Dockets: A-27-15
A-28-15
A-143-15
A-172-15
Citation:
2016 FCA 248
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CORAM:
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DAWSON J.A.
WEBB J.A.
RENNIE J.A.
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Docket:A-27-15
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BETWEEN:
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TEVA CANADA
LIMITED
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Appellant
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and
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PFIZER CANADA
INC. and
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THE MINISTER OF
HEALTH and
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THE ATTORNEY
GENERAL OF CANADA
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Respondents
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Docket:A-28-15
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AND BETWEEN:
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THE ATTORNEY
GENERAL OF CANADA
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and THE
MINISTER OF HEALTH
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Appellants
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and
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PFIZER CANADA INC.
and
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TEVA CANADA
LIMITED
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Respondents
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Docket:A-143-15
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AND BETWEEN:
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ATTORNEY
GENERAL OF CANADA
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and THE
MINISTER OF HEALTH
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Appellants
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and
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JANSSEN INC. and
THE KENNEDY TRUST
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FOR
RHEUMATOLOGY RESEARCH and HOSPIRA HEALTHCARE CORPORATION
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Respondents
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Docket:A-172-15
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AND BETWEEN:
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HOSPIRA
HEALTHCARE CORPORATION
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Appellant / (Respondent)
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and
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JANSSEN INC. and
THE KENNEDY TRUST FOR RHEUMATOLOGY RESEARCH
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Respondents / (Applicants)
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and
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THE MINISTER OF
HEALTH and
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ATTORNEY
GENERAL OF CANADA
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Respondents / (Respondents)
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REASONS
FOR JUDGMENT
DAWSON J.A.
[1]
Each of the four appeals before the Court raise
the following two issues. First, what is the standard of review to be applied
to a decision of the Minister of Health to issue a Notice of Compliance to a generic
manufacturer in circumstances when the Minister determines that the generic’s
drug submission is administrative in nature so that it does not trigger the
notice requirement found in section 5 of the Patented Medicines (Notice of
Compliance) Regulations, SOR/93-133 (PMNOC Regulations or Regulations)?
Second, did the Federal Court err when it decided that the Minister’s decisions
should be set aside? This, in turn, requires consideration of whether the
Minister erred in issuing two Notices of Compliance (NOC) without requiring
each applicant to notify the affected patentee that the applicant was seeking a
NOC.
[2]
Briefly, two decisions made by the Minister are
at issue on these appeals:
i.
The decision of the Minister made on October 1,
2013, to issue a NOC to Teva Canada Limited for an exemestane tablet for oral
administration in 25 mg strength. This is a generic version of exemestane
tablets marketed by Pfizer Canada Inc. under the brand name AROMASIN.
ii.
The decision of the Minister made on June 4,
2014, to issue a NOC to Hospira Healthcare Corporation for its 100 mg/vial
infliximab powder for solution. This is a generic version of the 100 mg/vial
infliximab powder marketed by Janssen Inc. under the brand name REMICADE.
[3]
Pfizer challenged in the Federal Court the
decision of the Minister to issue the NOC to Teva in respect of exemestane.
[4]
For reasons cited as 2014 FC 1243, issued in the
proceeding brought by Pfizer, a judge of the Federal Court found the standard of
review of the Minister’s decision to be correctness. The Federal Court went on
to find that the Minister’s interpretation of the PMNOC Regulations was
incorrect (reasons, at paragraph 56). In consequence, the Minister’s decision
to issue the NOC to Teva in respect of exemestane was set aside.
[5]
Two of the appeals before the Court relate to
this decision of the Federal Court: an appeal brought by Teva in Court Docket A-27-15
and an appeal brought by the Attorney General of Canada and the Minister of
Health in Court Docket A-28-15. These appeals were consolidated. As a result, a
copy of these reasons will be placed in each Court file.
[6]
Janssen also challenged in the Federal Court the
decision of the Minister to issue a NOC to Hospira in respect of infliximab.
The Federal Court issued its judgment in respect of exemestane while Janssen’s
application for judicial review of the Minister’s decision with respect to
infliximab was pending. With the consent of the parties, the Federal Court set
aside the decision of the Minister to issue the NOC to Hospira, without prejudice
to any right to appeal from the judgment. This judgment was made to permit the
parties to appeal the judgment and to ask that the appeals be heard together
with the appeals brought against the judgment of the Federal Court with respect
to exemestane.
[7]
Two of the appeals before the Court relate to
this judgment of the Federal Court: an appeal brought by the Attorney General
of Canada and the Minister of Health in Court Docket A-143-15 and an appeal
brought by Hospira in Court Docket A-172-15. These appeals were also
consolidated, as a result a copy of these reasons will be placed in each Court
file.
[8]
The Court ordered that the consolidated appeals
be heard together.
[9]
For the reasons that follow, I have concluded
that the Federal Court erred by reviewing the Minister’s decisions on the
standard of correctness. Applying the standard of reasonableness, I have
concluded that the Minister’s decisions were reasonable. It follows that I
would allow each appeal with costs here and in the Federal Court, set aside the
judgments of the Federal Court and dismiss the applications for judicial review
brought in respect of the two decisions of the Minister.
[10]
I begin my analysis by briefly reviewing the
regulatory framework and then move to consider the drug submissions at issue in
these appeals, the decision of the Federal Court and the appropriate standard
of review of the Minister’s decisions. Finally, I apply the appropriate
standard of review to the decisions at issue.
I.
The Regulatory Framework
[11]
I begin with some background context to the
current regulatory regime. In 1923, the Patent Act, R.S.C. 1923, c. 23
was amended to introduce compulsory licensing specific to the manufacture of
food and medicine. A compulsory license is a license mandated by statute that
gives a licensee the right to manufacture, use, or sell a patented invention
prior to the expiration of the patent.
[12]
In 1992, the government introduced Bill C-91,
the Patent Act Amendment Act, 1992, in order to amend the Patent Act,
R.S.C. 1985, c. P-4 (Act or Patent Act) to implement obligations Canada
had accepted under the Agreement on Trade-Related Aspects of Intellectual
Property Rights and the North American Free Trade Agreement. Bill C-91 eliminated
compulsory licenses issued on or after December 20, 1991 for pharmaceutical
products.
[13]
In order to facilitate the early entry of
generic drugs to the market following the expiration of patent protection, Bill
C-91 created an exception to an action for patent infringement. What is known
as the “early working” exception allows a person
to use a patented invention while the relevant patent is in force for the sole
purpose of obtaining regulatory approval to sell a product equivalent to the
patented product on the expiry of the relevant patent. The early working
exception eliminated the often lengthy regulatory lag after the expiration of a
patent while a generic manufacturer took the required steps to obtain a NOC.
[14]
The early working exception is found in
subsection 55.2(1) of the Act:
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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.
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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.
