the Minister of Health (the Minister), by his
delegate, refused to add the patent to the Patent Register. GSK seeks judicial
review of that decision.
II. Issues
[2]
The
overarching issue in this application is whether the Minister's decision was
correct or reasonable as the case may be.
[3]
In
determining this fundamental issue, I must address a number of questions,
namely:
1
Should
the Court receive new evidence in the way of expert affidavits and if so, for
what purpose or purposes?
2
What
is the proper standard of review of the Minister's decision?
3
Having
regard to the proper standard of review:
a.
What
is the construction of the claims of the '517 patent?
b.
What
is the dosage form already approved in the existing Notices of Compliance
(NOC)?
c.
What
is a proper comparison of the claim and the NOC approved dosage form?
III. Further
Written Submissions
[4]
After
the hearing of this matter, the Federal Court of Appeal released its decision
in Abbott Laboratories Limited v. Canada (Attorney General), 2008 FCA
354 (Abbott-CA), which decision affirmed the decision of Justice Hughes
in Abbot Laboratories Limited v. Canada (Attorney General), 2008 FC 700,
67 C.P.R. (4th) 51 (Abbott-Trial). The Court of Appeal addressed
two issues that are before me in this application; those are: (a) the standard
of review; and (b) use of expert affidavit evidence. I asked the parties to
make further written submissions on these two issues. These Reasons have been
completed taking into account the decision in Abbott-CA and the further
written submissions of the parties.
IV. Statutory
Framework
[5]
The NOC
Regulations, first put in place in 1993, incorporates a scheme by which pharmaceutical
products are brought to market. In addition to health and safety concerns, the NOC
Regulations also address the rights of patent holders. A “register” of
patents (the Patent Register) is maintained by the Minister. Pursuant to s.
3(2) of the NOC Regulations, “the Minister may refuse to add or may delete any
patent . . . that does not meet the requirements of [s. 4]”.
[6]
The
Patent Register is an important element of the Regulations. Listing on the
Patent Register provides a patent holder with various benefits. Rather than
detailing those benefits, I refer the reader to the decision of the Court of
Appeal in Hoffmann-La Roche Ltd. v. Canada (Minister of Health), 2005
FCA 140, [2006] 1 F.C.R. 141, where Justice Sharlow, at paragraph 7, outlined
the advantages of listing. In short, a decision of the Minister not to list a
patent has serious negative consequences to the patent holder. While the holder
of a non-listed patent will always be able to enforce its rights under the Patent
Act, R.S.C. 1985, c. P-4, such holder is not afforded the extra benefits of
the NOC Regulations.
[7]
Not
every patent pertaining to an approved drug qualifies for inclusion on the
Patent Register. As stated in the Regulatory Impact Analysis Statement (RIAS)
which accompanied the latest amendments (2006 Amendments) to the NOC Regulations
(Regulations Amending the Patented Medicines (Notice of Compliance)
Regulations, SOR/2006-242):
|
. .
. not every patent pertaining to an approved drug qualifies for enforcement
under the scheme. Only those patents which meet the current timing, subject
matter and relevance requirements set out in section 4 of the regulations are
entitled to be added to Health Canada’s
patent register . . .
|
Il s'ensuit que ce ne sont pas tous les
brevets protégeant une drogue approuvée qui peuvent se prévaloir du mécanisme
d'application prévu par le règlement de liaison. Seuls les brevets respectant
les exigences énoncées à l'article 4 du règlement relatives au délai, à
l'objet et à la pertinence, peuvent être inscrits au registre des brevets de
Santé Canada . . .
|
[8]
Of
importance in this case are certain of the 2006 Amendments that relate to
“dosage form patents”. Subsequent to the 2006 Amendments, s. 2 of the NOC
Regulations defines the term “claim for the dosage form”:
|
“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» 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.
|
[9]
The
provisions of the amended NOC Regulations of primary relevance to this
application are ss. 4(2)(c) and 4(3)(b), which set out when such a claim is
eligible for listing. The underlined provisions are those of particular
interest:
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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
. . .
(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
(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
. . .
(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;
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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 :
. . .
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;
(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 :
. . .
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;
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[10]
The
objective of the amendments that address this matter is described in the RIAS
as follows at pages 1517-1518:
|
. . . the
scope of eligible subject matter is being broadened to include patents for
approved dosage forms.
