SUPREME
COURT OF CANADA
Between:
Celgene
Corporation
Appellant
and
Attorney
General of Canada
Respondent
Coram: McLachlin C.J. and Binnie, LeBel, Deschamps, Fish, Abella,
Charron, Rothstein and Cromwell JJ.
Reasons
for Judgment:
(paras. 1 to 35)
|
Abella J. (McLachlin C.J. and Binnie,
LeBel, Deschamps, Fish, Charron, Rothstein and Cromwell JJ. concurring)
|
Celgene
Corp. v. Canada (Attorney
General), 2011 SCC 1, [2011] 1 S.C.R. 3
Celgene Corporation Appellant
v.
Attorney General of Canada Respondent
Indexed as: Celgene
Corp. v. Canada (Attorney
General)
2011 SCC 1
File No.: 33579.
2010: November 10; 2011: January 20.
Present: McLachlin C.J. and Binnie, LeBel,
Deschamps, Fish, Abella, Charron, Rothstein and Cromwell JJ.
on
appeal from the federal court of appeal
Legislation
― Statutory interpretation ― Scope of the Patented Medicine Prices
Review Board’s price‑regulating and remedial authority ― Meaning of
“sold in any market in Canada” ― Whether concept should be interpreted in
accordance with commercial law principles or be responsive to surrounding
legislative context and purpose ― Patent Act, R.S.C. 1985, c. P-4,
ss. 80(1) (b), 83(1) , 85 .
Administrative law ― Judicial review
― Standard of review ― Reasonableness of Patented Medicine Prices
Review Board Board’s interpretation of its enabling legislation ― Patent
Act, R.S.C. 1985, c. P‑4, ss. 80(1) (b), 81(1) (a), 83(1) , 85 .
C
is a New Jersey-based distributor of a pharmaceutical sold under the brand name
Thalomid. Since 1995, C’s sales of this drug to Canadians have been made
pursuant to the Special Access Programme (“SAP”) as C did not get a Notice of
Compliance from Health Canada to sell the medicine in Canada. When a Canadian
doctor orders Thalomid under the SAP, the
medicine is packed in C’s facilities in the U.S. and shipped Free on Board to
the doctor in Canada. C prepares an invoice in New Jersey, mails it to Canada,
and directs that payment be made in U.S. dollars and couriered or mailed to C
in New Jersey. No Canadian taxes are paid on these transactions. The drug is
never redistributed in Canada and any unused portions must be returned to C’s
facility in Pennsylvania.
When
C obtained the Canadian patent in relation to Thalomid in 2006, the Patented
Medicine Prices Review Board (“Board”) advised C that it now had jurisdiction
to request pricing information from C from the time it first sold Thalomid
through the SAP in 1995. C initially provided some pricing information;
however, it refused to continue supplying the requested information, arguing
that under commercial law principles, the medicine was “sold” in New Jersey and
was outside the Board’s authority under s. 80(1) (b) of the Patent Act .
The Board concluded that C’s
Thalomid sales to Canadians pursuant to SAP were sales “in any market in
Canada” and fell within both its authority for price investigation and its
related remedial powers. The Board’s decision was initially reversed on
judicial review but the Federal Court of Appeal agreed with the Board’s
interpretation of its mandate.
Held:
The appeal should be dismissed.
The
legislative context and the consumer protection purpose of ss. 80(1) (b),
83(1) and 85 of the Patent Act support the Board’s conclusion that,
based on the language of the provisions, it has authority over C’s sales of
Thalomid to Canadians through the SAP. The Board was
justified in concluding that in order to comply with its mandate, sales “in any market in Canada” for the purposes of
the relevant provisions, should be interpreted to include sales of medicines
that are regulated by the public laws of Canada, will be delivered and
dispensed in Canada, and where, in particular, the cost of the medicine will be
borne by Canadians. All of these prerequisites are satisfied in the case of
C’s sales of Thalomid to Canadians through the SAP.
