Docket: A-139-15
Citation: 2015 FCA 286
CORAM:
|
DAWSON J.A.
NEAR J.A.
BOIVIN J.A.
|
BETWEEN:
|
ELI LILLY
CANADA INC.
and ICOS
CORPORATION
|
Appellants
|
and
|
MYLAN
PHARMACEUTICALS ULC
and THE
MINISTER OF HEALTH
|
Respondents
|
Heard at Ottawa, Ontario, on December 15, 2015.
Judgment delivered from the Bench at Ottawa, Ontario, on December
15, 2015.
REASONS FOR JUDGMENT OF THE COURT BY:
|
DAWSON
J.A.
|
Docket: A-139-15
Citation:
2015 FCA 286
CORAM:
|
DAWSON J.A.
NEAR J.A.
BOIVIN J.A.
|
BETWEEN:
|
ELI LILLY
CANADA INC.
and ICOS
CORPORATION
|
Appellants
|
and
|
MYLAN
PHARMACEUTICALS ULC
and THE
MINISTER OF HEALTH
|
Respondents
|
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Ottawa, Ontario, on
December 15, 2015).
DAWSON J.A.
[1]
In comprehensive and thoughtful reasons cited as
2015 FC 178 a judge of the Federal Court dismissed an application for
prohibition brought by Eli Lilly Canada Inc. and ICOS Corporation (together Eli
Lilly) under the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133. In the prohibition application Eli Lilly sought to prohibit the
issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC for a generic
version of the drug tadalafil until after the expiration of Canadian Patent
2,379,948.
[2]
In the Federal Court Mylan alleged that it would
not infringe the ‘948 Patent and that, in any event, the ‘948 Patent was
invalid because it was obvious. The Judge agreed and found the allegations of
non-infringement and invalidity were each justified. This is an appeal from
that decision. The Minister of Health did not take part in the appeal.
[3]
On this appeal Eli Lilly asserts numerous legal
and factual errors on the part of the Judge. Notwithstanding counsel’s submissions,
we are all of the view that the appeal should be dismissed. We reach this
conclusion for the following reasons.
[4]
First, Eli Lilly asserts that the Judge erred in
law in his obviousness analysis by applying an incorrect test for obviousness
when he wrote, at paragraph 150 of his reasons, that the “test, rather, is whether the skilled person had good reason
to pursue predictable solutions or solutions that provide a ‘fair expectation
of success’”. We agree that the correct test, and the test that ought to
be applied by the Federal Court, is that articulated by the Supreme Court of
Canada in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61,
[2008] 3 S.C.R. 265, at paragraph 66: “For a finding
that an invention was ‘obvious to try’, there must be evidence to convince a
judge on a balance of probabilities that it was more or less self-evident to
try to obtain the invention. Mere possibility that something might turn up is
not enough.” This said, the Judge went on, at paragraph 151 of his
reasons, to note that it was “more or less self-evident”
that the invention ought to work. The Judge then concluded “even if the standard is not ‘fair expectation of success’,
I find that the invention was ‘obvious to try’ according to the test in”
Sanofi-Synthelabo. It follows that any error by the Judge in his initial
articulation of the test for assessing obviousness was not material to the
Judge’s decision.
[5]
Second, with respect to the
balance of the issues asserted by Eli Lilly, we are of the view that the appeal
should be dismissed substantially for the reasons given
by the Judge.
[6]
It follows that the appeal will be dismissed
with costs.
“Eleanor R. Dawson”
FEDERAL
COURT OF APPEAL
NAMES
OF COUNSEL AND SOLICITORS OF RECORD
DOCKET:
|
A-139-15
|
|
STYLE OF CAUSE:
|
ELI LILLY
CANADA INC. and ICOS CORPORATION v. MYLAN PHARMACEUTICALS ULC and THE
MINISTER OF HEALTH
|
|
PLACE OF
HEARING:
|
Ottawa, Ontario
|
DATE OF
HEARING:
|
December 15, 2015
|
REASONS
FOR JUDGMENT OF THE COURT BY:
|
DAWSON J.A.
NEAR J.A.
BOIVIN J.A.
|
DELIVERED
FROM THE BENCH BY:
|
DAWSON J.A.
|
|
|
|
|
APPEARANCES:
Jamie Mills
Beverley Moore
|
For The
Appellants
|
Tim Gilbert
Sana Halwani
Zarya Cynader
|
For The
Respondent
MYLAN PHARMACEUTICALS ULC
|
SOLICITORS OF RECORD:
Borden Ladner Gervais LLP
Ottawa, Ontario
|
For The
Appellants
|
Gilbert’s LLP
Toronto, Ontario
|
For The
Respondent
MYLAN PHARMACEUTICALS ULC
|