Date: 20070205
Docket: T-2196-06
Citation: 2007 FC 124
BETWEEN:
SANOFI-AVENTIS CANADA INC.
Applicant
and
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL OF CANADA
AND APOTEX INC.
Respondents
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
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