Date: 20061025
Docket: T-1770-05
Citation: 2006
FC 1278
Ottawa, Ontario,
October 25, 2006
PRESENT: The Honourable Mr. Justice Blais
BETWEEN:
ELI
LILLY CANADA INC.
Applicant
and
NOVOPHARM
LIMITED and THE MINISTER OF HEALTH
Respondents
and
TAKEDA PHARMACEUTICAL COMPANY LIMITED
Respondent/Patentee
REASONS FOR ORDER AND ORDER
[1]
This is a
motion by the respondent Novopharm Limited (“Novopharm”) to strike the
affidavit of Dr. Gerard Raymond Colca, sworn August 9, 2006 (the “Colca
affidavit”), and also to strike paragraph 8 and exhibit A of the affidavit of
Dr. Bernard Robert Landau, sworn August 8, 2006 (the “Landau affidavit”).
[2]
Madam
Prothonotary Aronovitch issued an order dated July 19, 2006. This order allowed
Takeda Pharmaceutical Company Limited (“Takeda”) to file succinct reply
evidence to clearly defined issues raised in the affidavit of Mr. Peter
O’Brien, sworn March 31, 2006 (the “O’Brien affidavit”).
[3]
Having
carefully reviewed the order of Prothonotary Aronovitch, paying particular
attention to the endorsement and the specific elements mentioned in the order,
I find that Prothonotary Aronovitch was very clear in setting out the scope of
the elements that could be addressed by Takeda in its reply evidence. The
relevant sections of the order for the purposes of this motion are paragraphs
2(a)-(d), (g) and (h).
2. Takeda has leave to serve
and file, by no later than August 10, 2006, succinct reply evidence limited to
commenting on the following:
(a)
Whether
the missing information, namely items a) to e) at para. 53 of the O’Brien
affidavit, are required to validate the reported ED25 values.
(b)
Three
items of information O’Brien says is lacking from the patent specification
regarding reported toxicity data (O’Brien affidavit at para. 54).
(c)
The more
“relevant” measure of toxicity, i.e. the biochemical analyses and
histochemistry ofa ra,s blood (O’Brien affidavit at para. 55).
(d)
Whether
the allegation that the ratio of wet weight to dry weight should have been
determined and whether a protein determination should have been carried out
(Obrien affidavit a para. 56).
. . .
(g)
The
significance of the ‘323 patent specification not providing information
regarding safety margins between pharmacological effect and toxicity o
unfavourable side reactions, as being necessary to meet the promised utility of
compound (I) and going to the ability to draw conclusions on a peculiar
advantage (O’Brien affidavit at paras. 67 and 68).
(h) The impossibility, based on the ‘323
patent specification, to calculate the therapeutic index or safety margin
because of a lack of information regarding the doses used in the experiments,
or that the skilled person could therefore not evaluate whether compound (I)
possessed any special advantage over prior art compounds (O’Brien affidavit at
para. 69).
[4]
Following
this order, Takeda proceeded to file the following reply evidence:
(a)
Affidavit
of Dr. Gerard Raymond Colca, sworn August 9, 2006;
(b)
Affidavit
of Dr. Bernard Robert Landau, sworn August 8, 2006;
(c)
Affidavit
of Dr. James B. Hendrickson, sworn August 8, 2006; and
(d)
Affidavit
of Dr. Loren D. Koller, sworn August 7, 2006.
[5]
Pursuant
to the motion before this Court, Novopharm seeks to strike the Colca affidavit
in its entirety, as well as paragraph 8 and exhibit A of the Landau affidavit,
on the ground that these clearly fall outside the scope of the order of
Prothonotary Aronovitch (Pfizer Canada Inc. v. Canada (Minister of Health),
[2006] F.C.J. No. 1009).
Colca Affidavit
[6]
I have
carefully reviewed the Takeda reply and I have asked very precise questions of counsel
for the respondent Takeda regarding the scope of the decision by Prothonotary
Aronovitch and to identify which part of the Colca affidavit was responding directly
to the particular sections of the O’Brien affidavit identified by Prothonotary
Aronovitch.
[7]
Unfortunately,
the respondent Takeda failed to provide a clear demonstration that the Colca affidavit
provided a precise and succinct response to the order of Prothonotary
Aronovitch. In fact, counsel for the respondent Takeda suggested to this Court
that the Colca affidavit should be taken as a whole as addressing all of the elements
of the O’Brien affidavit listed in the order of Prothonotary Aronovitch,
instead of trying to match particular segments of the Colca affidavit to
particular sections of the order.
