Date: 20090915
Dockets: T-482-03
T-2300-06
Citation: 2009 FC 915
Ottawa, Ontario, September 15, 2009
PRESENT: The Honourable Mr. Justice Zinn
Docket: T-482-03
BETWEEN:
AVENTIS-PHARMA INC. and
AVENTIS PHARMA DEUTSCHLAND GmbH
Applicants
and
PHARMASCIENCE INC. and
THE MINISTER OF HEALTH
Respondents
and
SCHERING CORPORTION
Respondent/Patentee
Docket: T-2300-06
AND
BETWEEN:
SANOFI-AVENTIS CANADA INC.
Applicant
and
PHARMASCIENCE INC. and
THE MINISTER OF HEALTH
Respondents
and
SCHERING CORPORTION
Respondent/Patentee
REASONS FOR ORDER AND ORDER
[1]
The
Respondent Pharmascience Inc. (Pharmascience) brings a motion to set aside orders
of prohibition and to dismiss applications previously granted by this Court under
the Patented Medicines (Notice of Compliance) Regulations (the
Regulations). It is seeking this remedy in light of a recent judicial
determination relating to the patent at issue, Canadian Patent No. 1,341,206
(the ‘206 Patent).
[2]
All
parties are agreed that some direction or order of this Court is required; they
differ on the terms such a direction or order ought to take. Although the
motion was originally brought only with respect to File T-482-03, it was agreed
by all parties at the hearing that these Reasons and Order would also apply to related
File T-2300-06. Accordingly both actions are listed on the Style of Cause and
these Reasons for Order and Order shall be placed on both Court Files T-482-03
and T-2300-06.
Background
Docket
T-482-03
[3]
On
August 31, 2001, Pharmascience made a submission to the Minister of Health,
pursuant to the Regulations, for the issuance of a Notice of Compliance (NOC)
to market capsules of ramipril for the treatment of hypertension. Although
originally two patents were put in issue, only the ‘206 Patent was germane to
the Court’s ultimate determination as the Court held that the allegation of
non-infringement of the second patent was justified and accordingly the
application was dismissed in respect of that second patent.
[4]
Pharmascience
alleged that the claims of the ‘206 Patent that covered ramipril were invalid
only on the basis of double patenting. Justice Snider found that the claims of
the ‘206 Patent were not invalid on the basis of double patenting: Aventis
Pharma Inc. v. Pharmascience Inc., 2005 FC 340,
aff’d 2006 FCA 229, leave to appeal to the Supreme Court of Canada denied,
[2006] S.C.C.A. No. 362.
[5]
Justice
Snider issued an Order on March 11, 2005, that, in relevant part, granted the application
and prohibited The Minister of Health from issuing an NOC
pursuant to the Regulations to Pharmascience in respect of ramipril until after
the expiry of the ‘206 Patent.
Docket T-2300-06
[6]
Following
the decision in T-482-03, Pharmascience issued a new Notice of Allegation
asserting that the ‘206 Patent was invalid on several additional grounds not
argued in the previous application. Justice Mactavish held that
Pharmascience’s allegation of invalidity with respect to the ‘206 Patent had
been finally determined by Justice Snider in T-482-03 and that issue estoppel
operated to preclude Pharmascience from making further allegations of
invalidity with respect to the ‘206 Patent, on different grounds: Sanofi-Aventis
Canada Inc. v. Pharmascience Inc., 2007 FC 1057.
Accordingly, she issued a declaration to that effect by Order dated November
27, 2007. On June 20, 2008, she granted the application and issued an Order
prohibiting the Minister of Health from issuing an NOC
to Pharmascience in respect of its ramipril capsules until after the expiration
of the ‘206 Patent.
The Invalidity of Some ‘206
Patent Claims
[7]
In
2007 the Applicants and the Respondent/Patentee in T-482-03 and T-2300-06 commenced
actions against Apotex Inc. (T-161-07) and Novopharm Limited (T-1161-07) for
patent infringement arising from their sale of ramipril in Canada. After a
trial of these actions, Justice Snider, by Judgment dated June 29, 2009, found
that claims 1, 2, 3, 6, and 12 of the ‘206 Patent are invalid, void,
unenforceable and of no force or effect: Sanofi-Aventis Canada v.
