Date: 20070810
Docket: T-127-07
Citation:
2007 FC 832
Toronto, Ontario, August 10, 2007
PRESENT: Kevin R. Aalto, Esquire, Prothonotary
BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This
is a motion by the Defendant (Riva) to strike out the Notice of Application of
the Plaintiff (Sanofi-Aventis) or alternatively, to strike out portions of the
Notice of Application. In the event the Notice of Application is not
struck other ancillary relief is sought. The motion is brought pursuant
to section 6(5)(b) of the Patented Medicines (Notice of Compliance)
Regulations which reads as follows:
6(5)
In a proceeding in respect of an application under subsection (1), the court
may, on the motion of a second person, dismiss the application in whole or
in part
(b)
on the ground that it is redundant, scandalous, frivolous or vexatious or is
otherwise an abuse of process in respect of one or more patents.
(emphasis
added)
Background
[2]
On
or about December
5, 2006,
Riva served a Notice of Allegation (NOA) on Sanofi-Aventis regarding the drug
product ramipril. Riva alleges that it intends to make and market
ramipril only for the “old” use of essential hypertension. The patents in
issue are Patent No. 2,382,549 and Patent No. 2,382,387 (collectively the HOPE
Patents) both of which contain claims to new uses of the old compound ramipril.
[3]
In
response to the NOA, Sanofi-Aventis commenced this Notice of Application on
January 19, 2007 seeking an order prohibiting the Minister of Health from
issuing a Notice of Compliance (NOC) to Riva. Sanofi-Aventis sought
similar prohibition orders in T-1384-04 and T-1888-04 involving these same
parties in respect to four other patents, three of which claimed new uses of
ramipril. Those applications were dismissed by the Honourable Mr. Justice
Harrington on May 17, 2007. This Notice of Application is the last hurdle
to Riva from obtaining its NOC so it can enter the market with its drug
ramipril.
[4]
Riva’s
NOA alleges that it will not infringe any of the relevant use claims of the
HOPE Patents nor will it induce or procure the infringement of the use
claims. Riva’s product monograph and other materials have been disclosed
to Sanofi-Aventis in the prior proceedings. Riva states that it will
include in its product monologue a statement that its ramipril product is
approved only for the use and indication for which the NOC is issued and the
Riva product is not to be used for anything other than the approved use and
indication.
[5]
There
are four issues raised in this Notice of Application by Sanofi-Aventis.
They are:
1.
Riva has no standing to deliver a NOA because it is a privy of
Pharmascience Inc.;
2.
Riva cannot get a NOC unless and until another generic, Pharmascience
Inc., obtains a NOC from the Minister of Health (the Cross-Reference Issue);
3.
the NOA is deficient; and,
4.
the allegations of non-infringement are not justified.
Are
Riva and Pharmascience Privies?
[6]
Simply
put, the answer is no. This issue was an issue which also arose in the
prior proceedings involving these Parties. In Sanofi-Aventis et
al v. Laboratoire Riva et al., [2007] FC 532. The Honourable Mr.
Justice Harrington determined that Riva and Pharmascience were not
privies. He noted at par. 27:
However,
I am not satisfied that the facts above and the fact that Riva’s expert, Dr.
Christensen, was first approached by Pharmascience establish that the two were
privies. All that has been established is that they have a trade
relationship, and that is not enough. (citations omitted).
[7]
There
is no evidence produced by Sanofi-Aventis in this proceeding which establishes
in any way that Riva and Pharmascience are privies. This issue has no chance
of success and need not be re-litigated. It is therefore struck out.
The Cross Reference
Issue
[8]
Sanofi-Aventis
alleges in its Notice of Application that:
10. In a prior
proceeding involving these parties (Court File T-1384-04) Riva’s NOA referred
to an “ANDS cross-referenced to pms-Ramipril”. PMS is Pharmascience Inc.
(“Pharmascience”). Pms-ramipril is a reference to a Pharmascience ramipril
product.
11. Pursuant to the
Order of Madam Justice Snider dated March 11, 2005, the Minister is prohibited
from issuing a NOC to Pharmascience for
ramipril until expiry of the patent at issue in the proceeding: 2005 FC 340;
aff’d 2006 FCA 229.
12. No NOC can issue
to Riva since any alleged Riva submission is cross-referenced to a submission
for which the Minister cannot presently issue a NOC.