[8]
Takeda was
allowed to provide succinct reply evidence limited to commenting on nine
elements of the O’Brien affidavit, as set out in paragraphs 2(a) to 2(h) of the
order of Prothonotary Aronovitch. I agree with the respondent Novopharm that
the Colca affidavit does not contain any evidence on the three categories of
permitted reply evidence identified, namely information a person skilled in the
art would need to assess the claim in the 323 Patent that pioglitazone has (i)
greater activity over prior art compounds, (ii) lower toxicity than prior art
compounds, or (iii) advantages over prior art compounds (greater activity and
lower toxicity).
[9]
In
fact, half of the Colca affidavit consists of a summary of his educational and
professional background, as well as his past experience with Takeda. More
specifically, Dr. Colca states that he was directly involved with the
screening, selection, clinical testing and preparations for the commercial
development of pioglitazone from 1984 until 1993, in the course of his
employment with Upjohn Laboratories / Pharmacia & Upjohn (“Upjohn”).
[10]
Dr.
Colca’s opinion evidence is set out in paragraphs 13 to 23 of his affidavit, in
which he opines that Takeda’s data was valid because Upjohn verified the data through
their own tests and that, based on the testing by Upjohn and Takeda,
pioglitazone stood out as a superior compound.
[11]
While the Colca
affidavit discusses the patent in question, it does not speak to whether the
five missing items of information identified by Dr. O’Brien in paragraph 53 of
his affidavit are required for a person skilled in the art to validate the
reported ED25
values, as was clearly stated at paragraph 2(a) of the order of Prothonotary
Aronovitch. The Colca affidavit does not speak to whether the three items
identified by Dr. O’Brien in paragraph 54 of his affidavit are necessary for a
person skilled in the art to assess the claims in the 323 Patent that
pioglitazone has lower toxicity than prior art compounds, as required by paragraph
2(b) of the order of Prothonotary Aronovitch. The Colca affidavit opinion
evidence does not speak to whether the more relevant measure of toxicity
identified by Dr. O’Brien in paragraph 55 of his affidavit is necessary for a
person skilled in the art to assess the claims in the 323 Patent that
pioglitazone has lower toxicity than prior art compounds, pursuant to paragraph
2(c) of the order of Prothonotary Aronovitch.
[12]
In fact,
the Colca affidavit fails to address any of the elements clearly identified by
Prothonotary Aronovitch in paragraphs 2(a), (b), (c), (d), (g) and (h) of her
order.
[13]
Counsel
for Takeda expressed concern that if this affidavit were to be struck out, it
could result in a denial of justice, given that it contains first-hand
knowledge from someone who participated in the clinical testing and
preparations for commercial development of pioglitazone at Upjohn, and in the
process tested the data derived from the experiments conducted by Takeda on
this particular patent.
[14]
In my
view, the respondent Takeda had the opportunity to submit evidence from Dr.
Colca in its initial filing of evidence. Having failed to do so at the proper
time, I see no reason why it should be allowed to use the order of Prothonotary
Aronovitch to bring this information in the form of reply evidence, when such
evidence is clearly outside the scope of said order, simply because they now
claim this information to be unique and important to the presentation of their
case.
[15]
Based on
all of the above, I am convinced that Takeda’s reply evidence falls outside the
scope of the order of Prothonotary Aronovitch and should be struck out.
Landau Affidavit
[16]
Regarding
the Landau affidavit, I am concerned by Dr. Landau’s statement that he was
advised by counsel that testing in the nature of testing done for regulatory
approval is not necessary for patenting, and by his reference to jurisprudence
from Canada and the United States to support his opinion.
[17]
It is
quite clear in my view that this opinion is hearsay and also consists of legal
arguments. I agree with counsel for the respondent Novopharm that on that basis
alone, paragraph 8 is improper reply evidence. This paragraph can be easily
removed as it clearly stands out from the remainder of the Landau affidavit
which specifically addresses the elements raised by the order of Prothonotary
Aronovitch and, as such, is not being challenged by the respondent Novopharm.
[18]
I have no
hesitation to conclude that paragraph 8 and exhibit A of the Landau affidavit
are clearly beyond the scope of permitted reply evidence pursuant to the terms
of the order of Prothonotary Aronovitch and thus should be struck out.
ORDER
Therefore, THIS COURT
ORDERS THAT:
1. This motion by Novopharm is
allowed;
2. The Colca affidavit in its
entirety as well as paragraph 8 and exhibit A of the Landau affidavit are
struck out; and
3. Costs in favour of the
applicant Novopharm.
“Pierre
Blais”
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