The
Board’s interpretation of its mandate under the relevant provisions was
consistent with its consumer protection purpose and should not be disturbed.
The Board is responsible for ensuring that the monopoly that accompanies the
granting of a patent is not abused to the financial detriment of Canadian
consumers. While words like “sold” may well have a commercial law meaning in
some statutory contexts, accepting a technical commercial law definition in
this context would undermine the Board’s consumer protection objectives by
preventing it from protecting Canadian purchasers of medicine entering Canada
through the SAP.
Although
the Board’s decision is unassailable under either standard of review, the
operative standard is reasonableness.
Cases Cited
Distinguished: Canada
(Deputy Minister of National Revenue) v. Mattel Canada Inc., 2001 SCC 36,
[2001] 2 S.C.R. 100; referred to: Dunsmuir v. New
Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190; Public
Service Alliance of Canada v. Canadian Federal Pilots Assn., 2009 FCA 223,
[2010] 3 F.C.R. 219; Canada Trustco Mortgage Co. v. Canada, 2005 SCC 54, [2005] 2 S.C.R.
601; Dole Refrigerating Products Ltd. v. Canadian Ice Machine Co. (1957),
28(2) C.P.R. 32; Domco Industries Ltd. v. Mannington Mills,
Inc. (1990), 29 C.P.R. (3d) 481, leave to appeal refused, [1990] 2 S.C.R.
vi; ICN Pharmaceuticals Inc. v. Patented Medicine Prices Review Board
(1996), 108 F.T.R. 190, aff’d [1997] 1 F.C. 32; Canada (Citizenship and
Immigration) v. Khosa, 2009 SCC 12, [2009] 1 S.C.R. 339; Nolan v.
Kerry (Canada) Inc., 2009 SCC 39, [2009] 2 S.C.R. 678.
Statutes and Regulations Cited
Act to amend the Patent Act and to
provide for certain matters in relation thereto,
S.C. 1987, c. 41.
Food and Drug Regulations, C.R.C. 1978, c. 870, ss. C.08.002, C.08.004, C.08.010, C.08.011.
Patent Act,
R.S.C. 1985, c. P-4, ss. 80(1) (b), 81(1) (a), 83(1) , 85 .
Patent Act Amendment Act, 1992, S.C. 1993, c. 2.
Authors Cited
Canada. Health Canada. Guidance
Document for Industry and Practitioners: Special Access Programme for Drugs.
Ottawa: Health Canada, 2008.
Canada. House of Commons. House of
Commons Debates, vol. I, 2nd Sess., 33rd Parl., November 20,
1986, pp. 1369, 1373.
Canada. House of Commons. House of Commons Debates,
vol. XII, 3rd Sess., 34th Parl., December 10, 1992, pp. 14998,
15001.
APPEAL
from a judgment of the Federal Court of Appeal (Evans, Sharlow and Ryer JJ.A.), 2009 FCA 378, 315 D.L.R. (4th) 270, 398 N.R. 233, 100 Admin. L.R.
(4th) 244, 81 C.P.R. (4th) 93, [2009] F.C.J. No. 1666 (QL), 2009
CarswellNat 4439, setting aside a decision of Campbell J., 2009 FC 271, 344 F.T.R. 45, 81 C.P.R. (4th) 79, [2009]
F.C.J. No. 668 (QL), 2009 CarswellNat 1499. Appeal dismissed.
William Vanveen and Henry S. Brown, Q.C., for the appellant.
Christopher Rupar and Jan Brongers, for the respondent.
The judgment
of the Court was delivered by
[1]
Abella J. — The Patented Medicine Prices Review Board (“Board”) has authority
under ss. 80(1) (b) and 81(1) (a) of the Patent Act,
R.S.C. 1985, c. P-4 , to require a patentee of a medicine to provide
it with information so it can investigate the price at which the medicine “is
being or has been sold in any market in Canada”. If the Board finds that the
price charged is excessive, under s. 83(1) it can order that the price be
reduced. This appeal centres on a single issue: whether the concept of “sold in any market in Canada” in the relevant provisions
should be interpreted strictly in accordance
with commercial law principles, or whether its definition should be responsive
to the surrounding legislative context and purpose.
