Date:
20071016
Docket: A-51-06
Citation: 2007 FCA 327
CORAM: SEXTON J.A.
SHARLOW J.A.
TRUDEL J.A.
BETWEEN:
ASTRAZENECA
AB and ASTRAZENECA CANADA INC.
Appellants
and
APOTEX
INC. and THE MINISTER OF HEALTH
Respondents
Heard at Ottawa,
Ontario, on October 16,
2007.
Judgment delivered from the Bench at Ottawa, Ontario, on October 16, 2007.
REASONS FOR JUDGMENT OF THE COURT BY: SHARLOW
J.A.
Date:
20071016
Docket: A-51-06
Citation: 2007
FCA 327
CORAM: SEXTON
J.A.
SHARLOW
J.A.
TRUDEL
J.A.
BETWEEN:
ASTRAZENECA
AB and ASTRAZENECA CANADA INC.
Appellants
and
APOTEX INC.
and THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT OF THE
COURT
(Delivered
from the Bench at Ottawa, Ontario, on October 16, 2007)
SHARLOW J.A.
[1]
This is an appeal from the judgment of Justice Layden-Stevenson (2006
FC 7) dismissing the application of the appellant for an order prohibiting the
Minister of Health from issuing a notice of compliance to the respondent Apotex
Inc. for its 10 and 20 mg magnesium omeprazole tablets until after the
expiration of Canadian Patent No. 2,186,037.
[2]
The only claim in issue is claim 1. It reads as follows:
1. An oral pharmaceutical dosage form comprising:
(a) a core material that contains a proton pump inhibitor and an
alkaline reacting compound;
(b) an enteric coating layer comprising an enteric coating polymer;
and
(c) a water soluble separating layer that is formed in situ as a
water soluble salt between the core material and the enteric coating layer by a
reaction between the enteric coating polymer and the alkaline reacting
compound.
[3]
Justice Layden-Stevenson construed element (a)
as requiring the proton pump inhibitor and the alkaline reacting compound to be
two different substances. The appellant argues that this construction is incorrect,
and that the material described in element (a) could be a single substance that
is both a proton pump inhibitor and an alkaline reacting compound.
[4]
The main argument for the appellant is that
Justice Layden-Stevenson, having recognized that the language of element (a)
could include a single substance that functions as both a proton pump inhibitor
and an alkaline reacting compound, was not entitled to consider any other
interpretation. We do not accept that argument. Justice Layden-Stevenson was
faced with a situation where the claim language was capable of bearing more
than one meaning. To resolve the ambiguity, she considered the language of the
patent claim and the disclosure, informed by a detailed analysis of conflicting
expert evidence. We can find no error in her analysis or her conclusion.
[5]
It is undisputed that the Apotex product will have
a core that does not contain an alkaline reacting compound that is separate
from the proton pump inhibitor. It follows that Justice Layden-Stevenson was
correct to find that the non-infringement allegation is justified, and to
dismiss the prohibition application.
[6]
The appeal will be dismissed with costs.
"K.
Sharlow"
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-51-06
(APPEAL FROM AN ORDER OF
LAYDEN-STEVENSON J. DATED JANUARY 4, 2006, DOCKET NO. T-766-03)
STYLE OF CAUSE: ASTRAZENECA
AB and
ASTRAZENECA CANADA INC.
and
APOTEX
INC. and THE MINISTER OF HEALTH
PLACE OF HEARING: OTTAWA, ONTARIO
DATE OF HEARING: OCTOBER 16, 2007
REASONS FOR JUDGMENT OF THE COURT BY: SEXTON, SHARLOW, TRUDEL JJ.A.
DELIVERED FROM THE BENCH BY: SHARLOW J.A.
APPEARANCES:
|
Y. Kang
S.A. Beeser
|
FOR THE APPELLANTS
|
|
A. R.
Brodkin
Mr. Rick Tuzi
No one appearing
|
FOR THE RESPONDENT
APOTEX INC.
FOR THE RESPONDENT
THE MINISTER OF HEALTH
|
SOLICITORS OF RECORD:
|
Smart & Biggar
Toronto, Ontario
|
FOR THE
APPELLANTS
|
|
Goodmans LLP
Toronto, Ontario
John H. Sims, Q.C.
Deputy Attorney General of Canada
Ottawa, Ontario
|
FOR THE
RESPONDENTS
APOTEX INC.
FOR THE RESPONDENTS
THE MINISTER OF HEALTH
|
Email this Content