Date: 20040902
Docket: T-1878-02
Citation: 2004 FC 1208
Toronto, Ontario, September 2nd, 2004
Present: The Honourable Mr. Justice Lemieux
BETWEEN:
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Applicants
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] Apotex is the Respondent in two proceedings in Court files T-1878-02 and T-766-03 initiated by the Applicants pursuant to the Patented Medicines (Notice of Compliance) Regulations (the Regulations).
[2] Apotex sought but was refused, hence these appeals before me, permission from Prothonotary Lafrenière (the Prothonotary) to file reply affidavits to the affidavit dated April 15th, 2004 of Dr. Lindquist, one of the Applicants' experts, who reported the results of the tests he conducted on samples of Apotex's omeprazole tablets which the Applicants had recently obtained from Apotex despite the fact they asked Apotex for the samples for purposes of testing when they commenced the proceedings by way of Notice of Application on November 8th, 2002 in Court file T-1878-02 and on May 13th, 2003 in Court file T-766-03.
[3] Dr. Lindquist's affidavit was filed pursuant to the Order of Justice von Finckenstein dated May 25th, 2004 who allowed an appeal from the Prothonotary. He considered Dr. Lindquist's evidence as vital to the outcome of the two proceedings. (See para 20 in [2004] F.C. 762). He was sustained by the Federal Court of Appeal on July 7th, 2004 (See Docket: A-289-04, July 7, 2004).
[4] The Prothonotary dismissed Apotex's motion to file reply affidavits from the Bench on July 30th, 2004 without hearing from counsel for the Applicants; he issued an Order and Reasons for Order on August 19th, 2004.
[5] In his reasons, the learned Prothonotary described the background to Apotex's motions as follows:
Apotex seeks leave to file evidence responding to the affidavit of Dr. Jörgen Lindquist, sworn April 15, 2004 in Court Nos. T-1878-02 and T-766-03. The background to the two motions is fully set out in paragraphs 7 to 41 of the Applicants' written representations. In summary, Apotex sent a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in respect of magnesium omeprazole tablets. The Applicants' patents at issue are directed to a pharmaceutical composition comprising a core including omeprazole or a salt thereof, a subcoating and an enteric coating. Apotex alleged non-infringement on the basis it will bring into contact the enteric coating with the core so that its formulation will not contain a subcoating. In response, the Applicants brought a Notice of Application seeking an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex until the expiry of the patents. The Notice of Application asserted that the disclosure of Apotex's samples was necessary in order to allow the Applicants to assess whether a subcoating is present and/or Apotex's allegation of non-infringement of the patent was justified.
[6] He described the proposed Apotex reply affidavits in the following terms:
Apotex's proposed evidence consists of four additional affidavits. Apotex seeks leave to file responding evidence to explain the chemical constituents contained within the fluorescent layer visible in Apotex's tablets, to address the acetone washing methodology, and to provide an interpretation of peaks seen in Dr. Lindquist's infra-red spectra. Apotex also seeks to adduce responding evidence with respect to the following matters:
a) "Dr. Lindquist has for the first time in this proceeding introduced a surface analytical technique known as TOF-SIMS. Apotex has not had an opportunity to respond to Dr. Lindquist's methodology or conclusions with respect to this type of analysis;"
b) "The appropriateness of the methodology utilized to determine if the purported acetone insoluble layer dissolves or quickly disintegrates in water; and"
c) "The accuracy of Dr. Lindquist's interpretation of the FT-IR, ATR Spectroscopy data, and his assignment of specified signals."
[7] Prothonotary Lafrenière expressed the reasons for his refusal to allow Apotex to file its reply affidavits as follows:
Having reviewed the proposed additional affidavits submitted by Apotex, I am not satisfied that leave to file should be granted. I am substantially in agreement with the Applicants' analysis of Apotex's proposed evidence, which is done in the context of the entire evidentiary record, and their detailed submissions that explain why the said affidavits do not constitute proper reply evidence.