When seized of
the question, courts have consistently held that the current language “claim
for the medicine itself” in section 4 is insufficient to support the listing
of dosage form patents. However, in light of representations from the
innovative industry regarding the significant therapeutic advantages afforded
by novel dosage forms, the Government has come to the view that inventions in
this area merit special protection of the PM(NOC) Regulations. This is
particularly true where biologic drugs are concerned, as effective
administration of the medicinal ingredient is often dependent on the
development of new and innovative delivery mechanisms. Amended section 4 thus
contains new language necessary to implement this change, and a new
definition for the phrase “claim for the dosage form” has been added to
section 2 in order to clarify the scope of protection this change is intended
to effect.
Although
amended section 2 defines the phrase "claim for the dosage form" in
very general terms, in order to accommodate future advancements in this
field, the intent is to provide protection for the novel delivery system
by which the approved medicinal ingredient, or a formulation containing that
ingredient, is administered to the patient. Examples include controlled-release
tablets and capsules, implants and transdermal patches. As with other
eligible subject matter, a dosage form patent must include a claim to the
specific dosage form described in the NDS (typically as identified in the
notification issued by the Minister pursuant to paragraph C08.004(1)(a)). In
addition, it must contain a claim that includes within its scope the approved
medicinal ingredient. This latter requirement is meant to ensure that a
patent directed solely to a device, such as an intravenous stand or a
syringe, does not meet the definition of "dosage form" and remains
ineligible for listing. [Emphasis added]
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. . . la portée
de l'objet admissible à la protection du règlement est élargie de façon à
inclure les brevets relatifs aux formes posologiques approuvées.
Les tribunaux, lorsque
saisis de la question, s'entendent pour dire que le libellé actuel de
l'article 4, à savoir « revendication du médicament en soi » est
insuffisant pour permettre l'inscription des brevets relatifs à des formes posologiques.
Toutefois, à la lumière des observations reçues de l'industrie innovatrice au
sujet des avantages thérapeutiques considérables qu'offrent de nouvelles
formes posologiques, le gouvernement est d'avis que les inventions à ce titre
méritent la protection spéciale prévue par le règlement de liaison. Ceci
est d'autant plus vrai dans le cas des médicaments biologiques dont
l'administration efficace de l'ingrédient médicinal est souvent tributaire du
développement de mécanismes d'administration nouveaux et novateurs. L'article
4 modifié offre ainsi un nouveau libellé nécessaire à la mise en œuvre de ce
changement, et une nouvelle définition du terme « revendication de la
forme posologique » a été ajoutée à l'article 2 afin de préciser la portée
de la protection que ce changement est censé conférer.
Bien que l'article 2 modifié définisse
le terme « revendication de la forme posologique » en termes très
généraux pour tenir compte des progrès qui seront réalisés dans ce domaine, l'objectif
consiste à conférer une protection au nouveau système par lequel l'ingrédient
médicinal approuvé ou une formulation contenant cet ingrédient est administré
au patient. Parmi ces modes, mentionnons les comprimés et les capsules à
libération contrôlée, les implants et les timbres transdermiques. Comme dans
le cas d'autres contenus, un brevet relatif à une forme posologique doit
contenir une revendication pour la forme posologique précise décrite dans la
PDN [(généralement telle qu'identifiée dans l'avis émis par le ministre,
conformément à l'alinéa C08.004(1)a)]. En outre, le brevet doit
également contenir une revendication incluant dans sa portée l'ingrédient
médicinal approuvé. Cette dernière exigence vise à faire en sorte qu'un
brevet portant uniquement sur du matériel médical, par exemple un pied à
perfusion ou une seringue, ne corresponde pas à la définition du terme
« revendication de la forme posologique » et demeure inadmissible à
l'inscription au registre. [Non souligné
dans l’original].
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[11]
As
the parties have suggested, the RIAS may be helpful in interpreting the
scope of “claim for the dosage form.” The Supreme Court of Canada has relied on
the RIAS to ascertain Parliament’s intentions with respect to the NOC
Regulations (See, for example, Bristol‑Myers Squibb Co. v. Canada
(Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533 at para. 46 and
paras. 155‑159).
V. Analysis
A. Should the affidavits be
admitted?
[12]
As
part of its record in this judicial review, GSK presented three affidavits that
were not before the Minister. In oral submissions, GSK relied on only one of
those affidavits, that of Dr. Louis Cartilier. Dr. Louis Cartilier was
asked by GSK to provide his opinion on whether the '517 Patent contains a claim
for the dosage form of products, referred to as ADVAIR and FLOVENT HFA. The
Respondent has raised the issue of whether I should have regard to this
affidavit.
