Date: 20100708
Docket: T-248-10
Citation: 2010 FC
738
Ottawa,
Ontario,
July 8, 2010
PRESENT: The Honourable Mr. Justice Crampton
BETWEEN:
PURDUE PHARMA
Applicant
and
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1]
The
Applicant, Purdue Pharma, seeks judicial review of a decision of the Office of
Patented Medicines and Liaison (OPML) in which the OPML determined that one of
the Applicant’s patents is not eligible for listing on the Patent Register.
[2]
The
Applicant claims that the OPML erred by misinterpreting paragraph 4(2)(c) of
the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations).
[3]
For
the reasons discussed below, this application is dismissed.
I. Background
[4]
In
May 2009 the Applicant, an innovator drug company, filed a New Drug Submission
(NDS) as part of its application for a Notice of Compliance (NOC) to market and
sell the drug TARGIN in Canada. The Applicant received that NOC in
December 2009.
[5]
TARGIN
is a controlled-release drug in tablet form that contains two medicinal
ingredients: oxycodone hydrochloride (oxycodone), a painkiller, and naloxone
hydrochloride (naloxone), which counteracts certain side effects of oxycodone,
such as constipation.
[6]
Along
with its NDS, the Applicant applied to list Canadian Patent No. 2,098,738 (the “‘738
Patent”) pursuant
to section 4 of the Regulations
in relation to TARGIN. The ‘738 Patent, filed on November 25, 1992,
contemplates a controlled-release technology for delivering oxycodone. It
contains 28 claims, none of which mention naloxone. For the purposes of this
proceeding, Purdue confined its submissions to Claim 3 and Claim 5.
[7]
Claim
3 contains the following formulation claim:
A controlled
release oxycodone formulation for oral administration to human patients,
comprising from, about 10 to about 40 mg oxycodone or a salt thereof in a
matrix, said formulation providing a mean maximum plasma concentration of
oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5
hours after administration, and a mean minimum plasma concentration from about
3 to about 30 ng/ml from a mean of about 10 to about 14 hours after repeated
administration every 12 hours through steady-state conditions.
[8]
Claim
5 contains the following dosage form claim:
A
solid controlled release oral dosage form, comprising
oxycodone
or a salt thereof in an amount from about 10 to about 160 mg said oxycodone or
salt thereof being dispensed in a matrix which includes;
an
effective amount of a controlled release matrix selected from the group
consisting of hydrophilic polymers, hydrophobic polymers, digestible
substituted or unsubstituted hydrocarbons having from about 8 to about 50
carbon atoms, polyalkylene glycols, and mixtures of any of the foregoing;
a
suitable amount of a suitable pharmaceutical diluent, wherein said composition
provides a mean maximum plasma concentration of oxycodone from about 6 to about
240 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a
mean minimum plasma concentration from about 3 to about 120 ng/ml from a mean
of about 10 to about 14 hours after repeated administration every 12 hours
through steady-state conditions.
[9]
In
June 2009,
the OPML advised the Applicant of its preliminary decision that the ‘738 Patent
is not eligible for listing in the Patent Register in relation to TARGIN, on
the grounds that the requirements set forth in paragraphs 4(2)(b) and (c) of
the Regulations were not met. Those paragraphs establish the eligibility
requirements for listing patents that make a claim to a formulation containing
a medicinal ingredient or a dosage form of a drug or drug formulation
containing a medicinal ingredient, respectively, as more specifically set forth
in Part II below. In recognition of the preliminary nature of its decision, the
OPML invited further submissions from the Applicant.
[10]
The
Applicant made further submissions to the OPML in August 2009. Those
submissions included affidavits of Dr. Louis Cartilier and Dr. Kris
Krishnamurthy. Dr. Krishnamurthy provided some factual information regarding
TARGIN and the history of the ‘738 Patent, while Dr. Cartilier construed the
‘738 Patent and compared its claims to the formulation and dosage form of TARGIN.
Dr. Cartilier concluded that “the presence of additional ingredients like
undisclosed excipients or another active ingredient in Purdue’s TARGINTM
product will not cause the formulation or dosage form to fall outside the scope
of Claims 3, 4 and 5.” In essence, Dr. Cartilier found “that since the term
‘comprising’ has been used, a dosage form can also include in addition to
oxycodone or a salt thereof, excipient(s) and active ingredient(s) undisclosed
in the claim.”