Apotex Inc., 2009 FC 676.
[8]
It
is common ground among all parties that the only claims of the ‘206 Patent that
were relevant in Files T-482-03 and T-2300-06 are claims 1, 2, 3, 6, and 12 –
the very claims that have now been found to be invalid.
[9]
As
a consequence of this Court’s recent findings of invalidity of these claims of
the ‘206 Patent, Pharmascience, by message dated July 10, 2009, asked the
Minister to issue the NOC for which it had previously applied for its ramipril
capsules.
[10]
Following
a discussion, the Minister responded to Pharmascience’s request for an NOC as
follows:
I am writing in reply to your correspondence of July 10, 2009 in
which you requested that a Notice of Compliance (“NOC”) be issued to
Pharmascience Inc. for the above-noted product as a result of the judgements
rendered in Court File Nos. T-161-07 and T-1161-07.
Court File Nos. T-161-07 and T-1161-07 were patent infringement
actions under the Patent Act filed by Sanofi-Aventis Canada Inc. against
Apotex Inc. and Novopharm Limited respectively, with respect to Patent No.
1341206 (“the ‘206 patent”). The court declared that claims 1,2,3,6 and 12 of
the ‘206 patent are invalid, unenforceable and of no force or effect. However,
no declaration was made regarding the remaining eight claims. Therefore, since
there has not been a declaration by the court that the ‘206 patent is invalid,
the ‘206 patent cannot be considered to be expired. This is in accordance with
the principles established at, for example, paragraphs 56 and 58 of Apotex Inc.
v. Syntex Pharmaceuticals International Inc., 2009 FC 494.
In the application for prohibition, Court File No. T-2300-06, filed
by Sanofi-Aventis Canada Inc. against Pharmascience Inc. with respect to the
above-noted drug submission and the ‘206 patent, the court granted an order
prohibiting the Minister of Health from issuing an NOC to Pharmascience for the
2.5, 5 and 10 mg capsules until the expiry of the ‘206 patent. As the ‘206
patent remains invalid, this order of prohibition remains in effect and the Minister
remains bound by it.
Furthermore, as the ‘206 patent was added to the Patent Register on
April 17, 2001, paragraph 3.1(1) of the Patented Medicines (Notice of
Compliance) Regulations (PM(NOC) Regulations) is applicable.
Paragraph 3.1(1) of the PM(NOC) Regulations states:
3.1(1) The Minister shall not delete from the register a patent on a
patent list that was submitted before June 17, 2006. unless
(a) the patent has expired;
(b) a court has, under subsection 60(1) of the Patent Act, declared
that the patent is invalid or void
. . .
(d) the patent is found, under paragraph 6(5)(a), not to be eligible
for inclusion on the register.
As none of the above exceptions apply, the ‘206 patent remains
listed on the Patent Register. As such, pursuant to section 7 of the PM(NOC)
Regulations [S.O.R./93-133 as amended], Pharmascience Inc. will not receive an
NOC for the above-noted submission.
[11]
As
a consequence of this response, Pharmascience brought this motion seeking to
set aside the two Orders of Prohibition previously granted by this Court and
dismissing the applications in those two matters, notwithstanding that they had
previously been granted.
[12]
When
the motion came on for hearing the Applicants informed the Court that an appeal
of Justice Snider’s Judgment of June 29, 2009 has been filed; however, they had
no objection to Pharmascience being issued the NOC for ramipril. They took the
position that it is unnecessary to set aside the Orders of Prohibition and that
it would be unnecessary and inappropriate to dismiss the underlying
applications. They speculate that Pharmascience is seeking to have the
applications dismissed in order that it can take advantage of a claim for
damages under section 8 of the Regulations.
