Date: 20080404
Docket: T-884-07
Citation: 2008
FC 437
Ottawa, Ontario, April 4, 2008
PRESENT: The Honourable Justice Johanne Gauthier
BETWEEN:
GD
SEARLE & CO. and PFIZER CANADA INC.
and
MINISTER
OF HEALTH
REASONS FOR ORDER AND ORDER
[1]This judicial review of the
decision of the Minister of Health to remove Canadian patent number 2,319,201
(‘201 patent) from the Patent Register raises a new question with respect to
the construction of subsection 4(3) of the October 5, 2006 amendments to the Patented
Medicines Notice of Compliance Regulations, SOR/98-166; SOR/93-133 as
amended (NOC Regulations). The amendments were adopted to clarify the
eligibility requirements of patents listed in relation to Supplementary New
Drug Submissions (SNDS).
[2]For the reasons that follow, the Court
finds that the Minister’s decision is well-founded and should not be interfered
with.
BACKGROUND
[3]Pfizer Canada Inc. (Pfizer) manufactures
and markets the drug Celebrex® ® in Canada in capsule dosage (100 mg, 200 mg and
400 mg). Celebrex® ® is a non-steroidal anti-inflammatory drug (NSAID) that
functions by acting as a cyclooxygenase-2
(COX-2) inhibitor.
It contains the medicinal ingredient celecoxib.
[4]On April 14, 1999, pursuant to an
original New Drug Submission (NDS) for celecoxib, Health Canada issued Pfizer an NOC for use
in “the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis
in adults”. Canadian patents No. 2, 177, 576 (‘576 patent) and 2, 267,186
(‘186 patent) owned by GD Searle and Co were listed by Pfizer against that NOC.
The ‘576 Patent claims a class of compounds which includes celecoxib as well as
the use of such compounds in the treatment inter alia of arthritis and
inflammation associated disorders including pain and fever, whereas the ‘186
patent claims a new therapeutic use for COX-2 inhibitors, that is, the
treatment and prevention of neoplasia.
[5]Since then, Pfizer has filed and received
approval for several SNDSs including SNDS 072375, which was filed on July 4,
2001. That SNDS describes a new indication or new use of Celebrex® ®, namely the “short term
(≤ 7 days) management of moderate to severe acute pain in adults in
conditions such as: musculoskeletal and/or soft-tissue trauma including
sprains, post-operative orthopaedic, and pain following dental extraction”.
This SNDS was approved by Health Canada
and resulted in the issuance of an NOC on September 7, 2004.
[6]About two years later, on July 11, 2006,
the ’201 Patent was issued to GD Searle and Co. in respect of a patent application
that had been filed on November 30, 1999. Under subsection 4(4) of the NOC
Regulations as they read prior to the October 5, 2006 amendments, patent owners
were granted 30 days from the date of patent issue to submit a patent for
listing on the Patent Register in relation with eligible drug submissions,
provided the application for said patent had been filed before the date of
filing of the drug submission. Thus, the ’201 patent could not be listed
against the 1999 NOC for Celebrex® ® but could be listed in respect
of SNDS 072375, as it contained a claim for the medicine celecoxib (formulation). It was
added by the Minister to the Patent Register on July 27, 2006. The submission
to list the patent was made by Pfizer with GD Searle’s consent.
[7]As mentioned, on October 5, 2006, the NOC
regulations were amended. Section 6 of the transitional provisions specifies
that all patent lists filed after June 17, 2006 would be subject to the newly
introduced patent listing requirements. As the ‘201 patent was submitted for
listing on July 19, 2006, it was subject to the amended NOC Regulations.
[8]The Minister reaudited the patents filed
after June 17, 2006 and concluded that the ‘201 patent did not meet the
requirements of subsection 4(3) of the NOC Regulations.
[9]The Minister informed Pfizer that it
proposed to delist the ’201 patent. Pfizer made oral and written submissions
opposing the proposed delisting on the basis, among other things, that the
patent should be listed if the new indication falls within the scope of one or
more claims in the patent. Pfizer submitted reports from five experts to show
that, as a matter of fact, the new indication was covered by claims 14 and 15
of the ‘201 patent.
[10]
Ultimately,
the Minister found that the ’201 patent did not meet the requirements of the
NOC Regulations and it was delisted on May 1, 2007.
[11]
Claims 14
and 15 of the '201 patent read as follows:
14. Use of a composition as defined in
any one of claims 1 to 10 for the preparation of a medicament for the treatment
and/or prophylaxis of a medical condition or disorder in a subject where
treatment with a cyclooxygenase-2 inhibitor is indicated.
15. The use according to claim 14,
wherein the condition or disorder is rheumatoid arthritis, osteoarthritis or
pain.
[12]
It is
agreed by the parties that the approved version of Celebrex® currently on the
market embodies a drug composition covered by the ‘201 patent. Thus, product
specificity is not an issue here.
LEGISLATIVE
PROVISIONS
[13]
For ease
of reference, the legislative and regulatory provisions relevant to this matter
are reproduced here:
Section
55.2 (1) of the Patent Act, R.S.C. 1985, c. P-4;
|
55.2 (1) It is not an infringement of a patent for any
person to make, construct, use or sell the patented invention solely for uses
reasonably related to the development and submission of information required
under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale
of any product.
(4) The Governor in Council may make such regulations as the Governor in
Council considers necessary for preventing the infringement of a patent by
any person who makes, constructs, uses or sells a patented invention in
accordance with subsection (1), including, without limiting the generality of
the foregoing, regulations
(a) respecting the conditions that must be
fulfilled before a notice, certificate, permit or other document concerning
any product to which a patent may relate may be issued to a patentee or other
person under any Act of Parliament that regulates the manufacture,
construction, use or sale of that product, in addition to any conditions provided
for by or under that Act;
(b) respecting the earliest date on which a
notice, certificate, permit or other document referred to in paragraph (a)
that is issued or to be issued to a person other than the patentee may take
effect and respecting the manner in which that date is to be determined;
(c) governing the resolution of disputes between a
patentee or former patentee and any person who applies for a notice,
certificate, permit or other document referred to in paragraph (a) as
to the date on which that notice, certificate, permit or other document may
be issued or take effect;
(d) conferring rights of action in any court of
competent jurisdiction with respect to any disputes referred to in paragraph
(c) and respecting the remedies that may be sought in the court, the
procedure of the court in the matter and the decisions and orders it may
make; and
(e) generally governing the issue of a notice,
certificate, permit or other document referred to in paragraph (a) in
circumstances where the issue of that notice, certificate, permit or other
document might result directly or indirectly in the infringement of a patent.
|
55.2 (1) Il n’y a pas
contrefaçon de brevet lorsque l’utilisation, la fabrication, la construction
ou la vente d’une invention brevetée se justifie dans la seule mesure
nécessaire à la préparation et à la production du dossier d’information
qu’oblige à fournir une loi fédérale, provinciale ou étrangère réglementant
la fabrication, la construction, l’utilisation ou la vente d’un produit.