The proposed affidavits are, for the most part, a reiteration of previously filed evidence, a reinterpretation of old results or, more significantly, an attempt to introduce new evidence which could have been adduced earlier, or which cannot fairly be viewed as a reply to the evidence of Dr. Lindquist. One must bear in mind that it is Apotex, and not the Applicants, that first introduced evidence of testing of samples. As a result, it is not automatically entitled to have the "final word". Apotex should have anticipated that the Applicants would be conducting its own testing and put its best case forward at the first opportunity. Further, the Applicants' evidence can be tested through cross-examination. Finally, the proposed evidence, if admitted, would cause serious prejudice to the Applicants, since the Applicants will not be able to respond to the new matters raised at this late stage.
For the above reasons, and being substantially in agreement with the Applicants' written representations, I conclude that Apotex has failed to establish that its proposed evidence will serve the interests of justice. [Emphasis mine]
[8] In order to appreciate the Prothonotary's ruling, I outline the sequence of the affidavits filed in these proceedings, I separate out T-1878-02 from T-766-03 because the amounts and timing of affidavits filed are different.
(1) T-1878-02
(a) CIMA 1
[9] Apotex's main affidavit in response to the Applicants' lead evidence is the affidavit of Dr. Cima (CIMA 1) filed on March 31st, 2003. His mandate, against the background of the Applicants' patents and Apotex's NOA, was to determine, inter alia, whether Apotex's tablets contained a subcoating material between the tablet core and the outer enteric coating and specifically whether the tablets contained a salt of the enteric coating polymer as a subcoating.
[10] In CIMA 1, Dr. Cima examined the use of an acetone wash and subsequent FT-IR spectroscopy procedure previously described in documents he reviewed as a means of detecting the presence of an in situ subcoating and concluded this means of detection was not feasible in his case because his attempts to wash off the outer enteric coating of the Apotex tablets failed for a number of reasons.
[11] He used fluorescence microscopy, Raman spectroscopy and EDAX as discovery techniques of the presence of a subcoating and its chemical composition.
[12] In his CIMA 1, he stated he detected some fluorescent material (a fluorescent layer) located between the tablet core and the enteric coating but concluded the chemical constituents that produce this layer are not the salt of the enteric coating polymer but are degradation products of omeprazole which were not present at the time of manufacture but developed over weeks and months following manufacture.
(b) Lindquist 1
[13] After obtaining leave of the Court as proper reply evidence, the Applicants filed the affidavit of Dr. Lindquist in response to CIMA 1. Dr. Lindquist expressed concerns on how Dr. Cima prepared his samples of the Apotex tablets for experimentation; said Dr. Cima's use of Raman spectroscopy (Raman) to determine whether Apotex tablets contained a salt of enteric coating polymer as a subcoating was flawed because Raman does not let you discover that salt; criticized the wave length Dr. Cima used in his fluoroscopy test and dismissed Dr. Cima's reservations on the removal of the enteric coating through acetone wash because in his view, Dr. Cima had used an improper too rough washing technique.
(c) CIMA 2
[14] Apotex obtained leave to reply to Lindquist 1 by filing CIMA 2 on August 27th, 2003. The granting of that leave is presently before the Federal Court of Appeal. Dr. Cima said his sample was appropriately prepared, disagreed Raman was inadequate to discover the salt; tested his fluorescent results at a different wave length and found no difference and challenged as unsupported by science Dr. Lindquist's view the enteric coating polymer (the polymer) was soluble in acetone. He performed two tests to conclude the polymer swelled but did not dissolve. He tested portions of regions of the exposed core but could not detect a salt of the enteric coating.
[15] Dr. Cima concluded there was no scientific support or validation for Dr. Lindquist's conclusions that the enteric coating was soluble; the polymer was fluorescent and the fluorescent layer was a salt of the coating polymer. He concluded Dr. Lindquist's method of discovering the in situ subcoating was not accepted in the scientific community.
(2) T-766-03
(a) CIMA 3
[16] Apotex responded to the Applicants' main evidence by filing on August 22nd, 2003 Dr. Cima's affidavit sworn on August 22nd, 2003. His purpose was to review the 037 patent, follow its teachings and test a number of formulations, including the Apotex tablet for the presence of an in situ separating layer, that is, in a salt of the enteric coating layer.
[17] As in CIMA 1, he detected a fluorescent layer at various wave lengths. He then tested whether the layer was a magnesium salt of enteric coating polymer and concluded it was not. He then ran tests to determine the chemical composition of the layer. He ran tests on various formulations and concluded it was the result of a degradation reaction of omeprazole. He also ran additional tests on glass slides that had been coated with a pure polymer film used by Apotex in the coating of its tablets and developed a protocol in this connection.