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[15]
The PMNOC Regulations were enacted in 1993 in
conjunction with the amendments to the Patent Act that terminated
compulsory licensing and created the early working exception. The Regulations
were enacted in order to, among other things, prevent abuse of the early
working exception. The linkage between the early working exception and the
PMNOC Regulations is expressly reflected in subsection 55.2(4) of the Act. This
is the provision which allows the Governor in Council to enact regulations. It
authorizes the enactment of regulations considered necessary for preventing the
infringement of a patent by any person who engages in the early working of the
patented invention. More specifically:
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55.2(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 …
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55.2 (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 …
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(emphasis added)
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(soulignement ajouté)
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[16]
The protection provided to innovators in the
PMNOC Regulations is in addition to the remedy for patent infringement under
the Act.
[17]
The salient features of the regulatory regime as
it applies to pharmaceutical drugs such as exemestane may be briefly summarized
as follows:
i.
A drug manufacturer who wishes to advertise or
sell a new drug in Canada must first obtain a NOC pursuant to Part C, Division
8 of the Food and Drug Regulations, C.R.C. c. 870. This is done by
filing one of a number of types of drug submissions. A drug manufacturer is defined
to include an entity who sells a drug “under their own
name” (Food and Drug Regulations, section A.01.010).
ii.
A drug approved to be marketed in Canada is
assigned a unique Drug Identification Number which identifies the following
characteristics of the drug: its brand name, manufacturer, medicinal ingredient
or ingredients, the strength of the medicinal ingredient or ingredients, the pharmaceutical
dosage form and the route of administration.
iii.
Typically, an innovator drug manufacturer
seeking authorization to advertise or sell a new drug in Canada files a new
drug submission (NDS) pursuant to section C.08.002(1) of the Food and Drug
Regulations. This type of drug submission generally requires substantial
evidence of clinical trials and studies to demonstrate that the new drug is
safe and effective.
iv.
Another type of drug submission is an
abbreviated new drug submission (ANDS), which is available under subsection
C.08.002(1) of the Food and Drug Regulations. Typically, a generic drug
manufacturer will file an ANDS in order to obtain a NOC. The generic
manufacturer will make its own version of a previously approved brand-name drug.
The brand-name drug is defined in section C.08.001.1 of the Food and Drug Regulations
to be a “Canadian reference product”. The generic
manufacturer tests its version of the Canadian reference product in order to
demonstrate that the generic’s version is bioequivalent to the Canadian
reference product. Thus, the safety and effectiveness of the generic drug is
established by demonstrating its bioequivalence to a drug whose safety and
effectiveness has previously been established.
v.
The PMNOC Regulations provide a mechanism by
which a patent holder may delay the entry of a generic version of its patented
drug onto the market. Section 4 permits an innovator who has filed a NDS and
obtained a NOC to submit a patent list to the Minister in respect of the drug.
If the patent or patents on the list meet the requisite criteria, the Minister
may add the patent or patents to the Patent Register maintained by the
Minister. The patent holder who submits a patent list is referred to as a “first-person”.
vi.
Thereafter, if a “second person”, usually a
generic drug manufacturer, seeks a NOC based on demonstrating the
bioequivalence of its drug to a Canadian reference product, the second person
must address each patent listed on the Patent Register in association with the
Canadian reference product. The second person may address a listed patent by
stating that the second person accepts that the NOC will not issue until all
relevant patents expire. Alternatively, the second person may allege that a
listed patent is not valid or that a listed patent will not be infringed if the
second person is permitted to make, use or sell the version of the drug for
which the second person seeks the NOC (subsection 5(1) of the PMNOC
Regulations).
vii.
A second person who alleges patent invalidity or
non-infringement must then serve the first person with particulars of its
allegations in a “notice of allegation”, and must prove service of the notice
of allegation on the first person to the Minister (subsection 5(3) of the PMNOC
Regulations).
viii.
A patentee served with a notice of allegation
may apply to a court for an order prohibiting the Minister from issuing a NOC
until after the expiration of a patent that is the subject of the notice of
allegation (subsection 6(1) of the PMNOC Regulations).
ix.
A patentee’s application for prohibition under
subsection 6(1) automatically triggers a statutory stay (subsection 7 of the
PMNOC Regulations). During the period of the statutory stay, the Minister may
not issue a NOC until one of a number of prescribed events has occurred. For
example, one event that terminates the statutory stay is when a court declares
that an allegation that the patent is not valid or will not be infringed by the
second person is justified. Another event is when a period of 24 months elapses
after the Minister receives proof that a court application has been made under
subsection 6(1). Additionally, the stay triggered by the service of a notice of
allegation is terminated if 45 days expires from the date a notice of
allegation is served on a patentee and the patentee fails to apply for an order
of prohibition under subsection 6(1) of the PMNOC Regulations.
[18]
Having briefly reviewed the regulatory framework
as it applies to pharmaceutical drugs such as exemestane, it is necessary to
note that infliximab is a biologic, not a pharmaceutical, drug. Biologic drugs
are derived through the metabolic activity of living organisms; they are variable
and structurally complex. Biologic drugs are typically manufactured from
animals, microorganisms, or through the use of animals or microorganisms.
[19]
The approval process for subsequent entry
biologic (SEB) drugs differs in certain ways from the approval process for
generic pharmaceutical drugs. The main differences may be summarized as
follows:
i.
The approval of a SEB is sought by filing a NDS
pursuant to section C.08.002 of the Food and Drug Regulations. This is
to be contrasted with the filing of an ANDS for the approval of a generic version
of a pharmaceutical drug.
ii.
In its NDS, the SEB sponsor seeks a NOC based on
the demonstrated similarity of its product to a previously approved reference
biologic drug. Therefore, the NDS will provide extensive data demonstrating the
similarity of the subsequent entry biologic with the reference biologic drug. This
reliance on the reference biologic drug reduces the required amount of clinical
and non-clinical information required to demonstrate safety and efficacy.
[20]
Having reviewed the regulatory framework, I now
turn to review the drug submissions at issue in these appeals.
II.
The Drug Submissions
(1) Pfizer’s
Supplemental New Drug Submission for AROMASIN
[21]
On March 17, 2005, Pfizer filed a supplemental
NDS seeking approval to market tablets containing the medicinal ingredient
exemestane in 25 mg strength under the trade name AROMASIN. A NOC issued in
respect of this submission on May 12, 2006.
[22]
On May 12, 2006, Pfizer filed a patent list in
order to list Canadian Patent No. 2,409,059 (059 patent) on the Patent Register
in respect of the AROMASIN tablets in 25 mg strength.
[23]
On May 18, 2006, the 059 patent was listed on
the Patent Register. It follows that Health Canada was satisfied that the
patent complied with subsection 4(2) of the PMNOC Regulations. A patent
complies with this provision if, for example, the patent contains a claim for a
medicinal ingredient and the medicinal ingredient was approved through the
issuance of a NOC in respect of a NDS (paragraph 4(2)(a) of PMNOC
Regulations).