(4) Afin d’empêcher la contrefaçon d’un brevet
d’invention par l’utilisateur, le fabricant, le constructeur ou le
vendeur d’une invention brevetée au sens du paragraphe (1), le
gouverneur en conseil peut prendre des règlements, notamment :
a) fixant des conditions complémentaires nécessaires à la
délivrance, en vertu de lois fédérales régissant l’exploitation, la
fabrication, la construction ou la vente de produits sur lesquels porte un
brevet, d’avis, de certificats, de permis ou de tout autre titre à quiconque
n’est pas le breveté;
b) concernant la première date, et la manière de la fixer,
à laquelle un titre visé à l’alinéa a) peut être délivré à quelqu’un
qui n’est pas le breveté et à laquelle elle peut prendre effet;
c) concernant le règlement des litiges entre le breveté,
ou l’ancien titulaire du brevet, et le demandeur d’un titre visé à l’alinéa a),
quant à la date à laquelle le titre en question peut être délivré ou prendre
effet;
d) conférant des droits d’action devant tout tribunal
compétent concernant les litiges visés à l’alinéa c), les conclusions
qui peuvent être recherchées, la procédure devant ce tribunal et les décisions
qui peuvent être rendues;
e) sur toute autre mesure concernant la délivrance d’un
titre visé à l’alinéa a) lorsque celle-ci peut avoir pour effet la
contrefaçon de brevet.
|
Section 2 of the Patented Medicines (Notice of
Compliance) Regulations;
|
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; (
revendication de la forme posologique )
"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; ( revendication de la formulation )
"claim
for the medicinal ingredient" includes
a claim in the patent for the medicinal ingredient, whether chemical or
biological in nature, when prepared or produced by the methods or processes
of manufacture particularly described and claimed in the patent, or by their
obvious chemical equivalents, and also includes a claim for different
polymorphs of the medicinal ingredient, but does not include different
chemical forms of the medicinal ingredient; ( revendication de l’ingrédient médicinal )
"claim
for the medicine itself" [Repealed,
SOR/2006-242, s. 1]
"claim
for the use of the medicinal ingredient" means a claim for the use of the medicinal ingredient for
the diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or its symptoms; ( revendication de l’utilisation de
l’ingrédient médicinal )
|
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. ( claim for the dosage form )
«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. ( claim for the formulation )
«revendication de l’ingrédient médicinal» S’entend, d’une part, d’une revendication, dans le brevet, de
l’ingrédient médicinal — chimique ou biologique — préparé ou produit selon
les modes ou procédés de fabrication décrits en détail et revendiqués dans le
brevet ou selon leurs équivalents chimiques manifestes, et, d’autre part,
d’une revendication pour différents polymorphes de celui-ci, à l’exclusion de
ses différentes formes chimiques. ( claim for the medicinal ingredient ) «revendication de l’utilisation de
l’ingrédient médicinal» Revendication de
l’utilisation de l’ingrédient médicinal aux fins du diagnostic, du
traitement, de l’atténuation ou de la prévention d’une maladie, d’un
désordre, d’un état physique anormal, ou de leurs symptômes. ( claim for the use of the medicinal
ingredient )
|
Section 3 (2) of
the Patented Medicines (Notice of Compliance) Regulations;
|
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.
|
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.
|
Section 4 of the
Patented Medicines (Notice of Compliance) Regulations;
|
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.
(3) A patent on a patent list in relation to a
supplement to a new drug submission is eligible to be added to the register
if the supplement is for a change in formulation, a change in dosage form or
a change in use of the medicinal ingredient, and
(a) in the case of a change in formulation, the
patent contains a claim for the changed formulation that has been approved
through the issuance of a notice of compliance in respect of the supplement;
(b) in the case of a change in dosage form, the
patent contains a claim for the changed dosage form that has been approved
through the issuance of a notice of compliance in respect of the supplement;
or
(c) in the case of a change in use of the
medicinal ingredient, the patent contains a claim for the changed use of the
medicinal ingredient that has been approved through the issuance of a notice
of compliance in respect of the supplement.
(4) A patent list shall contain the following:
(a) an identification of the new drug submission
or the supplement to a new drug submission to which the list relates;
(b) the medicinal ingredient, brand name, dosage
form, strength, route of administration and use set out in the new drug
submission or the supplement to a new drug submission to which the list
relates;
(c) for each patent on the list, the patent number,
the filing date of the patent application in Canada, the date of grant of the
patent and the date on which the term limited for the duration of the patent
will expire under section 44 or 45 of the Patent Act;
(d) for each patent on the list, a statement that
the first person who filed the new drug submission or the supplement to a new
drug submission to which the list relates is the owner of the patent or has
an exclusive licence to the patent, or has obtained the consent of the owner
of the patent to its inclusion on the list;
(e) the address in Canada for service, on the first
person, of a notice of allegation referred to in paragraph 5(3)(a) or
the name and address in Canada of another person on whom service may be made
with the same effect as if service were made on the first person; and
(f) a certification by the first person that the
information submitted under this subsection is accurate and that each patent
on the list meets the eligibility requirements of subsection (2) or (3).
(5) Subject to subsection (6), a first person who
submits a patent list must do so at the time the person files the new drug
submission or the supplement to a new drug submission to which the patent
list relates.
(6) A first person may, after the date of filing of
a new drug submission or a supplement to a new drug submission, and within 30
days after the issuance of a patent that was issued on the basis of an
application that has a filing date in Canada that precedes the date of filing
of the submission or supplement, submit a patent list, including the
information referred to in subsection (4), in relation to the submission or
supplement.