Background
[2]
Celgene Corporation is the New Jersey-based distributor of a pharmaceutical
sold under the brand name Thalomid. This drug contains the active ingredient
thalidomide. Thalomid has proven to be an effective treatment for conditions
such as leprosy and multiple myeloma and is approved for those uses in the
United States.
[3]
Most sales of medicines in Canada occur after
Health Canada is satisfied of the medicine’s safety and effectiveness and has
issued a Notice of Compliance (“NOC”) pursuant to ss. C.08.002 and C.08.004 of the Food and Drug Regulations,
C.R.C. 1978, c. 870. Where the manufacturer has not applied for an NOC, or
Health Canada has not yet granted one, medicines may in some cases be sold to medical practitioners through an alternate route
— the Special Access Programme (“SAP”): see Food and Drug Regulations,
ss. C.08.010 and C.08.011. The SAP has been interpreted to allow access to
drugs not otherwise available in a particular market for the treatment of
“serious or life-threatening conditions where conventional therapies have
failed, are unsuitable, or are unavailable either as marketed products or
through enrollment in clinical trials”: Health Canada, Guidance Document
for Industry and Practitioners: Special Access Programme for Drugs (2008),
at p. 1.
[4]
There is no limit on the volume of sales that
can be made pursuant to the SAP, nor on the period of time that a manufacturer
may supply the medicine through it. If Health Canada approves the request for
sales pursuant to the SAP, the manufacturer is authorized to sell the medicine
for the use of the specific patient or clinical trial identified in the
request.
[5]
Celgene did not get
an NOC for Thalomid. Since 1995, its sales of this drug to Canadians have been
made pursuant to the SAP. Of the approximately 26,000 requests made under the
SAP in 2006 by medical practitioners,
approximately 4,500 were for Thalomid, making it the most frequently sourced
drug under the SAP.
[6]
When a Canadian doctor orders
Thalomid under the SAP, the medicine is packed in Celgene’s facilities in the
United States and shipped Free on Board to the doctor in Canada. Celgene
prepares an invoice in New Jersey, mails it to Canada, and directs that payment
be made in U.S. dollars and couriered or mailed to Celgene in New Jersey. No
Canadian taxes are paid on these transactions. The drug is never redistributed
in Canada — any unused portions must be returned to a Celgene facility in
Pennsylvania.
[7]
Celgene obtained a Canadian patent in relation
to Thalomid on April 4, 2006. Seven days later, the Board advised Celgene that
in view of this patent, the Board now had jurisdiction to request pricing
information from Celgene from the time it first sold Thalomid through the SAP
in 1995.
[8]
Celgene initially provided some pricing
information without prejudice to its position that the Board lacked
jurisdiction to obtain it. Ultimately, however, it refused to continue
supplying the requested information, arguing that because, under commercial law
principles, the medicine was “sold” in New Jersey, it was outside the Board’s
authority under s. 80(1) (b), which extended only to medicine “sold . . .
in Canada”.
[9]
A motion was brought to the
Board seeking an order that Celgene provide the pricing
information so a determination could be made by the
Board as to whether the price charged to Canadian purchasers was
excessive.
[10]
In its decision, the Board acknowledged that the
medicine was sold through Celgene’s head office in New Jersey and that, as the
parties freely acknowledged, New Jersey would be considered the locus of
the sale for commercial law purposes (PMPRB-07-D1-THALOMID). But in the
Board’s view, ordinary commercial law definitions of place
of sale were not germane to, let alone determinative of its authority.