[18] I now describe Lindquist 2 to which Apotex wants to reply by filing the affidavits for which leave was denied by the Prothonotary. Lindquist 2 was filed in both T-1878-02 and T-766-03. Lindquist 2 details the test results Dr. Lindquist performed on the Apotex tablets. He was asked to conduct and interpret tests appropriate for the determination of the existence of a subcoating and in situ separating layer.
[19] He prepared the sample tablet by cutting it in the middle with a rotary circular cutter. He washed three bisected tablets in acetone to dissolve the enteric coating during various time frames. He used fluorescence microscopy to examine the bisected tablets. He also used FT-IR spectroscopy. He tested an acetone washed tablet in pure water. He also employed a new technique called TOF-SIMS not used by or referred to by Dr. Cima or by him in prior affidavits.
[20] He concluded the Apotex tablet had a subcoating or layer between the enteric coating and the core; this layer was continuous separating the tablet core from the enteric coating and the layer contained a salt of magnesium and enteric coating polymer.
[21] As mentioned by the Prothonotary, Apotex seeks to reply to Lindquist 2 by filing four affidavits: one by Dr. Cima; one by Dr. Sodhi specific to TOF-SIMS; and two background affidavits by Dr. Bernard Sherman and Dr. Ng-Cheng-Hin.
Analysis
[22] As noted, Justice von Finckenstein in these same proceedings reversed the Prothonotary's decision not to grant leave to file Lindquist 2. He was sustained on appeal (See AB Hassle et al. v. Apotex Inc. et al., [2004] F.C. 762).
[23] Justice von Finckenstein correctly described the standard of review from a Prothonotary's decision when he wrote this at paragraph 19:
The standard for review on appeals from the orders of Protonotaries is well established. In Merck & Co. v. Apotex Inc. (2003), 315 N.R. 175, reformulating the test in Canada v. Aqua-Gem Investments Ltd. (1993), 149 N.R. 273, Décary J.A. stated at para.19:
Discretionary orders of Protonotaries ought not to be disturbed on appeal to a judge unless:
a) the questions in the motion are vital to the final issue of the case, or
b) the orders are clearly wrong, in the sense that the exercise of discretion by the prothonotary was based upon a wrong principle or upon a misapprehension of facts.
[24] That standard where case management is involved is higher.
[25] I also accept Justice von Finckenstein's description of the test for leave to file reply evidence under Rule 312 of the Federal Court Rules, 1998 again in these proceedings but in respect of a different Prothonotary's decision namely his 24th of December 2003 decision cited as AB Hassle et al. v. Apotex Inc. et al., [2003] F.C. 1522 where he wrote this at paragraph 29:
The Court has the discretion, pursuant to Rule 312 of the Federal Court Rules, to allow the filing of affidavits beyond those initially filed by the applicant and the respondent. The principles governing the application of Rule 312 are whether the additional material will:
a) Serve the interests of justice;
b) Assist the Court in making its final determination; and
c) Cause substantial or serious prejudice to the applicants.
See Eli Lilly & Co. v. Apotex Inc. (1997), 137 F.T.R. 226 at 230 (F.C.T.D.).
[26] There can be no doubt that the issue whether the Apotex tablets contain a separating subcoating consisting of a magnesium salt of the enteric coating polymer is at the heart of the proceedings: the Applicants' patents and Apotex's NOA. This issue is critical to the success of either party to these proceedings.
[27] With respect, I believe the Prothonotary erred in principle when he analysed the proposed reply affidavits and applied that analysis equally to both proceedings. T-1878-02 and T-766-03 do not stand on the same footing.
[28] T-766-03 in the record before me, shows two affidavits describing the tests done on the Apotex tablets: CIMA 3 and Lindquist 2.
[29] T-1878-02 has a more fullsome record. That record contains the testing evidence (CIMA 1 and Lindquist 2) but also contains the experts affidavits criticizing the testing methodologies which are not seen in T-766-03.
[30] In my view, the learned Prothonotary should not have transposed some of the T-1878-02 evidence into the T-766-03 proceeding where it is not present or different.