(7) A first person who has submitted a patent list must
keep the information on the list up to date but, in so doing, may not add a
patent to the list.
(8) The Minister shall insert on the patent list
the date of filing and submission number of the new drug submission or the
supplement to a new drug submission in relation to which the list was
submitted.
|
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.
(3) Est admissible à l’adjonction au
registre tout brevet, inscrit sur une liste de brevets, qui se rattache au
supplément à une présentation de drogue nouvelle visant une modification de
la formulation, une modification de la forme posologique ou une modification
de l’utilisation de l’ingrédient médicinal, s’il contient, selon le
cas :
a) dans le
cas d’une modification de formulation, une revendication de la formulation
modifiée, la formulation ayant été approuvée par la délivrance d’un avis de
conformité à l’égard du supplément;
b) dans le
cas d’une modification de la forme posologique, une revendication de la forme
posologique modifiée, la forme posologique ayant été approuvée par la
délivrance d’un avis de conformité à l’égard du supplément;
c) dans
le cas d’une modification d’utilisation de l’ingrédient médicinal, une
revendication de l’utilisation modifiée de l’ingrédient médicinal,
l’utilisation ayant été approuvée par la délivrance d’un avis de conformité à
l’égard du supplément.
(4) La liste de brevets
comprend :
a) l’identification de la présentation de drogue nouvelle ou du
supplément à la présentation de drogue nouvelle qui s’y rattachent;
b)
l’ingrédient médicinal, la marque nominative, la forme posologique, la
concentration, la voie d’administration et l’utilisation prévus à la
présentation ou au supplément qui s’y rattachent;
c) à
l’égard de chaque brevet qui y est inscrit, le numéro de brevet, la date de
dépôt de la demande de brevet au Canada, la date de délivrance de celui-ci et
la date d’expiration du brevet aux termes des articles 44 ou 45 de la Loi
sur les brevets;
d) à
l’égard de chaque brevet qui y est inscrit, une déclaration portant que la
première personne qui a déposé la présentation de drogue nouvelle ou le
supplément à une présentation de drogue nouvelle qui s’y rattachent en est le
propriétaire, en détient la licence exclusive ou a obtenu le consentement du
propriétaire pour l’inclure dans la liste;
e)
l’adresse au Canada de la première personne aux fins de signification de
l’avis d’allégation visé à l’alinéa 5(3)a) ou les nom et adresse au
Canada d’une autre personne qui peut en recevoir signification comme s’il
s’agissait de la première personne elle-même;
f) une
attestation de la première personne portant que les renseignements fournis
aux termes du présent paragraphe sont exacts et que chaque brevet qui y est
inscrit est conforme aux conditions d’admissibilité prévues aux paragraphes
(2) ou (3).
(5) Sous réserve du paragraphe (6), la
première personne qui présente une liste de brevets doit le faire au moment
du dépôt de la présentation de drogue nouvelle ou du supplément à une
présentation de drogue nouvelle qui s’y rattachent.
(6) La première personne peut, après la
date de dépôt de la présentation de drogue nouvelle ou du supplément à une
présentation de drogue nouvelle et dans les trente jours suivant la
délivrance d’un brevet faite au titre d’une demande de brevet dont la date de
dépôt au Canada est antérieure à celle de la présentation ou du supplément,
présenter une liste de brevets, à l’égard de cette présentation ou de ce
supplément, qui contient les renseignements visés au paragraphe (4).
(7) La première personne qui a présenté
une liste de brevets doit tenir à jour les renseignements y figurant, mais ne
peut toutefois y ajouter de brevets.
(8) Le ministre inscrit sur la liste de
brevets la date de dépôt et le numéro de la présentation de drogue nouvelle
ou du supplément à une présentation de drogue nouvelle qui se rattache à la
liste présentée.
|
Section
2 of the pre-October 2006 Patented Medicines (Notice of Compliance)
Regulations
[Repealed,
SOR/2006-242, s. 1];
|
2. In these
Regulations,
"claim
for the medicine itself" includes
a claim in the patent for the medicine itself when prepared or produced by
the methods or processes of manufacture particularly described and claimed or
by their obvious chemical equivalents; (
revendication pour le médicament en soi )
"claim
for the use of the medicine" means
a claim for the use of the medicine for the diagnosis, treatment, mitigation
or prevention of a disease, disorder or abnormal physical state, or the
symptoms thereof; ( revendication pour l’utilisation du médicament )
|
2. Les définitions qui suivent
s’appliquent au présent règlement.
«revendication pour le médicament en soi» S’entend notamment d’une revendication, dans le brevet, pour le
médicament en soi préparé ou produit selon les modes du procédé de
fabrication décrits en détail et revendiqués ou selon leurs équivalents
chimiques manifestes. ( claim
for the medicine itself )
«revendication pour l’utilisation du médicament» Revendication
pour l’utilisation du médicament aux fins du diagnostic, du traitement, de
l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état
physique anormal, ou de leurs symptômes. ( claim for the use of the medicine )
|
ANALYSIS
A)
Standard
of review
[14]
In their written
representations, the applicants had raised an issue of procedural fairness as
well as preliminary issues in respect of the filing of new evidence not before
the decision maker. Affidavit evidence explaining the Minister’s decision was
also submitted. At the hearing, the parties agreed that the Court will not
have to deal with such issues and that this application should be decided on
the merits of the main question, which is whether the ’201 patent meets the
requirements set out in subsection 4(3) of the NOC Regulations.
[15]
The Minister
submitted that the application of the NOC Regulations to a particular patent is
a question of mixed fact and law which normally requires assessing the subject
matter of the drug submission and comparing it with the patent that has been
submitted for listing. Such an issue is normally subject to the standard of
patent unreasonableness.
[16]
However, at the
hearing the Minister also agreed that as set out in the recent Federal Court of
Appeal recent decision in Ferring Inc. v. Canada (Minister of Health),
2007 FCA 276 at paragraph 8:
“…where there is a mixed
question of law and fact then the standard of review is patent unreasonableness
unless the question of law is extricable from the question of fact in which
case the question of law is determined on the basis of correctness”.