While commercial law principles for determining where a sale took
place are helpful in enforcing contractual terms and determining the physical
location at which risk to the goods and transportation costs pass from the
vendor to the purchaser, the Board concluded that its authority under the Patent
Act is unrelated to allocation of risk, cost of transportation, or choice
of law in a contractual dispute. Because its mandate includes protecting
Canadians from excessive prices that may be charged for patented medicines, it
concluded that sales “in any market in Canada” include sales of medicine that
are regulated by Canadian law, that will be delivered and used in Canada, and where the cost of the medicine
will be borne by Canadians. Since the SAP is a Canadian law, Celgene’s sales
under this programme are included in this mandate.
[11]
Moreover, in the Board’s view, an interpretation
that is based on the commercial law approach to the location of the sale would
have the incongruous effect of giving it authority over commercial sales made
in Canada to foreign purchasers. This would be inconsistent with its
statutory mandate to protect Canadian consumers. It therefore
concluded that Celgene’s Thalomid sales to Canadians pursuant to the SAP fell
within both its authority for price investigation and its related remedial powers.
[12]
On judicial review, Campbell J. found that this
was a jurisdictional issue and that the appropriate standard of review was
correctness (2009 FC 271, 344 F.T.R. 45). In his view, although Thalomid is
sold to Canadians, it is sold in the United States, not Canada, and cannot fall
within the words “sold in any market in Canada”. The Board therefore had no
jurisdiction to order either the Thalomid pricing information or a price
reduction.
[13]
The Federal Court of Appeal (2009 FCA 378, 315
D.L.R. (4th) 270) agreed with the Board’s interpretation of its mandate. The
parties had jointly submitted that correctness was the appropriate standard of
review, characterizing the question as jurisdictional in nature. Evans
J.A. doubted that this was a proper characterization of either the standard or
the question, but since in his view the standard of review did not materially
affect the disposition of the appeal, he was prepared to accept the parties’
invitation to review the Board’s decision on a correctness standard (Dunsmuir v. New Brunswick, 2008 SCC 9, [2008] 1
S.C.R. 190; Public Service Alliance of Canada v. Canadian Federal Pilots
Assn., 2009 FCA 223, [2010] 3 F.C.R. 219, at paras. 36-52).
[14]
Engaging in a textual interpretation of the relevant provisions,
Evans J.A. noted that the interpretation should be based on the full phrase in
s. 80(1) (b), namely, “sold in any market in Canada”, not just the
words “sold in Canada”, as Celgene had urged. In his view, because the
language was open to different interpretations, one should be
chosen which best implemented the consumer protection objectives of the
price-regulation provisions of the Patent Act . If the provisions were
interpreted in a way that exempted Celgene’s Thalomid sales through the SAP,
Canadians would be deprived of the price protection that underlay the
enactment of those provisions.
[15]
In his dissenting reasons, Ryer J.A. did not
accept that the provisions were aimed at consumer protection. In his view, the jurisdiction of the Board is not engaged
unless it is established that the medicine in question has been the subject of
a sale taking place in Canada. Based on the ordinary commercial law
meaning of the words “sold in any market in Canada”, the medicine was “sold” in
the United States. This meant that the Board could not require Celgene to
provide pricing information for Thalomid.
[16]
For the reasons that follow, I share Evans
J.A.’s view that the Board’s decision should not be disturbed.
Analysis
[17]
The Board is responsible for monitoring and
regulating the prices of patented medicines. Under s. 81(1)(a) of the Patent
Act , the Board may order a patentee “of an invention pertaining to a
medicine to provide the Board with information and documents respecting . . .
any of the matters referred to in paragraphs 80(1) (a) to (e)”.
The particular provision at issue in this case is s. 80(1) (b), which
states that the Board is entitled to certain pricing information:
80. (1) A patentee of an invention
pertaining to a medicine shall, as required by and in accordance with the
regulations, provide the Board with such information and documents as the
regulations may specify respecting
. . .
