Date: 20080520
Docket: A-27-08
Citation: 2008 FCA 186
CORAM: LÉTOURNEAU
J.A.
SHARLOW J.A.
TRUDEL
J.A.
BETWEEN:
ABBOTT LABORATORIES LIMITED,
TAP PHARMACEUTICALS INC. and
TAP PHARMACEUTICAL PRODUCTS INC.
Appellants
and
ATTORNEY GENERAL OF CANADA and
MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
SHARLOW J.A.
[1]
This is an
appeal of a decision of Justice Hughes (2007 FC 1318) rejecting the application
of the appellants (collectively, “Abbott”) made under section 18 of the Federal
Courts Act, R.S.C. 1985, c. F-7. Abbott seeks an order prohibiting the
Minister of Health (the “Minister”) from issuing a notice of compliance (“NOC”)
to any person for a generic version of Prevacid 15 mg or 30 mg delayed release
capsules without requiring that person to address, under section 5 of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “PM (NOC)
Regulations”), Canadian patent number 1,327,010 (the “010 patent”) and
Canadian patent number 1,338,377 (the “377 patent”).
Statutory framework
[2]
Most cases
under the PM (NOC) Regulations involve a dispute between an “innovator”
(the manufacturer of a drug that embodies a patent claim) and a generic drug
manufacturer who wishes to market a generic version of the innovator drug. This
case involves a dispute between an innovator and the Minister.
[3]
The PM
(NOC) Regulations were enacted to discourage potential abuses of the early
working exception in section 55.2(1) of the Patent Act, R.S.C.1985, c.
P-4, in relation to certain pharmaceutical patents. Pursuant to the early
working exception, a generic drug manufacturer does not infringe a patent embodied
in an innovator drug merely by making use of the patented invention, before the
patent expires, for the purpose of seeking regulatory approval for a generic
version of the innovator drug.
[4]
No drug
may be marketed in Canada without a NOC issued by the
Minister under the Food and Drug Regulations, C.R.C. c. 870. The PM
(NOC) Regulations operate through that drug approval process. Generally, a NOC
is issued when the Minister is satisfied that the applicable conditions in the Food
and Drug Regulations are met. Once the Minister is so satisfied, he must
issue the NOC (Apotex Inc. v. Canada (Attorney General (C.A.), [1994] 1 F.C. 742), unless he is
precluded from doing so by section 7 of the PM (NOC) Regulations.
[5]
The PM
(NOC) Regulations require the Minister to maintain a “patent register”.
When the Minister issues a NOC to an innovator for a drug that embodies a
patent claim, the innovator may apply to have the patent listed on the patent
register in respect of that drug. If the patent is listed in respect of the
drug, and a generic drug manufacturer files an abbreviated new drug submission
(“ANDS”) seeking a NOC for a generic version of the drug based on certain
comparisons establishing bioequivalence, then section 7 of the PM (NOC)
Regulations precludes the Minister from issuing a NOC for the generic drug
until the later of certain dates. One of those dates is the day on which the
generic drug manufacturer “complies with section 5” of the PM (NOC)
Regulations. A generic drug manufacturer’s application for a NOC is said to
be on “patent hold” if the Minister completes his regulatory review of the
proposed generic drug, but cannot issue a NOC immediately because of the
constraints imposed by section 7 of the PM (NOC) Regulations.
[6]
A generic
drug manufacturer complies with section 5 of the PM (NOC) Regulations by
“addressing” the patents listed on the patent register in respect of the drug
to which the generic drug is compared. A generic drug manufacturer may address
a patent by accepting that it will not receive a NOC for its generic drug until
the patent expires. Or the generic drug manufacturer may address a patent by
making one or more “allegations” that, if true, would entitle the generic drug
manufacturer to disregard the listed patent. For example, a patent may be
addressed by an allegation that the patent has expired, the patent is not
valid, or that no claim of the patent for the medicinal ingredient, the
formulation, the dosage form or the use of the innovator drug would be
infringed by the generic drug. If such an allegation is made, the generic drug
manufacturer must serve the innovator with a detailed statement containing
prescribed information about the basis for the allegation.
[7]
The
serving of the detailed statement permits the innovator to apply to the Federal
Court under section 6 of the PM (NOC) Regulations for an order
prohibiting the Minister from issuing a NOC for the generic drug until after
the listed patent expires. The commencement of that application marks the start
of a 24 month statutory stay (which may be shortened or lengthened by the
Federal Court in certain circumstances) during which the Minister cannot issue
a NOC for the generic drug unless one of a number of possible events occurs.