[11]
Approximately
two weeks later, on August 17, 2009, the Applicant sent a further letter
attaching a copy of a decision released on July 16, 2009 by Justice Harrington,
concerning another drug (OXYCONTIN) in respect of which the Applicant had
sought to list the ‘738 Patent (Purdue Pharma v. Pharmascience Inc. et al.,
2009 FC 726).
[12]
In
October 2009, the OPML advised the Applicant that it remained of the view that
the ‘738 Patent is not eligible for listing. However, the OPML noted that a
similar issue regarding the interpretation of subsection 4(2)(b) was then
before this Court in Bayer Inc. v. Canada (Minister of
Health),
2009 FC 1171 [Bayer (2009)]. The OPML offered the Applicant 30 days from
the date of the judgment in Bayer to make any further submissions.
[13]
This
Court’s judgment in Bayer was rendered
by Justice Russell on November 17, 2009. The Applicant made its further
submissions to the OPML on December 17, 2009.
[14]
After
the OPML issued its final decision, the Federal Court of Appeal dismissed, in
reasons given from the Bench on June 15, 2010, an appeal from Justice Russell’s
decision for “substantially for the reasons he gave” (Bayer Inc. v. Canada
(Minister of Health), 2010 FCA 161).
II. The Relevant Legislation
[15]
Subsection
4(2) of the Regulations states:
|
4.
(2) A patent on a patent list in relation to a new drug submission is
eligible to be added to the register if the patent contains
(a)
a claim for the medicinal ingredient and the medicinal ingredient has been
approved through the issuance of a notice of compliance in respect of the submission;
(b)
a claim for the formulation that contains the medicinal ingredient and the
formulation has been approved through the issuance of a notice of compliance
in respect of the submission;
(c) a claim
for the dosage form and the dosage form has been approved through the
issuance of a notice of compliance in respect of the submission; or
(d) a claim for the use of the medicinal ingredient, and
the use has been approved through the issuance of a notice of compliance in
respect of the submission.
|
|
4.
(2) Est admissible à l’adjonction au registre tout brevet, inscrit sur une
liste de brevets, qui se rattache à la présentation de drogue nouvelle, s’il
contient, selon le cas :
a)
une revendication de l’ingrédient médicinal, l’ingrédient ayant été approuvé
par la délivrance d’un avis de conformité à l’égard de la présentation;
b)
une revendication de la formulation contenant l’ingrédient médicinal, la
formulation ayant été approuvée par la délivrance d’un avis de conformité à
l’égard de la présentation;
c)
une revendication de la forme posologique, la forme posologique ayant été
approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation;
d)
une revendication de l’utilisation de l’ingrédient médicinal, l’utilisation
ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation.
|
[16]
Section
2 states, among other things:
|
2. In these
Regulations,
“claim for the
dosage form” means a claim for a delivery system for administering a
medicinal ingredient in a drug or a formulation of a drug that includes
within its scope that medicinal ingredient or formulation;
“claim for the
formulation” means a claim for a substance that is a mixture of medicinal and
non-medicinal ingredients in a drug and that is administered to a patient in
a particular dosage form;
|
|
2.
Les définitions qui suivent s’appliquent au présent règlement.
[…]
«
revendication de la forme posologique » Revendication à l’égard d’un
mécanisme de libération permettant d’administrer l’ingrédient médicinal d’une
drogue ou la formulation de celle-ci, dont la portée comprend cet ingrédient
médicinal ou cette formulation.
«
revendication de la formulation » Revendication à l’égard d’une substance qui
est un mélange des ingrédients médicinaux et non médicinaux d’une drogue et
qui est administrée à un patient sous une forme posologique donnée.
|
[17]
Additional
legislation relevant to this decision is set forth in Annex “A” below.
III. The Decision under Review
[18]
On
February 5, 2010, the OPML issued its final decision stating that the ‘738
Patent is not eligible to be listed on the Patent Register in relation to
TARGIN.
[19]
With
respect to the Applicant’s formulation claim, the OPML noted that the Applicant
had not made any new representations subsequent to the OPML’s preliminary
decision in October 2009. Accordingly, the OPML simply referred the Applicant
to the reasoning in that preliminary decision. There, the OPML stated its view
“that in order to be eligible for listing on the Patent Register under paragraph
4(2)(b), a patent must contain a claim to the formulation that contains all the
medicinal ingredients” that are included in the formulation that was approved
through the issuance of a NOC. Given that Claim 3 of the ‘738 Patent does not
mention naloxone as a medicinal ingredient, it was not eligible to be listed in
respect of TARGIN.