(b) the
price at which the medicine is being or has been sold in any market in
Canada and elsewhere;
[18]
Section 83(1) of the Patent Act empowers
the Board to order the reduction of the price at which a patentee is selling
the medicine in any market in Canada when it is of the view that this price is
excessive:
83. (1) Where
the Board finds that a patentee of an invention pertaining to a medicine is
selling the medicine in any market in Canada at a price that, in the
Board’s opinion, is excessive, the Board may, by order, direct the patentee to
cause the maximum price at which the patentee sells the medicine in that market
to be reduced to such level as the Board considers not to be excessive and as
is specified in the order.
[19]
The Board’s decision to make a s. 83(1) remedial
order depends on the factors listed in s. 85 :
85. (1) In
determining under section 83 whether a medicine is being or has been sold
at an excessive price in any market in Canada, the Board shall take into
consideration the following factors, to the extent that information on the
factors is available to the Board:
(a) the prices at which the
medicine has been sold in the relevant market;
(b) the prices at which
other medicines in the same therapeutic class have been sold in the relevant
market;
(c) the prices at which the
medicine and other medicines in the same therapeutic class have been sold in
countries other than Canada;
(d) changes in the Consumer
Price Index; and
(e) such other factors as
may be specified in any regulations made for the purposes of this subsection.
(2) Where,
after taking into consideration the factors referred to in subsection (1), the
Board is unable to determine whether the medicine is being or has been sold
in any market in Canada at an excessive price, the Board may take into
consideration the following factors:
(a) the costs of making and
marketing the medicine; and
(b) such other factors as
may be specified in any regulations made for the purposes of this subsection or
as are, in the opinion of the Board, relevant in the circumstances.
(3) In determining under
section 83 whether a medicine is being or has been sold in any market in
Canada at an excessive price, the Board shall not take into consideration
research costs other than the Canadian portion of the world costs related to
the research that led to the invention pertaining to that medicine or to the
development and commercialization of that invention, calculated in proportion
to the ratio of sales by the patentee in Canada of that medicine to total world
sales.
[20]
The common language in ss. 80(1) (b),
83(1) , and 85 is: sold (or selling) in any market in Canada. I acknowledge
that these words may lend themselves to different interpretations. The
question is whether the one selected by the Board is justified.
[21]
The parties both relied on the approach used in Canada
Trustco Mortgage Co. v. Canada, 2005 SCC 54, [2005] 2 S.C.R. 601, at
para. 10, which confirmed that statutory interpretation involves a
consideration of the ordinary meaning of the words used and the
statutory context in which they are found:
It has been long established as a
matter of statutory interpretation that “the words of an Act are to be read in
their entire context and in their grammatical and ordinary sense harmoniously
with the scheme of the Act, the object of the Act, and the intention of
Parliament”: see 65302 British Columbia Ltd. v. Canada, [1999] 3
S.C.R. 804, at para. 50. The interpretation of a statutory provision must
be made according to a textual, contextual and purposive analysis to find a
meaning that is harmonious with the Act as a whole. When the words of a
provision are precise and unequivocal, the ordinary meaning of the words play a
dominant role in the interpretive process. On the other hand, where the
words can support more than one reasonable meaning, the ordinary meaning of the
words plays a lesser role. The relative effects of ordinary meaning, context
and purpose on the interpretive process may vary, but in all cases the court
must seek to read the provisions of an Act as a harmonious whole.
The
words, if clear, will dominate; if not, they
yield to an interpretation that best meets the overriding purpose of the
statute.
[22]
But although the parties agreed on the proper interpretive approach, they
disputed its application. The Attorney General argued that the phrase “sold in
any market in Canada” is broad and should not be given the limited, technical
interpretation ascribed to it by Celgene. Celgene, on the
other hand, argued that the word “sold” is so “precise and unequivocal” that it
must play the determinative role in the interpretive process (Canada Trustco,
at para. 10). Citing Canada (Deputy Minister of
National Revenue) v. Mattel Canada Inc., 2001 SCC 36, [2001] 2 S.C.R. 100,
Celgene argued that “sold” is a legal term of art that should presumptively be
given its private law, commercial meaning. In its view, the plain
meaning of “sold in any market in Canada” connotes a commercial contract of
sale occurring in Canada.
