Abbott Laboratories v. Canada (Minister of Health)

Abbott Laboratories v. Canada (Minister of Health) Court (s) Database Federal Court of Appeal Decisions Date 2004-03-04 Neutral citation 2004 FCA 97 File numbers A-49-04, A-50-04, A-51-04 Decision Content Date: 20040304 Dockets: A-49-04 A-50-04 A-51-04 Citation: 2004 FCA 97 Present: Sharlow J.A. A-49-04 (T-1035-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and PHARMASCIENCE INC. Respondents A-50-04 (T-1133-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and APOTEX INC. Respondents A-51-04 (T-1847-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and RATIOPHARM, a division of RATIOPHARM INC. Respondents Dealt with in writing without appearance of parties. Order delivered at Ottawa, Ontario on March 4, 2004. REASONS FOR ORDER BY: SHARLOW J.A. Date: 20040304 Dockets: A-49-04 A-50-04 A-51-04 Citation: 2004 FCA 97 Present: Sharlow J.A. A-49-04 (T-1035-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and PHARMASCIENCE INC. Respondents A-50-04 (T-1133-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and APOTEX INC. Respondents A-51-04 (T-1847-02) BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and RATIOPHARM, a division of RATIOPHARM INC. Respondents REASONS FOR ORDER Sharlow J.A. [1] These are appeals from a Federal Court decision made on January 29, 2004. Expedited hearings have been ordered. The hearings are scheduled for April 7 and 8, 2004. [2] There are two disputes as to the contents of the appeal books. Before me is a motion to settle the matter. One of the disputes relates to material in respect of a motion record submitted to the Federal Court by Abbott Laboratories and Abbott Laboratories Limited (collectively, "Abbott'). The other relates to material in an application in the Federal Court that has been settled. I will deal with the two disputes separately. Background [3] This matter arose as a result of proceedings under the Patented Medicines (Notice of Compliance) Regulations, SOR 93/133, as amended. [4] Abbott owns Canadian Letters Patent No. 2,261,732 (the 732 patent), which has been listed by the Minister in respect of a drug called Biaxin. Abbott received six notices of allegation in respect of Biaxin and the 732 patent, one from each of Novopharm Limited, Pharmascience Inc., Apotex Inc. and ratiopharm, and two from Genpharm. [5] In respect of each of the notices of allegation, Abbott commenced an application in the Federal Court for an order under section 6 of thePatented Medicines (Notice of Compliance) Regulations prohibiting the Minister from issuing a notice of compliance. The Federal Court file numbers for the six applications are T-1236-02 (Novopharm), T-1035-02 (Pharmascience), T-1133-02 (Apotex), T-1847-02 (ratiopharm), T-711-02 (Genpharm) and T-2274-03 (Genpharm). According to the material submitted by Abbott in support of the motion before me, two of those applications are not proceeding because the notices of allegation have been withdrawn: T-1236-02 (Novopharm) and T-711-02 (Genpharm). [6] The respondents in four of the applications (that is, all except Genpharm) moved to strike out the prohibition applications. The four dismissal motions were argued together in the Federal Court. No order was made in respect of the dismissal motion in T-1236-02 (Novopharm) because the Judge was aware that it had been settled. The orders made in the remaining three cases, T-1035-02 (Pharmascience), T-1133-02 (Apotex), T-1847-02 (ratiopharm), are the subject of these appeals. New evidence motion in the Federal Court [7] The three motions to dismiss were heard together in the Federal Court in May, 2003. The Judge reserved to await the decision of this Court in another case, which was issued on June 19, 2003: Ferring Inc. v. Canada (Attorney General) (2003), 26 C.P.R. (4th) 155, (2003) 310 N.R. 186 (leave to appeal to the Supreme Court of Canada dismissed March 4, 2004: [2003] S.C.C.A. No. 396). The Judge did not render her decision right away because the parties wished to make submissions on the effect of the Ferring case. [8] On June 26, 2003, counsel for Abbott wrote a letter to the Court indicating, among other things, that Abbott wished to have the Court consider a letter dated May 29, 2003 that it had received from Health Canada, advising that the 732 patent would remain on the patent list despite a third party complaint. The respondents objected to any attempt to include that letter in the record unless it was admitted pursuant to a formal motion to present new evidence. [9] On August 26, 2003, before the parties had made their submissions on Ferring, Abbott delivered to the Federal Court Registry a motion record for each of the three cases, containing a notice of motion for leave to file new evidence. The proposed new evidence in each case was the May 29, 2003 letter from Health Canada referred to above. [10] The motion record was incomplete, in that it included supporting affidavits but no written submissions. Copies had been served on the respondents. The notices of motion did not specify a hearing date or ask that the motions be considered on the basis of the written material pursuant to Rule 369, but cover letters asked that the proposed motions be brought to the attention of the Judge so that she could