[20]
Similarly,
with respect to the Applicant’s dosage form claim, the OPML observed that
“Claim 5 … appears to be limited to delivering a formulation containing only
oxycodone as the medicinal ingredient”. However, in the OPML’s view:
… in order to be eligible for listing in
respect of a combination drug (a drug containing multiple medicinal
ingredients) under paragraph 4(2)(c), a patent must contain a claim for a
delivery system for administering all the medicinal ingredients in a drug or a
formulation of a drug that includes within its scope the medicinal ingredients,
or formulation.
[21]
Elaborating,
the OPML stated:
…
a formulation containing a single medicinal ingredient must be a different
formulation from one which contains multiple medicinal ingredients. A patent
containing claims for a dosage form for delivering a particular formulation
cannot “match” the approved dosage form unless both formulations explicitly
contain the same medicinal ingredients.
[22]
The
OPML then specifically rejected the Applicant’s submission that the word
“comprising” in the ‘738 Patent is non-limiting, such that naloxone can be
considered to be within the scope of the patent. The OPML stated that “the
conclusion that an unlimited number of other medicinal ingredients are within
the scope of the ‘738 patent supports the view that it does not meet the
requirement of product specificity under section 4.”
[23]
In
this latter regard, the OPML observed that in Bayer (2009), above,
Justice Russell recognized that in the absence of product specificity, the
patent at issue could be listed against any drug that contained ethinyl
estradiol, contrary to the intent of section 4 of the Regulations.
[24]
The
OPML further observed that Justice Russell drew a distinction between the
requirement for product specificity contemplated by the Regulations and the
prevention of patent infringement. The OPML noted that at paragraph 89 of his
decision, Justice Russell stated:
In my view, the Applicant is inviting the Court
to equate specificity under the Regulations with patent infringement. My
reading of the RIAS [Regulatory Impact Analysis Statement] is that this
is not what specificity means and it is fully recognized that not all patents
will be protected and that some patents may be infringed.
IV. Issues
[25]
In
its correspondence with the OPML, the Applicant maintained that the ‘738 Patent
contains claims to the formulations and dosage forms of TARGIN, as contemplated
by the Regulations.
[26]
However,
as a result of the decision in Bayer (2009), above, the Applicant is no
longer contesting the OPML’s rejection of its position that Claim 3 of the ‘738
Patent contains a claim to the formulation of TARGIN that was approved through
the issuance of an NOC.
[27]
Accordingly,
the sole substantive issue is whether the OPML erred in finding that the ‘738
Patent is ineligible for listing in relation to the dosage forms of TARGIN that
are contemplated by the NOC.
[28]
The
Respondent has also raised a procedural issue regarding two pieces of evidence
submitted by the Applicant in this proceeding, namely, (i) an affidavit of Dr.
Roland Bodmeier (the “Bodmeier Affidavit”), and (ii) an exhibit to the
cross-examination of Elsa Maria Thompson (the “Maillé Transcript”).
V. The Standard of Review
[29]
In
Abbott Laboratories Ltd. v. Canada (Attorney General), 2008 FCA
354 at paras. 29 – 32, the Court endorsed the view that the Minister’s
determination of whether a patent is eligible for listing comprises three
questions. In the context of paragraph 4(2)(c) of the Regulations, those
questions can be restated as follows:
i.
What
dosage form does the patent claim?
ii.
What
is the dosage form approved by the existing NOC?
iii.
Does
the dosage form approved by the NOC fall within the scope of the ‘738 Patent?
[30]
The
Court held that (i) the first question is a question of law that is reviewable
on a standard of correctness, (ii) the second question is a question of law
that is reviewable on a standard of reasonableness, and (iii) the third
question is a question of mixed fact and law, the factual component of which is
reviewable on a standard of reasonableness and the legal component of which is
reviewable on a standard of correctness. In this case, the legal component of
the latter question concerns the appropriate interpretation of paragraph
4(2)(c) of the Regulations.
[31]
The
approach described above is the approach that will be applied in my review of
the issues raised in this application. In short, the OPML’s decision will stand
unless it is based on an incorrect construction of Claim 5, an incorrect
interpretation of paragraph 4(2)(c) of the Regulations, an unreasonable
conclusion as to the approved dosage form of TARGIN, or an unreasonable
conclusion as to whether the approved dosage form of TARGIN falls within the
scope of the ‘738 Patent (G.D. Searle & Co. v. Canada (Minister of
Health), 2009 FCA 35 at para. 36).