One of those events is the dismissal or discontinuance of the prohibition
application.
Facts
[8]
Since
1995, Abbott has been authorized to market Prevacid capsules in Canada pursuant to NOCs issued by
the Minister. Several patents are listed on the patent register in respect of
Prevacid, including the two patents in issue in this case, the 010 patent and
the 377 patent. It is undisputed in this case that those patents contain claims
for compositions of lansoprazole, the active medicinal ingredient in Prevacid.
It is also undisputed in this case that the formulation of Prevacid that Abbott
is authorized to market in Canada embodies, and has always embodied, at least
one claim of each of those patents.
[9]
The 010
patent was issued on February 15, 1994 and the 377 patent was issued on June
11, 1996. It appears that an application could have been made under subsection
4(6) of the PM (NOC) Regulations to list the two patents within 30 days
of their issuance, but that was not done. The record contains no explanation
for that. In any event, Abbott applied to have the two patents listed when it
made a supplementary new drug submission (“SNDS”) for new administration
options for Prevacid. On August 2, 2006, the Minister issued a new NOC for those
new administration options and, on the next day, listed the 010 patent and the
377 patent in respect of Prevacid. For the purposes of this appeal, I assume
without deciding that the Minister was correct to list both patents at that
time.
[10]
Prior to
the listing of the 010 patent and the 377 patent in respect of Prevacid, Novopharm
and one other generic drug manufacturer had each filed an ANDS to obtain a NOC
for a generic version of Prevacid. The Novopharm ANDS had been approved by the
Minister and placed on patent hold before August 3, 2006, when the 010 patent
and the 377 patent were listed in respect of Prevacid. By letter dated February
28, 2007, the Minister advised Novopharm that it would not be required to
address either of those patents.
[11]
Abbott commenced
the present application in the Federal Court on February 7, 2007, after the
filing of the two ANDSs referred to above, but before the Minister had advised
Novopharm that it would not be required to address the 010 patent and the 377
patent.
Discussion
[12]
What
prompted Abbott to commence the present application? The answer begins with the
decision of the Supreme Court of Canada in AstraZeneca Canada Inc. v. Canada (Minister of Health), [2006] 2 S.C.R. 560, 2006
SCC 49. That decision was released on November 3, 2006.
[13]
AstraZeneca
had obtained a NOC for the original formulation of a drug called Losec 20,
which was marketed in Canada from 1989 to 1996. The patent
for the active medicinal ingredient in Losec 20 expired in 1999. Apotex Inc., a
generic drug manufacturer, applied for a NOC for a generic version of the
original formulation of Losec 20, for the originally approved use. Meanwhile,
AstraZeneca had sought and obtained a NOC for a new formulation of Losec 20 for
a new use, but containing the same medicinal ingredient. AstraZeneca then listed
two additional patents (referred to as “the 037 patent” and the “470 patent”)
in respect of Losec 20.
[14]
Justice
Binnie, writing for the Court, held that Apotex Inc. was not required to
address the two newly listed patents pursuant to section 5 of the PM (NOC)
Regulations, because it was comparing its generic drug to the pre-1996
formulation of Losec 20 for its original use, and had not taken advantage of
the early working exception with respect to the inventions disclosed in the two
newly listed patents.
[15]
In analysing the scheme of the PM (NOC) Regulations,
Justice Binnie noted that they established a certain linkage between the
submission of an innovator for a NDS or SNDS, the issuance of a NOC upon the
approval of that NDS or SNDS, and the listing of a patent upon the issuance of
that NOC. As he said in paragraph 21 (emphasis in original):
[21]
I emphasize the words in s. 4(5) that in the case of
patents added afterwards, “the first person must identify the submission
to which the patent list or the amendment relates, including the
date on which the submission was filed”. In addition, s. 3(3)
provides that “[n]o information submitted pursuant to section 4 shall be
included on the register until after the issuance of the notice of
compliance in respect of which the information was submitted.” These
provisions, it seems to me, provide an important key to understanding the
scheme. Entry of the “Patent list” does not destroy the linkage between the
patent and the submission(s) to which it relates, nor to the NOC to which the
submission(s) are directed. Specific patents are associated with one or
more NDS, ANDS or SNDS, which in turn (if approved) give rise to specific NOCs,
which in turn approve a specific manufacturer’s product, which a generic
manufacturer may seek to copy. There is no linkage between the 037 and
470 patents and the submissions that lead to the Losec 20 product copied
by Apotex. Those after-acquired patents were listed in relation to a SNDS
dated January 22, 1999 by AstraZeneca for a new medical use for Losec 20
(treatment of H. Pylori), a use for which the Apotex product is not
approved, and to an administrative SNDS submitted by AstraZeneca dated July 12,
2000, which submission has nothing at all to do with the technology
incorporated in Losec 20.
