Date: 20071207
Docket: T-1718-07
Citation: 2007
FC 1291
Ottawa, Ontario, December 7, 2007
PRESENT: The Honourable Mr. Justice Phelan
BETWEEN:
ABBOTT LABORATORIES LIMITED
and
TAP PHARMACEUTICALS INC.
Applicants
and
THE MINISTER OF HEALTH,
NOVOPHARM LIMITED and
TAKEDA PHARMACEUTICAL COMPANY
LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1]
Abbott
Laboratories Limited and TAP Pharmaceuticals Inc. (referred to together as “Abbott”)
moved for an order requiring Novopharm Limited (Novopharm) to serve its evidence
prior to service of Abbott’s evidence; a reverse order of evidence filing. The
proceeding in question is an application under the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133. The patent in issue is
Canadian Patent No. 2,009,741 (the '741 Patent).
[2]
This is
the second NOC in respect of this '741 Patent. In Abbott Laboratories Ltd. v.
Canada (Minister of Health) (2007), 55 C.P.R. (4th)
48, Justice von Finckenstein dealt with the issue of whether Novopharm’s
(Novopharm) generic version of the drug lansoprazole would infringe the '741
Patent in the manner it was proposed to be marketed.
[3]
Justice
von Finckenstein found that infringement would occur because Novopharm’s
product monograph and label would induce or encourage physicians to prescribe
the generic version for use that would infringe the '741 Patent.
[4]
Subsequent
to that judgment, Novopharm filed a new Notice of Allegation (NOA) in respect
of its generic version of the drug. As a result, Abbott seeks to have Novopharm
file its evidence first despite the fact that Abbott is the applicant for an
order prohibiting the issuance of a Notice of Compliance in favour of
Novopharm.
[5]
Abbott
relies on the unique circumstances of this case – that it is the re-litigation
of the infringement issue. Abbott contends therefore that Novopharm must have
“better evidence” and an explanation for not initially putting forward its best
case (“best foot forward”) so as to avoid this second litigation being an abuse
of process.
[6]
While it
is somewhat counter-intuitive to many that a losing party can re-litigate its
NOC proceeding by filing a new NOA, because of the unusual nature of NOCs, this
is the case in certain circumstances. (See Abbott Laboratories v. Canada (Minister of Health), 2007 FCA 140)
[7]
Novopharm
argues firstly that this Court has no jurisdiction to make the proposed order
because the Rules require an applicant to file evidence first and secondly that,
in any event, this is not an appropriate case to make such an order.
[8]
For the
reasons to follow, I disagree with Novopharm in respect of the first point but
agree on the second.
A. Jurisdiction
[9]
Rule 55
gives this Court sufficient authority “in special circumstances” to make an
order dispensing with the usual rules under which an applicant files its
evidence first.
[10]
Similarly,
if this case was under “case management”, which it is not but will be, it would
be within the discretion of the case management judge/prothonotary to make a
similar order in the appropriate circumstances.
[11]
Therefore,
the real issue in this motion is whether this is an appropriate case or are there
special circumstances to make an order reversing the order of filing evidence
and the making of submissions.
B. Special
Case/Appropriate Circumstances
[12]
The
Applicant relies on what are described as the unique facts of this proceeding –
the fact that there had been an earlier NOC decision on the same issue. The Applicant
does not say that this latest NOC proceeding is an abuse of process or is
covered by the principles of res judicata or issue estoppel.
[13]
The
starting point of the analysis of the appropriateness of the proposed order are
the comments by Justice Sexton in Abbott Laboratories, supra, at
paragraph 46, where he recognizes that multiple NOC proceedings as to the infringement
issue may be permissible where there are significant differences in
formulations between the respective NOCs. This is not the case for validity
challenges in NOCs.
[14]
NOC
proceedings are unusual proceedings. Once commenced, there are limited
circumstances for amendment which generally require a court decision before a
new amended formulation can be filed. The burden for a generic is that the
submission of an amended formulation results in a 24-month stay imposed on a
generic manufacturer no matter how meritorious the generic’s position may be.
[15]
The
difference in regards to multiple NOCs between invalidity challenges and
infringement challenges is based on the distinctly different characteristics of
the challenges. A challenge to validity is based upon immutable facts; the
patent is fixed and it is either valid or it is not. An infringement challenge
is based upon the proposed use, which use can be changed.
[16]
With
respect to infringement, the generic describes the proposed use – it is then
incumbent on the innovators to show how that use will infringe the patent.
[17]
Given the
recognition that infringement claims may be the subject of subsequent NOC
proceedings, after a court decision on the same patent, there are no “special
circumstances” which justify a departure from the usual order of proceeding.
The Applicant is in the best position to know in what manner the new
formulation infringes the patent.
[18]
To the
extent that there are issues as to whether the new formulation is a significant
change and issues as to discoverability, due diligence and explanations
regarding “best foot forward”, these are matters which are more appropriately
dealt with by the judge hearing the NOC proceeding. It is a more efficient and
fairer manner of proceeding and there is no argument advanced here to strike
the NOC on the grounds of abuse.
[19]
Therefore,
this motion is dismissed with costs to Novopharm. Since infringement not
validity was the critical issue, Takeda Pharmaceutical Company Limited’s
involvement was not strictly necessary and no costs on this motion will be
awarded to it.
[20]
The
parties acknowledge that case management would be helpful and therefore a
separate order placing this matter under case management will be issued.
ORDER
THIS COURT ORDERS that this motion is dismissed with
costs to Novopharm.
“Michael
L. Phelan”
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