[13]
The
Minister submitted a brief letter to the Court dated July 2, 2009, and attended
at the hearing to make oral submissions. The Minister’s position with respect
to T-482-03 and T-2300-06, as set out in his letter, is as follows:
In light of Madam Justice Snider’s Reasons dated June 29, 2009 in
T-161-07 and T-1161-07 the Minister of Health requests directions to clarify
the orders in T-482-03 and T-2300-06 under section 6 of the Patented
Medicines (Notice of Compliance) Regulations which prohibited the Minister
from issuing a notice of compliance to Pharmascience Inc. until expiry of the
Canadian Patent No. 1,341,206 (“the ‘206 patent”).
In particular, in T-161-07 and T-1161-07 the Court held that claims
1, 2, 3, 6 and 12 are invalid such that there are no longer claims to the
compound ramipril in the ‘206 patent that was the basis for the prohibition
orders in the above noted section 6 proceedings.
As there are no longer claims to ramipril in the’206 patent, the
Minister requests clarification as to whether the prohibition orders remain in
effect.
Pharmascience Inc. has taken the position that the effect of Madam
Justice Snider’s decision is that the ‘206 Patent is no longer a bar to issuing
a notice of compliance to Pharmascience for ramipril.
[14]
The
Applicants submit that it is well established that pursuant to the Regulations,
an Order of Prohibition ceases immediately to have effect upon expiry of the
patent. They cite and rely upon the decisions in Hoffman La Roche v. Canada (Minister of
National Health and Welfare), (1999), 167 F.T.R. 111 (F.C.T.D.) at para
14, Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA
229 at paras. 11-12, Zeneca Pharma Inc. v. Canada (Minister of National
Health and Welfare) (1996), 66 C.P.R. (3d) 169 at 174 (F.C.T.D.), Aventis Pharma Inc. v. Apotex Inc., 2006 FCA 328 and Apotex
Inc. v. Syntex Pharmaceuticals International Ltd., 2009 FC 494 at para. 58
wherein Justice Hughes stated the law, as follows:
Thus the Minister need not
delay in granting a Notice of Compliance to a generic if the relevant patent has
expired by its term ending, or by lapse of that patent such as failure to pay
maintenance fees, or if the Court in the PMNOC proceeding declares the
patent invalid between the parties to that proceeding, or by any Court making,
by operation of law such as under section 60 of the Patent Act, a
declaration that the patent is invalid.
[15]
In
all of these authorities, the patent as a whole was declared to be invalid. No
case was cited by any party, nor is the Court aware of any, where consideration
was given to the impact on a previous order under the Regulations where,
subsequently, the relevant patent claims but not the entire patent had been found
to be invalid. A declaration of partial invalidity only becomes relevant to
such a previous order when, as here, the very claims declared invalid are the
only claims relevant to the application under the Regulations.
[16]
The
Court appreciates the concern of the Minister that the previous Orders of
Prohibition made reference to the Minister being prohibited from issuing a
notice of compliance until the expiry of the patent. In this case, the
patent has not yet expired and only some of its claims have been held to be
invalid. Thus, unlike the cases where the patent as a whole has been found to
be invalid or has expired, it is not plain and obvious that the Orders of Prohibition
no longer prevent the Minister from issuing an NOC to Pharmascience. In order
to come to the conclusion that the Minister ought no longer to be prevented
from issuing the NOC, one must look behind the orders to the real issues that
were determined and that were in dispute.
[17]
The
wording of the Orders of Prohibition that issue from this Court in NOC matters
is a direct reflection of the wording of section 6 of the Regulations which
limits the Court to issuing a prohibition order “until after the expiration of
a patent that is the subject of allegation.” On a strict interpretation of the
provision this Court has no jurisdiction to issue an Order of Prohibition until
after the expiration or invalidity of the relevant claims of a patent that are
the subject of allegation.
|
6. (1) A first person may,
within 45 days after being served with a notice of allegation under paragraph
5(3)(a), apply to a court for an order prohibiting the Minister from
issuing a notice of compliance until after the expiration of a patent that is
the subject of the notice of allegation.