[17]
Because the Minister
conceded that the relevant SNDS was for a change in the use of the medicinal
ingredient that was approved through the issuance of an NOC, the parties agree that the
‘201 patent’s eligibility for listing depends entirely on the construction of
claims 14 and 15 as well as the construction of subsection 4 (3) of the NOC
Regulations. Both issues are pure questions of law.
[18]
The Court
is satisfied that in this particular case, the two questions of law are
extricable from the question of fact (which was conceded) and that therefore,
the decision of the Minister in respect of those two questions will be reviewed
on the basis of correctness.
B) Did the Minister err by
concluding that the ‘201 Patent was not eligible?
[19]
At the
hearing and later, in written submissions provided to answer specific queries
from the Court, the parties clarified and refined their respective positions.
[20]
The main
differences between their respective interpretations of the NOC Regulations and
how they apply to the ‘201 Patent are as follows:
[21]
On the one
hand, the applicants say that the October 5, 2006 amendment added specific
listing criteria for patents filed in association with an SNDS in order to
specifically eliminate the existing piecemeal approach set out in Hoffman-
LaRoche Ltd.v. Canada (Minister of Health), 2006 FCA 335, and Wyeth
Canada v. Ratiopharm, 2007 FCA 264; thus questions relating to what
the patented invention is, what the spirit of the invention is or what the
patent is about are irrelevant to the task the Minister must perform to apply
paragraph 4(3)(c) of the NOC Regulations.
[22]
According
to the applicants, the new system is a simple one; if an SNDS is submitted for
a change in formulation, dosage or in the use of a medicinal ingredient, the only
requirement to be met for a patent to be eligible for listing (excluding
timing from the discussion at this stage) is that it contain one claim that
covers within its ambit the relevant change requested in the SNDS and approved
by Health Canada through the issuance of an NOC.
[23]
More
specifically here, to determine whether pursuant to paragraph 4(3)(c) of the
NOC Regulations a particular claim in a patent is for the changed use of the
medicinal ingredient, the Court must employ the principles of construction set
out by the Supreme Court of Canada in Free World Trust v. Electro
Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 and Whirlpool v. Camco Inc.,
[2000] SCC 67, [2000] 2 S.C.R. 1067 for there can be only one construction of a
claim for all the purposes of the Patent Act, be it validity,
infringement, or eligibility for listing which is at issue.
[24]
For the
applicants, there is thus no doubt that the new definition of “claims for the
use of a medicinal ingredient” includes, as it used to under the old version of
the NOC Regulations, claims for the use of a formulation wherein the only
active ingredient is the medicinal ingredient. It is irrelevant to ask the
question of whether the use of the medicinal ingredient is the novel element of
the claim, as this issue is to be dealt with by the Court (not the Minister) when
and only when allegations of patent invalidity or the invalidity of the
specific claims mentioned in subsection 5(1) of the NOC Regulations are
challenged through the issuance of an application under subsection 6(1).
[25]
Moreover,
given the general principle of construction whereby words used in a regulation
or provision must be ascribed the same meaning throughout, it is evident that
claims 14 and 15 in the ‘201 Patent are for the use of the medicinal ingredient
in Celebrex® , for the Minister has conceded that the 07375 SNDS is for a change
in the use of the medicinal ingredient as required under the first part of
paragraph 4(3)(c).
[26]
In respect
of the Minister’s arguments that the language of the claim for the changed use
must closely correspond to the language used to describe the indication in the
SNDS, the applicants submit that all of the evidence before the Court indicates
that the exact condition described in the new indication in the 07375 SNDS
approved by Health Canada would be understood by a person skilled in the art to
be covered by claims 14 and 15. In respect of claim 14, this is because a
person skilled in the art would know that celecoxib is a COX-2 inhibitor, and
that COX-2 inhibitors are useful in the treatment of inflammatory pain and are
not indicated to treat neuropathic pain (these being the two broad classes of
pain). Also, the disclosure of the ‘201 Patent clearly refers to the specific
conditions covered by the new indication (for example, sprains – page 9, line
31 and page 11, line 22; postoperative orthopaedic and dental pain – page 9,
line 31, page 12, lines 17 and 18, page 16, lines 4 and 5) Finally, claim 15,
which is dependent on claim 14, is even clearer in that respect as it expressly
refers to “pain”.
[27]
Finally,
the applicants also adduced evidence explaining that the drafting of claims is
done well before the patentee concludes clinical trials or Health Canada reviews the indications of
the product that embodies its invention. The concerns of Health Canada when reviewing the wording of
indications are totally different from those of a claim drafter. It would thus
be impractical and would lead to an absurd result (i.e. the exclusion of most
if not all patents) to require that the language of a patent claim closely
match the language of the indication that will ultimately be approved by Health
Canada in an NOC.
[28] It also bears mention that the applicants
urged the Court to follow the conclusion adopted in Abbott Laboratories v.
Canada (Attorney General), wherein a patent delisted by the Minister
pursuant to the new NOC Regulations was ordered restored to the Register, as
the Court found the patent included a claim for the changed use on the basis of
what appears to have been a literal interpretation of that claim. However,
given that in Abbott the Court did not engage in a detailed analysis
that would enable one to assess the similarities or differences in the
arguments considered there and those before the Court here, and given that the
decision is presently on appeal and is being strongly contested by the
Minister, the Court will proceed with its own analysis.
[29]
The
Minister takes the position that the Regulatory Impact Analysis Statement
(RIAS) which accompanied the October 2006 amendments to the NOC Regulations
clearly indicates that the “subject matter of a patent” is still relevant to
determine eligibility for listing. The Minister must thus consider the fact
that the ‘201 Patent is not a “use patent”. The patented invention here is a
novel formulation (special dose units comprising particles of celecoxib of
certain sizes) and not a new use of celecoxib.
[30]
In
addition, the NOC Regulations require a specific link between at least one
claim of the “relevant patent” and the change described in the SNDS. The
subject matter of such a claim must be the changed formulation or dosage form
or use of the medicinal ingredient, and the claims must fall within the very
specific definitions of such claims in the NOC Regulations.
