OTTAWA, Ontario, September 15, 2006
PRESENT: The Honourable Mr. Justice Teitelbaum
BETWEEN:
ALTANA PHARMA AG
and
THE MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
I. Background
[1] The present motion arises within an application for prohibition under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The respondent Apotex Inc. (“Apotex”) served a notice of allegation on January 18, 2006 alleging non-infringement of Canadian Patent No. 2,092,694 (the “‘694 Patent”) and No. 2,089,748 (the “‘748 Patent”). The applicants Pharma Inc. and Altana Pharma AG initiated proceedings on March 9, 2006 seeking an order prohibiting the Minister of Health (the “Minister”) from issuing a notice of compliance to Apotex in respect to its proposed 20mg and 40 mg pantoprazole sodium tablets (the “Tablets”).
[2] In a notice of motion dated April 5, 2006, the applicants asked the court for an order to compel Apotex to produce samples of the Tablets. In an order dated June 27, 2006, Prothonotary Milczynski ordered Apotex to provide to the applicants the details of the formulation of the Tablets that Apotex currently had on file with the Minister relating to the notice of allegation, including the dissolution methodology and data. In that same order she dismissed the motion for production of samples. The applicants appealed Prothonotary Milczynski’s decision with respect to the production of samples. The Court dismissed the appeal in an order dated July 28, 2006.
[3] The April 5, 2006 motion for production of samples (the “Samples Motion”) was brought under s. 6(7) of the Regulations. Under s. 6(7), a sample can be compelled if it was submitted to the Minister as part of an Abbreviated New Drug Submission (ANDS). Apotex had not submitted any sample to the Minister and, therefore, s. 6(7) is not available to the applicants. The present motion, begun by notice of motion dated August 9, 2006, seeks an order compelling Apotex to provide the applicants with samples of the Tablets. In this motion, the applicants argue that the court can compel production under its inherent jurisdiction.
II. The Applicants’ Submissions
[4] The applicants argue that the case law prior to the enactment of s.6(7) of the Regulations demonstrates that the court has an inherent jurisdiction to order limited production in an appropriate case, where the relevance of the information was established by the party seeking production. In particular, the applicants rely on SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999), 3 C.P.R. (4th) 22 (F.C.T.D.) for the proposition that before the enactment of s.6(7) the court had a discretionary power to order production of confidential information in notice of allegation proceedings. The applicants also rely on a number of other cases where production was ordered based on the inherent jurisdiction of the court (Janssen Pharmaceutical Inc. v. Apotex Inc. (1996), 68 C.P.R. (3d) 114 (F.C.T.D.), Eli Lilly and Co. v. Novopharm Limited (1996), 69 C.P.R. (3d) 81 (F.C.T.D.) and Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 53 C.P.R. (3d) 368 (F.C.T.D.) [Merck Frosst]). The applicants submit that such a discretionary power still exists despite the enactment of s.6(7).
[5] The applicants argue that AB Hassle v. Apotex Inc., 2004 FCA 255 [AB Hassle] established that the court can compel production of samples prior to cross-examination where the samples are referred to in affidavits. They acknowledge that the finding in AB Hassle does not directly apply in this motion as affidavits referring to the samples have not yet been filed by Apotex. The applicants argue that the discretionary right to order production which existed in the case law prior to the enactment of s.6(7) allows the court to extent the finding in AB Hassle to compel production of samples even before affidavits referring to the testing of samples have been filed. The applicants argue that extending the finding in AB Hassle in this manner would be the most expedient way to proceed in this case.
[6] In anticipation of an argument on issue estoppel from Apotex, the applicants submit that they can properly move for an order for production because this motion is new. They submit that the new evidence put forward in this motion distinguishes it from the Samples Motion and that this evidence should change the nature of the motion. The new evidence is the affidavit of Dr. J. McGinity that alleges that the dissolution methodology data provided by Apotex to the applicants is insufficient to determine whether there is infringement of Patent ‘694 and Patent ‘748.
III. The Respondent’s Submissions
[7] Apotex argues that the motion should be dismissed because the doctrines of issue estoppel and abuse of process operate to prevent the applicants from bringing this motion when the Samples Motion was already heard and dismissed.
[8] Apotex argues that issue estoppel arises where three preconditions arise: (1) the issue must be the same as the one decided in the prior decision; (2) the prior judicial decision must have been final; and (3) the parties to both proceedings must be the same (Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460 [Danyluk]). Apotex argues that all three preconditions are met. First, this motion is essentially the same as the Samples Motion. Second, the Prothonotary’s decision was final. And third, the Samples Motion was a decision between the same parties as this motion.
[9] Apotex also argues that it would be an abuse of process to allow this motion and that judges have an inherent and residual discretion to prevent an abuse of the court’s process (Toronto (City) v. C.U.P.E., Local 79, [2003] 3 S.C.R. 77; AB Hassle v. Apotex Inc. (2005), 38 C.P.R. (4th) 216 (F.C.T.D.)). Apotex argues that allowing this motion would violate judicial principles such as consistency, finality and the integrity of the administration of justice since the matters at issue have already been determined by this court.
[10] Finally, Apotex argues that the court does not have jurisdiction to make an order for production of samples unless the Minister has a sample. Apotex argues that there is no case law to support the applicants’ submission that the court has inherent jurisdiction to order production of samples and Apotex argues that the jurisprudence is clear that samples are only compellable if they have been provided to the Minister. Apotex points out that in all of the cases relied on by the applicants the Minister had the information which was compelled for production.