(2) Generic Medical Partners Inc.’s ANDS for
MED-EXEMESTANE
[24]
Of limited relevance is an ANDS filed by Generic
Medical Partners Inc. (GMP) that was not properly served on Pfizer. Through
administrative error this led to a short-lived NOC issued to GMP and, later, a
related NOC issued to Teva. The Federal Court discussed this at paragraphs 37
to 42 of its reasons. Of greater relevance is the drug submission made by GMP that
led to the NOC at issue on these appeals.
[25]
On May 22, 2012, GMP filed an ANDS seeking
approval to market tablets containing the medicinal ingredient exemestane in 25
mg strength under the trade name MED-EXEMESTANE. Subsequently, on August 16,
2013, GMP served a notice of allegation on Pfizer in which it made allegations
in respect of the 059 patent.
[26]
Although properly served with the NOC, Pfizer
did not commence an application seeking prohibition pursuant to subsection 6(1)
of the PMNOC Regulations.
[27]
In consequence, the Minister issued a NOC to GMP
on October 1, 2013.
(3) Teva’s ANDS for TEVA-EXEMESTANE
[28]
On June 18, 2013, Teva filed an ANDS, which
cross-referenced GMP’s ANDS, in which Teva sought approval to market tablets
containing the medicinal ingredient exemestane in 25 mg strength under the
trade name TEVA-EXEMESTANE.
[29]
Teva’s ANDS did not contain any data. It
included a certification in which Teva certified that all aspects of Teva’s
drug product were identical to GMP’s cross-referenced drug product except for
the names of the manufacturer and the product. Teva also certified that its
drug product would be manufactured in the same location as GMP’s drug product,
with identical specifications and procedures. Teva also included in its
submission an authorization from GMP permitting the Minister to access GMP’s
ANDS when processing Teva’s ANDS.
[30]
On October 1, 2013, the Minister issued a NOC to
Teva.
(4) Janssens’ NOC for REMICADE
[31]
On September 27, 2001, based on a NDS filed by
Centocor Inc., a NOC issued to Centocor with respect to a 100 mg/vial infliximab
powder for solution product marketed under the brand name REMICADE. At the same
time, a Drug Identification Number was issued with respect to this medication:
02244016.
[32]
On June 20, 2011, Janssen filed an
administrative NDS to transfer the Drug Identification Number issued for
REMICADE from Centocor to Janssen. On August 5, 2011, Janssen was issued a NOC
in response to its administrative NDS and the Drug Identification Number was
transferred to Janssen.
[33]
With the consent of the patent owner, The
Kennedy Trust for Rheumatology Research, Janssen filed a Patent List in order
to list Canadian Patent No. 2,261,630 (630 patent) on the Patent Register in
respect of REMICADE.
[34]
On December 4, 2012, the 630 patent issued. It
was listed on the Patent Register on December 6, 2012 in respect of REMICADE.
(5) Celltrion Healthcare Co. Ltd.’s NDS for
INFLECTRA
[35]
On November 14, 2012, Celltrion Healthcare Co.
Ltd. filed a NDS seeking approval to market its subsequent entry biologic
INFLECTRA which contained the medicinal ingredient infliximab in 100 mg/vial strength
in powder for solution dosage form. In its NDS Celltrion sought to demonstrate
similarity between INFLECTRA and REMICADE.
[36]
Celltrion’s NDS nominated Hospira to be a
distributor for INFLECTRA (affidavit of Beryl Chan, the Regulatory Affairs
Director of Hospira, at paragraph 16).
[37]
As at November 14, 2012, the filing date of
Celltrion’s NDS, no patent was listed on the Patent Register in respect of
REMICADE. As a result, on January 15, 2014, the Minister issued a NOC to
Celltrion in respect of INFLECTRA. The Minister assigned a Drug Identification
Number to INFLECTRA: 02419475.
[38]
Hospira was entitled to sell INFLECTRA under
this NOC (affidavit of Beryl Chan, at paragraph 16).
(6) Hospira’s NDS
for INFLECTRA
[39]
On April 7, 2014 Hospira filed a NDS
cross-referencing Celltrion’s NDS seeking approval to market INFLECTRA.
[40]
Hospira’s NDS did not contain any scientific
data. It included its certification that Hospira and Celltrion had entered into
a licensing agreement with respect to INFLECTRA and that pursuant to this
agreement Celltrion would no longer be selling the product. In the
certification Hospira certified that, except the manufacturer’s name, all
aspects of its drug product were identical to the cross-referenced Celltrion
drug product and that the product would be manufactured in the same location
with identical specifications and procedures. As well, a letter of
authorization was provided from Celltrion permitting the Minister to cross-reference
its NDS when processing Hospira’s NDS.
[41]
The Biologics and Genetic Therapies Directorate
of Health Canada concluded that because there were no changes to the previously
approved drug product itself, there were no patents that Hospira was required
to address (Exhibit I to the affidavit of Pino DiFranco, a Patent Officer-Legal,
employed by Health Canada).
[42]
On June 4, 2014 the Minister issued a NOC to
Hospira in respect of its NDS for INFLECTRA. The Minister assigned the same
Drug Identification Number to Hospira’s INFLECTRA as had previously been
assigned to Celltrion’s INFLECTRA.
III.
The Decision of the Federal Court
[43]
As mentioned above, the Federal Court found the
standard of review of the Minister’s decision to be correctness. It went on to
find that the Minister’s interpretation of the PMNOC Regulations was incorrect.
[44]
Central to the reasoning of the Federal Court
were its conclusions that:
i.
the prior jurisprudence had not satisfactorily
settled the applicable standard of review (reasons, at paragraphs 70-72,
105-108);
ii.
the reasonableness standard of review “is presumptively applicable whenever an administrative
decision-maker interprets its constituent statute or a statute or regulation
that is closely connected with its function” unless certain limited
exceptions apply (reasons, at paragraphs 67, 109);
iii.
notwithstanding the broad language employed by
the Supreme Court in Canadian National Railway Co. v. Canada (Attorney
General), 2014 SCC 40, [2014] 2 S.C.R. 135, at paragraphs 59-62, to
describe the deference owed to the Governor in Council when interpreting
legislation closely related to its economic regulatory review function, this
decision did not establish a fixed rule that the presumption of reasonableness may
only be rebutted if the decision at issue falls into one of four categories.