[31]
To make a
determination as to whether or not a particular claim falls within said
definitions, the Minister must adopt the approach followed by the Federal Court
of Appeal when it was required to determine the somewhat similar issue of
whether a claim in a given patent met the regulatory requirements set out in paragraph
4(2)(b) (see also subparagraph 5(1)(b)(iv)) of the “old” version of the NOC
Regulations (see for example Biovail Corp. v. Canada (Minister of
National Heath and Welfare), [2006] F.C.J No. 475, 2006 FCA 105 and Proctor
& Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health),
[2006] F.C.J. No.515.)
[32]
Here, the
Court does not understand the Minister to say that no claim for the use of a
formulation or dosage form could meet the definition of a “claim for the use of
a medicinal ingredient”, but simply that in this particular case, when one
considers the language of claims 14 and 15 individually as well as in the
context of the ‘201 Patent as a whole (i.e., alongside the other claims and the
disclosure), it becomes clear that what is claimed in claims 14 and 15 is not a
particular use of the medicinal ingredient celecoxib.
[33]
Finally
(and it is not clear if this is an alternative position), the Minister says
that at the very least, the wording of the claim for the changed use of the
medicinal ingredient referred to in paragraph 4(3)(c) must be very specific and
align closely with the changed indication sought in the SNDS. A general
reference to all uses for which the medicinal ingredient can be used, as in
claim 14 or even claim 15, is not sufficient.
[34]
It is
evident here that the Minister is concerned that the interpretation proposed by
the applicant in this case will trivialize the specific linkage required by the
legislator and referred to in paragraph 4(3)(c) of the NOC Regulations.
[35]
Although not
spelled out as such, one can also appreciate that the interpretation proposed
by the applicants could favour or create an imbalance in the protection
afforded an innovator whose inventive contribution is solely in developing new
formulations or dosage forms, over those innovators whose inventions relate to
new medicinal ingredients or new uses of a medicinal ingredient itself. That
is to say that a patent for a new medicinal ingredient could
only be listed against an NDS and would be subject to the NOC Regulations’
strict timing requirements, while a new use patent for the medicinal ingredient
itself could only be listed against an NDS which specifically describes the new
use, or an SNDS that covers a change in use covered by one of the claims of the
patent. Given that in a typical new use patent, the claims would have to be
limited to those where the novelty resides in the new use itself, the number of
such new use(s) would normally be limited.
[36]
With
respect to patents wherein the patented invention is a new formulation or a new
dosage form that contain a claim that falls within the definitions of the NOC
Regulations, it must be borne in mind that the inventor is entitled to claim
all aspects of his invention and may include use claims if they are described
in the disclosure and are based on the utility upon which the patentability of
the product (the formulation on dosage form) is predicated. Such use claims
will typically cover all known uses of the active ingredient contained in the
formulation or dosage form unless there is some good reasons not to. Applying
the applicants' interpretation, such patents could thus be listed against an
NDS on the basis of a claim for the formulation as well as a use of the
formulation (as a use of the medicinal ingredient) or an SNDS covering a change
in the formulation or any change in indication (all known uses of the medicinal
ingredient being referred to in the use claims relating to the novel
formulations), even though such uses are not attributable to the inventive
ingenuity of the innovator. It would therefore be possible for the innovator to
completely bypass the philosophy underlying the timing requirements set out in
the NOC Regulations.
[37]
This
apparent imbalance is difficult to reconcile with the fact that from the outset
the legislator appears to have been concerned first and foremost to afford
protection through this regulatory scheme to the innovator bringing about
patents for new medicinal ingredients or new uses of medicinal ingredients
(courts then extended this protection to compositions or formulations that in
fact described or claimed the medicinal ingredient ). As
mentioned in the RIAS, claims for dosage forms were only brought under the
umbrella of the NOC regime because the legislator was convinced by
representations made to the effect that those falling within the new statutory
definition have significant therapeutic value.
[38]
But
identifying the problem does not automatically mean that the Minister or the
Court can solve it without amendments to the NOC Regulations, for the question
remains as to whether the new provisions lend themselves to the interpretation
proposed by the Minister, having regard to the applicable principles of
statutory interpretation and claims construction.
[39]
Before
commenting any further in this regard, however, the Court will first turn to
the issue of whether or not the ‘201 Patent contains a claim for the changed
use of the medicinal ingredient, as this was the main focus of the parties’
arguments and the answer to this question is decisive of the outcome of this
application.
Does
the ‘201 Patent contain a claim for the changed use of the medicinal ingredient
in Celebrex®?
[40]
To answer this question, one must first
determine whether the ‘201 Patent contains a “claim for the use of the
medicinal ingredient” as defined in the NOC Regulations, and if so whether it
is a claim that covers the “changed use” described in the SNDS.
[41]
Underlying the applicants’ position is the
assumption that a “claim for the use of a medicinal ingredient” still covers
the use of all compositions or formulations which previously fell under the
definition of “medicine”. This seems to be based on the principle enunciated
in Hoffman–La Roche v Minister of Health and Welfare, [1995]
F.C.J. No. 1775 and is not in my view a proper assumption.
[42]
In Hoffman-La
Roche, above, the Federal Court of Appeal had to construe the then recent
NOC regulations to determine if the definition of “claim for the medicine
itself” encompassed claims for a pharmaceutical composition (formulation). It
concluded that it could. This principle was never put in question thereafter.
But it quickly became clear that its application was not as easy as it seemed,
for it remained to be determined in each given instance whether a particular
claim was directed to the active ingredient in the composition or formulation,
or whether instead it covered a particular dosage form or delivery system as
opposed to the medicine itself (Biovail Corp. v. Canada (Minister of
Health), 2005 FCA 105, at para. 7; GlaxoSmithKline v. Canada (A.G.), 2005
FCA 197, paras. 19, 25, 29-44). As discussed below, the Court believes that the
approach taken to answer this question is still relevant to determining whether
a particular claim is a “claim for the use of the medicinal ingredient”.
[43]
But
otherwise, the conclusion in Hoffman- La Roche (1995) is no longer
relevant insofar as the new NOC Regulations expressly distinguish between a
“claim for a formulation” and a “claim for a medicinal ingredient”. What is
required, therefore, is to consider how this distinction bears upon the meaning
of a “claim for the use of the medicinal ingredient.” Is one to construe the
words “medicinal ingredient” in that definition in the same limited way (as
excluding formulations or dosage form), or is it meant to also include claims
for the use of a formulation or a dosage form.?