(2)
The court shall make an order pursuant to subsection (1) in respect of a
patent that is the subject of one or more allegations if it finds that none
of those allegations is justified.
|
6. (1) La première personne
peut, au plus tard quarante-cinq jours après avoir reçu signification d’un
avis d’allégation aux termes de l’alinéa 5(3)a), demander au tribunal
de rendre une ordonnance interdisant au ministre de délivrer l’avis de
conformité avant l’expiration du brevet en cause.
(2)
Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard du
brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des
allégations n’est fondée.
|
[18]
In
spite of the able submissions of the Applicants, I am not persuaded that an
order setting aside the prohibition orders is not necessary in order that the
Minister may issue the notice of compliance. The Applicants submit that if
such an order issues, it should take effect only as of the issue date of the
order. Rule 392(2) of the Federal Courts Rules provides that “unless it
otherwise provides, an order is effective from the date that it is endorsed in
writing and signed by the presiding judge or prothonotary.” I see no reason
why an order setting aside these prohibition orders should be effective from
any earlier date than the date hereof.
[19]
Pharmascience
is also seeking an order dismissing the applications which had previously been
granted by Justices Snider and Mactavish. The Applicants oppose such an order
and advance the following arguments.
1. If granted,
Pharmascience may be permitted to take advantage of section 8 of the
Regulations and claim damages from the Applicants. It would be improper to
permit that to occur given that the original applications were properly decided
and, in one case, affirmed by the Court of Appeal. They submit that they
“should not be penalized for bringing an application which has been judicially
decided to be meritorious.”
2. The
jurisprudence indicates that it is unnecessary to issue an order dismissing an
original application that was granted. In Hoffman La Roche, Justice
Reed granted the order being sought but did so only to provide greater certainty
as she was of the view that it was unnecessary to do so. Justice Hughes in Syntex
shared that view.
[20]
The
application in T-482-03 was granted because Pharmascience had argued that the
‘206 Patent was invalid only on the grounds of double patenting. That decision
found that the patent was not invalid on that basis. That finding has not been
upset by Justice Snider’s recent finding in her decision in 2009 FC 676 that
Claims 1, 2, 3, 6 and 12 are invalid on the basis of lack of utility. Further,
she expressly states in paragraph 8 of that decision that having found
invalidity on the grounds of utility it was unnecessary to consider the other
grounds advanced, however, she goes on to state that had it been necessary she
would not have found that it was invalid for double patenting, thus affirming
her earlier decision.
[21]
The
application in T-2300-06 was granted by Justice Mactavish on the basis that
issue estoppel applied to prevent Pharmascience from attacking the ‘206 Patent
on other grounds, having been unsuccessful in its attack in T-482-03 on the
one limited ground it advanced. That finding has not been upset by Justice
Snider’s recent decision in 2009 FC 676.
[22]
Accordingly,
it is my view that it would be improper for the Court now to set aside the
findings of the Court in those cases by issuing orders that would dismiss those
two previous applications. However, an order setting aside the Orders of Prohibition
is warranted in order that the Minister may issue the notice of compliance to
Pharmascience without being in breach of the previous prohibition orders issued
by this Court.
[23]
The
issues raised in this motion are unique and of sufficient significance that it
is appropriate in my judgment that no costs be awarded.
ORDER
THIS COURT
ORDERS AND ADJUDGES that:
1.
The
Order of this Court issued in T-482-03 dated March 11, 2005, which states that
“The Minister of Health is prohibited from issuing a Notice of Compliance
pursuant to the Patented Medicines (Notice of Compliance) Regulations to the
Respondent, Pharmascience Inc. to market the capsules of ramipril” is hereby
set aside; and
2.
The
Order of this Court issued in T-2300-06 dated June 20, 2008, which states that
“The Minister of Health is prohibited from issuing a
Notice of Compliance to Pharmascience in respect of its ramipril capsules 1.25
mg, 2.5 mg, 5 mg and 10 mg, until after the expiration of Canadian patent No.
1,341,206 is hereby set aside; and
3.
No costs are ordered.
“Russel W. Zinn”
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