Those categories are constitutional questions, true jurisdictional questions,
questions of competing jurisdiction between administrative tribunals and
questions of general importance to the legal system as a whole which are
outside of the decision-maker’s expertise (reasons, at paragraph 88);
iv.
the presumption of reasonableness may be
rebutted if a contextual analysis demonstrates that Parliament did not intend
the question to be left to the decision-maker to determine because the question
falls more appropriately within the expertise of the reviewing court (reasons,
at paragraph 104);
v.
having regard to the purpose of the
decision-maker, the nature of the question at issue and the expertise of the
decision-maker, the presumption of reasonableness was rebutted (reasons, at
paragraphs 111-120);
vi.
more specifically, the Federal Court found that:
a.
nothing in the PMNOC Regulations indicated that
the Governor in Council intended the issue of whether an applicant has made a “submission for an NOC” that “directly
or indirectly compares” its product to that of another innovator be left
to the Minister or officials within Health Canada (reasons, at paragraph 113);
b.
indeed, the regulatory and statutory context
indicated that the issue is not to be left to Health Canada because the
Minister enjoys no discretion as to whether to issue a NOC (reasons, at
paragraph 114); and,
c.
the Governor in Council left to the Court the
ultimate determination of whether a NOC should issue under the PMNOC
Regulations. The Court’s role is inconsistent with application of the
reasonableness standard to the Minister’s decisions. Further, the case was
similar to that in Takeda Canada Inc. v. Canada (Minister of Health),
2013 FCA 13, 440 N.R. 346 where the dissenting judge rebutted the presumptive
application of the reasonableness standard on the basis that the question before
the Minister was purely legal, the Minister had no experience in legal
interpretation and nothing in the legislation suggested deference should be
given to the Minister’s decision (reasons, at paragraphs 116-118);
vii.
the Federal Court then turned to the application
of the correctness standard to the decision of the Minister, recognizing that
the applicable statutory and regulatory provisions were to be interpreted in a
purposive manner (reasons, at paragraphs 121, 131);
viii.
the Federal Court rejected the notion that the
purpose of the PMNOC Regulations “is to allow the ‘early
working’” of a patented drug by a generic drug manufacturer. These
Regulations exist not only to allow early working but also to balance the
interest in promoting early access to less expensive generic drugs with the
interest of patentees in obtaining proper protection for their patented
inventions. It is irrelevant to the objects of subsection 5(1) of the PMNOC
Regulations that Teva did not take advantage of the early working exception.
Once “the purpose of the PMNOC Regulations is properly
understood, it supports the conclusion that a company in the position of Teva
must comply with subsection 5(1) of the Regulations” (reasons, at
paragraphs 133-136);
ix.
the Federal Court rejected the argument that
Teva’s administrative drug submission did not come within the scope of
subsection 5(1) of the PMNOC Regulations. The Federal Court could not
distinguish the decisions of this Court in Nu-Pharm Inc. v. Canada (Attorney
General) (1998), 80 C.P.R. (3d) 74, [1998] F.C.J. No. 274 (Nu-Pharm 1);
and Merck & Co., Inc. v. Canada (Attorney General) (2000), 179
F.T.R. 278, 5 C.P.R. (4th) 138 (Nu-Pharm 2) (together the Nu-Pharm
decisions). The Federal Court viewed these cases to indicate that “subsection 5(1) of the PMNOC Regulations exists to require
all generic companies who obtain their rights through a licence to address an
innovator company’s patent on the Patent Register created by the Regulations,
whether they make a direct or an indirect comparison to the innovator’s product”.
Further, just as in the present cases, in the Nu-Pharm decisions the
generic company had acquired the right to produce the drug in question under a
license from another generic company and filed a submission that made a direct
or indirect comparison to an innovator’s drug (reasons, at paragraphs 137,
141);
x.
the Federal Court rejected the submission that
the situation before the Court was identical to that before the Court in GlaxoSmithKlein
Inc. v. Canada (Attorney General), 2004 FC 1302, 38 C.P.R. (4th) 27 (Glaxo)
where the Federal Court held that the administrative new drug submissions filed
in that case did not engage the PMNOC Regulations because such submissions were
not “submissions” within the meaning of subsection 5(1) of the PMNOC
Regulations. In the Federal Court’s view, the decision was distinguishable
because in Glaxo the generic company had complied with subsection 5(1)
of the PMNOC Regulations and had served a notice of allegation on the innovator
company and the Judge’s comments relied upon by the Attorney General were obiter
(reasons, at paragraph 142); and,
xi.
finally, the Federal Court found that the cases
interpreting the meaning of “submission” in the context of section 4 of the PMNOC
Regulations for the purpose of listing a patent on the Patent Register are
inapplicable to the issues in this case - the concerns about an innovator
company extending its entitlements under the Regulations through administrative
filings do not arise in this case (reasons, at paragraph 143).
IV.
The Standard of Review to be applied to the Decision
of the Federal Court
[45]
It is well-settled, and not in contention on
these appeals, that when reviewing a decision of the Federal Court made in the
context of an application for judicial review, this Court is required to
determine whether the Federal Court identified the appropriate standard of
review and then properly applied the standard (Agraira v. Canada (Public
Safety and Emergency Preparedness), 2013 SCC 36, [2013] 2 S.C.R. 559, at
paragraph 45).
V.
Did the Federal Court err when it identified the
appropriate standard of review to be correctness?
[46]
I agree with the Federal Court that the prior
jurisprudence had not satisfactorily determined the standard of review to be
applied to the decisions of the Minister. I reject the submissions of the
respondents Pfizer, Janssen and The Kennedy Trust that decisions such as Bristol-Myers
Squibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533,
at paragraph 36 (Biolyse) and AstraZeneca v. Canada (Minister of
Health), 2006 SCC 49, [2006] 2 S.C.R. 560, at paragraph 25 selected the
standard of review in a manner binding upon this Court and the Federal Court.
As the Federal Court correctly noted, in Agraira, at paragraph 48, the
Supreme Court instructed that the standard of review cannot be seen to be
satisfactorily established “if the relevant precedents
appear to be inconsistent with recent developments in the common law principles
of judicial review”. In my view this is the case in the present appeals
because both Biolyse and AstraZeneca were decided without regard
to the presumption of reasonableness articulated in cases such as Alberta
Teachers’ Association v. Alberta (Information and Privacy Commissioner),
2011 SCC 61, [2011] 3 S.C.R. 654, at paragraph 39.
[47]
I also agree with the Federal Court that the
presumption of reasonableness may be rebutted when a contextual analysis
reveals Parliament’s intent “not to protect the
tribunal’s jurisdiction in relation to certain matters; the existence of
concurrent and non-exclusive jurisdiction on a given point of law is an
important factor in this regard” (Mouvement laïque
québécois v. Saguenay (City), 2015 SCC 16, [2015] 2 S.C.R. 3,
at paragraph 46; citing, Tervita Corp. v. Canada (Commissioner of
Competition), 2015 SCC 3, [2015] 1 S.C.R. 161, at paragraphs 35-36 and
38-39; McLean v. British Columbia (Securities Commission), 2013 SCC 67,
[2013] 3 S.C.R. 895, at paragraph 22; Rogers Communications Inc. v. Society
of Composers, Authors and Music Publishers of Canada, 2012 SCC 35, [2012] 2
S.C.R. 283, at paragraph 15).
[48]
Where my analysis diverges from that of the
Federal Court is that in my view a contextual analysis does not rebut the
presumption of reasonableness.
[49]
The Federal Court relied upon the following
considerations to rebut the presumption of reasonableness:
i.
the Minister has no discretion whether to issue
a NOC. The Minister may not issue a NOC until the criteria in section 7 of the
PMNOC Regulations are met (reasons, at paragraph 114);
ii.
the Governor in Council left the ultimate
decision of whether a NOC should issue under the PMNOC Regulations to the
Court, because the Federal Court is required to adjudicate applications for
prohibition. This role is inconsistent with reasonableness review (reasons, at
paragraph 116); and,
iii.
the question was purely legal, and nothing in
the PMNOC Regulations suggests that deference should be given to the Minister’s
interpretation of the Regulations (reasons, at paragraph 118).