[23]
Mattel is of
limited assistance in this case. It involved an interpretation of s. 48(5) (a)(iv)
of the Customs Act, R.S.C. 1985, c. 1 (2nd Supp .), a provision concerned
with whether royalties paid between two private parties in a commercial
transaction were “a condition of the sale of the goods for export to Canada”.
Major J. concluded that in the particular context of that provision — which
assists in calculating customs duties on items imported into Canada — the word
“condition” in the phrase “condition of the sale” had a settled meaning in sale
of goods law which governed in interpreting this private transaction (see
paras. 58-59).
[24]
I accept that, as Mattel demonstrates,
words like “sold” may well have a commercial law meaning in some statutory
contexts, including, for example, in other parts of the Patent Act (see Dole
Refrigerating Products Ltd. v. Canadian Ice Machine Co. (1957), 28(2)
C.P.R. 32 (Ex. Ct.); Domco Industries Ltd. v. Mannington Mills, Inc.
(1990), 29 C.P.R. (3d) 481 (F.C.A.), leave to appeal refused, [1990] 2 S.C.R.
vi).
[25]
But that does not mean that the Board
misinterpreted the words “sold” and “selling” in the context of ss. 80(1) (b),
83(1) and 85 . In rejecting the technical commercial law definition, the Board
was guided by the consumer protection goals of its mandate, concluding that
Celgene’s approach would undercut these objectives by preventing the Board from
protecting Canadian purchasers of Thalomid and other foreign-sold SAP patented
medicines.
[26]
The Board’s interpretive choice is supported
by the legislative history. The Board was established in
amendments contained in Bill C-22, An Act to amend the Patent Act and to
provide for certain matters in relation thereto, which received Royal
Assent on November 19, 1987, as S.C. 1987, c. 41. Introducing the Bill for
second reading, the Hon. Harvie Andre made the following relevant comments
about the Board’s objectives:
In
essence, the amendments I propose in Bill C-22 will create a climate favourable
to new investment in research and development by giving patent holding
pharmaceutical firms in Canada a guaranteed period of protection. These
changes will also ensure consumer protection by creating a drug prices review
board to monitor drug prices. . . .
. . .
I humbly
submit that anybody who takes an objective view of what we are proposing will
see that we have in place enormous checks and balances to ensure that
consumer prices of drugs remain reasonable. They should look at
what we will get by way of research and development, and at the jobs this will
create.
. . .
Whatever
costs might be associated with this legislation will be minimal. They will not
hit the consumer. [Emphasis added.]
(House of Commons Debates, vol. I,
2nd Sess., 33rd Parl., November 20, 1986, at pp. 1369 and 1373)
[27]
When the Patent Act
was further amended in 1993 (Patent Act Amendment Act, 1992, S.C. 1993,
c. 2), the then Minister of Consumer and Corporate Affairs and Minister of
State (Agriculture), the Hon. Pierre Blais, reiterated the Board’s consumer
protection mandate:
With Bill
C-91, we also wanted to strengthen consumer protection, so that consumers can
continue to obtain patented medicine at reasonable prices. I think that all
Canadians are entitled to that.
. . .
. . . The
board will thus be able to provide all Canadian consumers with even more
effective price control. These new powers will authorize the board to order a
reduction of prices it considers too high. . . .
. . . I
am convinced that these new provisions will assure Canadian consumers, of
reasonable prices, like those they have had since 1987.
(House of Commons Debates, vol. XII,
3rd Sess., 34th Parl., December 10, 1992, at pp. 14998 and 15001)
[28]
The
Board’s consumer protection purpose was affirmed
in ICN Pharmaceuticals Inc. v. Patented Medicine Prices Review Board
(1996), 108 F.T.R. 190, aff’d [1997] 1 F.C. 32 (C.A.), where
Cullen J. said:
Sections 79 to 103 of the Patent
Act , creating the Patented Medicine Prices Review Board, were enacted in
response to the abolition of the compulsory licensing regime. Parliament’s
intent was certainly to address the “mischief” that the patentee’s monopoly
over pharmaceuticals during the exclusivity period might cause prices to rise
to unacceptable levels. Accordingly, the words of these sections of
the Patent Act should be read purposively . . . .
