Date: 20130219
Docket:
T-599-11
Docket:
T-679-11
Citation: 2013
FC 142
BETWEEN:
Docket:
T-599-11
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NOVARTIS
PHARMACEUTICALS
CANADA INC.
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Applicant
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and
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APOTEX INC.
AND
THE
MINISTER OF HEALTH
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Respondents
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and
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NOVARTIS AG
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Respondent/
Patentee
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AND BETWEEN:
Docket:
T-679-11
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NOVARTIS
PHARMACEUTICALS
CANADA INC.
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Applicant
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and
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TEVA CANADA
LIMITED AND
THE
MINISTER OF HEALTH
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Respondents
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and
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NOVARTIS AG
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Respondent/
Patentee
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PUBLIC
REASONS FOR JUDGMENT
(Confidential Reasons for Judgment released February 8,
2013)
SNIDER J.
I.
Introduction
[1]
Novartis AG (Novartis) is the recorded owner of Canadian
Patent No. 2,093,203 (the '203 Patent), a patent applied for on April 1, 1993,
granted to Novartis on November 26, 2002, and which will expire on April 1,
2013. Novartis Pharmaceuticals Canada Inc. (Novartis Canada), an affiliate of
Novartis, sells a drug in Canada with the trademark of GLEEVEC, which is best
known as a highly-effective drug for the treatment of chronic myeloid leukemia
(CML). The active ingredient in GLEEVEC is imatinib mesylate. Imatinib and its
salt, imatinib mesylate, are compounds included in the '203 Patent.
[2]
Teva Canada Limited (Teva) and Apotex Inc. (Apotex) wish to
sell generic versions of imatinib and they have, separately, taken three steps
to enable them to do so. Specifically, each has:
(a)
applied to the Minister of Health (the Minister) for a
Notice of Compliance (NOC) in respect of orally administered 100 mg and 400 mg
tablets containing imatinib, pursuant to the Patented Medicines (Notice of
Compliance) Regulations, SOR/93-133 (the PM (NOC) Regulations
or Regulations);
(b)
served Novartis Canada with a Notice of Allegation (NOA)
with respect to the '203 Patent, in which Teva or Apotex, as applicable,
alleges that all or certain claims of the '203 Patent are invalid; and
(c)
commenced an action against Novartis, seeking a declaration
under s. 60(1) of the Patent Act, RSC 1985, c P-4 (Patent Act)
that some or all of the claims of the '203 Patent are invalid (the Teva
Impeachment Action in Court File No. T-2021-10 and the Apotex Impeachment
Action in Court File No. T-833-11).
[3]
In response to each of the NOAs, Novartis Canada filed a
Notice of Application requesting that the Court: (a) declare the NOA to be a
nullity; or (b) issue an Order of Prohibition in accordance with s. 6(1) of the
PM (NOC) Regulations preventing the Minister of Health from authorizing
the second person to market imatinib until the expiry of the '203 Patent. The
two applications are the subject of these reasons for judgment and are referred
to as follows:
1.
the Teva Prohibition Application filed by Novartis Canada on April 18, 2011 (Court File No. T-679-11); and
2.
the Apotex Prohibition Application filed by Novartis Canada on April 8, 2011 (Court File No. T-599-11).
[4]
By Order of Prothonotary Tabib dated May 30, 2011, the Teva
Impeachment Action, the Apotex Impeachment Action, the Teva Prohibition
Application and the Apotex Prohibition Application were consolidated. All four
matters were dealt with in the course of 14 days of evidence and 5 days of
argument.
[5]
These Reasons for Judgment address the issues raised by the
Prohibition Applications. The Impeachment Actions are jointly dealt with in a
separate set of Reasons for Judgment and Judgment:
(a)
2013 FC 141 (the Teva Impeachment Action in Court File No.
T-2021-10); and
(b)
2013 FC 141 (the Apotex Impeachment Action in Court File
No. T-833-11).
[6]
Novartis Canada raises two issues in these Prohibition
Applications:
1.