[50]
I begin my analysis by rejecting the
respondents’ submission that the argument for reasonableness review rests on
the incorrect characterization of the PMNOC Regulations as the Minister’s home
statute. While I agree that these regulations are enacted pursuant to the Patent
Act which falls under the Minister of Industry, not Health, this is too
narrow a view of the prevailing jurisprudence. The presumption of
reasonableness applies when an administrative decision-maker is interpreting
not just its home statute, but also when the decision-maker is interpreting “statutes closely connected to its function” (Dunsmuir
v. New Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190, at paragraph 54). This
applies equally to regulations such as the PMNOC Regulations that are closely
connected to the function of the Minister of Health.
[51]
Having concluded that it should be presumed that
the decision of the Minister interpreting the PMNOC Regulations is reviewable
on the standard of reasonableness, neither the fact that this raises a legal
question nor the fact that the PMNOC Regulations do not suggest deference point
away from the reasonableness standard.
[52]
Since Dunsmuir, the Supreme Court has
stated that the interpretation of unclear language in an administrative
decision-maker’s home statute (or regulation) is usually best left to the administrative
decision-maker (McLean, at paragraph 33). The proper inquiry is whether
the PMNOC Regulations evidence Parliament’s intention that decisions of the
Minister interpreting the Regulations be reviewed on a less deferential standard
of review (Tervita, at paragraphs 38-39).
[53]
I can find no indication of such intention in
the PMNOC Regulations.
[54]
I also disagree that the role of the Court in
the PMNOC Regulations is inconsistent with reasonableness review, and disagree
that this case is “somewhat similar to Rogers
Communications Inc. in which Justice Rothstein for the majority applied the
correctness standard to the review of the Copyright Board’s interpretation of
its constituent Act on the basis that the Board and the courts shared
concurrent jurisdiction under the statute…” (reasons, at paragraph 117).
[55]
The Minister has exclusive jurisdiction to
decide whether a drug submission filed by a second person makes a comparison
with a Canadian reference product so as to require the second person to address
a patent listed on the Patent Register. It is only if this question is answered
by the Minister in the affirmative, a notice of allegation is served by the
second person, and a prohibition application is commenced by the first person
that the Minister is prohibited from issuing a NOC under paragraph 7(1)(e)
of the Regulations (section 7 PMNOC Regulations).
[56]
Aside from the Court’s potential role on an
application for judicial review of a Ministerial decision made under section 5,
the PMNOC Regulations provide a role for the Court as a first instance
decision-maker only under section 6: where a first person has initiated an
application for prohibition it is for the Court to determine whether the
allegations contained in a second person’s notice of allegation are justified.
On an application for prohibition, the Court does not consider whether section
5 ought to have been triggered in the first place. It follows that in a
prohibition application there is no possibility of conflicting interpretations
between the Minister and the Court with respect to whether section 5 was
triggered.
[57]
In my view, the question of whether a drug
submission triggers section 5 of the PMNOC Regulations is a question of mixed
fact and law. It is well-settled that reasonableness is the standard of review
to be applied to such questions (see, for example, Tervita, at paragraph
40).
[58]
In Dunsmuir, at paragraphs 55 and 68, the
Supreme Court recognized that where there is a discrete or special
administrative regime in which the decision-maker has special expertise, that
decision-maker is entitled to deference. In my view Health Canada, and through
it the Minister, are required on a regular basis to interpret section 5 of the
Regulations. For example, the Minister is required to determine whether to
issue a NOC or to place a drug submission on patent hold. In AstraZeneca,
the Supreme Court required the Minister to conduct a patent-specific analysis
when applying subsection 5(1) because a “generic
manufacturer is only required to address the cluster of patents listed against
submissions relevant to the NOC that gave rise to the comparator drug” (AstraZeneca,
at paragraph 39).
[59]
It follows from the nature of the question and
the Minister’s expertise that the decisions at issue should be reviewed on the
standard of reasonableness.
[60]
I now turn to the second issue.
VI.
Was it unreasonable for the Minister to conclude
that section 5 of the PMNOC Regulations was not engaged by the drug submissions
at issue such that NOCs should issue to Teva and Hospira?
[61]
Because the Federal Court did not apply the
appropriate standard of review it is necessary for this Court to apply the
appropriate standard of review, reasonableness, to the decisions of the
Minister. This said, it is helpful to review the conclusions that led the
Federal Court to its determination that the decisions of the Minister were
incorrect.
[62]
The pertinent conclusions of the Federal Court
on this point were as follows:
i.
the Federal Court rejected the notion that the
purpose of the PMNOC Regulations “is to allow the
‘early working’” of a patented drug by a generic drug manufacturer.
These Regulations exist not only to allow early working but also to balance the
interest in promoting early access to less expensive generic drugs with the
interest of patentees in obtaining proper protection for their patented
inventions. Therefore it was irrelevant to the objects of subsection 5(1) of
the PMNOC Regulations that Teva did not take advantage of the early working
exception (reasons, at paragraphs 133-135);
ii.
the Federal Court rejected the argument that
Teva’s administrative drug submission did not come within the scope of
subsection 5(1) of the PMNOC Regulations. The Federal Court could not
distinguish the Nu-Pharm decisions of this Court. These cases held that “subsection 5(1) of the PMNOC Regulations exists to require
all generic companies who obtain their rights through a licence to address an
innovator company’s patent on the Patent Register created by the Regulations,
whether they make a direct or an indirect comparison to the innovator’s
product”. Just as in the Nu-Pharm decisions, Teva “filed a submission that makes a direct or indirect
comparison” to a first person’s drug (reasons, at paragraphs 137, 141);
iii.
the Federal Court rejected the submission that
the situation before the Court was identical to that before the Court in Glaxo,
where the Federal Court held that the administrative new drug submissions filed
in that case did not engage the PMNOC Regulations, because in Glaxo the
generic company had complied with subsection 5(1) of the PMNOC Regulations and
had served a notice of allegation on the innovator company. Moreover, the
comments relied upon by the Attorney General were obiter (reasons, at
paragraph 142); and,
iv.
finally, the Federal Court found that the cases
interpreting the meaning of “submission” in the context of section 4 of the
PMNOC Regulations for the purpose of listing a patent on the Patent Register were
inapplicable to the issues in this case - the concerns about an innovator
company extending its entitlements under the Regulations through administrative
filings did not arise in this case (reasons, at paragraphs 143).
[63]
I will deal with each point in turn.
[64]
First, I disagree that it is irrelevant for the
purpose of subsection 5(1) of the PMNOC Regulations whether Teva or Hospira
took advantage of the early working exception.