specify a hearing date. The letters indicated that once a hearing date was set, complete motion records would be provided, with written submissions. [11] For obvious reasons, the Federal Court Registry did not formally "file" the incomplete motion records that were received from Abbott. Thus, the incomplete motion records technically do not form part of the Federal Court file, although they were physically present in the file at the relevant time. [12] The Federal Court hearing was resumed by conference call on November 13, 2003 to schedule a date for submissions on the Ferring case. According to the minutes of the Registrar, the Judge indicated that she would not hear Abbott's new evidence motions. Obviously, it would have been futile at that point for Abbott to file a completed motion record, and they did not do so. For that reason, none of the respondents have had an opportunity to make submissions on the merits of the new evidence motion that Abbott attempted to bring in the Federal Court. [13] The decision of the Judge not to hear the new evidence motion is not the subject of a formal order. The orders under appeal say nothing about the new evidence motions. As of this date, reasons for judgment have not yet been issued for the Federal Court decision although they are in preparation. [14] Abbott argues that the incomplete motion records should be included in the appeal book. The Minister agrees. All of the other respondents object. The principal objection is that the incomplete motion records were not before the Federal Court. It is also argued that Abbott missed its opportunity to appeal the Judge's decision not to consider the new evidence motion, and that at this stage Abbott should file a motion under Rule 351 for leave to present new evidence on appeal. [15] It is not clear from the material before me whether the Judge considered the contents of the incomplete motion records when she indicated that she would not hear the motion. For the sole purpose of settling the contents of the appeal books, I am prepared to assume that she did so. That is a sufficient basis for concluding that the incomplete motion records should be included in the appeal books. [16] Even if my assumption is wrong, I would be prepared in the unusual circumstances of this case to recognize an exception to the general rule that the appeal book cannot contain anything that was not in the record in the Court below. One of the grounds of appeal is that the Judge erred in deciding not to hear the new evidence motion. There appears to be a debate as to whether and in what manner that aspect of the case is subject to appeal by Abbott. To ensure that the panel hearing this appeal has a factual foundation for such a debate, it would be helpful to them to have access to the relevant documents. [17] The respondents will be aware that I have chosen not to deal with every argument they have raised as to why the incomplete motion records should not be included in the appeal books. Nothing I have said in these reasons should be taken as foreclosing any of the parties from raising any argument they see fit as to the procedure Abbott followed or ought to have followed in attempting to have the May 29, 2003 letter considered by the Judge or by this Court. [18] I conclude that the incomplete motion records that Abbott submitted to the Federal Court Registry on August 26, 2003 should be included in the appeal books. The Novopharm material [19] Two of the respondents, Apotex and Pharmascience, have suggested that it might be helpful to the Court if the appeal books were to include the evidence from T-1236-02 (Novopharm), which as indicated above was fully argued with the other three cases but was apparently settled before the Judge made the orders that are now under appeal. It appears that neither respondent intends to refer to that material. Their view is that in case the Judge refers to the Novopharm evidence in her reasons, this Court should have access to the material. [20] It appears that although all four of these matters were argued together, there was never an order consolidating them. Therefore, once the Novopharm matter fell away, there would be no reason for the Judge to refer to the Novopharm evidence. In these circumstances, I would consider it highly unlikely that the Judge would do so in her reasons. It is so unlikely that I am not prepared to order that the Novopharm evidence be included in the appeal books. "K. Sharlow" J.A. FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-49-04 A-50-04 A-51-04 STYLE OF CAUSE: Abbott Laboratories et al v. Minister of Health & Pharmascience Inc. / Apotex Inc. / Ratiopharm MOTION DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES REASONS FOR ORDER BY: Sharlow J.A. DATED: March 4, 2004 WRITTEN REPRESENTATIONS BY: William H. Richardson FOR THE APPELLANTS Carol Hitchman FOR THE RESPONDENT, PHARMASCIENCE INC. David W. Aitken FOR THE RESPONDENT, RATIOPHARM H.B. Radomski FOR THE RESPONDENT, APOTEX INC. SOLICITORS OF RECORD: McCarthy Tétrault Toronto, Ontario FOR THE APPELLANTS Hitchman & Sprigings Toronto, Ontario FOR THE RESPONDENT, PHARMASCIENCE INC. Osler, Hoskin & Harcourt LLP FOR THE RESPONDENT Toronto, Ontario RATIOPHARM Goodmans LLP FOR THE RESPONDENT, Toronto, Ontario APOTEX INC.