[13]
In Abbott-CA,
above, at paragraph 37, the Court of Appeal confirmed the general rule that, in
judicial review proceedings, the record put before the Court should not include
any material that was not put before the maker of the decision under review. The
Court of Appeal went on to recognize an exception to the general rule where an
application for judicial review requires a determination on a point of patent
construction. In such cases, the Court of Appeal noted that an affidavit
providing an expert opinion on patent construction can be of benefit to the
Court, and confirmed that a judge should have the discretion to admit such an
affidavit. However, the Court of Appeal observed that, in deciding whether to
exercise such discretion, the judge should consider whether or not the
construction of the patent proposed in the affidavit is one that was put to the
Minister for consideration at the time of his decision making (Abbott-CA,
above, at para. 39).
[14]
In
this case, GSK could have produced expert evidence in its reply to the
Minister’s notification of December 21, 2006 that the '517 Patent was not
eligible for listing; it did not do so. The evidence on patent construction
provided to this Court in the affidavit of Dr. Cartilier was not provided to
the Minister. Further, Dr. Cartilier was asked to provide his opinion on a
matter that went beyond the construction of the patent. In his affidavit, for
example, Dr. Cartilier provides his opinion on the interpretation of “claim for
the dosage form” in the NOC Regulations. This question involves
statutory interpretation, an area that is not within his expertise.
[15]
As
a result, and on these facts, I decline to exercise my discretion to admit Dr.
Cartilier’s affidavit evidence.
B. Process of Analysis under s.
4(2)(c)
[16]
In
the decision, the Minister’s delegate described the requirements for
eligibility as follows:
.
. . to determine the eligibility of a patent for listing on the Patent Register
in relation to a new drug submission, the OPML [Office of Patented Medicines
and Liaison] must, pursuant to subsection 4(2) of the PM(NOC) Regulations,
assess whether a patent contains a claim for the medicinal ingredient which has
been approved through the issuance of a notice of compliance in respect of the
new drug submission. Further, to determine the eligibility of a patent for
listing on the Patent Register in relation to a supplement to the new drug
ingredient, the OPML must, pursuant to subsection 4(3) of the PM (NOC)
Regulations, assess whether a patent contains a claim for the changed
formulation, a claim for the changed dosage form, or a claim for the changed
use of the medicinal ingredient respectively, which has been approved through
the issuance of a notice of compliance.
[17]
In
my view, the Minister’s delegate correctly described his task. I would restate
the process in terms of the steps set out by Justice Hughes in Abbott–Trial,
above. Although Justice Hughes discussed the steps in determining whether a
claim for the use of a medicinal ingredient met the listing requirements of s.
4(2)(d) of the NOC Regulations (Abbott-Trial, above, at paras. 4,
24), adapting his reasoning to s. 4(2)(c) of the NOC Regulations and
the decision before me, the decision to list involves a three-step
determination:
1
What
does the '517 Patent claim?
2
What
is the approved dosage form?
3
Do
the claims of the '517 Patent correspond to the approved dosage form?
C. What is the Standard of
Review?
[18]
GSK
submits that the issue turns on the Minister’s interpretation of the NOC
Regulations, thus meriting a correctness standard. (Apotex Inc. v.
AstraZeneca Canada Inc. et. al., 2006 SCC 49, [2006] 2 S.C.R. 560 at para.
25).
[19]
The
Respondent submits that the present case turns on a question of mixed fact and
law, which requires the Minister to make factual determinations about the
patent in determining whether it meets the s.4 requirements of the NOC
Regulations. As such, the appropriate standard of review is reasonableness
(Ferring Inc. v. Canada (Minister of Health), 2007 FCA 276, 370 N.R.
63; Dunsmuir v. New Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190). The Respondent also
relies on the analysis and conclusion of Justice Hughes in Abbott-Trial,
above.
[20]
In
my view, the decision of the Court of Appeal in Abbott-CA, above, is
dispositive of the issue of standard of review. The Court acknowledged Justice
Hughes’ three-question analysis of a decision of the Minister and then
proceeded to examine the applicable standard of review for each question. In
conclusion, Justice Sharlow found as follows at paragraph 34:
In
summary, the Minister’s decision not to list the 620 patent must stand unless
it is based on an incorrect construction of claim 6 of the 620 patent, an incorrect
interpretation of paragraph 4(2)(d) of the NOC Regulations, an
unreasonable conclusion as to the approved use of Meridia, or an unreasonable
conclusion as to whether the use of the sibutramine claimed in the 620 patent
is an approved use of Meridia.