[44]
In this respect, the
RIAS provide little guidance; the only relevant passage in respect of the
definition of “claim for the use of the medicinal ingredient” says as follows:
Although
the definition for “claim for the use of the medicinal ingredient” in these
amendments is unchanged from the current definition for “claim for the use of
the medicine”, a point of clarification regarding the intention underlying this
aspect of the PM (NOC) Regulations is in order. It is acknowledged that the
regulatory language employed in the health and safety context to describe the
use for which a medicinal ingredient in a drug [sic] is sometimes at
odds with the manner in which claims are drafted in the many different kinds of
so-called “use patents” which exist in the pharmaceutical realm. Examples of
the latter include kit claims, “Swiss-type” claims and claims for dosing
regimens. However, the combined effect of the definition under this part and
the requirement that the claimed use be one described in the underlying NDS
should be to limit the eligibility of use patents to those which contain a
claim to an approved method of using the medicinal ingredient, for an approved
indication. This link should be apparent from a comparison of the claims in
the patent with the relevant portions of the product monograph and labeling for
the approved drug. (at p. 1517)
[45]
The most that can be
made of the above is that the legislator intended to privilege substance over
form. Thus the definition is not intended to cover only certain types of use
claims and the focus is whether what is claimed is the use of the medicinal
ingredient.
[46]
Thus, it is entirely
conceivable that a claim could take the form of a so-called Swiss-type claim
(i.e., use of composition X for the preparation of a medicament to be used for
Y), or a Shell-Oil type use claim (use of the composition defined in claim(s) X
for the treatment of Y) and still be claiming the use of the active medicinal
ingredient itself. This approach is not new; in effect it was the one taken by
the Court prior to the amendments to the NOC Regulations in decisions such as Pfizer
Canada v. Apotex Inc., 2007 FC 971, where the Court construed the Swiss-type
use claim as a claim for the use of the medicine.
[47]
However, one cannot
simply say that a claim for the use of a composition or formulation is ipso-facto
a claim for the use of a medicinal ingredient, for while a claim which reads
literally as the use of a composition or formulation may still fall within the
definition a claim for the use of a medicinal ingredient, one is left with the
same type of questions that developed after the decision in Hoffman La-Roche
(1995), that is, whether it is in fact the use of the medicinal ingredient
that is claimed, or simply the use of the formulation or dosage form.
[48]
In effect, this
appears to be the only conclusion one can reach, when it is considered that the
legislator, having seen fit to adopt express and distinct definition for the
terms “claims for the dosage form” claim for the formulation”, “claim for the
medicinal ingredient” and “claim for the use of the medicinal ingredient” chose
not to refer, define or expressly contemplate a claim for the use of a formulation
or a dosage form. Certainly the reference to “medicinal ingredient” instead of
formulation or dosage form must be given effect.
[49]
It is
clear that in construing claims to determine whether they fall within the
regulatory definition under the old scheme, the Courts have been using the now
well settled principles of claims construction enunciated by the Supreme Court
of Canada in Free World Trust and Whirlpool at paragraphs 42-45
and 49.
[50]
In that
respect, the Court agrees with the applicants that neither the Minister nor the
Court (in the context of motion under paragraph 6 (5) (a)) can refer to the
patents listed against the NOC issued as a result of the original NDS to
determine what is claimed in claims 14 and 15 of the ‘201 Patent. The construction
of the claims rests solely on the reading of said claims of the ‘201 Patent in
the context of all the other claims and the disclosure. The patent is read
through the eyes of a person skilled in the art who may use for that purpose
his or her common general knowledge, but the Court cannot look to any other
extraneous matter or documents. (Novartis Pharmaceuticals Canada Inc.
v Canada (Minister of Health), 2003 FCA 299, para.22)
[51]
However,
having carefully considered the case law dealing with whether or not a claim
was a claim listed in the former paragraph 4(2)(b), the Court cannot agree with
the applicants that the exercise here is on all fours with the one undertaken
for the purpose of assessing patent validity and infringement. In effect, the
determination of the essential elements of the claim does not necessarily
provide the answer to the question of whether or not the claims properly
construed fall within the regulatory definition of a claim for the use of the
medicinal ingredient.
[52]
It is
useful to refer to a few of the cases to illustrate the point. In Biovail,
above, claim 30 of the patent under review claimed compositions wherein the
active substance was from a group of specifically identified medicines. It is
quite clear from a simple reading of this dependent claim that an essential
element of it was the use of one of the active ingredient listed in the group;
this was its only distinguishing feature thus was unavoidable. Presumably, it
is on this basis that Biovail argued that claim 30 was “manifestly” a claim for
the medicine described therein.
The Federal Court of Appeal disagreed. Applying general principles of patent
construction (at paragraph 7), it concluded that despite the fact that the
active ingredients specifically described were intimately mixed with the two
polymers (inactive substances) in the tablets, the claimed composition was a
delivery system. Claim 30 was not claiming the medicine itself.
[53]
In Janssen-Ortho
Inc. v. Canada (Attorney General), [2007] F.C.J. No. 979, at
paras.7-16, one can see from paragraph 7, that the tablets claimed in claims 1
to 7 of the patent under review expressly contained methylphenidate or one of
its salts, and that claims 26 and 27 claimed the use of such tablets for the
treatment of attention deficit disorder. Once again, it is likely that the
active ingredient in the tablets was an essential element of those claims.
Despite this, the Court concluded that those claims were not for the medicine
methylphenidate or for its use. The same holds true for the situation before
Justice Yves de Montigny in Jannsen-Ortho Inc. v. Canada (Minister of Health), (2005) F.C. 765 (see
paragraphs 26, 27, 29). It is of particular interest to note that in that last
case, the Court specifically rejected as untenable the proposition that the
jurisprudence dealing with claims for the medicine is irrelevant when one
considers whether a claim is for the use of the medicine. The Court found that
a claim relating to a method or a device to deliver a medicine cannot be construed
as a claim to the medicine itself or as a claim to the use of the medicine (see
paragraph 33-34). Obviously, the facts and claims in those cases differ greatly
from those at issue
here, especially when one considers that it is not disputed that the ‘201
patent contains at least one claim that would qualify under the old scheme as a
claim for the medicine. As mentioned, the point rather is to draw attention to
the analytical approach adopted previously.
