Date: 20031010
Docket: T-74-03
Citation: 2003 FC 1320
OTTAWA, ONTARIO, THIS 10TH DAY OF OCTOBER 2003
Present: THE HONOURABLE MR. JUSTICE MARTINEAU
BETWEEN:
PFIZER CANADA INC. and
PFIZER INC.
Applicants
- and -
NOVOPHARM LIMITED and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
[1] These are my reasons for order delivered orally from the bench on October 10, 2003 which have been reviewed and edited for the purposes of reliability and clarity.
[2] This is a motion by Pfizer Canada and Pfizer Inc. (Pfizer) for:
1. An order pursuant to Rules 91, 94, 96 and 97 of the Federal Court Rules, SOR/98-106 (Rules) requiring Novopharm's witness, Dr. Francis Chouinard, to re-attend at his own expense on the cross-examination of his affidavit dated July 15, 2003, and to produce at the said re-attendance, the tableted material upon which Novopharm conducted their analysis including the packaging associated therewith that is referred to in his affidavit so that the applicant's may conduct their own analysis of the material and file reply evidence if required.
2. An order pursuant to Rules 91, 94, 96 and 97 of the Rules requiring Dr. Chouinard to re-attend at his own expense on the cross-examination of his affidavit dated July 15, 2003, and to produce at the said re-attendance, all relevant portions of its abbreviated new drug submission (ANDS) for 250 mg tablets of azithromycin including the closed portions of the drug master file referred to the ANDS, which is filed with the Minister of Health and which set out:
(i) The process to make bulk azithromycin; and
(ii) Pages X-X of Novopharm's parent company Teva's drug master file referred to and incorporated by reference in the drug substance section of Novopharm's ANDS.
3. In the alternative, an order pursuant to paragraph 6(7)(a) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations) requiring Novopharm to produce all relevant portions of its abbreviated new drug submission (ANDS) for 250 mg tablets of azithromycin including the portions of the drug master file which is referred to in the ANDS, both files being with the Minister of Health and which set out:
(i) The process to make bulk azithromycin; and
(ii) Novopharm's supplier's drug master files referred to and incorporated by reference in Novopharm's ANDS;
4. An order pursuant to paragraph 6(7)(b) of the Regulations requiring the Minister of Health to verify within 30 days of the receipt of the information referred to in paragraphs 2 and 3 that (1) the portions of the Novopharm's ANDS already produced, and (2) the relevant portions of Novopharm's drug master file ordered under paragraph 4 to be produced, corresponds fully to the information on file with the Minister;
5. An order amending the schedule currently in place in this proceeding requiring Dr. Chouinard to re-attend within three weeks of the date of this order; permitting the applicant to file responding evidence within 30 days of the receipt of the samples and relevant portions of the ANDS and drug master file, permitting the Respondent 15 days to conduct cross-examination on the reply material and extending the time for filing of the applicant's record until 30 days after any cross-examination on the said reply affidavits;
6. The costs of this motion; and
7. Such further and other relief as this Court may deem just.
[3] Having read the motion records filed by the parties, and upon hearing the submissions of counsel for the parties, and having also reviewed the authorities cited by counsel, I have come to the following conclusions.
[4] The first issue to be determined is whether Novopharm should be required to produce all relevant portions of Novopharm's abbreviated new drug submission (ANDS) for 250 mg tablets of azithromycin, including the drug master file referred to and incorporated by reference in Novopharm's ANDS.
[5] Pfizer commenced this proceeding in response to a Notice of allegation (NOA) sent by Novopharm in respect of the drug azithromycin. In the NOA, Novopharm alleges that it will not infringe claims 1 and 5 of Pfizer's Canadian Patent No. 1,314,876 ('876 Patent) for azithromycin dihydrate.
[6] More particularly, Novopharm alleges that product claim 1 and composition claim 5 of the '876 Patent will not be infringed by "the making, constructing, using or selling by Novopharm of the Novopharm Product" (my emphasis).
[7] Claim 1 is directly relevant to the present proceeding. It is related to crystalline azithromycin dihydrate. To that effect, Novopharm alleges:
The Novopharm Product is free of crystalline azithromycin dihydrate. More specifically, Novopharm Azithromycin is azithromycin monohydrate. The Novopharm Product is formulated with Novopharm Azithromycin. The Novopharm Product, therefore, contains azithromycin monohydrate, which is stable and does not convert to azithromycin dihydrate. As they are free of crystalline azithromycin dihydrate, neither Novopharm Azithromycin nor the Novopharm Product could be found to infringe claim 1.
[8] In its Notice of application for an order in accordance with subsection 6(1) of the Regulations, Pfizer submits, inter alia, that Novopharm's detailed statement is defective in that it does not state which form of azithromycin monohydrate it will be making, nor does it state that its form of azithromycin will not convert to the dihydrate over time. Moreover, Novopharm does not outline in its detailed statement how its bulk azithromycin will be crystallized, the excipients of its tablet formulation, the process for tableting or other information that Novopharm has that compares its bulk and tablets to those of Pfizer's. As part of its purification process, it is likely that azithromycin dihydrate will be made (paragraphs 12 and 13 of the Notice of application).