Are the letters of Teva dated March 7, 2011 and Apotex
dated February 18, 2011 proper NOAs under the PM (NOC) Regulations; and
2.
If so, are the allegations contained in those letters
justified?
[7]
The second issue identified by Novartis Canada is, in this case, determinative. Because of my decision in the Impeachment Actions
that dismisses each of the actions and holds that the claim to imatinib in the
'203 Patent is not invalid, it follows that the allegations of invalidity
contained in the NOAs cannot be justified. That is a sufficient reason for this
Court to issue the Orders of Prohibition sought by Novartis. I have not
repeated those reasons in this decision and refer the reader to that much
lengthier decision in 2013 FC 141.
[8]
Because of my conclusions that the allegations in the NOAs are
not justified, I have concluded that I need not address the propriety of the
NOAs. I have, however, included in these reasons enough of the background to
provide context to the reader for the question.
II.
Statutory
Scheme
[9]
To situate the reader, I begin with an overview of the drug
approval process and the relevant PM (NOC) Regulations. Before a
pharmaceutical company can market a prescription drug in Canada, it must comply with the provisions of the Food and Drug Regulations, CRC,
c 870 [F&D Regulations] and obtain approval in the form of a
Notice of Compliance (NOC).
[10]
Section C.08.002(1)(a) of the F&D Regulations
provides that anyone who wishes to sell a drug in Canada must submit to the
Minister of Health (through Health Canada), either a new drug submission (NDS)
or an abbreviated new drug submission (ANDS). An NDS is filed by an innovative
drug company, or “first person”, seeking approval to market a new drug product.
In contrast and in very general terms, an ANDS is filed by a generic
manufacturer, or “second person”, that wishes to market a generic version of a
drug that has already been approved. The second person may rely on much of the
technical, health and safety information originally filed as part of the NDS by
the first person. In other words, it may compare its drug with, or make
reference to, a brand name drug (F&D Regulations, above at s.
C.08.002.1. (1))
[11]
An essential element of the regulatory scheme is the
“Patent Register”. The PM (NOC) Regulations allow an innovator who has
filed an NDS or a supplement to a new drug submission (SNDS) to submit a list
of the associated patents to the Minister for inclusion on the register of
patents (Patent Register or Register) (s. 4(1)).
[12]
If a patent is listed on the Patent Register, s. 5 of the PM
(NOC) Regulations provides that the second person, with respect to each
patent on the Patent Register, must, in its application for an NOC:
•
state that it accepts that the NOC will not issue until the
patent expires (s. 5(1)(a)); or
•
allege that:
-
the first person is not the patentee or licensee of the
listed patent (s. 5(1)(b)(i));
-
the patent has expired (s. 5(1(b)(ii));
-
the patent is not valid (s. 5(1)(b)(iii)); or
-
the second person will not infringe the listed patent (s.
5(1)(b)(iv)).
[13]
The second person identifies its election by marking the
applicable box on the document entitled “Form V: Declaration Re: Patent List”
(Form V) submitted with its ANDS. On the Form V, the second person provides a
certification: “I certify that the information included in this Declaration
is accurate and relevant to the Patented Medicines (Notice of Compliance)
Regulations”.
[14]
If the second person elects to wait for the expiry of the
patent, no notice is given to the first person.
[15]
Ms. Anne Bowes, Director of the Office of Submissions and
Intellectual Property within the Therapeutic Products Directorate of Health Canada, provided very helpful evidence about Health Canada’s drug approval procedures. During her
testimony, Ms. Bowes advised that Health Canada would commence its review of
the ANDS upon receipt of the Form V, even where the second person was electing
to await expiry of patents on the Patent Register.
[16]
If a second person alleges that an NOC should issue in
spite of the listed patents, it must serve an NOA on the first person (PM
(NOC) Regulations, s. 5(3)). The first person may, within 45 days after
service, apply to the Federal Court for an order prohibiting the Minister from
issuing an NOC until the expiration of a patent that is the subject of the
notice of allegation (PM (NOC) Regulations, s. 6(1)). This action
triggers a stay that may remain in place for up to 24 months (PM (NOC)
Regulations, s. 7(1)(e)).