[54]
Although
not strictly binding on the Court, these authorities are still persuasive given
that the Court is called to review the same type of question that was before
the Courts in those cases.
[55]
Before
applying this approach to the particular facts of this case there are two last
arguments that need to be addressed.
[56]
First,
because the construction of a claim as well as the statutory interpretation of
the definitions in section 2 of the NOC Regulations are matters of law, the Minister’s concession in these
proceedings as regards the purpose of SNDS no. 072375 (i.e., that it was
submitted for a change in use of celecoxib) cannot have any impact on the
Court's determinations with respect to these issues.
[57]
Second, the Court
agrees with the applicants that normally the same words should be ascribed the same
meaning when they appear more than once in a regulation. In paragraph 4(3)(c),
the words “use of the medicinal ingredient” are found twice. The first time,
they are used with reference to information contained in the SNDS submitted for
approval to Health Canada. The second time, they are used in the
context of a claim for the use of a medicinal ingredient in the patent proposed
for listing. The definition at section 2 only applies to the use of medicinal
ingredient in the context of a patent claim. This would explain why at first
blush, the Minister’s position may appear somewhat contradictory, as it appears
to ascribe one meaning to the expression “use of the medicinal ingredient” in
the first part of the paragraph, and another meaning in the context of a claim
for the use of a medicinal ingredient. In this particular context, it would
not offend the rules of statutory construction to give to that first use the
technical meaning it may have in the application of the Food and Drug
Regulations by the Minister.
[58]
Having dealt with
these two points, the Court will proceed to apply the principles set out above.
The Court considered the wording of the individual claims in the light of the
expert evidence filed by the applicants. It is notable that the only expert to
deal specifically with the definition included in the NOC Regulations was Mr.
Barrigar, QC. Although his approach is informative, with respect to the '201
Patent, his is not the perspective of the person skilled in the art to whom the
patent is addressed. Otherwise, none of the other experts focused on whether
the claims in question are for the use of the medicinal ingredient. Their
evidence is still useful insofar as it supports the view that a person skilled
in the art would know without the need for explanation what a COX-2 inhibitor
like celecoxib is normally used for. It also indicates that celecoxib is a
known compound and that its properties in respect of the treatment of pain are
also known.
[59]
This evidence is in
line with what one reads in the patent disclosure at page 1, line 15 to page
2, line 12 and page 3, line 26-29, which indicates that celecoxib is known as
a COX-2 inhibitor useful in treating inflammation related disorders, as well as
arthritis and osteoarthritis, among other conditions and disorders. The
disclosure also notes at page 12 that “a brief description of the potential
utility of COX-2 inhibitors is given in an article by John Vane, Nature, vol.
367, 1994 and in an article in Drug News and Perspectives, vol. 7, 1994”.
[60]
The disclosure states
at page 3, lines 3-5 that “a need exists for solutions to numerous problems
associated with preparation of suitable pharmaceutical compositions and dosage
forms comprising celecoxib,” because “it is difficult to prepare a pharmaceutical
composition containing celecoxib that has the desired blend uniformity”, and
because “handling problems are encountered during the preparation of
pharmaceutical compositions comprising celecoxib.” As well, “the formulation
of celecoxib for effective oral administration to a subject has hitherto been
complicated by the unique physical and chemical properties of the compound
particularly its low solubility and factors associated with its crystal
structure… celecoxib is usually insoluble in aqueous media (page 2, line
18-22)”.
[61]
The disclosure
describes the benefit of the invention in terms of the possibility of providing
a range of formulations having bioavailability characteristics tailored to
different indications; as such it represents a significant advance in the
treatment of COX-2 mediated conditions and disorders.
[62] Claims 1 to 10 refer to compositions
comprising one or more discrete dose units each comprising particulates of
celecoxib of specific sizes and dimensions. The differences between those
claims appear to relate to dosage form, the relative bioavailability of the
compositions versus celecoxib per se, or deal with the use of different
diluents, disintegrates, binding agents and lubricants, and amounts thereof, in
the compositions. Claims 11 to 16 are various types of use claims.
[63]
Having considered the
whole of the patent, the Court is satisfied that the Minister was correct in
its construction of claims 14 and 15. These are not claims for the use of
celecoxib; they are not claims for the use of the medicinal ingredient that
fall within the definition at section 2 of the NOC Regulations.
[64]
This conclusion is
dispositive of the application as clearly the ‘201 patent could not be eligible
for listing against SNDS no. 072375 without such a claim. However, in the event
that the Court is mistaken in its finding in that respect, the further issue of
whether these claims are for the “changed use” as required by paragraph 4(3)(c)
of the NOC Regulations will be addressed.
[65]
As regards the
specificity of the language of the claims, the Court concludes that if claims
14 and 15 were proper claims for the use of the medicinal ingredient itself, in
light of the expert evidence on how they would be construed by persons skilled
in the art, the Court is satisfied that they cover the changed use described in
the indication in SNDS no. 072375.
[66]
The Court is of the
view that requiring more specificity of language is not the appropriate way of
ensuring respect for the legislator’s intentions, insofar as the relevance of
the patent and the claims is concerned. If the invention claimed at claims 14
and 15 is the use of celecoxib, it would be totally impractical to require that
the indications in the SNDS read identically with the claims, and would lead to
absurd results given the time difference and the different concerns of the two
audiences to whom the indications and the claims are directed.
[67] In light of the conclusions above, it is not strictly necessary
to engage here in a full review of the new regulatory scheme as compared to the
pre-October 2006 scheme in respect of the listing of patents in relation to
SNDS. However, as the issue is a new one, the Court will proceed to say a few
words in this respect.
Listing
requirements old and new
[68]
The first
thing that comes to mind here is that even if the legislator's main purpose in
amending the NOC Regulations, as disclosed in the RIAS, was to clarify and
create certainty, this dispute suggests that it may not have been achieved.
However, one must remember when looking at the new language that the legislator
did not have the benefit of the Supreme Court of Canada’s teachings in Astrazeneca
Canada Inc. v. Canada (Minister of Health) 2006 SCC 49, or the Federal
Court of Appeal’s teachings in Wyeth; this would have enabled the use of
language more compatible with those decisions and would have helped the Court
to construe the legislator’s intentions in relation to said case law.