[9]
Again,
this issue has no chance of success. There are two compelling reasons why
this is so. First, the undisputed evidence before the Court includes a
letter dated June 21, 2007 from counsel for the Minister of Health to counsel
for Riva in which it is stated:
In particular, Health Canada is no longer of the view that
Riva cannot receive a notice of compliance until such time as the Pharmascience
submission to which Riva’s product is ‘cross-referenced’ is itself approved.
As a result, should Riva ultimately be successful in the prohibition
proceedings ongoing in T-127-07, and otherwise meet all of its obligations
under the Patented Medicines (Notice of Compliance) Regulations, it will
be eligible to receive a notice of compliance, regardless of whether the
Pharmascience submission has fully complied with the NOC Regulations and
received a notice of compliance. I can also advise that Health Canada will
soon be providing Riva with a letter confirming that this is so.
[10]
Second,
in the Sanofi-Aventis case, supra, Justice Harrington also dealt
with this issue and for all intents and purposes the issue is now res
judicata. Justice Harrington commented with respect to this issue as
follows:
Sanofi-Aventis also argues that these proceedings
are abusive in that it is the Minister’s policy not to issue an NOC where a
submission cross-references an earlier submission, unless and until that
earlier submission is successful. The application by Pharmascience was
unsuccessful. However, I am not concerned with whatever policy the Minister
may have. What are before me are allegations of invalidity and
non-infringement, no more and no less. If the Minister decides not to issue an
NOC on other grounds, then that decision might be the subject of a separate
judicial review.
It is clear from both
the letter and this passage that the Cross Reference Issue will not
succeed. It is struck out.
Deficiency of NOA
[11]
Sanofi-Aventis
makes a number of allegations regarding the sufficiency of Riva’s NOA.
The primary allegation being that Riva has not produced the product monograph,
labeling or marketing materials for its ramipril product. Those materials
are specifically identified in the NOA as being the materials provided to Sanofi-Aventis
and its counsel in proceedings T-1888-04 and T-1384-04, the cases decided by
Justice Harrington. The NOA consents to Sanofi-Aventis and its counsel
reviewing those materials “for the purpose of determining whether to proceed
with litigation pursuant to the Regulations”.
[12]
In
this proceeding, Sanofi-Aventis argues that because there were protective
orders in those prior proceedings the review of the materials cannot be relied
upon by Sanofi-Aventis. This argument is without merit. The
materials are in the possession of Sanofi-Aventis by virtue of the prior
proceedings, even though subject to a protective order, and Riva has
unequivocally stated that Sanofi-Aventis may review them in this proceeding for
the “purpose” of determining whether to proceed with litigation. It can
hardly be said that Sanofi-Aventis is in some way denied the opportunity to
understand the product monograph, labeling or marketing materials or that it is
somehow prejudiced by the protective order. The parties have litigated
over Riva’s ramipril product in prior proceedings.
[13]
Further,
the evidence filed by Sanofi-Aventis is to the effect that dispensing
pharmacists usually do not have any reason “to consult the generic’s product
monograph” (Nenadovich Affidavit, par. 10). There is no evidence that Sanofi-Aventis
will be influenced in any way by the contents of the product monograph.
Thus, this allegation has no chance of success.
[14]
Of the remaining allegations of insufficiency of the NOA, the only one
worth mentioning is that Riva fails to specify what “reports of the HOPE Study”
it is referring to in the NOA. The HOPE Study is specifically described
in the NOA and it is readily available in the literature dealing with
ramipril. Sanofi-Aventis knows the case it has to meet. The
allegations of insufficiency of the NOA have no chance of success and are
struck out.