VI. Analysis
A. The Bodmeier
Affidavit and Maillé Transcript
[32]
These
pieces of evidence were not before the OPML. Accordingly, they would not
ordinarily be admissible in an application for judicial review before this
Court. However, where an application for judicial review requires a
determination on a point of patent construction, this Court has the discretion
to admit evidence which may be helpful in that regard (Abbott Laboratories,
above, at para. 39).
[33]
I
do not find either of the two documents to be particularly helpful.
[34]
The
Bodmeier Affidavit consists of twelve introductory paragraphs followed by a
single paragraph in which Dr. Bodmeier simply states that he has reviewed and
completely agrees with the opinions, comments and observations in Dr.
Cartilier’s Affidavit.
[35]
As
to the Maillé Transcript, it was an Exhibit to the cross-examination of Elsa
Maria Thompson, a paralegal with clerical duties in the OPML. That Exhibit was
attached to an affidavit filed in another proceeding, which in turn attached
the Notice of Application and Maillé Transcript from a third proceeding. In the
brief discussion regarding the Maillé Transcript that took place during the
hearing before me, it was apparent to me that there was little, if anything, in
that document which would be of assistance in addressing the questions
identified above.
[36]
Accordingly,
I agree with the Respondent that the Bodmeier Affidavit and the Maillé
Transcript ought not to be admitted as evidence in this proceeding.
B. What
dosage form is claimed by the ‘738 Patent?
[37]
The
‘738 Patent specifically makes a claim to “oxycodone or a salt thereof ” in the
dosage form claim that is made in Claim 5.
[38]
The
Applicant maintains that the word “comprising” in Claim 5 contemplates that
medicinal and non-medicinal ingredients that are not specifically mentioned can
also be included within the scope of that claim, except to the extent that they
have been specifically excluded. Dr. Cartilier, a person skilled in the art,
agreed with this interpretation. The Respondent did not adduce evidence in this
regard from anyone skilled in the art.
[39]
Patent
construction is a task for the Court, “assisted by experts if necessary to
explain the meaning of words, terms, science and background” (Abbott
Laboratories Ltd. v. Canada (Attorney General), 2008 FC 700
at para. 16).
[40]
In
performing this task, it is necessary and appropriate to adopt a “purposive
construction,” to identify “what the inventor considered to be the ‘essential’
elements of his invention” (Whirlpool Corp. v. Camco Inc., [2000] 2
S.C.R. 1067 at para 45). In this regard, a purposive construction can “cut
either way,” in the sense that it can either expand or limit a literal text (Whirlpool,
above, at subparagraph 49(h)).
[41]
The
Applicant submits that the presence of naloxone, which is not excluded by Claim
5, in TARGIN does not change the fact that the dosage form of TARGIN is within
the scope of Claim 5. More generally, the Applicant submits that “a product
containing all of the ingredients in the dosage form as described in the claim
and one or more active ingredients would still be included within claim 5, so
long as one of those active ingredients is oxycodone or a salt thereof.”
[42]
The
Applicant further submits that to construe Claim 5 in a manner that does not
encompass a dosage form that includes naloxone would require Claim 5 to be
construed in a manner different to how it would be construed for the purpose of
considering infringement or validity. (See, for example, Pfizer Canada Inc.
et al. v. Ratiopharm Inc. et al., 2010 FC 612 at para. 75.) The Applicant
states that this would be contrary to the Supreme Court of Canada’s observation
that “it has always been a fundamental rule of claims construction that the
claims receive one and the same interpretation for all purposes” (Whirlpool,
above, at subparagraph 49(b)).
[43]
The
latter observation must be viewed in the context within which it was made. That
context was the Court’s reluctance to embrace a view that could result in a
different claims construction for the purpose of validity than for the purpose
of infringement. In my view, the purpose for which patent construction is
conducted in the context of section 4 of the Regulation is sufficiently unique
and different from the other purposes for which patents are constructed that it
is unlikely that the Court intended its observation to apply in the former
context.