[21]
I
see no reason why a decision of the Minister under s. 4(2)(c) should attract
any different standard of review. Nevertheless, as can be seen from the
following analysis, I conclude that, even on the higher standard of
correctness, the Minister’s decision not to list should be upheld.
D. What does the '517 Patent
claim?
[22]
The
first step in the analysis is to construe the claims of the '517 Patent. In his
decision, the Minister’s delegate states that “the '517 patent contains claims
directed towards an aluminium can with coated internal surfaces, in the form of
a metered dose inhaler”.
[23]
Claim
1 of the '517 patent refers to:
A metered dose inhaler comprising a can
said metered dose inhaler having part of all of its internal surfaces coated
with a polymer blend comprising one or more fluorocarbon polymers in
combination with one or more non-fluorocarbon polymers, and wherein said can is
made of strengthened aluminium and comprises a substantially ellipsoidal base,
for dispensing an inhalation drug formulation comprising fluticasone propionate
or a physiologically acceptable solvate thereof and a fluorocarbon propellant.
[24]
Claims
2 to 25 are related to the metered dose inhaler and make reference to claim 1.
[25]
As
set out Claim 1 of the '517 Patent, the metered dose inhaler (MDI) is to be
used “for dispensing an inhalation drug formulation comprising fluticasone
propionate or a physiologically acceptable solvate thereof and a fluorocarbon
propellant”.
[26]
The '517
Patent is clearly directed at an MDI that was developed to improve the efficacy
of delivery of fluticasone propionate to a patient. This construction of
the claims is consistent with the description set out in the patent. In the
section entitled “Background of the Invention”, the inventors state as follows:
Some
aerosol drugs tend to adhere to the inner surfaces, i.e. walls of the can,
valves, and caps of the MDI. This can lead to the patient getting significantly
less than the prescribed amount of the drug upon each activation of the MDI.
The problem is particularly acute with hydrofluoroalkane (also known as simply
“fluorocarbon”) propellant systems . . .
We
have found that coating the interior can surfaces of MDI’s with a fluorocarbon
polymer significantly reduces or essentially eliminates the problem of adhesion
or deposition of fluticasone propionate on the can walls and thus ensures
consistent delivery of medication in aerosol from the MDI.
[27]
While
the claims are directed to the new and improved MDI, the inventors claim only
one use for the MDI; that is, claims 2 to 25 include the MDI described in the '517
Patent only when used for dispensing fluticasone propionate or a
physiologically acceptable solvate thereof and a fluorocarbon propellant.
[28]
Claim
26 is for the use of the MDI for the treatment of respiratory disorders.
[29]
As
acknowledged by GSK, in oral submissions, there may be other ways to administer
fluticasone propionate. The '517 Patent covers one way only of administering
this useful drug.
[30]
In
sum, on the question of patent construction, I conclude that the claims of the '517
Patent are properly construed as claims directed to an improvement to a device.
In other words, I agree with the conclusion of the Minister that “the '517
patent contains claims directed towards an aluminium can with coated internal
surfaces, in the form of a metered dose inhaler”.
E. What is the “approved dosage
form”?
[31]
A
Notice of Compliance (NOC) is required for a company to market a drug. The
amended language of s. 4 of the NOC Regulations reflects a link between
the subject matter of a patent on a patent list and the content of the
underlying submissions for the NOC related to the drug. The question to be
addressed is this: What is the content of the underlying NOCs?
[32]
In
this case, between December 18, 2000 and November 11, 2006, GSK had made a
number of submissions for ADVAIR and, between April 10, 2000 and May 3, 2005
for FLOVENT HFA. An NOC was issued to GSK on July 18, 2001 in respect of
FLOVENT HFA and on September 3, 1999 in respect of ADVAIR, based on new drug submissions
(NDS) by GSK. Since those NOCs were issued, there have been a number of
supplements to the new drug submission (SNDS) submitted. The Minister’s
delegate reviewed these submission and NOCs. He concluded as follows:
The
approved dosage form as indicated on the notices of compliance issued for the
above-mentioned submissions [for ADVAIR and FLOVENT HFA] that support the
listing of a patent . . . is not for a device, namely a “metered dose inhaler”
as specified in Claim 1 of the 517 patent, but for an aerosol for metered dose
inhalation . . .
