedited. It is quite possible that the addition of an intervener would complicate the matter and delay the hearing.
[15] What it comes down to in my view is that Novopharm has an interest in the Minister’s current interpretation of the Regulations, but that interest is not sufficient to justify giving it intervener status, at least at this level.
[16] The same reasoning applies to the motion to consolidate the hearing of the three applications. However, I ordered that, if ready, T-2188-06 and T-2189-06 be heard immediately following this matter. Given that all three cases deal with the same two patents, the same medicine, the bearing of the AstraZeneca decision on the Regulations, and the Minister’s administration thereof, it is, in my opinion, in the interests of justice that the same judge hear all three matters.
“Sean Harrington”
Ottawa, Ontario
February 5, 2007
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-2196-06
STYLE OF CAUSE: SANOFI-AVENTIS CANADA INC. v. THE MINISTER OF HEALTH, THE ATTORNEY GENERAL OF CANADA AND APOTEX INC.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: January 30, 2007
REASONS FOR ORDER: HARRINGTON J.
APPEARANCES:
|
Mr. Steven Garland Mr. Jeremy Want
|
|
|
Mr. Rick Woyiwada |
FOR THE RESPONDENT, THE MINISTER OF HEALTH |
|
|
|
|
Mr. Ben Hackett
|
FOR THE RESPONDENT, APOTEX INC. |
|
Mr. Jonathan Stainsby Mr. Mark Davis |
FOR THE PROPOSED INTERVENER, NOVOPHARM LTD. |
|
|
|
SOLICITORS OF RECORD:
|
Smart & Biggar Barristers & Solicitors
|
FOR THE APPLICANT |
|
John H. Sims, Q.C. Deputy Attorney General of Canada
|
|
|
Goodmans LLP Barristers & Solicitors |
FOR THE RESPONDENT, APOTEX INC. |
|
|
|
|
Heenan Blaikie LLP Barristers & Solicitors |
FOR THE PROPOSED INTERVENER, NOVOPHARM LIMITED |