Date: 20090508
Docket: T-382-08
Citation: 2009 FC 474
Ottawa, Ontario, May 8, 2009
PRESENT: The Honourable Mr. Justice Barnes
BETWEEN:
ELI
LILLY CANADA INC.
Applicant
and
ATTORNEY GENERAL OF CANADA
and MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1]
This
is an application by Eli Lilly Canada Inc. (Eli Lilly) challenging a decision
by the Minister of Health (Minister) refusing a request to add Eli Lilly’s
Canadian Patent No. 2,265,712 (the '712 Patent) to the patent register as
of the date of the submission of its associated patent lists. The Minister
took the position that the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133 (NOC Regulations) mandate that a patent can only be
added to the patent register as of the date that it is deemed to be eligible
for listing and not before.
I.
Background
[2]
On
November 27, 2006 Eli Lilly submitted to the Minister patent lists seeking to
add its '712 Patent for olanzapine dihydrate to the patent register with
respect to several supplementary new drug submissions (SNDS). Those requests
were refused by the Minister on January 17, 2007 on the basis that the '712
Patent was, for a variety of stated reasons, ineligible for listing on the
patent register. This refusal was followed by an exchange of correspondence
between Eli Lilly and the Minister and the provision of additional information
in support of Eli Lilly’s position. On November 19, 2007 the Minister agreed
to list the '712 Patent against three SNDS.
[3]
On
November 26, 2007 Eli Lilly asked the Minister to consider adding the '712
Patent to the patent register as of the date of its original patent list filing
on November 27, 2006. The justification for this request was stated as
follows:
Assuming that the objective of filing a
patent list (Form IV) is to provide notice as to the existence of a patent that
is potentially relevant to a medicine, the date of filing of the Form IV
suffices for that purpose. Consequently, any submissions filed that make reference
to Lilly ZYPREXA ZYDIS products should address the '712 Patent if they were
filed after the date of filing of Lilly’s Form IVs Patent List. In the event
that a submission was filed under the Old Regulations prior to the
amendments of October 2006, those submissions are subject to the Old
Regulations which do not provide for a patent freeze. In that event, those
submissions must also address the '712 Patent as listed.
We trust that you will take every step to
ensure that this patent is properly addressed depending upon the filing dates
of any Abbreviated New Drug Submissions that make reference to these products,
given the proper filing of the '712 Patent List in November 2006. In
particular, we note that there are submissions filed by Pharmascience that
should address the '712 Patent. We ask for confirmation from the Minister that
no NOC will issue in respect of the Pharmascience submissions (or any others
filed in respect of orally disintegrating olanzapine) until the '712 has been
properly addressed by virtue of a NOA.
[4]
By
letter dated January 4, 2008 the Minister refused Eli Lilly’s request for an
early listing on the basis that the '712 Patent was properly listed when the
Minister determined its eligibility for listing on November 19, 2007. In the
result, it was that date that dictated whether a second person was required to
address the '712 Patent under s. 5 of the NOC Regulations.
[5]
Eli
Lilly then sought a reconsideration from the Minister’s decision but the
initial decision was maintained for the following reasons:
During the January 16, 2008
meeting, you emphasized your earlier position that the objective of filing a
Form IV is to provide notice to a second person as to the existence of a patent
that is potentially relevant to a medicine. In your view, the date of filing
of the Form IV is the relevant date for this purpose. You, therefore,
maintained the position that generic drug submissions filed after the date of filing
should trigger section 5 of the Patented Medicines (Notice of Compliance)
Regulations [S.O.R./93-133 as amended] (“PM(NOC) Regulations”).
