Date: 20070214
Dockets: T-899-06
Citation: 2007
FC 167
Toronto, Ontario, February 14, 2007
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
PFIZER CANADA INC. and PFIZER
INC.
Applicants
and
THE MINISTER OF HEALTH and
PHARMASCIENCE INC.
Respondents
REASONS FOR ORDER AND ORDER
[1]
The
Applicants Pfizer Canada Inc. and Pfizer Inc. have brought a motion to add
Pfizer Limited as a party to these proceedings. The Respondent, Pharmascience
Inc. opposes this motion, and has itself brought a motion to strike these
proceedings in respect of one of the patents at issue, the ‘393 patent, on the
basis that Pfizer Limited was not included as one of the Applicants when these
proceedings were initiated. The Respondent, Minister of Health takes no
position with respect to either motion.
[2]
In another
proceeding taken by the same Applicants against the Minister and a different
Respondent, Cobalt Pharmaceuticals Inc. T-768-06, a similar motion was brought
by the Applicants to add Pfizer Limited as a party to these proceeding and a
similar motion was brought by Cobalt to strike those proceedings as against the
‘393 patent. Again, the Minister took no position.
[3]
For the
reasons that follow, I am adding Pfizer Limited as a party Applicant in each
proceeding and I am dismissing the motion of each of Pharmascience and Cobalt
to dismiss their respective proceedings as to the ‘393 patent.
[4]
Both the
T-768-06 (Cobalt) and T-899-06 (Pharmascience) proceedings are brought under
the provisions of the Patented Medicines (Notice of Compliance) Regulation
SOR/93-133 as amended (NOC). The presently named Applicants are the same,
Pfizer Canada Inc. and Pfizer Inc. In both proceedings the Applicants have put
in issue two Canadian Patents, being those numbered 1,321,393 (‘393 patent) and
2,355,493 (‘493 patent). It is common ground that the ‘493 patent was issued
and granted to one of the presently named Applicants, Pfizer Inc. and, as for
as the record shows, that entity remains as owner. The ‘493 patent is not the
subject of the motions presently under consideration.
[5]
The record
indicates that the ‘393 patent was issued and granted to Pfizer Limited (not
Pfizer Inc.) on August 17, 1993. It appears that Pfizer Limited remains as
owner (patentee) of that patent. Pfizer Limited has not been named as a party
to either the Cobalt or Pharmascience proceedings.
[6]
The NOC Regulations
are unusual, their history and purpose was discussed recently by the Supreme
Court of Canada in Apotex Inc. v. AstraZeneca Canada Inc. (2006), 52
C.P.R. (4th) 145, 2006 SCC 49. The general scheme of the NOC
Regulations is to create a patent registry with the Department of Health in
which innovator drug companies may list patents relevant to their various drug
submissions for regulatory approval. A generic drug company who wishes to
enter the market before the expiry of such patents must challenge the validity
or applicability of the patents by way of a notice of allegation sent to the
party listing the patents. This notice will generally trigger an application
to this Court seeking to prohibit the Minister from issuing an approval to the
generic to market the drug, the issue being whether the allegations of the
generic are justified.
[7]
The
application to this Court is to be made under section 6(1) of the NOC Regulations
by a “first person” who is defined in section 2 of those Regulations by
reference to section 4(1) of those Regulations as “a person who files, or has
filed a submission for, or has been issued a notice of compliance”. It can be
seen that such a person is not necessarily the patentee. A “patentee” is
defined in the Patent Act R.S.C. 1985, c. P-4 section 2 as “the person
for the time being entitled to the benefit of the patent”, the “benefit” is the
grant of the patent monopoly as set out in section 42 of the post October 1,
1993 and 1996 versions of the Act and section 44 of the pre October 1,
1989 version of that Act. In this case, the ‘393 patent was granted to
Pfizer Limited, not currently a party to these proceedings. As far as we know,
Pfizer Limited remains the grantee, that is the owner, of that patent.
[8]
Section
6(4) of the NOC Regulations provides that where the “first person” is not the
“owner of each patent” that is the subject of the proceedings, the owner shall
be made a party.
[9]
In the two
proceedings at issue the owner of the ‘393 patent, Pfizer Limited, was not a
named party in the Notice of Application, however, it seeks to become a party
now. The reasons for the omission of Pfizer Limited as a named Applicant is
set out in paragraph 15 of the Nicola affidavit sworn June 21, 2006. It was a
matter of inadvertence and oversight, she as one of the solicitors acting for
the Applicants swears that the instructions were at all times that Pfizer
Limited should be a named Applicant. It appears that shortly after the error
was noticed, the solicitors for Pharmascience and Cobalt were contracted and
asked to consent to the addition of Pfizer Limited as a party Applicant. They
refused. It appears from the evidence of the Ms Nicola that a similar error was
made in other proceedings respecting the same patent but against other
generics. It seems that other generics consented to the addition of Pfizer
Limited as a party Applicant. This is irrelevant to the matter now before me,
as the matter here is contested.