[65]
In Biolyse, the Supreme Court considered
the situation where Bristol-Myers Squibb had a number of patents related to new
and useful formulations and methods of administration of the drug paclitaxel.
Bristol-Myers Squibb did not have a patent on paclitaxel itself ‒ a drug
discovered by the National Cancer Institute of the United States and then put
into the public domain. Bristol-Myers Squibb argued that, pursuant to what was
then subsection 5(1.1) of the Regulations, a generic manufacturer was required
to address its patents simply because its formulation contained paclitaxel and
the offending Biolyse product was bioequivalent to Bristol-Myers Squibb’s
product.
[66]
At first instance, the Federal Court had found
that the Biolyse product had been properly characterized as an innovator drug.
Notwithstanding, the Federal Court found the Biolyse product to be captured by
subsection 5(1.1) of the Regulations.
[67]
Subsection 5(1.1) then in force provided:
|
5.(1.1) Subject to subsection (1.2), where subsection (1) does not
apply and where a person files or has filed a submission for a notice
of compliance in respect of a drug that contains a medicine found in
another drug that has been marketed in Canada pursuant to a notice of
compliance issued to a first person and in respect of which a patent list
has been submitted, the person shall, in the submission, with respect to each
patent included on the register in respect of the other drug containing the
medicine, where the drug has the same route of administration and a
comparable strength and dosage form,
|
5.(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe
(1) ne s’applique pas, la personne qui dépose ou a déposé une demande
d’avis de conformité pour une drogue contenant un médicament que l’on
trouve dans une autre drogue qui a été commercialisée au Canada par suite de
la délivrance d’un avis de conformité à la première personne et à l’égard
de laquelle une liste de brevets a été soumise doit inclure dans la demande,
à l’égard de chaque brevet inscrit au registre visant cette autre drogue
contenant ce médicament, lorsque celle-ci présente la même voie
d’administration et une forme posologique et une concentration
comparables :
|
|
(a) state that the person accepts that the notice of compliance
will not issue until the patent expires; or
|
a) soit une déclaration portant qu’elle accepte que l’avis de
conformité ne soit pas délivré avant l’expiration du brevet;
|
|
(b) allege that
|
b) soit une allégation portant que, selon le cas :
|
|
(i) the statement made by the first person pursuant to paragraph
4(2)(c) is false,
|
(i) la déclaration faite par la première personne aux termes de
l’alinéa 4(2)c) est fausse,
|
|
(ii) the patent has expired,
|
(ii) le brevet est expiré,
|
|
(iii) the patent is not valid, or
|
(iii) le brevet n’est pas valide,
|
|
(iv) no claim for the medicine itself and no claim for the use of
the medicine would be infringed by the making, constructing, using or selling
by that person of the drug for which the submission for the notice of
compliance is filed.
|
(iv) aucune revendication pour le médicament en soi ni aucune
revendication pour l’utilisation du médicament ne seraient contrefaites
advenant l’utilisation, la fabrication, la construction ou la vente par elle
de la drogue faisant l’objet de la demande d’avis de conformité.
|
|
(emphasis added)
|
(soulignement ajouté)
|
[68]
The majority of the Supreme Court made a number
of key points when rejecting Bristol-Myers Squibb’s submission:
i.
the scope of a regulation is constrained by its
enabling legislation (reasons, at paragraph 38). It followed that the
Regulations had to be read in the light of subsection 55.2(4) of the Act;
ii.
while the word “submission” provided the “gateway”
into subsection 5(1.1), the term was not defined in the Regulations (reasons,
at paragraph 40);
iii.
reading the Regulations in the light of
subsection 55.2(4), it followed that the Regulations were directed to persons
who made use of a “patented invention” (reasons, at paragraph 52);
iv.
not every use of a patented invention triggered
the Regulations. Subsection 55.2(4) was directed to preventing infringement by
persons who use “the patented invention” for the “early working” exception.
This is all the Governor in Council is authorized to regulate (reasons, at
paragraph 53);
v.
the fact paclitaxel was found in the Biolyse product
did not mean that Biolyse “took advantage of” Bristol-Myers Squibb’s inventions
for the purpose of “early working” a generic copy in anticipation of the
expiration of the Bristol-Myers Squibb patents (reasons, at paragraph 54);
vi.
the interpretation of subsection 5(1.1) sought
by Bristol-Myers Squibb went well beyond the provision’s purpose of preventing
generic manufacturers from hiding their reliance on innovator drugs by putting
forward as a reference drug another generic manufacturer’s product. “If the approval of the generic drug is related to the work
of another drug manufacturer in respect of which a patent list has been filed
(as in the Nu-Pharm type situations), it will be caught by s. 5(1.1).”
(reasons, at paragraph 65).
[69]
On this last point, the Supreme Court’s
reference to the “Nu-Pharm type situations”
shows that when making this statement the Supreme Court had in its
contemplation the situation where a second generic relies on the drug
submission of a first generic who did not comply with subsection 5(1) of the
Regulations. In Nu-Pharm the first generic neither served a notice of
allegation nor was required to deal with subsection 5(1) because no patent was
listed against its Canadian reference product.
[70]
Subsequently, in AstraZeneca the Supreme
Court made the following points of relevance to these appeals:
i.
the Court reiterated that the grant of the
regulation-making power in subsection 55.2(4) of the Act is expressly limited
to prevention of infringement by a generic manufacturer who takes advantage of
the early working exception (reasons, at paragraph 15);
ii.
for the purpose of considering a generic
manufacturer’s obligations under subsection 5(1) of the PMNOC Regulations, the
important aspect of Biolyse was the emphasis it placed on the need to
interpret the Regulations “with careful regard to the
limited purposes” set out in subsection 55.2(4) of the Act (reasons, at
paragraph 16);
iii.
if Apotex did not early work two after-listed
patents because they were not incorporated into any product available to Apotex
to copy, it was difficult to see why Apotex should be required to comply with
the Regulations in respect of those patents (reasons, at paragraph 18);
iv.
a supplementary NDS may be submitted for either
substantive or purely administrative reasons (reasons, at paragraph 19);
v.
the “whole obligation
incurred by the generic manufacturer under the [PMNOC Regulations] is based on
its ‘early working’ of patents embodied in ‘another drug for the purpose of
demonstrating bio-equivalence’” (reasons, paragraph 37); and,
vi.
when a generic is erroneously required to comply
with the Regulations, the balance struck by Parliament between making safe and
effective drugs available to the public and preventing abuse of the early
working exception is undermined (reasons, at paragraph 39).
[71]
In sum, because Apotex did not make use of the
patented inventions taught by the patents at issue Apotex did not fall within
the mischief aimed at by the PMNOC Regulations (AstraZeneca, at
paragraph 38).
[72]
Subsequently, in reliance upon AstraZeneca,
this Court has held that the Minister must attempt to determine whether a
listed patent was early worked before requiring a generic to address a listed
patent (Canada (Health) v. Pharmascience Inc., 2009 FCA 183, 392 N.R.
315, at paragraphs 25-26).
