Aventis Pharma Inc. v. Apotex Inc.

Aventis Pharma Inc. v. Apotex Inc. Court (s) Database Federal Court Decisions Date 2004-04-15 Neutral citation 2004 FC 570 File numbers T-1742-03 Notes Digest Decision Content Date: 20040415 Docket: T-1742-03 Citation: 2004 FC 570 OTTAWA, (Ontario), this 15th day of April, 2004 Present: THE HONOURABLE JOHANNE GAUTHIER BETWEEN: AVENTIS PHARMA INC. Applicant and APOTEX INC. and THE MINISTER OF HEALTH Respondents and SCHERING CORPORATION Respondent/Patentee REASONS FOR ORDER AND ORDER [1] Last February, Apotex sought an order striking the whole of the evidence filed by Schering Corporation ("Schering") on the basis that it constituted an abuse of process because Schering, as patentee, had no right to file separate evidence to support Aventis Pharma Inc.'s ("Aventis") application and to establish that Apotex' allegations of invalidity of several claims of the Canadian Patent No. 1,341,206 (the "'206 Patent") is not justified. [2] On February 12, 2004, Prothonotary Tabib dismissed Apotex' motion on the basis that Aventis had the right to name Schering as a party respondent, and there was no general principle of law that would allow the Court to curtail Schering's right as a full party. She found that in the particular circumstances of this case, Apotex had failed to establish, regardless of the validity of their position at law, sufficient evidence of abuse to justify striking Schering's affidavits. However, she granted an extension of time to Apotex to serve and file its evidence up to March 3rd, 2004. [3] Apotex asks the Court to set aside this decision, except for the portion granting it an extension of time to file its evidence. [4] The standard of review applicable to an appeal from a Prothonotary's decision is well established (Canada v. Aqua-Gem Investments Ltd., [1993] F.C.J. No. 103 (C.A.) (QL), as restated in Merck & Co. v. Apotex Inc., [2003] F.C.J. No. 1925 (C.A.) (QL)). [5] Apotex submits that the Court should exercise its discretion de novo because the issue before the Prothonotary should be considered vital to the final determination of the case and, in any event, because she erred in law in failing to strike Schering's evidence in its entirety. Schering contests this characterization of Prothonotary Tabib's decision, because among others, there is no indication how its evidence will impact on the final determination of the application. [6] The Court is not convinced that the issue before the Prothonotary was a vital issue. Apotex' evidence indicates that Schering produced evidence on issues with respect to which Aventis had not filed any evidence to contradict the detailed statement contained in its Notice of Allegation ("NOA"). This particular argument was not addressed in any detail at the hearing. It is also difficult to assess it because it involves considering the presumption of truth of factual statements contained in the NOA, the burden of proof of Aventis and the potential impact of the evidence put forth by Schering. [7] But rather than attempting to make this assessment, I have decided to exercise my discretion de novo because this will not have a material impact on the determination of this motion. In effect, I come to the same conclusion as Prothonotary Tabib. [8] The facts relevant to this motion can be briefly summarized. [9] Aventis filed an application pursuant to subsection 6(1) of thePatented Medicines (Notice of Compliance) Regulations, SOR/93-133, amended by SOR/98-166 and SOR/99-397 (the "Regulations") to prevent the issuance of a Notice of Compliance to Apotex for his Ramipril product. The validity of the '206 Patent is at issue. [10] Pursuant to subsection 6(4) of the Regulations, Aventis, a licensee of the '206 Patent, was required to make Schering, the patentee, a party to the application. [11] Aventis and Schering are not related companies and they are represented by distinct counsel. Relying on Rule 303 of the Federal Court Rules, 1998 (the "Rules"), Aventis included Schering as the respondent/patentee. There is no dispute that it was entitled to do so. [12] On October 24, 2003, Prothonotary Lafrenière issued a consent order granting an extension of time to Aventis to file its evidence and fixing a new schedule for the filing of the evidence in the proceedings. Pursuant to that order, both Apotex and Schering were to serve and file their evidence on or before January 21, 2004. [13] On January 20, 2004, Schering filed three affidavits, one by Dr. Smith, a listed inventor of the '206 Patent, one by Mr. Mazer, a patent attorney for Schering and the last from Dr. Roach, a chemist. Pursuant to Prothonotary Tabib's order, Schering was also granted permission to file an additional affidavit on or before February 13, 2004. [14] It appears that Schering's evidence deals mostly with the soundness of the predictability of claims 1, 2, 3 and 6 of the '206 Patent while Aventis' evidence only dealt with the soundness of the predictability of claims 12 and 3. It is not clear if Aventis filed evidence with respect to other arguments raised by Apotex with respect to claims 1, 2, 3 and 6. [15] The nature of Schering's evidence involved additional work for Apotex' experts and counsel. For example, to respond to the affidavits of Mr. Mazer and Dr. Roach, Apotex had to look at material not referred to in Aventis' evidence, such as the file history of the corresponding European Patent application and the Meinwald Declaration (a document cited in the NOA). [16] Apotex says that this cannot simply be cured by the granting of separate or punitive costs or by granting it additional delay to file its affidavits. [17] It submits that