[9] In addition to the alleged deficiencies, Pfizer submits that the allegation of non-infringement of the '876 Patent is not justified. In particular, Novopharm did not state what form of azithromycin monohydrate would be used to make its tablets. Pfizer currently states that the process for the manufacture of monohydrate forms can result in the formation of some dihydrate. Furthermore, some monohydrate forms convert over time to the dihydrate (paragraphs 14 and 15 of the Notice of application).
[10] The authorities are clear that the detailed statement required by paragraph 5(3)(a) of the Regulations must contain all of the facts that a second person is relying upon in support of its paragraph 5(1)(b) allegation. Thus, it must make the patentee fully aware of the ground for which it is alleged that the patent will not be infringed (AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.); (2000), 256 N.R. 172; SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 10 C.P.R. (4th) 338 (F.C.A.); and Merck Frosst Canada Inc. v. Minister of Health et al. (2001), 12 C.P.R. (4th) 447 (F.C.A.) at p. 454).
[11] As was held in AB Hassle, supra, at paragraphs 19, 20 and 23:
The detailed statement is not a pleading per se but represents a pivotal step in the process leading up to the assurance of an NOC ...
... the allegation and detailed statement assist in an important way in framing the issues and facts to be determined in the Section 6 proceedings ...
The intent appears to be that the entire factual basis be set forth in the statement rather than be revealed piecemeal when some need happens to arise in Section 6 proceedings.
[12] Upon an examination of the documentation produced by the parties, the issues in this proceeding are whether Novopharm's azithromycin tablets:
(1) utilize azithromycin dihydrate as an intermediate during manufacture;
(2) contain azithromycin dihydrate; or
(3) convert to azithromycin dihydrate over time.
[13] In the portions of the ANDS provided to the applicants, there is limited information setting out the process of manufacture of bulk azithromycin. The intermediates referred are simply identified as "azithromycin" and are silent as to the form of azithromycin. Further, the pages demonstrating the testing done for the characterizations of the intermediates have been omitted. If the intermediates are the dihydrate, Pfizer submits that there is infringement to the '876 Patent. Novopharm's employee, Dr. Chouinard, is unaware of these details but confirmed that they would be found in the drug master file (DMF).
[14] It was held in Abbott Laboratories et al. v. Minister of Health et al. 2002 FCT 1103 at paragraphs 4 and 5, that this information is considered to be part of the ANDS whether it is physically present or incorporated by reference (Pharmascience v. Minister of Health 2003 FCA 333 at paras. 27-30).
[15] Subsection 6(7) of the Regulations confers on the Court a discretion to order production of any portion of a submission for a notice of compliance relevant to the disposition of the issues in the prohibition proceeding. In exercising its discretion, the Court should consider the evidence in respect of the disclosure request on a balance of probabilities standard (Novartis Pharmaceuticals Canada Inc. v. Abbott Laboratories (2000), 7 C.P.R. (4th) 264 (F.C.A.) at paras. 12 and 19).
[16] Based on a review of the NOA, the Notice of application, the affidavits and the documentary evidence filed by the parties, I am satisfied on a balance of probabilities that the production of the requested information is both relevant and important to the disposition of the issues in the present proceeding.
[17] In exercising my discretion, I have considered the arguments raised by Novopharm against the production of the requested information. I also took into consideration the factual situation of the cases cited by counsel which may have been somewhat different, different from the present case. For instance, see Pfizer Canada Inc. v. Apotex 2002 FCT 498 at paras. 16, 21, 31 to 34; Pharmascience, supra, at para. 22; and SmithKline Beecham Pharma Inc. et al v. Apotex et al. (2000), 3 C.P.R. (4th) 22 at para. 8, among other cases that were cited by counsel.
[18] At this stage, I cannot accept Novopharm's argument to the effect that the process by which the bulk material is manufactured by a related third party (Teva), should not be relevant in determining whether Novopharm's allegation of non-infringement is justified. Clearly this is an issue raised in the present proceeding and it will have to be addressed and determined by the Court on its merit upon a proper examination of the principles of applicable law (Wellcome Foundation Ltd. v. Apotex (1992), 39 C.P.R. (3rd ) 289 (F.C.T.D.) at pages 313-15 and the cases cited therein). I accept the arguments brought forward by Pfizer. I consider the requested information necessary to establish the evidentiary foundation in order to allow this Court to assess the allegation of non-infringement. An order shall issue accordingly.