III.
Teva and Apotex
ANDS and NOA
[17]
In these Prohibition Applications, Novartis Canada is the first person, with the '203 Patent listed on the Patent Register. Teva and
Apotex are second persons. Since Teva and Apotex compare their proposed
imatinib tablets to Novartis’s GLEEVEC, they were required to address the '203
Patent by filing Form Vs with their applications.
[18]
During the course of their dealings with Health Canada, each of Teva and Apotex amended its Form V, changing its position from one where it
would await expiry of the '203 Patent to one where it challenged the validity
of the '203 Patent. Novartis Canada’s position is that the change of the Form
Vs was not permitted by the scheme of the PM (NOC) Regulations; in
Novartis Canada’s view, the NOAs are invalid.
A.
Apotex History
[19]
Apotex filed its ANDS with Health Canada on November 29, 2007 with respect to its proposed Apo-imatinib product. With its
ANDS, Apotex included two Form Vs (one for the 100mg strength tablets and one
for the 400 mg strength tablets), certified as described above by Dr. Sherman,
founder and Chairman of Apotex TX 4, Tab 2). Apotex checked the box on the Form
Vs that stated that:
The Second Person accepts that the Notice of Compliance
will not be issued until the declared expiration date for the above patent
number [the '203 Patent].
[20]
Under cover letter to Health Canada dated February 22, 2011
(TX 4, Tab 4), Apotex sent revised Form Vs for its ANDS in respect of the 100
mg and 400 mg Apo-imatinib tablets. In the revised Form Vs, Apotex checked the
two boxes alleging that:
The ['203 Patent] patent is not valid.
No claim for the medicinal ingredient, no claim for the
formulation, no claim for the dosage form and no claim for the use of the
medicinal ingredient would be infringed by the second person making,
constructing, using, or selling the drug for which the submission is filed.
[21]
On February 18, 2011, Apotex served its NOA on Novartis Canada as described above. Its key allegation, in very summary form, is that the '203
Patent and each of Claims 1 to 48 thereof, are invalid for (TX 4, Tab 3,
section IV.4):
1)
Lack of utility and sound prediction;
2)
Inutility;
3)
Insufficient specification;
4)
Claims broader that any invention made or disclosed; and
5)
Ambiguity.
[22]
On [Redacted], Health Canada advised Apotex that the
examination of its submission had been completed on [Redacted] and that
the NOC would not issue until the requirements of the PM (NOC) Regulations
had been met (TX 4, Tab 5). This is commonly referred to as a Patent Hold
Letter.
B.
Teva History
[23]
Ratiopharm Inc., predecessor by amalgamation to Teva (TX
26, Tab 3) and referred to as Teva, filed an ANDS with Health Canada on June 30, 2010 with respect to its proposed Apo-imatinib product. With its ANDS,
Teva included two Form Vs (one for the 100mg strength tablets and one for the
400 mg strength tablets), certified as described above by Dr. Denike on behalf
of Teva (TX 26, Tabs 11-12). Teva checked the box on the Form Vs that stated
that:
The Second Person accepts that the Notice of Compliance
will not be issued until the declared expiration date for the above patent
number [the '203 Patent].
[24]
The Form Vs were re-submitted on July 14, 2010 to correct
the Brand Name of the product (TX 26, Tabs 13-14). No change was made to the
election at that time.
[25]
In further revised Form Vs dated June 10, 2011, Teva
purported to amend its election (TX 26, Tabs 18-19). In the revised Form Vs,
Teva checked the box alleging that “the ['203 Patent] is not valid”.
[26]
On March 7, 2011, Teva served its NOA on Novartis Canada as described above. Its key allegations, in very summary form, that the claims of
the '203 Patent are invalid for (TX 26, Tab 21):
1)
Lack of utility;
2)
Insufficient specification; and
3)
Claims broader that any invention made or disclosed.
[27]
I assume that Teva has not yet received a Patent Hold
Letter.
IV.