[69]
After these two
decisions, it appears that the principles governing the listing of patents were
the following.
[70]
As a result of Astrazeneca
(in particular paragraphs 23, 39 and 40) as construed by Justice Roger Hughes’
at paragraph 22 of Wyeth (which was expressly affirmed by the Federal
Court of Appeal, at paragraph 29), when inquiring whether a given patent could
be listed against a particular NOC issued as a result of NDS or SNDS, the
Minister was obliged to determine if there was a relationship or link between
the patented invention described in the patent and the NOC, such that said
patent could properly be considered to be relevant to the particular NOC.
Obviously, such a patent also had to include either a “claim for the medicine itself”
or for the “use of the medicine” to be eligible for listing, per the
requirements of the former paragraph 4(2)(b).
[71]
On the basis of the earlier
decision of the Federal Court of Appeal in Hoffman-La Roche v. Canada
(Minister of Health), [2006] F.C.J. No. 1545, it had already been
established that an SNDS could only support the listing of a relevant patent if
the change reflected in the later could be relevant to the potential
infringement of a patent claim coming within the scope of the regulatory scheme,
that is, a patent claim of the type contemplated at paragraph 4(2)(b) and subparagraph
5(1)(b) (iv) of the former NOC Regulations (see Wyeth (appeal decision),
at paragraphs 24 and 25).
[72]
When discussing the
case law summarized in Hoffman-La Roche, above, Justice Karen Sharlow in
Wyeth noted, at paragraph 26, the use in a number of decisions of the adjective
“substantive” to describe the type of SNDS that could support a listing. She said
that this had to be understood to mean “substantive in relation to the patented
invention or the patent claims”(see also paragraph 47). Up until then, the
Court understands that the analysis of the nature of the SNDS was carried out
to determine if the SNDS fell within the meaning of subsection 4(1), such that a
patent list could be submitted against it for registration. In contrast, the
concept of “relevance of the patent” commented upon in Astrazeneca and
discussed at paragraph 22 of Justice Hughes’ decision in Wyeth appears
to be directed to a linkage between a patent and an NOC, as required by
subsection 4(5) and 5(1) of the former NOC Regulations.
[73]
The issues are
closely related, and following Wyeth, it may well be that they were effectively
merged into a single exercise, although this is not clear.
[74]
As it was noted by
Justice Hughes in Wyeth, the concept of the “patented invention” is not necessarily
coextensive with the patent claims. It appears that the Supreme Court of Canada
was careful to use the former expression, because of the language of section
55.2 of the Patent Act which refers to the use of the patented invention only.
[75]
Be that as it may, it
is clear that the legislator only had in mind the case law summarized in Hoffman-La
Roche when he adopted subsection 4(3) of the post-October 2006 scheme, which
is directed to the issue of which patents may be listed in relation to an NDS
or an SNDS. As it was the case before the decision of the Supreme Court of
Canada in Astrazeneca set out a linkage requirement as regards the
“patented invention”, subsection 4(3)(c)deals only with the content of the SNDS
itself (a change in the formulation, a change in the dosage or a change in the
use of the medicinal ingredient) and with the subject matter of claims that a
patent must contain (a claim for dosage form, a claim for a formulation or a
claim for the use of the medicinal ingredient and it must be for the specific
change embodied in the SNDS). Here, however, the relevant claims previously
set out in paragraph 4(2)(b) are redefined and somewhat enlarged, given that
they now include claims for dosage form as well as formulation.
[76]
Although the former subsection
4(5) has been replaced, the requirement to identify the NDS or the SNDS to
which a list relates is still found at paragraph 4(4)(a) and subsection 5(1).
[77]
In the RIAS one also finds the
following statements:
(…)In
particular, the amended PM (NOC) Regulations reaffirm the application of strict
time limitations for adding a patent to the register and contain an additional
requirement that patents be relevant to the strength, dosage form and route of
administration of the approved drug. [at p. 1513]
(…)
To
the extent that the efficient functioning of the regime depends upon a
threshold determination of what patents can be listed, in making that
determination the minister can only be called upon to assess the relationship
between the patent and the drug described in the innovator’s submission for a
NOC. [at p. 1515-1516]
(…)
Whereas
the above described amendments to section 4 are intended to clarify existing
policy by reinforcing the link between the subject matter of a patent and the
content of the NDS, other changes mark an expansion in that policy. In
particular, the scope of eligible subject matter is being broadened to include
patents for approved dosage forms. [at p. 1517]
[78] Keeping in
mind the overall purpose of these regulations as defined in s. 55.2 of the
Patent Act, the Court believes that the requirement enunciated by the Supreme
Court of Canada for a relationship between a particular NOC and the patented
invention can
still inform and still be relevant to the listing of patents under the new NOC
Regulations if viewed as an overarching principle that complements the
particular criteria now embodied in subsection 4(3) of the NOC Regulations.
While the outcome of this application does not turn on whether or not the Court
is correct in this regard, clarification on this point would be welcome from
the Federal Court of Appeal.
Conclusion
[79]
The decision of the Minister
was well founded. The ‘201 Patent was ineligible for listing as it did not
contain a claim for the use of the medicinal ingredient celecoxib, let alone
the changed use described in SNDS no. 072375. The application is dismissed
with costs.
ORDER
THIS COURT ORDERS that the application is dismissed
with costs.
“Johanne
Gauthier”
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-884-07
STYLE OF CAUSE: GD
SEARLE & CO. and PFIZER CANADA INC. and THE MINISTER OF HEALTH
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: November 13, 2007 (1 day)
REASONS FOR ORDER
AND ORDER: The Honourable Justice Johanne
Gauthier
DATED: April 4, 2008
APPEARANCES:
|
Michael A.
Penny
W Grant Worden
|
FOR THE APPLICANTS
|
|
David Cowie
|
FOR THE RESPONDENT
|
SOLICITORS
OF RECORD:
|
Michael A.
Penny
W Grant
Worden
Torys LLP
Toronto, Ontario
David Cowie
Department
of Justice
Ottawa, Ontario
|
FOR THE APPLICANTS
FOR THE RESPONDENT
|
Email this Content