[33]
Having
reviewed the drug submissions of GSK, as well as the product monographs, for
ADVAIR and FLOVENT HFA, I agree with the Minister’s finding that the approved
dosage form, as reflected in the submissions is an aerosol. There are numerous
references in the NOCs that support this conclusion. For example:
·
The
NOC issued July 18, 2001, is an approval for “FLOVENT HFA metered-dose
(aerosol) for inhalation 50mcg, 125mcg and 250mcg/act”.
·
In
the SUMMARY PRODUCT INFORMATION in the product monograph for FLOVENT HFA, the
Dosage Form/ Strength is listed as “Inhalation Aerosol/50. 125, and 250
mcg/metered dose”.
·
The
NOC in respect of ADVAIR, dated December 21, 2001, specifically states “New
Dosage Form: Inhalation Aerosol”.
·
The
product monograph for ADVAIR, in the section entitled “DOSAGE FORMS,
COMPOSITION AND PACKAGING” [AR 485] describes ADVAIR as an “inhalation
aerosol”.
[34]
GSK
points to some instances in this documentation where there is reference to the
metered dose inhaler. For example, GSK refers to the Certified Product
Information Document-Chemical Entities (CPID-CE) submitted as an SNDS in
respect of ADVAIR. At page 1 of that document, GSK lists the dosage form as a
“Metered dose inhaler”. While I acknowledge this description, I note that,
elsewhere in the CPID-CE, GSK separately describes the container system. At
best, the CPID‑CE is unclear, in spite of the reference to the “Metered
dose inhaler” as the dosage form.
[35]
In
sum on this question, I conclude that the better view is that the “approved
dosage form” is for an inhalation aerosol. The Minister’s conclusion on this
question is not unreasonable.
F. Do the claims of the '517
Patent correspond to the “approved dosage form?
[36]
As
noted above, s. 4 of the NOC Regulations sets out the eligibility
requirements for a patent to be added to the patent register. Pursuant to the
October 5, 2006 amendments, the Regulations now allow patents containing
a claim for a “dosage form” to be listed on the register, but only if the
claimed dosage form corresponds with the dosage form of the approved drug
submission with which the patent is to be listed.
[37]
I
have concluded above the '517 Patent is directed to a device – that being an
MDI with the properties described in the claims of the patent. Secondly, I
have concluded that the “approved dosage form” for ADVAIR and FLOVENT HFA is
that of an inhalation aerosol. There being no correspondence, the requirements
of s. 4(2)(c) for listing are not met. The decision of the Minister to refuse
the listing of the '517 Patent was correct.
[38]
Justice
Russell dealt with a very similar issue in Bayer Inc. v. Canada (Minister of
Health), 2008 FC 857, 68 C.P.R. (4th) 1, a case related to the
eligibility of the alleged dosage form of a package system used to prevent
problems associated with the exposure of a particular drug to moisture. In
rejecting the drug company’s claim, he wrote, at paragraph 56:
In other words, the invention contained
in the '970 Patent is directed at improving what is administered to the patient
and not the dosage form. It seems clear from the evidence that the exposure of estradiol
to moisture can result in hydrate forms and this can lead to changes in the
drug release rate. But preventing the formation of hydrate forms is still aimed
at improving what is administered to the patient through a transdermal patch
and not the dosage form itself.
[39]
In
effect, the same issue arises in the present case. The metered dose inhaler is
designed to ensure consistent delivery of the medicinal ingredient. It is
essentially an improved way of administering the aerosol drug. It is not the
dosage form approved in the NOCs issued for FLOVENT HFA and ADVAIR. As such,
the MDI, as claimed in the '517 Patent, is more closely akin to a device than
to a novel delivery system. Therefore, the Minister was correct in refusing to
add the '517 patent to the Patent Register on the grounds that it did not
contain a claim for a dosage form which had been approved through the issuance
of a NOC in respect of the new drug submissions for FLOVENT HFA and ADVAIR.
VI. Conclusion
[40]
For
these reasons, the application for judicial review will be dismissed with costs
to the Respondent.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that
1.
The
application for judicial review is dismissed; and
2.
Costs
are awarded to the Respondent.
“Judith
A. Snider”
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