Were the NOAs
proper?
[28]
In asserting that the PM (NOC) Regulations do not
permit the amendment of a Form V to change an election, Novartis Canada presents me with an issue of statutory interpretation.
[29]
The first question that I must address is whether I should
consider this issue. In my view, I should not.
[30]
The most important reason is that, in light of my
determination that the allegations of invalidity made by Apotex and Teva are
not justified, the question is not dispositive. I do not think that it is a
wise use of judicial resources to express what would be only obiter on
this important question of statutory interpretation. That is better done where
the facts give rise to a situation where such a question is determinative.
[31]
In addition, it is almost a certainty that the losing
parties (or even one of them) to these Prohibition Applications will appeal,
thus giving the Court of Appeal the opportunity to consider whether I erred in
my conclusion that the NOAs were not justified. If the Court of Appeal
determines that I erred in concluding that the NOAs were not justified, the
question of the validity of the NOAs would become factually relevant. The Court
of Appeal could return the question of the statutory interpretation of the
relevant provisions of the PM (NOC) Regulations to me for determination.
Alternatively, the Court of Appeal could decide to determine this question
itself. Beyond a few background facts which are uncontested and which I have
carefully set out above, the question before me is a legal one. As such, the
Court of Appeal would owe me no deference. By wading into this legal question –
which has become purely academic – I would not be assisting either the parties
before me or the Court of Appeal.
V.
Conclusion
[32]
For these reasons, and for the reasons set out in the
companion decision on the validity of the '203 Patent, I am satisfied that the
allegations of Teva and Apotex are not justified. It follows that NOCs for
their generic versions of imatinib should not issue until the expiry of the
'203 Patent.
[33]
The consolidation of the Prohibition Applications with the
Impeachment Actions meant that the Prohibition Applications were dealt with
somewhat differently than normally would have been the case. Usually, an
application under the PM (NOC) Regulations proceeds as an application
for judicial review in the Federal Court. Expert and fact evidence is presented
by way of affidavits with the other side able to cross-examine on the
affidavits. The Court is presented with a mountain of expert and other
affidavits, transcripts of cross-examination, memoranda of fact and law and
several days of oral arguments by lawyers. Although the prohibition
applications are considered to be summary proceedings, the volume of material
and the complexity of issues present great challenges to the hearing judge (or,
at least this judge). Because of the consolidation in this case, most experts
appeared in person to speak to their “reports”. The direct and
cross-examinations of the experts and fact witnesses, with the ability of the
judge to clarify the evidence, was invaluable. I am grateful to all parties and
their counsel for their cooperation and for their contributions to this
process.
[34]
Novartis Canada is entitled to its costs. Ever the optimist
(although my optimism is rarely borne out on the issue of costs), I hope that
the parties can agree on those costs. If they cannot do so, further written
submissions of no more than ten pages may be made within 60 days and reply
submissions of no more than five pages within a further 15 days.
POSTSCRIPT
[1]
The Confidential Reasons for Judgment were released to the
parties on February 8, 2013. Upon release of the Confidential Reasons, the
parties were requested to advise the Court of portions of the Reasons for
Judgment that they wished redacted for the Public Reasons. On February 14, 2013
and February 15, 2013, in separate letters, counsel for Novartis AG and
Novartis Pharmaceuticals Canada Inc. and counsel for Teva Canada Limited
advised the Court that there were no portions of the Reasons for Judgment that
should be redacted. Counsel for Apotex Inc. made submissions by letter to the
Court dated February 15, 2013 requesting certain redactions be made.
[2]
These Reasons for Judgment contain redactions made to the
Confidential Reasons for Judgment that were issued on February 8, 2013,
pursuant to the Amended Protective Order dated December 13, 2011. The
redactions were made in accordance with the correspondence received
from the
solicitors for Apotex Inc., with which this Court agrees, and are now
incorporated in the within Public Reasons for Judgment.
“Judith A. Snider”
Ottawa, Ontario
Public Reasons
– February 19, 2013
Confidential
Reasons – February 8, 2013
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