Date: 20100820
Docket: A-373-08
Citation: 2010 FCA 213
CORAM: NADON
J.A.
LAYDEN-STEVENSON
J.A.
TRUDEL
J.A.
BETWEEN:
APOTEX INC.
Appellant
and
JANSSEN-ORTHO INC. and
DAIICHI SANKYO COMPANY, LIMTED
Respondent
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
NADON J.A.
[1]
Before us
is a motion by the respondents, Janssen-Ortho Inc. and Daiichi Sankyo Co. Ltd.
for an Order varying this Court’s Judgment dated June 22, 2009 in the following
respects:
1.
setting
aside the Redetermination Order;
2.
dismissing
the substantive grounds of appeal; and
3.
reversing
the Order on Costs at the Federal Court of Appeal and at first instance.
[2]
The
respondent, Daiichi Sankyo Co. Ltd. (“Daiichi”) was the owner of Canadian patent
1,304,080 (the “080 patent”) which issued on June 23, 1992, and expired on June
22, 2009. The 080 patent disclosed and claimed levofloxacin, an antibiotic that
treats the most severe forms of pneumonia. The respondent Janssen-Ortho Inc.
(“Janssen-Ortho”) was a licensee of Daiichi and marketed and sold levofloxacin
products in Canada.
[3]
The
appellant Apotex Inc. (“Apotex”) sought to obtain regulatory approval for its
levofloxacin hemihydrate tablets and, in accordance with section 5 of the Patented
Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the
“Regulations”), it sent a Notice of Allegation (“NOA”) to the respondents,
alleging that the 080 patent was invalid and that, if valid, its tablets would
not infringe the patent.
[4]
On
September 2, 2005, the respondents commenced proceedings under the Regulations
for an order prohibiting the Minister from issuing a Notice of Compliance
(“NOC”) to Apotex for levofloxacin hemihydrate tablets until after the expiry
of the 080 patent on June 22, 2009.
[5]
On June
17, 2008, Shore J. of the Federal Court concluded that the respondents were entitled
to an order of prohibition and, thus, prohibited the Minister from issuing a
NOC to Apotex until after the expiry of the 080 patent.
[6]
On June
22, 2009, this Court, by a majority, allowed the appellant’s appeal. The
Judgment of the Court reads as follows:
The appeal is allowed with
costs, the decision of Shore J., 2008 FC 744, dated June 17, 2008, is set aside
and the matter is remitted back to him for redetermination on the basis
that there is no abuse of process on the part of Apotex Inc. in making the
allegations found in its Notice of Allegation and in contesting the application
for a prohibition order commenced by the respondents. Shore J. is instructed
to assess the evidence before him independently of any findings made by Hughes
J. in Janssen-Ortho v. Novopharm Limited, 2006 FC 1234, 300 F.T.R.
166. With respect to the proceedings below, there shall be no order as to
costs.
[Emphasis
added]
[7]
On June
14, 2010, Shore J. recused himself from sitting on the redetermination. More
particularly, at paragraphs 6 and 7 of his Reasons, he wrote as follows:
[6] In
addition, as the judgment of the undersigned has been borne out in subsequent
interpretation of the same subject matter outside of Canada through U.K. judgments (Generics
(UK) Limited v. Daiichi Pharmaceutical Co. Ltd. and Daiichi Sankyo Co. Ltd.,
[2008] EWHC 2413 in the High Court of Justice, Chancery Division, Patents Court
and also in Generics (UK) Ltd. v. Daiichi Pharmaceutical Co. Limited and
Daiichi Sankyo Co. Ltd., [2009] EWCA Civ 646 in the Supreme Court of
Judicature Court of Appeal (Civil Division) on Appeal from the High Court of
Justice, Chancery Division, Patents Court) and by subsequent expert
pronouncements and interpretations thereto, the undersigned is caught in a
situation where he would either deviate from deference to the majority in the
Federal Court of Appeal judgment, or from the judicial responsibility of
independent analysis through the proverbial state of being between a rock and a
hard place.
[7] Thus,
after time and much reflection, subsequent to receiving the new written
pleadings of the parties, the undersigned recognizes he cannot in good
conscience, in the integrity of spirit necessary for intellectual honesty,
required for the independence of a judge, sit on this matter, yet again,
without reaching the same conclusions through the same reasons. As a result, in
fairness to the parties, the following decision has been reached in the Order
below:
ORDER
THIS JUDGE
ORDERS
that
he recuse himself from sitting on this matter, and that he remit to the Chief
Justice of this Court this case to be heard by a different judge of this Court.
[8]
Relying on
Rule 399(2)(a) of the Federal Court Rules, which provides that “the
Court may set aside or vary an order … by reason of a matter that arose or was
discovered subsequent to the making of the order”, the respondents say that the
three conditions required for the varying of an order are met in the present
matter.
[9]
First,
they say that Shore J.’s recent decision is “a matter” within the meaning of Rule
399; second, that Shore J.’s decision was not discoverable by the exercise of
due diligence prior to the making of our Judgment of June 22, 2009; and; third,
that Shore J.’s decision would have had a determining influence on our Judgment
of June 22, 2009.
[10]
I need
only deal with the third condition with respect to which the respondents say
that this Court would not have remitted the matter back to Shore J. for
redetermination had it known that he had made his findings independently of
those made by Hughes J. in Janssen-Ortho Inc. v. Novopharm Ltd.., [2006]
F.C.R. 166. Consequently, they say that this information would have had a
determining influence on our Judgment.
[11]
In my
view, the motion is without merit. A majority of this Court found, contrary to
the reasons given by Shore J. in his recent decision, that his findings were
not made independently of those made by Hughes J. in Novopharm supra. Our
Judgment has not been appealed and is therefore a final decision.
[12]
With the
greatest of respect, I would add that the Order made by Shore J. on June 14,
2010, and the Reasons which he gives for that Order, are of no relevance in
determining whether or not this Court should vary its Judgment of June 22,
2009.
[13]
I would
therefore dismiss the motion.
“M.
Nadon
“I
agree.
Carolyn
Layden-Stevenson J.A.”
“I
agree.
Johanne
Trudel J.A.”
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