[73]
Given the Supreme Court’s observation in AstraZeneca,
at paragraph 18, that unless Apotex had taken advantage of early working
patents whose inventions were incorporated into Apotex’ reference product it
was difficult to see why Apotex should be subject to the Regulations, the
question of whether Teva or Hospira early worked the relevant patents was a
relevant consideration.
[74]
This is particularly pertinent to Hospira which
cross-referenced its drug submission to that of Celltrion. As a matter of law,
Celltrion could not have early worked Janssen’s patented invention for
infliximab: Janssen’s 630 patent was issued and listed after Celltrion filed
its NDS. Nor did Hospira use Celltrion’s INFLECTRA as a Canadian reference
product in the usual fashion in order to demonstrate bioequivalence. Hospira’s
drug product was Celltrion’s drug product.
[75]
Next, I am not persuaded that the Nu-Pharm
decisions cannot be distinguished from the cases before the Federal Court.
[76]
In my view, the Nu-Pharm decisions must
be read in the context of their unique factual circumstances. There, Apotex,
the first generic, filed its drug submission before the PMNOC Regulations were
enacted. Apotex therefore obtained its NOC without addressing the relevant
patent. In the present case, GMP complied with the Regulations by serving a
notice of allegation upon Pfizer. GMP’s NOC issued only after Pfizer failed to
challenge GMP’s allegations of invalidity and non-infringement. Celltrion was
not obliged to address any patent because none was listed against REMICADE. In Nu-Pharm
this Court was not required to consider the position of a second generic which was
licensed to sell a first generic’s drug by a first generic who either complied
with the Regulations or was not required to address any listed patent.
[77]
Moreover, I accept the submission that decisions
that pre-date Biolyse and AstraZeneca must be read with care.
Thus, in Biolyse the “Nu-Pharm type” situation was distinguished
from that where a generic did not early work the patented invention (Biolyse,
reasons at paragraph 65). Further, any interpretation of the Regulations not
limited to preventing infringement occurring as a result of the early working
exception will exceed the scope of regulation-making authority conferred by
subsection 55.2(4) of the Act.
[78]
Next, I am not persuaded that the Glaxo
decision is distinguishable on the basis articulated by the Federal Court. I
reach this conclusion for the following reasons.
[79]
First, I disagree with the Federal Court that in
Glaxo “the generic company … had complied with
subsection 5(1) of the Regulations and had served [a notice of allegation] on
the innovator company in respect of whose product it had undertaken a
comparison” (reasons, at paragraph 142). Apotex, the generic, did not
serve a notice of allegation on either 3M Canada (whose product AiromirÔ Apotex
cross-referenced in its drug submission) or GlaxoSmithKline (a patent holder
that alleged Apotex’ product contained the same medicine as its product
Ventolin). This is apparent from the fact that Apotex had entered into a
licensing agreement with 3M which allowed Apotex to sell 3M’s product under its
own name (Glaxo reasons, at paragraph 16) and from the fact the Federal
Court found that the Minister had properly issued a NOC to Apotex without
requiring it to serve a notice of allegation on GlaxoSmithKline (Glaxo
reasons, at paragraph 72).
[80]
Second, I disagree with the Federal Court that
in Glaxo the Federal Court’s conclusion that the administrative NDS did
not engage the PMNOC Regulations was obiter. As evidenced by paragraph
73 of the Glaxo reasons, the Federal Court’s reliance upon Apotex’
comparison with 3M’s product was only in the event it was wrong in its primary
conclusion that the Regulations did not apply to the administrative NDS.
[81]
The final reason given by the Federal Court for
its conclusion that Teva had directly or indirectly compared its product to AROMASIN
so that its drug submission fell within subsection 5(1) of the Regulations was
that cases that had interpreted the meaning of “submission” in the context of
section 4 of the Regulations were inapplicable because “the
concerns about an innovator company’s extending its entitlements under the
Regulations through administrative filings do not arise in this case”
(reasons, at paragraph 143). Again, I respectfully disagree.
[82]
Returning to the decision of the Supreme Court
in Biolyse, the Supreme Court was required to interpret the word
“submission” in the then current version of subsection 5(1.1) of the
Regulations. To do so, the Court looked to subsection 4(1) of the Regulations,
a provision the Court characterized to be a “reciprocal
provision” to then subsection 5(1.1) (Biolyse, at paragraph 61).
At paragraphs 57-61 Justice Binnie wrote:
57 The word “submission” is used in
various places in the NOC Regulations. In particular, the text of s. 4(1)
provides the template on which s. 5(1.1) is modelled. The relevant words in s.
4(1) are:
4.(1) A person who files or has filed
a submission for, or has been issued, a notice of compliance in respect
of a drug that contains a medicine ...
58 … The Federal Court has
consistently held that the word “submission” in s. 4(1) does not include
all submissions. It does not include a supplementary NDS. (Bristol-Myers
Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318
(F.C.T.D.), at paras. 13, 19 and 21, aff'd (2002), 16 C.P.R. (4th) 425, 2002
FCA 32; Ferring Inc. v. Canada (Attorney General) (2003), 26 C.P.R.
(4th) 155, 2003 FCA 274, at para. 18; Toba Pharma Inc. v. Canada (Attorney
General) (2002), 21 C.P.R. (4th) 232, 2002 FCTD 927, at para. 34; AstraZeneca
Canada Inc. v. Canada (Minister of Health) (2004), 36 C.P.R. (4th) 58, 2004
FC 736, at paras. 39-40).
59 Applying a purposive
interpretation, the Federal Court in these cases held that to read “submission”
in s. 4(1) to include all NDSs would allow innovator companies to sidestep the
time limits applicable to patent lists by the simple expedient of submitting a
supplementary New Drug Submission (SNDS) making corporate or technical changes
to their filing (Bristol-Myers, at para. 19). Such a result would not be
consistent with the scheme of the NOC Regulations as a whole. In my
view, this purposive approach is correct.
60 The parallel words in s. 5(1.1)
are:
5.(1.1) ... where a person files or
has filed a submission for a notice of compliance in respect of a drug
that contains a medicine ...
61 The text of s. 5(1.1) closely
tracks the language of s. 4(1). It is a reciprocal provision in the sense that
s. 4(1) sets up the patent list that the person subject to s. 5(1.1) must
circumnavigate. Section 5(1.1) should therefore receive a similarly purposive
interpretation. The word “submission” should also be construed so as to fulfill
the purposes laid out in s. 55.2(4) of the Patent Act.
[83]
In my view, on the basis of this analysis the
Federal Court erred in law by failing to apply the jurisprudence which
interpreted “submission” as used in subsection 4(1) of the Regulations when
interpreting “submission” in subsection 5(1) of the Regulations.
[84]
Having rejected the arguments advanced by the
Federal Court it remains to be considered whether the Minister reasonably
decided that the drug submissions filed by Teva and Hospira did not trigger the
notice requirement found in subsection 5(1) of the Regulations.
