Docket: T-1332-12
Citation:
2014 FC 1249
Ottawa, Ontario, December 19, 2014
PRESENT: The
Honourable Madam Justice Gleason
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BETWEEN:
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ACTELION PHARMACEUTICALS CANADA INC.
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Applicant
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and
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ATTORNEY GENERAL OF CANADA
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AND
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PHARMASCIENCE INC.,
MYLAN PHARMACEUTICALS ULC, COBALT PHARMACEUTICALS COMPANY AND
SANDOZ CANADA INC.
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Respondents
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JUDGMENT AND REASONS
[1]
In this application for judicial review the
applicant, Actelion Pharmaceuticals Canada Inc. [Actelion], seeks declaratory
relief and an order setting aside the decisions of the respondent, the Minister
of Health [the Minister], awarding early Notices of Compliance [NOCs] to the
respondents, Cobalt Pharmaceuticals Company [Cobalt] and Sadoz Canada Inc.
[Sandoz], for drugs that are the pharmaceutical and bioequivalent of a drug
that Actelion produces and held patent rights for under a patent listed on the
Patent Register established under sections 3 – 4 of the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133 [the PMNOC Regulations].
[2]
More specifically, Actelion sells bosentan, a
hypertension drug, in Canada under the brand name TRACLEER. It is the owner of
Patent No. 2,071,193 [the 193 Patent], which pertains to TRACLEER. The 193
Patent expired on June 12, 2012, but prior to its expiry was listed on the
Patent Register.
[3]
On January 5, 2011, the respondent, Mylan Pharmaceuticals
ULC [Mylan], sent Actelion a Notice of Allegation [an NOA] with respect to the
193 Patent. In response, Actelion initiated a prohibition application on
February 18, 2011, pursuant to section 6 of the PMNOC Regulations, but
subsequently settled the case. On August 31, 2011, Mylan sent a letter to the Office
of Patented Medicines and Liaison [OPML] at Health Canada withdrawing its NOA,
and on September 2, 2011, Actelion discontinued its prohibition application. A
few days later, it wrote to the OPML indicating that it was permitting Mylan to
make, construct, use or sell bosentan in Canada as of May 29, 2012. On May 29,
2012, Health Canada issued an NOC to Mylan for its bosentan product.
[4]
On March 22, 2012, the respondent, Pharmascience
Inc. [Pharmascience], also sent Actelion an NOA with respect to the 193 Patent.
In response, Actelion began a second prohibition application on May 4, 2012,
but soon thereafter reached a settlement with Pharmascience. On May 28, 2012,
Pharmascience sent a letter to the OPML withdrawing its NOA and on the same day
Actelion wrote to the OPML indicating that it was permitting Pharmascience to
make, construct, use or sell bosentan in Canada as of May 29, 2012. On May 30,
2012, Actelion discontinued its prohibition application in respect of Pharmascience,
and on May 29, 2012, Health Canada issued an NOC to Pharmascience for its
bosentan product.
[5]
On an unspecified date, Sandoz reached a
licensing agreement with Pharmascience under which Sandoz was permitted to
market Pharmascience’s bosentan product under Sandoz’s label. On April 25, 2012,
Sandoz filed an administrative drug submission seeking approval from the
Minister to market bosentan under the brand name SANDOZ-BOSENTAN,
cross-referencing the Pharmascience submission.
[6]
Cobalt also reached a licensing agreement with
Pharmascience under which Cobalt was similarly permitted to market
Pharmascience’s bosentan product under Cobalt’s label. On May 4, 2012, Cobalt
likewise filed an administrative drug submission seeking approval from the
Minister to market bosentan under the brand name CO-BOSENTAN, cross-referencing
the Pharmascience submission.
[7]
On June 4, 2012, the Minister issued NOCs to
Sandoz and Cobalt for their bosentan products. In so doing, the Minister applied
recent amendments to its Guidance Document, Patented Medicines (Notice of
Compliance) Regulations [the Guidance Document]. These amendments purport to
allow the Minister of Health to issue early NOCs to companies who market a
generic version of a drug listed on the Patent Register, without being required
to serve a Notice of Allegation [NOA] on the patent-holder under section 5 of
the PMNOC Regulations, if the company has been licensed to sell the drug by
another company that has previously complied with section 5 of the PMNOC
Regulations.
[8]
In the present application for judicial review,
Actelion seeks declarations that the Minister lacked the authority to issue the
NOCs to Cobalt and Sandoz and also seeks orders setting them aside.
[9]
For the reasons given in Pfizer Canada
Inc. v The Attorney General of Canada and Teva Canada Limited, T-1703-13, 2014
FC 1243, [Pfizer], issued concurrently with this judgment, I find that
the amendments to the Guidance Document contravene the PMNOC Regulations and
that the Minister was not entitled to issue the NOCs to Cobalt and Sandoz. I do
not find it necessary to address Actelion’s natural justice arguments. It
follows that Actelion is entitled to the declaratory relief it seeks in respect
of the interpretation of the PMNOC Regulations.
[10]
However, it appears that the request for an
order quashing the NOCs may well be moot as the 193 Patent expired on June 12,
2014. The parties did not fully argue the potential mootness of this remedy
before me and I therefore direct that if Actelion wishes to pursue its request
for an order quashing the decisions of the Minister to issue NOCs to Cobalt and
Sandoz, it must file submissions within 30 days setting out its arguments as to
why this remedy is not moot. If such submissions are filed, the respondents may
file responding submissions within 30 days of receipt of Actelion’s
submissions, and, if it desires, Actelion may file reply submissions within 15
days of receipt of the responding submissions.
[11]
Costs should follow the event and should be
based on the mid-point of Column III of Tariff B to the Federal Courts Rules,
SOR/98-106. As in Pfizer, I remit the issue of the quantification of
costs to the parties and trust that they will be able to settle on the amount(s)
payable. In the event they are unable to do so, their respective positions on
costs should be set out in the supplemental submissions on mootness or, if no
such submissions are made, in submissions dealing solely with costs, which
shall be filed within 45 days of the date of this Judgment.
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