[10]
The
provisions of section 6(4) of the NOC Regulations are similar to the provisions
of section 55(3) of the Patent Act post October 1, 1996, (section 55(3)
of the Post October 1, 1993 and pre October 1, 1989 versions) namely, that the
patentee shall be or be made a party to any action for infringement of a
patent. Infringement proceedings can be brought by the patentee but also by
“all persons claiming under the patentee” as provided in section 55(1) as it
appears in all versions of the Patent Act. The jurisprudence
establishes that both exclusive and non-exclusive licensees are “persons
claiming under the patentee” and can bring an action for infringement (Armstrong
Cork Canada Ltd. v. Domco Industries Ltd., [1982] S.C.R. 907 at 917-920). In
an infringement action when the patentee was not named as a party to the action
as filed, the action is not a nullity, the patentee can be added at a later
time (American Cyanamid Company v. Novopharm Ltd., [1972] FC 739 at 761
and 769 (FCA)).
[11]
Proceedings
under the NOC Regulations are different in many respects. They are started by
a “first person” who is not necessarily the patentee. The “first person” is
the person who seeks or has a notice of compliance from the Minister. Section
6(1) of the Regulations provides the proceedings are to be commenced by the
first person, no other person is named as a party entitled to bring the
application. Section 6(1) states that the purpose of the application is to
seek an “order prohibiting the Minister from issuing a notice of compliance
until the expiration of a patent that is the subject of the application”. Thus
the Minister is the appropriate named Respondent in the application. No
express provision is made for the addition of the generic, described as the “second
person” in the NOC Regulations as a respondent. However, Federal Court Rule
303(1)(a) requires that every person “directly affected” by the order sought
shall be a named respondent thus clearly the generic should be a named
respondent.
[12]
The NOC Regulations,
section 6(4), state that a patentee “shall be made a party to the application”.
Rule 303(1)(b) of this Court states that person who is required to be named as
a party under an Act of Parliament pursuant to which the application is brought
shall be a named respondent. There is a difference between an Act and a
Regulation, however, the Regulation is clear and nothing in Rule 303(1)(b)
prohibits a party whose presence is required by Regulation from being a party.
[13]
The
generics, here Pharmascience and Cobalt, argue that the effect of the NOC Regulations
is that the patentee shall be named as a party from the outset in the Notice of
Application or, at the very least, added within the 45 day period stipulated
for commencing an application provided for in section 6(1) of the NOC
Regulations. They argue that the Regulations require strict compliance,
failing which an application is a nullity and the patentee and others claiming
under it are left to their remedies in an ordinary infringement action.
[14]
I do not
view the matter in the same way as the generics Pharmascience and Cobalt do.
Section 6(1) is the mandatory provision, a “first party” must commence an
application directed to the Minister within 45 days of receipt of a notice of
allegation. That is mandatory. Once the application is commenced the matter
falls to be determined, as to procedure, under the Federal Courts Rules
unless there is a conflict with the NOC Regulations, in which case the
Regulations prevail. Section 6(4) of the Regulations require that a patentee
“shall be made party to the application”. If the only opportunity for doing so
was to be at the outset of the proceeding, then section 6(1) would have
provided for the patentee to be named at the that time. The separate provision
in section 6(4) indicates that while becoming a party is mandatory for a
patentee, the timing is not that of section 6(1) but rather is to be governed
by the practice and procedure of the Court in this case Rule 303 requiring
joinder of certain parties and Rules 103 and 104 which provided that a claim
shall not be defeated by reason of misjoinder or nonjoinder of a party and the
Court may order joinder subject to appropriate directions.
[15]
It is not
fatal to an application that the owner of the patent who is not a “first
person” was not a party initially provided that the owner is joined as a party
at an appropriate subsequent time. The purpose in joining the owner is clear,
the owner should be before the Court when its patent is under consideration.
If the owner will not join as an Applicant it can be joined as a Respondent.
[16]
The
Respondent generics, Cobalt and Pharmascience, say that they will be prejudiced
by the addition of the patentee since, in their view, the proceedings are a
nullity and ought to be struck out. Once struck out, given the timing provided
for in the Regulations, these proceedings could not be brought anew. This
argument presupposes that the proceedings are a nullity. They are not. The
patentee may be joined as a party after the proceedings are begun.
[17]
Therefore,
I find that in each of these proceedings T-768-06 and T-899-06 Pfizer Limited
shall be added as a party Applicant and the style of cause amended accordingly.
Pfizer Limited is to be represented by the same solicitors as to the present
Applicants and shall not be entitled to adduce any evidence or conduct
cross-examinations on its own behalf beyond that already adduced or to be
adduced and conducted or to be conducted by the present Applicants. It shall
not be entitled to make argument separate from that of the present Applicants. Since
the error arose through the inaction or inadvertence of the Applicants’
solicitors, I award costs to the Respondent, Pharmascience. The Minister was
not represented and shall not be entitled to costs.
ORDER
FOR THE REASONS PROVIDED HEREIN:
THIS COURT ORDERS that:
1.
Pfizer
Limited shall be added as a party Applicant to each of T-768-06 and T-899-06.
It shall be represented by the same solicitors as the other Applicants and
shall not adduce evidence or conduct cross-examinations or make argument other
than as together with the other Applicants;
2.
The style
of cause in each proceeding shall be amended accordingly;
3.
The
Respondent, Pharmascience, is entitled to its costs; and
4.
The motion
by Pharmascience to dismiss the application in respect of Canadian Patent
1,321,393 is dismissed without costs.
"Roger
T. Hughes"
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