[Emphasis added; para. 24.]
[29]
This is the approach to its mandate that the
Board applied, one that took into paramount account its responsibility for ensuring
that the monopoly that accompanies the granting of a patent is not abused to
the financial detriment of Canadian patients and their insurers:
The
mandate of the Board includes balancing the monopoly power held by the patentee
of a medicine, with the interests of purchasers of those medicines. The patentee of a medicine sold in Canada is subject to the
jurisdiction of the Board, and this jurisdiction requires the patentee to
report information to the Board concerning the price at which it has been
selling the patented medicine in any market in Canada. The Board compares this
price to the price of comparable medicines, and to the price at which the
medicine is sold in other countries, to determine whether or not its price in
Canada is excessive. In consultation with industry, government and consumer
stakeholders, the Board has developed detailed guidelines that patentees and
Board Staff use to ensure that the prices of patented medicines in Canada are
not excessive . . . . [Emphasis added; para. 5.]
[30]
The Board therefore concluded that in order to comply
with that mandate, sales “in any market in Canada” for
the purposes of the relevant provisions,
should be interpreted to “include sales of medicines that are regulated by the
public laws of Canada, that will be delivered in Canada, to be dispensed in
Canada, and where, in particular, the cost of the medicine will be borne by
Canadians — patients or taxpayers, as the case may be” (para. 34). All of
these prerequisites are satisfied in the case of Celgene’s sales of Thalomid to
Canadians through the SAP.
[31]
The Board also found, and I agree, that a strict
commercial law interpretation of “sold” in s. 80(1) (b) would give the
Board authority over sales which, while technically made “in Canada”, are
destined for other countries, a result incongruous with the legislative purpose
of regulating the price at which patented medicines are sold in Canadian,
not foreign, markets:
. . . the Board does not have a statutory
mandate to protect European purchasers of patented medicines, regardless of the
locus of the sale at common law. The locus of the sale at common
law, does not give rise to jurisdiction when the locus is Canada, and
does not deprive the Board of jurisdiction when the locus is outside of
Canada. [para. 36]
[32]
In my view, therefore, the legislative context and the
consumer protection purpose of ss. 80(1) (b), 83(1) and 85 of the Patent
Act support the Board’s conclusion that, based on the language of those
provisions, it has authority over Celgene’s sales of Thalomid to Canadians
through the SAP.
[33]
A final observation. In this Court, neither party
presented any argument on the standard of review. Both had proceeded throughout
the judicial review process on the basis that the applicable standard of review
was correctness. While the parties should not be able, by agreement, to contract
out of the appropriate standard of review, like Evans J.A. I am of the view
that the Board’s decision would be upheld under either standard.
[34]
And like Evans J.A., I also question whether
correctness is in fact the operative standard. This specialized tribunal is interpreting its enabling legislation. Deference will usually be accorded in these
circumstances: see Dunsmuir, at paras. 54 and 59; Canada
(Citizenship and Immigration) v. Khosa,
2009 SCC 12, [2009] 1 S.C.R. 339, at para. 44;
and Nolan v. Kerry (Canada) Inc., 2009 SCC 39, [2009] 2
S.C.R. 678. Only if the Board’s decision is unreasonable will it be set
aside. And to be unreasonable, as this Court said in Dunsmuir, the
decision must be said to fall outside “a range of possible, acceptable outcomes
which are defensible in respect of the facts and law” (para. 47). Far from
falling outside this range, I see the Board’s decision as unassailable under
either standard of review.
[35]
I would dismiss the appeal with costs.
Appeal
dismissed with costs.
Solicitors
for the appellant: Gowling Lafleur Henderson, Ottawa.
Solicitor
for the respondent: Attorney General of Canada, Ottawa.