[11] Apotex further argues that any discretionary power the court may have possessed has been overridden by the legislative enactment of s.6(7). On this point Apotex refers to the decision of Madam Justice Snider of the Federal Court in Pfizer Canada Inc. v. Apotex Inc. (2003), 24 C.P.R. (4th) 259 at para. 26 (F.C.T.D.) who held that “The exceptional instances in which production is required are clearly set out in that subsection and ought not to be expanded without clear legislative direction.”
IV. Analysis
[12] The parties agree that the court cannot order production of samples under s.6(7) of the Regulations unless samples were submitted to the Minister as part of the ANDS; however, they disagree on the question of whether samples can be compelled under some other rule where a sample was not submitted to the Minister as part of the ANDS.
[13] The Federal Court of Appeal in AB Hassle considered when samples could be compelled to be produced outside of s.6(7). In that case one party requested samples from the other party and was not provided with them until production of the samples was compellable when a witness testified and was cross-examined on the testing of the samples. The Federal Court of Appeal held that where production could not be compelled under s. 6(7) then cross-examination is an appropriate time to compel the samples. Responding to concerns about expediency, the court held that samples could be compelled before cross-examination. I cite the relevant portion of that decision:
In my view, in circumstances where the disclosure process envisaged in subsection 6(7) of the Regulations cannot be resorted to because the samples have not been provided to the minister and where the second person proceeds to their testing and file affidavit evidence of the results of these tests in the prohibition proceedings, expediency, fairness and the overall interest of justice given the first person the right to, immediately after such filing, seek by motion the production of these samples for a testing of its own.
(AB Hassle, above, at para. 11)
[14] The applicants cannot compel production based on the rule established in AB Hassle since affidavits on the subject of testing the Tablets have not been filed by Apotex.
[15] The applicants argue that the concern of expediency should compel this court to use its inherent jurisdiction to expand the rule laid out in AB Hassle so as to allow the court to order production of samples even before affidavits are filed. In my view, concerns of expediency, while important, cannot be used here to justify changing the nature of the proceeding and the scope of discovery in applications under the Regulations which seek to prohibit the Minster from issuing a notice of compliance. The court in AB Hassle refers to decisions of the Federal Court and the Federal Court of Appeal where the courts stressed the limited scope for discovery in these kinds of proceedings (AB Hassle, above, para. 8, citing Merck Frosst, above; Hoffman-La Roche Ltd. v. Minister of National Health and Welfare et al. (1996), 67 C.P.R. (3d) 484). Allowing orders for production of samples to be made before affidavits are filed changes the scope of discovery significantly.
[16] In my view, in this type of proceeding samples can only be compelled in two instances: first, under s. 6(7) of the Regulations and, second, where evidence on testing of the samples has been filed with the court. Since neither of these is available to the applicants the motion should be dismissed.
[17] The motion should be dismissed on the reasons stated above, however, I will briefly discuss issue estoppel which was raised by Apotex.
[18] Apotex argued that all three requirements for issue estoppel as laid out by the Supreme Court of Canada in Danyluk are met in this case, namely: 1) the issue must be the same as the one decided in the prior decision; (2) the prior judicial decision must have been final; and (3) the parties to both proceedings must be the same. I agree with Apotex that all three requirements are met in this case. The issue in this motion is the same as in the Samples Motion with the small difference that the first motion was brought under s. 6(7). The decision of the Prothonotary was final and the appeal of her decision was also final. The last requirement is easily met as the parties in the first motion are parties to this motion.
[19] I do not find the applicants’ submission that this motion is different than the Samples Motion convincing. The affidavit evidence submitted by the applicants to prove that production of samples is essential to its case does not in any way change the analysis of whether production should be ordered.
[20] In Danyluk, above, at para. 62, the Supreme Court held that even where all three requirements for issue estoppel are met, the court still has discretion whether to apply the doctrine. At para. 80, the court lays out a number of factors to be considered when deciding whether a court should exercise its discretion to apply the doctrine, the most important of which is whether in applying the doctrine of issue estoppel in the particular case an injustice would be done. In my view, applying the doctrine of issue estoppel in this motion would not be unjust because the applicants could still compel the samples at a later stage in the application if affidavits on the testing of samples are filed.
V. Conclusion
[21] The motion for production of samples brought by the applicants is dismissed. Orders for production of samples should be permitted under s. 6(7) of the Regulations or where affidavits which discuss testing of the samples have been filed.
[22] This motion is also dismissed on the grounds that issue estoppel applies. The issue of whether samples could be compelled was already decided by the Prothonotary and her decision was upheld on appeal. Further, there is no compelling reason for the court to exercise its discretion not to apply issue estoppel in this case.
ORDER
THIS COURT ORDERS that the present Motion is denied with costs.
“Max M. Teitelbaum”
Judge
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-427-06
STYLE OF CAUSE: Solvay Pharma Inc. and Altana Pharma AG v. Apotex Inc. and The Minister of Health
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: August 14, 2006
REASONS FOR ORDER: TEITELBAUM J.
APPEARANCES:
|
Mr. Ken Clark
|
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|
Mr. Andrew Brodkin Mr. Eric Peterson |
FOR THE RESPONDENT Minister of Health |
SOLICITORS OF RECORD:
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Gowling, Lafleur, Henderson, LLP Toronto, Ontario
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Goodmans LLP John H. Sims, Q.C. Deputy Attorney General of Canada |
FOR THE RESPONDENT Minister of Healh |