[19] That being said, I have also considered Novopharm's argument that it cannot be compelled to produce material which is not in its possession. I find that there is insufficient evidence to establish that Novopharm has tried, and failed, to obtain the cross-referenced information from the supplier (Teva), particularly since Novopharm took the position that the information was not relevant to the issues in the proceeding (cross-examination of Francis Chouinard on his affidavit, and more particularly questions 105 to 108 and the answers given by the witness on this occasion). In this regard, I am guided by the principles expressed by the Court of Appeal in Pharmascience, supra, at paragraph 31. See also Monarch Marking Systems Inc. v. Esselte Meto Ltd. et al. (1983), 75 C.P.R. (2d) 130 at pages 132-34; and Pfizer Canada Inc. v. Rhoxalpharma Inc. (T-807-03), more particularly the order by Prothonotary Roger Lafrenière dated September 23, 2003.
[20] An order pursuant to paragraph 6(7)(b) of the Regulations shall also be issued (SmithKline Beecham Pharma Inc., supra, at paras. 21-22).
[21] This brings me to the second issue raised by this motion, which deals with the production of the tableted material upon which Novopharm conducted its tests.
[22] Pfizer filed evidence in this proceeding indicating, amongst other things, that the information provided by Novopharm was insufficient to determine whether the patented dihydrate is formed in the manufacture of Novopharm's bulk azithromycin.
[23] In response thereto, Novopharm filed inter alia, the affidavits of Dr. Lesley Evans, Ms. Valerie Robertson and Dr. Francis Chouinard, that set forth certain analyses of material that was represented to be the Novopharm product. Novopharm conducted analyses of a different lot as well as the lot that was given to Pfizer for testing. Specifically, the tableted material that was provided to Pfizer was from lot #FT-582-12, whereas the material tested by Novopharm was from lot #10942P1, as well as lot #FT-582-12.
[24] Rule 94 of the Rules provides that a person being examined must produce for inspection at cross-examination all documents and other material requested in the direction to attend. In this case, two directions to attend were served on Dr. Chouinard, requiring him, inter alia, to produce samples of azithromycin that were tested by Novopharm. The other request relates to what has been previously discussed in the object of the first part of the motion for which I have decided to issue an order as none of the information was produced by Dr. Chouinard.
[25] When an affiant fails to produce documents or other material required to be produced, Rule 97 permits the Court to order the re-attendance of the affiant at his or her own expense or to strike all or part of the person's evidence.
[26] The applicable principle in determining whether information sought on cross-examination of an affiant is proper is well established. The information must be relevant based on matters arising from the affidavit itself or in order to test the credibility of the witness (Merck Frosst Canada Inc. v. Canada (1994), 55 C.P.R. (3d) 302 (F.C.A.)).
[27] I am satisfied that the information sought during cross-examination by Pfizer is highly relevant to this proceeding and arises from the affidavit itself. The azithromycin tablets tested by Novopharm are central to whether Novopharm's product contains azithromycin dihydrate or converts to azithromycin dihydrate over time.
[28] I further note that on September 16, 2003, Justice Lemieux ordered that Novopharm produce the samples tested by Dr. Evans and Ms. Robertson. I understand that the request of Dr. Chouinard was not included in this motion, because the transcript of his cross-examination was not ready. Justice Lemieux allowed Pfizer to file reply evidence in respect of the samples to be produced.
[29] I have also considered Novopharm's objections to Pfizer's request for the production of further samples and leave to file reply evidence. I have also carefully reviewed the explanations given by counsel with respect to the delay and the overall content of this proceeding. However, I will not refer to any part of the written representations made by counsel on this issue even though I am taking them into consideration.
[30] Finally, I recognize the difference between the present proceeding and an infringement action. I accept that fuller disclosure is needed in this case in order to allow Pfizer to present its best case. It would be unfair to grant absolute control on the samples to Novopharm. This outweighs, in my opinion, the negative factors stressed by Novopharm. An order shall issue accordingly.
[31] Taking all these factors in consideration, the Court grants that the present motion. Costs shall be in the cause. Reserving its jurisdiction with respect to the details and actual content of the order, the Court further directs counsel for Pfizer to serve and file a draft order by October 14, 2003. Novopharm shall have until October 15, 2003 to serve and file written representations and any alternative draft order. A telephone conference shall be later convened by the Court to discuss same, after which a final order shall issue.
__________________________________
Judge
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-74-03
STYLE OF CAUSE: PFIZER CANADA INC. ET AL. v. NOVOPHARM
LIMITED ET AL.
PLACE OF HEARING: OTTAWA, MONTRÉAL
DATE OF HEARING: OCTOBER 9, 10 AND 16, 2003
REASONS FOR ORDER : MARTINEAU, J.
DATED: OCTOBER 10, 2003
APPEARANCES:
PATRICK SMITH FOR THE APPLICANTS
CRISTIN WAGNER
RUTH PROMISLOW FOR THE RESPONDENT NOVOPHARM LTD.
SOLICITORS OF RECORD:
GOWLING LAFLEUR HENDERSON LLP FOR THE APPLICANTS
OTTAWA
BENNETT JONES LLP FOR THE RESPONDENT
TORONTO NOVOPHARM LTD.
MORRIS ROSENBERG FOR THE RESPONDENT
DEPUTY ATTORNEY GENERAL THE MINISTER OF HEALTH
OF CANADA