[44]
In
short, requiring patents to be construed under section 4 in the same manner in
which they are construed for all other purposes could seriously undermine a key
objective of the 2006 amendments to the Regulation. As described in the Regulatory
Impact Analysis Statement (RIAS) published with the 2006 amendments to the
Regulations, that objective was to entrench “the concept of product specificity
as the key consideration required of the Minister in applying the listing
requirements under section 4 of the [Regulations].” This was considered
necessary in order “to restore the balanced policy underlying” the Regulations
(RIAS, at p. 1510), which was perceived to have been distorted by jurisprudence
which appeared to be “predicated on the court’s view that the sole purpose of
the [Regulation] is the prevention of patent infringement” (RIAS, at p. 1513;
see also G.D. Searle, above, at para. 15). The RIAS specifically
recognized (at p. 1512) that:
…
there may be instances where a patent which does not qualify for the protection
of the [Regulation] is ultimately infringed by the fact of generic market
entry. However, the Government’s view is that where the patent fails to meet
the listing requirements described above, policy considerations tip the balance
in favour of immediate approval of the generic drug and the matter is better
left to the alternative judicial recourse of an infringement action.
[45]
In
my view, the foregoing passage makes it clear that the fact that an innovator
has invested time and money to test an invention and have it approved for sale
is secondary to the goals sought to be achieved by entrenching product
specificity in the Regulation.
[46]
In
its letter to the Applicant dated October 26, 2009, the OPML provided the
following support for its conclusion that the dosage form contemplated by Claim
5 relates to a formulation containing oxycodone as the sole medicinal
ingredient:
The OPML’s position appears to
be supported by numerous references in the patent. For example, the disclosure
states the following at page 5, line 29, under the heading “Detailed
Description”:
It has now been surprisingly discovered that the presently
claimed controlled release oxycodone formulations acceptably control pain over
a substantially narrower, approximately four-fold (10 to 40 mg every 12 hours –
around-the-clock dosing) in approximately 90% of patients. This is in sharp
contrast to the approximately eight-fold range required for approximately 90%
of patients for opioid analgesics in general.
In addition, page 9 states the
following at line 20:
The present oral dosage form preferably contains between 1
and 500 mg, most especially between 10 and 160 mg, of oxycodone hydrocholoride.
Alternatively, the dosage form may contain molar equivalent amounts of other
oxycodone salts or of the oxycodone base.
[47]
I
agree that these passages in the ‘738 Patent support the view that the dosage
form contemplated by Claim 5 relates to a formulation (mixture of medicinal and
non-medicinal ingredients) containing oxycodone as the sole medicinal
ingredient. In my view, a purposive interpretation of both Claim 5 and the ‘738
Patent in its entirety supports this view.
[48]
As
the OPML noted, further support for this view is provided in Justice
Harrington’s decision concerning another application brought by the Applicant in
respect of the ‘738 Patent, in relation to its OXYCONTIN drug (Purdue Pharma,
above). At paragraph 4 of that decision, Justice Harrington noted:
Suffice it to say that Purdue’s Canadian
patent 2,098,738 (‘738), which claims a novel 12-hour controlled release
formulation of oxycodone having a specific pharmacokinetic profile, is on the
list maintained by the Minister pursuant to s. 4 of the Regulations. […]
In addition, Justice
Harrington noted the following at paragraph 29:
The specification describes various solid
oral dosage forms containing about 10 to about 160 mg of oxycodone, or a salt
thereof, in which release after ingestion is spread out either by a retardant
coating or by a matrix. A matrix system consists of an active ingredient, in
this case oxycodone, being dispersed homogeneously throughout a matrix of
inert, erodible or swelling-controlled material, generally a polymer. It calls
for certain dissolution ranges in vitro and blood plasma levels over
time, “substantially independent of pH”.
It is also
noteworthy that the Applicant’s position was described by Justice Harrington at
paragraph 24, as follows:
According to Purdue, the patent
specification discloses an invention with three primary elements: 1) the choice
of oxycodone as the active ingredient for a product to be used in the treatment
of moderate to severe pain; 2) the choice of a particular pharmacokinetic
profile; and 3) the development of formulations which would result in the type
of profile being sought (12-hour controlled release). […]
[49]
In
conclusion, I find that the OPML correctly determined that the dosage form
contemplated by Claim 5 relates to a formulation containing oxycodone as the
sole medicinal ingredient, and that naloxone is not within the scope of Claim 5
for the purposes of the Regulation. A construction of Claim 5 that would
recognize a potentially unlimited number of unnamed other medicinal ingredients
to be within the scope of that claim would be inconsistent with the requirement
of product specificity that was enshrined in section 4 of the Regulations by
the 2006 amendments thereto. Such a construction would also “[invite] the Court
to equate specificity under the Regulations with patent infringement” (Bayer
(2009), above, at para. 89). Such a construction must therefore be rejected
(Abbott Laboratories Ltd. v. Canada (Attorney
General),
2008 FCA 244 at paras. 47-50; G.D. Searle, above, at para. 48).
C. What is the
dosage form approved by the NOC?