Infringement
[15]
Riva
asserts in its NOA that it will not induce or procure infringement of the HOPE
Patents. Sanofi-Aventis disputes this assertion and alleges that patients will
infringe the HOPE Patents and that Riva will be connected to this
infringement. Sanofi-Aventis has filed affidavits from ten individuals,
seven of which did not file any evidence in the prior applications. The
new affiants attest to the following facts:
·
Contrary
to Riva’s allegations, the possibility that patients may be exposed to
allegations and threats of infringement due to their use of a drug will not
occur to physicians; their prescribing decisions are based on the demonstrated
effectiveness of a drug; (Arnold Affidavit, paras. 24-25;
Lin Affidavit, paras. 33-34)
·
Most
prescriptions for Sanofi-Aventis’ ramipril products are given to patients for
the HOPE indication; (Wilson Affidavit, para. 13; Gravel Affidavit,
para. 25)
·
Riva
will likely promote its ramipril products based on price rather than for any
specific indication; (Nenadovich Affidavit, para. 13)
·
Riva
will likely apply for full interchangeability listing at the provincial level
and will proceed to negotiate exclusive supply contracts with independent
pharmacy owners, retail chains and other buying groups, such that they will be compelled
to dispense Riva’s ramipril products for all uses, including the HOPE
indication, which is the main use of ramipril in Canada today. (Gravel Affidavit, para.
25)
[16]
In
summary, Sanofi-Aventis argues that Riva will use price and exclusive supply
contracts to induce or procure infringement. Sanofi-Aventis alleges that this
conduct by Riva will be the “more” (i.e. in addition to making and selling the
drug) that establishes inducement or procurement. In Pharmascience
Inc v. Sanofi-Aventis et al., [2006] FCA 299, Sharlow J.A. makes the
point that mere marketing by a generic manufacturer “without more” does not
amount to infringement by the generic manufacturer or infringement through
inducement or procurement by others (see par. 35). On this issue, it is
not “plain and obvious” that the allegation of inducement or procurement of
infringement has no possibility of success. In the prior proceedings
heard by Justice Harrington, there was some discussion of inducing and
procuring of infringement. In Sanofi-Aventis, supra, Justice
Harrington noted:
The NOAs were sufficiently detailed, and
can hardly be Sanofi-Aventis to have taken Sanofi-Aventis by surprise. It may
well be, as Sanofi-Aventis alleges, that provincial government, physicians, pharmacists
and patients will infringe the patents. If so, the remedy is to give them
notice, and to sue for patent infringement, notwithstanding that this might be
a disastrous business plan. The remedy is not to prohibit the Minister from
allowing the generic onto the marketplace. Furthermore, drawing on the Manitoba court of Appeal, and as
discussed in the following paragraphs, a concession by a generic drug company
does not constitute an admission binding on physicians and pharmacists
(Astrazeneca Canada Inc. v. Apotex Inc., 2006 MBCA 21, [2006] M.J. 38 (QL) at
paragraph 55).
[17]
Sanofi-Aventis
has now led specific evidence relating to the use of price and exclusive supply
contracts by Riva to compel the use of Riva’s rampiril product. This is a
contentious issue and one that should not be struck at this point in the
proceeding. It is not clear and obvious that Sanofi-Aventis has, without
any doubt, no chance of success on this issue.
[18]
During
argument counsel for Sanofi-Aventis took issue with the jurisdiction of the
Court to strike out or dismiss only parts of the Notice of Application.
They argued that s. 6(5)(1) of the Regulations is an “all or nothing regime”
and they do not permit the Court to dismiss or strike out portions of the
Notice of Application. The phrase “in whole or in part” they argue does
not mean that an issue or issues can be dismissed. They further argued
that as this was a disputed interpretation of s. 6(5)(1)(b) that the correct
interpretation could only be decided at a full hearing of the
application. With respect, this argument makes no sense. The Notice
of Application is akin to a pleading and while it must be read as generously as
possible the court has the jurisdiction under the Regulations to strike
out the Notice of Application “in whole or in part”. The plain
meaning of the words “in whole or in part” in s. 6(5)(1)(b) when read in their
entire context and in their grammatical and ordinary sense compels an
interpretation that the Court has the authority to dismiss a part of the Notice
of Application which can only rationally refer to specific grounds or issues
raised.
[19]
In
their Notice of Motion, Riva seeks an order that this application proceed as a
specially managed proceeding in the event the Court determines that all or part
of it should continue. They also seek a confidentiality order in similar
terms to the confidentiality order in the prior proceedings. During
argument, counsel for Sanofi-Aventis did not take issue with designating this
application as a specially managed proceeding nor did they make submissions on
the form of the proposed draft confidentiality order. The proposed draft
confidentiality order is limited only to the information contained in Riva’s
Abbreviated New Drug Submission. The proposed draft order shall issue in
the form annexed as Schedule “A” to the Notice of Motion.
[20]
As
Riva has had substantial success on this motion they are entitled to their
costs.
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