As such, you suggested either
(a) listing the patent on an interim basis immediately on the filing date of
the Form IV in order to notify potential second persons, and then deleting it
from the Patent Register if necessary after a final decision of eligibility has
been made; or (b) where the patent can not be listed immediately because the notice
of compliance has not issued, back-dating the listing of the patent as of the
filing date of the Form IV once the notice of compliance has issued. In
response to the OPML’s January 4, 2008 reconsideration, you explained your
view that the language in subsection 5(1) of the PM(NOC) Regulations
supports your position by referring to a patent list that has been “submitted”
to the Minister.
While there may be certain
ambiguities in the language of section 5, the OPML is of the view that, when
read in their entire context, the PM(NOC) Regulations do not support the
listing of patents on the Patent Register on the date of filing of the relevant
Form IV.
Rather, subsection 5(4) of the
PM(NOC) Regulations refers to those patents that have been ‘added to the
register”, and is consistent with the language is subsections 5(1) and 5(2)
which refer to patents that have been both submitted and listed “on the
register”. This language appears to indicate that the appropriate date for
notice to a second person is the date of the decision of eligibility under
section 4 and not the date of filing of the relevant Form IV.
In further response to your
suggestions for listing, we would note that section 4 provides for certain
eligibility requirements to be met in advance of listing a patent on the Patent
Register, rather than listing all patents prior to determining their
eligibility. In addition, we do not view back-dating the listing of a patent
to be a practical option. The notice function upon which you base this
suggestion would be lost, as a generic drug manufacturer would not know which
patents need to be addressed when it files a submission. Furthermore,
back-dating the listing would not accord with subsection 5(4) of the PM(NOC)
Regulations.
Therefore, as noted in the
January 4, 2008 reconsideration letter, in the event that a patent is found to be
eligible for listing in respect of a drug, it will be added to the Patent
Register only upon issuance of the relevant notice of compliance for that
drug. When a notice of compliance has already issued, patents added to the
Patent Register under subsection 4(6) will be added as of the date of the final
decision of eligibility.
In light of the above, the
OPML maintains the position that the '712 patent was listed properly on
the Patent Register as of the date of the final decision of eligibility on November
19, 2007. November 19, 2007 is, therefore, the date used to determine whether
a second person is required to address the '712 patent under section 5 of the PM(NOC)
Regulations.
[6]
It
is this decision by the Minister which is challenged by Eli Lilly on this
application.
II. Issue
[7]
The
issue as framed by Eli Lilly is that its '712 Patent should have been listed on
the patent register by the Minister upon the submission of its associated patent
lists and not, as the Minister contends, on the date of the Minister’s later determination
of its eligibility for listing.
III. Analysis
[8]
I
agree with Eli Lilly that the issue it raises involves a point of statutory
interpretation which must be resolved on the standard of correctness: see AstraZeneca
Canada Inc. v. Minister of Health, 2005 FCA 189, 40 C.P.R. (4th) 353 at
paras. 25 and 26.
[9]
Eli
Lilly argues that the Minister errs in the interpretation of s. 5 of the NOC
Regulations by requiring generic manufacturers (or second persons) to address
only patents which have, as of the date of the generic’s Notice of Allegation
(NOA) submission, been added by the Minister to the patent register. Eli Lilly
says that the correct interpretation of s. 5 would require a generic
manufacturer to address a patent included in a patent list as of the date the
list is filed by the innovator (or first person) with the Minister under ss.
4(1) of the NOC Regulations. In this case Eli Lilly contends that its '712
Patent was legally on the patent register as of the date of the filing of its
patent lists on November 27, 2006 and not on November 17, 2007 when the
Minister determined that the patent was eligible for listing.
[10]
Eli
Lilly claims that its argument is supported by a purposive interpretation of
the NOC Regulations and, in particular, s. 5 which speaks to a generic
manufacturer comparing its proposed product to an innovator’s product “in
respect of which a patent list has been submitted”. According to Eli Lilly,
the interpretation adopted by the Minister creates an unbalanced scheme which
operates unfairly on the interests of innovators particularly where, as here,
there is a lengthy administrative delay between the submission of a patent list
and the actual listing of a patent on the register by the Minister. Here that
delay allowed at least one generic manufacturer to avoid having to address Eli
Lilly’s '712 Patent in its intervening NOA.