[50]
The
Applicant submits that the dosage form approved through the NOC issued in
December 2009 in respect of TARGIN is “controlled release tablets.” This begs
the question regarding the content of the controlled release tablets that were
approved.
[51]
As
will be discussed further in the next section of these reasons, a “claim for
the dosage form” is defined in Section 2 of the Regulations to mean “a claim
for a delivery system for administering a medicinal ingredient in a drug or a
formulation of a drug that includes within its scope that medicinal ingredient
or formulation.” In my view, this clearly contemplates that a dosage form
cannot merely be a delivery system, such as a controlled release tablet. It
must be a delivery system for either a drug or a formulation of a drug. In the
case of TARGIN, the dosage form that was approved is a controlled release
tablet for the delivery of specific strengths of a formulation containing both
oxycodone and naloxone.
[52]
This
interpretation is consistent with the description that appears in the table
entitled “Summary Product Information”, at page 3 of the TARGIN Product
Monograph dated May 19, 2009. Under the heading “Dosage Form / Strength,” the
following is stated:
Controlled Release Tablets
10 mg. oxycodone hydrochloride/
5 mg naloxone hydrochloride
20 mg. oxycodone hydrochloride/
10 mg. naloxone hydrochloride
40 mg. oxycodone hydrochloride/
20 mg. naloxone hydrochloride
[53]
In
my view, it was entirely correct, and in any event was not unreasonable, for
the OPML to implicitly conclude that the dosage form of TARGIN that was
approved is a controlled release tablet for the delivery of specific strengths
of a formulation containing both oxycodone and naloxone.
D.
Does the dosage form approved by the NOC fall within the scope of the ‘738
Patent?
[54]
As
noted at paragraph 30 above, this question is one of mixed fact and law. The
question of law concerns the appropriate interpretation of paragraph 4(2)(c) of
the Regulations. The question of fact is whether, having regard to that
interpretation, the approved dosage form of TARGIN can be said to fall within
the scope of the ‘738 Patent.
[55]
In
its final decision determining that the ‘738 Patent is not eligible for listing
in respect of TARGIN, the OPML held that “the eligibility for listing a patent
on the basis of a claim for the dosage form under paragraph 4(2)(c) must take
into consideration the requirement for product specificity.” Proceeding from
that premise, the OPML concluded:
[I]n
order to be eligible for listing in respect of a combination drug (a drug
containing multiple medicinal ingredients) under paragraph 4(2)(c), a patent
must contain a claim for a delivery system for administering all the medicinal
ingredients in a drug or a formulation of a drug that includes within its scope
the medicinal ingredients, or formulation.
[56]
In
reaching its conclusion, the OPML followed Justice Russell’s reasoning in Bayer
(2009), above. In that case, Justice Russell rejected the argument that the
words “contains the medicinal ingredient” in paragraph 4(2)(b) of the
Regulations simply requires that the patent claim contain (a) the medicinal
ingredient, without necessarily explicitly referring to that ingredient, and
(b) one, but not necessarily all, of the medicinal ingredients in the approved
formulation. In this regard, he observed, at para. 71, that subsection 33(2) of
the Interpretation Act provides that “words in the singular include the
plural, and words in the plural include the singular,” so there is nothing
incorrect about reading “the medicinal ingredient” in subsection 4(2)(b) of the
Regulations to include “the medicinal ingredients”. With this in mind,
he concluded, at para. 71:
[…]
it would distort the plain and ordinary meaning of ‘the medicinal ingredient’
if the phrase were to read to mean ‘one of the medicinal ingredients’ that has
been approved, because it is the formulation that must have been approved, and
the formulation in this case contains a mixture of two medicinal
ingredients.”
[57]
The Applicant notes that Bayer (2009), above, concerned
paragraph 4(2)(b), as opposed to paragraph 4(2)(c), and submits that the OPML
erred by ignoring the differences in language between those paragraphs as well
as between the definitions of “claim for the dosage form” and “claim for the
formulation” in section 2 of the Regulations. Relying on the principle of
statutory construction that different words should be interpreted to have
different meanings, the Applicant submits that the Governor in Council did not
intend paragraph 4(2)(c) to have the same meaning as paragraph 4(2)(b). In the
Applicant’s view, it was improper for the OPML to require its claim to the
dosage form to contain both of the medicinal ingredients in TARGIN.