allowing the filing of Schering's evidence gives Aventis two (2) distinct opportunities to file evidence to support its position. It also means that Schering is not constrained by the grounds set out in the application to challenge Apotex' NOA[1]. Finally, it says that Schering's filing of the evidence, which was due on the same day as Apotex', "blindsided" Apotex with new evidence and arguments in support of Aventis' position while shielding same from response. [18] For Apotex, in such circumstances, there was clearly an abuse of process by Schering and Aventis. And this abuse is manifest by "the absurdity of Schering's filing non responsive, "responding" evidence". It relies on the decision of Noël J. in Pfizer Canada Inc. v. Apotex Inc., (1997) 72 C.P.R. (3d) 379. [19] It is clear from the decisions of McGillis J. in Apotex Inc. v. Canada (Minister of Health), (2000) 4 C.P.R. (4th) 421 and Blanchard J. in Nu-Pharm Inc. v. Canada (Attorney General), (2001) 14 C.P.R. (4th) 280 (affirmed at (2002) 17 C.P.R. (4th) 288) that under the Federal Court Rules, 1998, there is no provision permitting the Court to limit the rights of a person who is a proper and necessary party to a proceeding. Thus, the respondent/patentee should be entitled to participate fully in the proceeding ans this includes the fundamental right to present its evidence. [20] Parliament saw fit to require that the owner of a patent in issue in proceedings instituted under the Regulations, be made a party to those proceedings. As noted by Noël J. in Pfizer, supra, "[...] The obvious reason for this requirement is to insure that [...] the patentee will also be bound by the outcome of prohibition proceedings under the Regulations [...]". On that basis, Noël J. confirmed that the patentee had the right to be represented by a counsel of its choice. On that same basis, I must also confirm Schering's right to file evidence supporting its view that the '206 Patent is valid and the NOA not justified. [21] I agree with the obiter in Pfizer[2], supra, that a "second person" should not be put to the task and expenses of responding to the same issues more than once. But, even in such cases, that does not mean that the appropriate remedy is necessarily the striking out of the evidence itself. Costs are especially well suited to take care of such abusive conduct (see Rule 400 of the Rules) and if an additional delay is incurred, the first person may have to defend a claim pursuant to s. 8 of the Regulations. [22] Here, Schering did not duplicate the evidence of Aventis. As explained during the hearing, there may be many good commercial reasons to explain why Schering may have a distinct interest in defending the validity of certain claims which may be of lesser imporance to a licencee such as Aventis. I find that Schering cannot be blamed or punished for having done exactly what Noël J. suggested in Pfizer, supra, that is ensuring that it did not duplicate the evidence of Aventis. [23] If the Court was to adopt Apotex' argument, the patentee (who is not the "first person") could not really file any evidence because same would either duplicate or go beyond that of the first person. [24] What really did not make good sense in this file, is the fact that Apotex would have to serve and file its evidence presumably also addressing the responding/patentee's evidence on the same day as the said respondent/patentee's evidence was due for filing. The problem arose from the schedule set out in Prothonotary Lafrenière's order not from the fact that Schering has a right to file evidence to support the validity of its patent. [25] One would have thought that this difficulty would have been evident but Apotex says that when it consented to the October 24, 2003 order, it never turned its mind to this issue and did not or could not anticipate that Schering would file any substantive evidence. When asked what kind of evidence it expected Schering to file on the day scheduled in the order, Apotex mentioned that it could have filed a copy of the '206 Patent. Schering says that it is clear from the terms of its appearance that it intended to support the validity of the patent and the application. Apotex said that it was "tricked". Be it as it may, Apotex' failure to raise this matter when the schedule was fixed, did cause the problem. [26] The Court simply cannot see how, in the present circumstances, it could grant the required order to strike all of the affidavits filed by Schering. The Court agrees with Prothonotary Tabib that there is indeed insufficient evidence to conclude to an abuse of process by Schering in this file. ORDER THIS COURT ORDERS that: The motion is dismissed with costs. "Johanne Gauthier" Judge FEDERAL COURT SOLICITORS OF RECORD DOCKET: T-1742-03 STYLE OF CAUSE: Aventis Pharma Inc. v. Apotex Inc. and The Minister of Health and Schering Corporation PLACE OF HEARING: Toronto, Ontario DATE OF HEARING: March 8, 2004 REASONS FOR ORDER AND ORDER BY: The Honourable Johanne Gauthier DATED: April 15, 2004 APPEARANCES: Mr. J. Hamilton Ms. Y. Kang FOR THE APPLICANT Mr. Andrew Brodkin FOR THE RESPONDENTS Mr. James Wills Ms. Wagner FOR THE RESPONDENT/PATENTEE SOLICITORS OF RECORD: SMART & BIGGAR FOR THE APPLICANT Toronto, Ontario GOODMANS LLP FOR THE RESPONDENTS Toronto, Ontario GOWLING LAFLEUR HENDERSON LLP Ottawa, Ontario FOR THE RESPONDENT/PATENTEE [1] The soundness of predictability of claims 1, 2, 3 and 6 was pleaded in the application (paragraphs 10 and 13(e)) so this argument does not in fact apply to this case. [2] I note that this decision was rendered before the 1998 amendements to the Regulations and the addition of section 8.