[16]
Following the release of AstraZeneca, and in an attempt to
apply its teaching, the Minister devised a framework for determining when the
requisite linkage existed, which in turn would determine whether there were
patents listed in respect of an innovator drug that a generic drug manufacturer
would not be required to address under section 5 of the PM (NOC) Regulations. That framework was summarized by
Justice Hughes in Ferring Inc. v. Minister of Health, 2007 FC 300, at
paragraph 63. First, the Minister would determine the date upon which the
generic drug manufacturer purchased the version of the innovator drug it used
for the purpose of testing for the required bioequivalence comparison. The
generic drug manufacturer would necessarily be required to address any patents
listed prior to that purchase. Second, the Minister would consider each NOC
issued for the innovator drug after the date of purchase, with a view to
determining whether the generic drug manufacturer had made use of any changes
made to the innovator drug since the date of purchase. If so, the generic drug
manufacturer would be required to address patents listed after the date of
purchase in relation to those changes.
[17]
Based on that analytical framework, the Minister reviewed a number
of pending cases in which patents had been listed in respect of a particular
drug after the filing of an ANDS for a generic version of the drug. In some
cases, the Minister issued notices of compliance for the generic drug without
requiring the generic drug manufacturer to address patents listed after the
filing of the ANDS. In others, the Minister concluded that the generic drug
manufacturer would be required to address the later listed patents. Five
separate judicial review applications were made to challenge the Minister’s
decisions. Those applications were heard by Justice Hughes and dismissed on
March 20, 2007 (Ferring, cited above). There were five appeals. One was
dismissed as moot (Novopharm Ltd. v. Minister of Health, 2007 FCA 275).
The others were dismissed on the merits (Ferring Inc. v. Minister of Health,
2007 FCA 276), released September 6, 2007.
[18]
As a result of certain comments made by Justice Hughes in Ferring,
the first step in the analytical framework adopted by the Minister after AstraZeneca
was changed slightly. The revision appears in the affidavit of a senior
official of Health Canada sworn April 12, 2007, and
filed in the present case. The change was to the first step. Instead of using
as a starting point the date of acquisition of the innovator drug for testing
purposes, the Minister would use the date of the filing of the generic drug
manufacturer’s ANDS. Thus, the generic drug manufacturer would always be
required to address patents listed in respect of the innovator drug before the
filing date of the ANDS. If an examination of NOCs issued for the innovator
drug after that date indicated that the generic drug manufacturer had
made use of changes made to the innovator drug after that date, the generic
drug manufacturer would be required to address patents listed after that date
in relation to those changes.
[19]
The most recent version of the Minister’s framework is found in a
document entitled “Guidance Document”, as amended on December 13, 2007, at pages
27 and 28. The description of the framework is substantially unchanged from the
description in the affidavit filed in this case. However, the Guidance Document
states that the framework is intended to be applied only in respect of the
version of the PM (NOC) Regulations considered in AstraZeneca or,
in other words, only where a generic drug manufacturer’s ANDS was filed
pursuant to the PM (NOC) Regulations as they read before certain
amendments came into force on October 5, 2006.
[20]
Abbott is
of the view that the Minister’s interpretation of AstraZeneca, and his
resulting analytical framework, is incorrect. Abbott argues that, because
Prevacid embodies claims of both the 010 patent and the 377 patent, any generic
drug manufacturer proposing to market a generic version of Prevacid must
necessarily have early worked the patented inventions in developing that
generic version. That distinguishes the facts of this case from the facts in AstraZeneca.
Abbott argues that if the Minister were to apply his framework as the basis for
issuing a NOC for a generic version of Prevacid without requiring the 010
patent and the 377 patent to be addressed, Abbott would be deprived wrongfully
of the benefit of the PM (NOC) Regulations, even if the ANDS for the
generic version of Prevacid was filed before the 010 patent and the 377 patent
were listed.
[21]
Justice
Hughes rejected Abbott’s application without discussing its criticisms of the
Minister’s interpretation of AstraZeneca or his analytical framework.
[22]
It is common ground that Justice Hughes was entitled in his
discretion to grant or to refuse Abbott’s application. A discretionary decision
will not be reversed on appeal unless there is an error of law, or a
failure to exercise the discretion judicially: see Sanofi-Aventis
Canada Inc. v. Novopharm Ltd., 2007 FCA 163, at paragraph 13. In my
view, Justice Hughes did not err in law or fail to exercise his discretion
judicially.