[58]
Instead,
the Applicant submits that for claims for the dosage form under paragraph
4(2)(c), all that is required is that the dosage form has been approved. In
support of this position, the Applicant suggests that the text of paragraph
4(2)(c) is devoid of any requirement relating to the medicinal ingredient.
[59]
I
am unable to agree with the Applicant’s interpretation of paragraph 4(2)(c).
[60]
Section
2 defines the words “claim for the dosage form” to mean “a claim for a delivery
system for administering a medicinal ingredient in a drug or a formulation of a
drug that includes within its scope that medicinal ingredient or formulation.”
Accordingly, on a plain reading of these words, paragraph 4(2)(c) is not
“devoid of any requirement relating to the medicinal ingredient”, as suggested
by the Applicant.
[61]
In
my view, when read together while keeping in mind the principle of specificity
that permeated the 2006 amendments to the Regulations, paragraph 4(2)(c) and
section 2 require more than simply that the dosage form in question have been
approved.
[62]
It
is implicit that the two dosage forms referred to in paragraph 4(2)(c) are
dosage forms of something. With respect to the first of those dosage forms,
namely, the “claim for the dosage form,” section 2 makes it clear that that something
is “a delivery system for administering a medicinal ingredient in a drug or a
formulation of a drug.” It can be inferred that the other reference to “dosage
form” in paragraph 4(2)(c) also refers to “a delivery system for administering
a medicinal ingredient in a drug or a formulation of a drug.” This inference is
consistent with the basic principle of statutory interpretation that the same
words in a statute should be given the same meaning (Ruth Sullivan, Sullivan
on the Construction of Statutes, 5th ed. (Markham: LexisNexis,
2008) at 215).
[63]
In
section 2, the words “that includes within its scope that medicinal ingredient
or formulation” require that the medicinal ingredient in a drug or formulation of
a drug to be administered by the claimed delivery system be included within the
scope of the dosage form claim in question. Pursuant to subsection 33(2) of the
Interpretation Act, the words “a medicinal ingredient” and “that
medicinal ingredient” may be interpreted to mean “medicinal ingredients” and
“those medicinal ingredients”, respectively. Keeping in mind the principle of
product specificity, it follows that where a claim has been made for a delivery
system for administering multiple medicinal ingredients in a drug or a
formulation of a drug, the claim in question must include within its scope each
of those medicinal ingredients.
[64]
As
discussed in Section VI.B of these reasons, the dosage form claimed by Claim 5 of
the ‘738 Patent is a delivery system for administering a formulation containing
oxycodone as the sole medicinal ingredient. For the purposes of the Regulation,
the medicinal ingredient naloxone is not within the scope of that claim.
[65]
However,
the approved dosage form of TARGIN is a delivery system for administering a
formulation containing two medicinal ingredients, namely, oxycodone and naloxone.
[66]
In
short, the dosage form claimed by Claim 5 and the dosage form that was approved
by the NOC issued in respect of TARGIN are delivery systems for administering
two different formulations (Bayer (2009), above, at para. 64).
[67]
In
my view, for the purposes of the Regulation, the two dosage forms are therefore
different. This is fatal for the Applicant’s attempt to list the ‘738 Patent in
relation to TARGIN, because paragraph 4(2)(c) plainly requires the claimed
dosage form and the approved dosage form to be the same. This is clear from the
use of the definite article “the” in the phrase “and the dosage form has been
approved”.
[68]
To
be eligible for listing under paragraph 4(2)(c) in relation to TARGIN, the
dosage form claimed in Claim 5 must include within its scope both of the
medicinal ingredients included in the approved dosage form of TARGIN.
[69]
Accordingly,
I conclude that the OPML correctly interpreted paragraph 4(2)(c) and section 2
of the Regulations as requiring a match between the dosage form claimed in
Claim 5 and the dosage form that was approved through the issuance of a NOC in
respect of TARGIN.
[70]
I
also conclude that it was not unreasonable for the OPML to conclude that there
is in fact no match between the dosage form claimed in Claim 5 and the dosage
form that was approved through the issuance of a NOC in respect of TARGIN.
Indeed, I believe that the OPML’s conclusion in this regard is correct.