[11]
Eli
Lilly’s argument is built upon a tenuous and isolated interpretation of the
language of s. 5 of the NOC Regulations and a self-serving view of the overall
legislative purposes of the NOC scheme.
[12]
Subsection
3(2) of the NOC Regulations requires the Minister to maintain the patent
register with the attendant authority to refuse to add or to delete any
patent. In the exercise of that authority, the Minister is both entitled to
consult with officials in the Patent Office and required to assess the
eligibility criteria set out in s. 4 for adding a patent to the register.
There is nothing in these provisions which even remotely supports Eli Lilly’s
argument that the Minister is entitled to list a patent on the register upon
the filing of a patent list subject to later delisting if the eligibility
requirements in s. 4 are not met.
[13]
Eli
Lilly relies heavily on the words in ss. 5(1) of the NOC Regulations requiring
a generic manufacturer to address in its NOA any reference drug “in respect of
which a patent list has been submitted”. This, it says, indicates that it is
the date of the submission of the patent list by the innovator that dictates
the patents that a generic manufacturer must address in its NOA.
[14]
Eli
Lilly’s argument requires that the words “in respect of which a patent list has
been submitted” be viewed in isolation from the surrounding language and from
the overall legislative context. The operative language in ss. 5(1) are the
words “with respect to each patent on the register”. This or similar language
is repeated throughout the NOC Regulations and, in particular, in ss. 5(4)
which stipulates that a second person is not required in its NOA to address any
patent that has not yet been “added to the register”. There is no reference in
this provision to a second person addressing patents that are included in a
patent list filed with the Minister. Indeed s. 4 makes a very clear
distinction between the innovator submitting its patent list to the Minister
and the determination of the eligibility of a patent “to be added to the
register”. A patent cannot be added to the register before it is deemed
eligible by the Minister.
[15]
The
obvious intent of these provisions is that the listing of a patent on the
register is to be done contemporaneously with the Minister’s determination of
the patent’s eligibility for listing. The effect of this is that, under ss.
5(4), a second person need not address any patent added to the register after
the date of the second person’s submission for a NOC under ss. 5(1) or ss.
5(2).
[16]
There
is no question that under the Minister’s interpretation of s. 5 of the NOC
Regulations the burden or risk created by the lapse of time between the filing
of a patent list and the Minister’s determination of eligibility under s. 4
falls on the innovator. But the legislative choice that is inherent in these
regulatory provisions cannot be regarded as unfair or imbalanced. It is simply
a reflection of a policy which empowers the Minister to determine whether and
when a patent is eligible for listing on the patent register thereby becoming
the required subject of acknowledgement by a second person. The option
asserted by Eli Lilly would create its own potential for mischief by making the
innovator the initial arbiter of which patents must be addressed by the simple
act of including a patent in a patent list filed with the Minister. Such an
approach would require a second person to unnecessarily address patents which
the Minister later determined were ineligible for listing on the register.
[17]
The
NOC Regulations are not and were not intended to be the solution for every
point of conflict or clash of competing interests between innovators and their
generic counterparts. The fact that a generic manufacturer may, in some cases,
obtain a procedural advantage from the inherent delay between the filing of a
patent list and the Minister’s eligibility determination does not deprive the innovator
of its substantive patent rights which can always be the subject of judicial
enforcement.
IV. Conclusion
[18]
There
is no merit to Eli Lilly’s argument. The Minister’s interpretation of the
applicable NOC Regulations was correct in law and the resulting decision under
review in this proceeding is, accordingly, upheld. The Minister is entitled to
costs payable under Column III.
JUDGMENT
THIS COURT ADJUDGES that this application is dismissed with costs payable to the
Respondents under Column III.
“ R. L. Barnes ”
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