[85]
To begin, I agree with the Federal Court that
there is more than one reasonable interpretation of subsection 5(1) of the
Regulations (reasons, at paragraph 56).
[86]
I accept the submission that the purposive
interpretation of the word “submission” articulated in Biolyse requires
consideration of each submission in issue in order to determine whether it is a
submission that triggers sections 4 or 5 of the Regulations.
[87]
Thus, in Hoffmann-La Roche Ltd. v. Canada
(Minister of Health), 2005 FCA 140, [2006] 1 F.C.R. 141, this Court found
that some drug submissions are excluded from the scope of section 4 of the
Regulations. Examples of such submissions were those made because of a change
in the brand-name of a drug, or a change in the name of the manufacturer of the
drug, or a change in the manufacturing site. Justice Sharlow wrote at paragraph
25 that:
… A change in the name of a drug or a drug
manufacturer, or a change of manufacturing site, cannot possibly be relevant to
any potential claim for infringement of a patent for a medicine found in the
drug. There is no justification for permitting patent holders to use such a
change to enhance the advantage they obtain under the Patented Medicines
(Notice of Compliance) Regulations. Thus, a supplemental new drug
submission is outside the scope of section 4 if it is filed to reflect a change
in the name of a drug or a drug manufacturer, or a change of manufacturing
site.
[88]
Later, in Hoffmann-La Roche Ltd. v. Canada
(Minister of Health), 2006 FCA 335, [2007] 3 F.C.R. 102, this Court
concluded that a supplement to a NDS made only to reflect changes in the name
of the drug manufacturer could not support an application to list a patent.
This was because:
37 There is a debate between the
parties as to the proper characterization of the April 30, 1998 submission.
Counsel for Roche characterizes it as a new drug submission and not a
supplement to a new drug submission, because it was filed to obtain a notice of
compliance that would permit Roche for the first time to market Bondronat.
Counsel for the Minister argues that the April 30, 1998 submission is what it
purports to be, an “administrative” submission or, in other words, a supplement
to the new drug submission originally filed by Boehringer Canada, reflecting a
change in the name of the corporation that would market Bondronat. The Minister
treated the April 30, 1998, submission as a supplement within the scope of
section C.08.003 of the Food and Drug Regulations, but not a supplement
that engaged the Minister’s obligation to assess the safety or effectiveness of
the drug.
38 I can find no fault with the
Minister’s characterization of the April 30, 1998 submission. On that date
there was an existing notice of compliance for Bondronat that had been issued
to Boehringer Canada. The April 30, 1998 submission reflected a proposed change
in the name of the entity that would be marketing Bondronat, which would
require that the labels be changed to identify Roche rather than Boehringer
Canada as the source of the drug (see paragraph C.08.003(2)(g) of the Food
and Drug Regulations).
[89]
Consistent with this jurisprudence, when
characterizing a drug submission the focus should be upon the drug product
itself. The question should be whether the changes reflected in the drug
submission give rise to a new or different basis for asserting that a particular
product is infringing.
[90]
In the case of Teva, GMP possessed a NOC that
entitled it to sell MED-EXEMESTANE tablets. GMP then licensed Teva to sell its
tablets. This required Teva to obtain its own NOC. Teva did not submit any data
in support of its application. Instead, it certified that its drug product was
identical to GMP’s drug except for the name of the manufacturer and the
product. It also certified that its drug product would be manufactured in the
same location as GMP’ s drug product, with identical specifications and
procedures. No evidence supports the submission that Teva “early worked”
Pfizer’s patented invention.
[91]
In this circumstance, I cannot conclude that the
Minister’s interpretation of subsection 5(1) of the Regulations was
unreasonable. Teva sought approval to market a product identical to that which
GMP was already entitled to market – in this circumstance it was not unreasonable
for the Minister to decline to confer on Pfizer the robust advantages conferred
on an innovator by the Regulations. Pfizer elected not to challenge GMP’s
notice of allegation. To require Teva to serve a new notice of allegation on
Pfizer for the identical product would, in effect, allow Pfizer to challenge
Teva’s later notice of allegation on the basis of Pfizer’s assessment of
competitive considerations; considerations unrelated to the nature of Teva’s
drug product. Importantly, it must be remembered that the issuance of a NOC to
Teva does not provide any defence to an action for patent infringement brought
by Pfizer. Pfizer may sue if Teva’s product infringes Pfizer’s patent.
[92]
This conclusion is, in my view, consistent with
the decision of the Federal Court in Glaxo where, in my view, the Court’s
conclusion that Apotex’ drug submission did not trigger the requirement to
address listed patents was founded on the evidence that Apotex certified that
all aspects of its submission were identical to 3M’s submission in respect of
AiromirÔ “except for a change in the manufacturer/sponsor’s
name and/or product name and that the product will be manufactured in the same
location with identical specifications and procedures” (emphasis in
original omitted) (Glaxo reasons, at paragraph 20).
[93]
This conclusion is also consistent with how
supplementary drug submissions are treated under subsection 5(2) of the PMNOC
Regulations. Under this provision, a supplement to a drug submission triggers
the requirement to address listed patents only when there is a change in
formulation, a change in dosage form, or a change in the use of the medical
ingredient. Changes of an administrative nature do not trigger the need to
address listed patents.
[94]
For the same reasons, I find that the Minister
of Health’s decision to issue a NOC to Hospira was reasonable.
[95]
Celltrion possessed a NOC that permitted it to
sell INFLECTRA in Canada and Celltrion’s NDS named Hospira as a distributor for
INFLECTRA. Hospira then filed a NDS cross-referencing Celltrion’s NDS in which
it sought approval to market INFLECTRA. Its NDS did not contain any scientific
data. Rather, it included Hospira’s certification that pursuant to the licensing
agreement it had been agreed that Celltrion would no longer sell INFLECTRA and
its additional certification that, except for the name of the manufacturer, all
aspects of its drug product were identical to Celltrion’s product and its product
would be manufactured in the same location with identical specifications and
procedures to that of Celltrion’s drug.
[96]
Again, any potential infringement of the 630
patent by Hospira may be addressed in infringement proceedings.
VII.
Conclusion
[97]
For these reasons, I would allow the appeals and
set aside the judgments of the Federal Court.
[98]
Pronouncing the judgments the Federal Court
should have made, I would order that the application for judicial review of the
decision of the Minister of Health brought by Pfizer in the Federal Court in
Court Docket T-1703-13 be dismissed, and Pfizer should pay one set of costs to
Teva and one set of costs to the Attorney General and the Minister of Health
both in this Court and in the Federal Court. I would further order that the
application for judicial review of the decision of the Minister of Health
brought by Janssen and The Kennedy Trust in the Federal Court in Court Docket
T-1516-14 be dismissed and Janssen and The Kennedy Trust should pay one set of
costs to Hospira and one set of costs to the Attorney General and the Minister
of Health both in this Court and in the Federal Court.
“Eleanor R. Dawson”
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“I agree.
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Wyman W. Webb
J.A.”
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“I agree.
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Donald J.
Rennie J.A.”
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