VII. Conclusion
[71]
This
application is dismissed with costs.
JUDGMENT
THIS COURT ORDERS AND ADJUDGES
THAT this application for judicial review is dismissed with costs.
“Paul S. Crampton”
__________________________
Judge
ANNEX "A"
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Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133
2. In these Regulations,
“claim for the
dosage form” means a claim for a delivery system for administering a
medicinal ingredient in a drug or a formulation of a drug that includes
within its scope that medicinal ingredient or formulation;
“claim for the
formulation” means a claim for a substance that is a mixture of medicinal and
non-medicinal ingredients in a drug and that is administered to a patient in
a particular dosage form;
[…]
“first person”
means the person referred to in subsection 4(1);
[…]
“Minister”
means the Minister of Health;
[…]
“patent list”
means a list submitted under subsection 4(1);
“register”
means the register of patents and other information maintained by the
Minister in accordance with subsection 3(2);
3.(2) The Minister shall maintain a register of patents and
other information submitted under section 4. To maintain the register, the
Minister may refuse to add or may delete any patent or other information that
does not meet the requirements of that section.
[…]
4. (1) A first person who files or who
has filed a new drug submission or a supplement to a new drug submission may
submit to the Minister a patent list in relation to the submission or
supplement for addition to the register.
(2) A patent
on a patent list in relation to a new drug submission is eligible to be added
to the register if the patent contains
(a) a claim
for the medicinal ingredient and the medicinal ingredient has been approved
through the issuance of a notice of compliance in respect of the submission;
(b) a claim
for the formulation that contains the medicinal ingredient and the
formulation has been approved through the issuance of a notice of compliance
in respect of the submission;
(c) a claim
for the dosage form and the dosage form has been approved through the
issuance of a notice of compliance in respect of the submission; or
(d) a claim
for the use of the medicinal ingredient, and the use has been approved
through the issuance of a notice of compliance in respect of the submission.
|
|
Règlement
sur les médicaments brevetés (avis de conformité), DORS/93-133
2.
Les définitions qui suivent s’appliquent au présent règlement.
[…]
«
liste de brevets » Liste présentée aux termes du paragraphe 4(1).
[…]
«
ministre » Le ministre de la Santé.
«
première personne » La personne visée au paragraphe 4(1).
«
registre » Le registre des brevets et des autres renseignements tenu par le
ministre conformément au paragraphe 3(2).
«
revendication de la forme posologique » Revendication à l’égard d’un
mécanisme de libération permettant d’administrer l’ingrédient médicinal d’une
drogue ou la formulation de celle-ci, dont la portée comprend cet ingrédient
médicinal ou cette formulation.
«
revendication de la formulation » Revendication à l’égard d’une substance qui
est un mélange des ingrédients médicinaux et non médicinaux d’une drogue et
qui est administrée à un patient sous une forme posologique donnée.
3. (2) Le
ministre tient un registre des brevets et des autres renseignements fournis
aux termes de l’article 4. À cette fin, il peut refuser d’y ajouter, ou en
supprimer, tout brevet ou tout autre renseignement qui n’est pas conforme aux
exigences de cet article.
[…]
4. (1) La première personne qui dépose ou
a déposé la présentation de drogue nouvelle ou le supplément à une
présentation de drogue nouvelle peut présenter au ministre, pour adjonction
au registre, une liste de brevets qui se rattache à la présentation ou au
supplément.
(2) Est admissible à l’adjonction au registre tout brevet,
inscrit sur une liste de brevets, qui se rattache à la présentation de drogue
nouvelle, s’il contient, selon le cas :
a)
une revendication de l’ingrédient médicinal, l’ingrédient ayant été approuvé
par la délivrance d’un avis de conformité à l’égard de la présentation;
b)
une revendication de la formulation contenant l’ingrédient médicinal, la
formulation ayant été approuvée par la délivrance d’un avis de conformité à
l’égard de la présentation;
c)
une revendication de la forme posologique, la forme posologique ayant été
approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation;
d)
une revendication de l’utilisation de l’ingrédient médicinal, l’utilisation
ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation.
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|
Interpretation
Act, R.S.C. 1985, c.
I-21
Number
33. (2) Words in the singular include the plural, and words
in the plural include the singular.
|
|
Loi
d'interprétation,
L.R.C. 1985, c. I-21
Nombre
grammatical
33. (2) Le pluriel ou le
singulier s’appliquent, le cas échéant, à l’unité et à la pluralité.
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