[23]
Justice Hughes said, and I agree, that the Federal Court will not grant an order that
simply requires the Minister to do what the PM (NOC) Regulations require.
In this case, it has not been suggested that the Minister has failed to do what
the PM (NOC) Regulations require. Rather, Abbott is concerned that the
Minister may make a decision in the future that will contravene the PM (NOC)
Regulations.
[24]
Justice
Hughes also said, and I agree, that the Federal Court should be reluctant to
prohibit the Minister from making any decision under the PM (NOC)
Regulations in the future unless it is certain that the Minister will make
that decision, and that the decision necessarily is or would result in a
contravention of the PM (NOC) Regulations. The requisite certainty is
lacking in this case because it is not clear when the Minister will be required
to decide whether to issue a NOC for a generic version of Prevacid, what the relevant
facts will be at that time, or whether at that time the Minister will still be
following the analytical framework described above. Also, the jurisprudence
relating to the PM (NOC) Regulations is continually evolving, and it is
not clear what the law will be when the Minister must make that decision.
[25]
In that
regard, it is relevant to note that there has already been considerable
litigation involving the application of the PM (NOC) Regulations to
Prevacid. Canadian patent number 2,269,053 (the “053 patent”) was listed on
the patent register in respect of Prevacid on July 25, 2006. On March 1, 2007,
the Minister removed that patent from the register. Abbott was successful in
having the listing restored: Abbott Laboratories Ltd. v. Canada, 2007 FC 797. An appeal from
that decision is scheduled to be heard on June 11, 2008 (A-383-07).
[26]
In
addition, Abbott has commenced at least three prohibition applications under
section 6 of the PM (NOC) Regulations in relation to Prevacid. One of
those applications (T-2052-06, Abbott Laboratories Ltd. v. Novopharm Limited)
involves the 053 patent referred to above. I assume that application will
continue if the Federal Court decision requiring the 053 patent to be listed
stands. Another prohibition application, relating to Canadian patent number
2,286,753, was dismissed: Abbott Laboratories Ltd. v. Novopharm Limited,
2007 FC 622, affirmed 2007 FC 865. A third application, relating to Canadian
patent 2,009,741 (the “741 patent”), was successful: Abbott Laboratories
Limited v. Novopharm Limited, 2006 FC 1411, affirmed 2007 FCA 251.
Therefore, regardless of the outcome of the litigation involving the 053
patent, the Minister cannot issue a NOC for Novopharm’s generic version of
Prevacid until the 741 patent expires on February 9, 2010.
[27]
I also
agree with Justice Hughes that granting Abbott the order it seeks would not be
fair to Novopharm or the other generic drug manufacturer who filed an ANDS for
a generic version of Prevacid prior to the listing of the 010 patent and the
377 patent, unless they are given an opportunity to be heard.
[28]
As
indicated above, Justice Hughes did not address the substance of Abbott’s
argument, and I will not do so either. However, I note that it remains an open
question whether the Minister would be correct to apply his analytical
framework in every case where a question arises as to whether a generic drug
manufacturer must address a patent listed after the date of the filing of the
generic drug manufacturer’s ANDS. Chief Justice Richard, speaking for
the Court in the Ferring appeals (cited above), said this at paragraph 6
of his reasons:
[6]
We have concluded that the analytical approach adopted by the Minister in these
four appeals was adequate for the factual circumstances of these cases. Whether
it is adequate for all possible circumstances [ . . . ] is a question upon
which we express no opinion.
[29]
It would
appear from the preface to the Guidance Document that the Minister is aware of
the need for a case by case determination. The preface reads in part as
follows:
Guidance
documents are administrative instruments not having force of law and, as such,
allow for flexibility in approach. Alternate approaches to the principles and
practices described in this document may be acceptable provided
they are supported by adequate justification.
[30]
I note
also that if the Minister issues a NOC for a generic version of Prevacid
without requiring the 010 patent and the 377 patent to be addressed because the
ANDS for the generic drug was filed before those patents were listed, the
dismissal of Abbott’s application in this case will not preclude Abbott from
challenging the Minister’s decision to issue the NOC. In addition, Abbott
retains all of its rights under the Patent Act to sue for infringement
if it has a basis for claiming that anyone marketing a generic version of
Prevacid would infringe the 010 patent or the 377 patent.
Conclusion
[31]
I would
dismiss this appeal with costs.
“K.
Sharlow”
“I
agree
Gilles
Létourneau J.A.”
“I
agree
Johanne
Trudel J.A.”
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