Ottawa, Ontario, October 25, 2006
PRESENT: The Honourable Mr. Justice Blais
BETWEEN:
and
NOVOPHARM LIMITED and THE MINISTER OF HEALTH
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.
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-1770-05
STYLE OF CAUSE: Eli Lilly Canada Inc. v
Novopharm Limited and others
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 28, 2006
APPEARANCES:
|
Ms. Ruth Promislow
|
(Novopharm – The moving party) |
|
Mr. Christopher van Barr Mr. Vik Tenekjian
|
(Takeda – the responding party)) |
SOLICITORS OF RECORD:
|
Gowling Lafleur Henderson LLP Ottawa, Ontario
|
(Eli Lilly) |
|
Bennett Jones LLP Toronto, Ontario
Gowling Lafleur Henderson LLP Ottawa, Ontario
Mr. John Sims Deputy Attorney General of Canada Ottawa, Ontario |
(Novopharm)
FOR THE RESPONDENT (Takeda)
FOR THE RESPONDENT (The Minister of Health) |