[31] Apotex wants to file its reply affidavits so that it can answer for the first time evidence proferred by the Applicants' expert who tested Apotex's tablets. If leave is not granted, the Lindquist affidavit will stand unanswered in terms of written reply evidence for which cross-examination is no substitute. In other words, the evidence between the parties on testing matters is not fairly joined. With respect, I believe the learned Prothonotary lost sight of this important factor.
[32] Clearly, it cannot be said Dr. Sodhi's proposed reply evidence is a reiteration of previously filed evidence, a reinterpretation of old results or matters which could have been anticipated. Before Lindquist 2, TOF-SIMS had not been referred to. Apotex is certainly entitled to criticize this test.
[33] Dr. Cima's proposed affidavit expresses concerns about Lindquist 2: (1) the fact that Dr. Lindquist does not offer any explanation as the chemical constituents of the "continuous bright layer" he observed; (2) Dr. Cima asserts the protocol for removing the enteric coating is flawed because Dr. Lindquist has never considered that extended exposure of the enteric coating and the core to the solvent during the coating removal process could cause the observation he sees and provided no controls; and (3) Dr. Lindquist offers no evidence that the comparison of FT-IR spectra indicates the presence of a magnesium salt of a methacrylic acid copolymer and that the peaks he relies on appear to be "noise" as opposed to a true signal.
[34] It is true Dr. Cima refers to his previous findings but does so to ask what causes the fluorescence Dr. Lindquist observed and why he did an experiment to determine if omeprazole could be definitely detected in a region between the core and coating to possibly cause the fluorescence observed. He suggests the use of Raman for this purpose. I consider this proposed evidence as proper reply arising directly from Dr. Lindquist's testing. It complies with the test for leave under Rule 312.
[35] It is not duplication of previous evidence but a new experiment arising from a perceived defect in the evidence in Lindquist 2.
[36] The same can be said of the protocol for removing the enteric coating and the results of the FT-IR comparisons in Dr. Lindquist's tests. Dr. Cima is dealing with Dr. Lindquist's test results which were first revealed in Lindquist 2 which contain an opposite conclusion Dr. Cima reached.
[37] It is proper reply within Rule 312 for Apotex to challenge the results and methods in Lindquist 2 and it is wrong to say in this context the proposed affidavits are a reiteration of previous evidence and a reintegration of old results. Dr. Cima's evidence focusses on new results which are in Lindquist 2. The fact that he may have touched upon the subject matter in other affidavits does not take away his Apotex's right to comment on the Lindquist 2 new results.
[38] I was concerned about prejudice to the Applicants particularly because of the new experiments referred to in the proposed affidavits. Applicants say there will be no opportunity to rebut. Counsel for Apotex told the Court Apotex would consent to a proper reply by the Applicants.
[39] I appreciate timing is tight and deadlines have been established in case management. I accept the point made by counsel for Apotex parties can reasonably accommodate the introduction of the Apotex's reply affidavits.
[40] As to the proposed affidavits of Dr. Sherman and Ng-Cheng-Hin, they simply provide background information.
[41] One last point, there is no merit to the Applicants argument Apotex's appeal is out of time. (See Business Depot Ltd. v. Canadian Office Depot Inc., [2000] F.C.J. No. 976).
ORDER
THIS COURT ORDERS that this appeal is allowed with costs, leave is granted to Apotex to file its proposed four affidavits. The parties are directed to proceed expeditiously.
"François Lemieux"
J.F.C.
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1878-02
STYLE OF CAUSE: AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Applicants
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: AUGUST 30, 2004
REASONS FOR ORDER
AND ORDER BY: LEMIEUX J.
DATED: SEPTEMBER 2, 2004
APPEARANCES BY:
Mr. Gunars Gaikus
Ms. Yoon Kang FOR THE APPLICANTS
Mr. Harry Radomski
Ms. Nathalie Butterfield FOR THE RESPONDENT, APOTEX INC.
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario FOR THE APPLICANTS
Goodmans LLP
Toronto, Ontario FOR THE RESPONDENT, APOTEX INC.
FEDERAL COURT
Date: 20040902
Docket: T-1878-02
BETWEEN:
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Applicants
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
AND ORDER