Janssen-Ortho Inc. v. Novopharm Ltd., 2005 FCA 6

Date: 20050106

Docket: A-630-04

Citation: 2005 FCA 6

CORAM:        RICHARD C.J.

ROTHSTEIN J.A.

PELLETIER J.A.

BETWEEN:

                                                     JANSSEN-ORTHO INC. and

                                         DAIICHI PHARMACEUTICAL CO., LTD.

                                                                                                                                          Appellants

                                                                                                                                        (Applicants)

                                                                           and

                                                    NOVOPHARM LIMITED and

                                                    THE MINISTER OF HEALTH

                                                                                                                                      Respondents

                                                                                                                                    (Respondents)

                                        Dealt with in writing without appearance of parties.

                                   Order delivered at Ottawa, Ontario, on January 6, 2005.

REASONS FOR ORDER BY:                                                                                     RICHARD C.J.

CONCURRED IN BY:                                                                                            ROTHSTEIN J.A.

                                                                                                                                 PELLETIER J.A.

Date: 20050106

Docket: A-630-04

Citation: 2005 FCA 6

CORAM:        RICHARD C.J.

ROTHSTEIN J.A.

PELLETIER J.A.

BETWEEN:

                                                     JANSSEN-ORTHO INC. and

                                         DAIICHI PHARMACEUTICAL CO., LTD.

                                                                                                                                          Appellants

                                                                                                                                        (Applicants)

                                                                           and

                                                    NOVOPHARM LIMITED and

                                                    THE MINISTER OF HEALTH

                                                                                                                                      Respondents

                                                                                                                                    (Respondents)

                                                        REASONS FOR ORDER

RICHARD C.J.

[1]                This is a motion brought by the respondent, Novopharm Limited (Novopharm) in accordance with Rule 369 of the Federal Courts Rules for an order dismissing the within appeal on the ground of mootness.

[2]                The background of this motion is as follows:

[3]                In December 2002, Novopharm filed an Abbreviated New Drug Submission (ANDS) with Health Canada seeking the issuance of a Notice of Compliance (NOC) for NOVO-LEVOFLOXACIN. Concurrent with the filing of the ANDS, Novopharm served on Janssen-Ortho Inc. a Notice of Allegation pursuant to section 4 of the Patented Medicines (Notice of Compliance) Regulations (Regulations).

[4]                On February 7, 2003, Janssen-Ortho Inc. commenced the above referenced application in the Federal Court pursuant to section 5 of the Regulations, seeking an order prohibiting the Minister of Health from issuing an NOC to Novopharm for NOVO-LEVOFLOXACIN.

[5]                On November 25, 2003, Health Canada issued to Novopharm a "patent hold" letter advising that it had approved Novopharm's ANDS and that the NOC would be issued upon resolution of the application commenced by Janssen-Ortho Inc.

[6]                By Order of Mr. Justice Mosley dated November 19, 2004, Janssen-Ortho's application was dismissed.

[7]                On November 23, 2004, Novopharm was informed by Health Canada that the NOC would be issued as soon as Health Canada had reviewed the Product Monograph for NOVO-LEVOFLOXACIN to ensure no changes were required to the monograph as a result of the ANDS being on patent hold for more than 6 months. Health Canada advised Novopharm that this review would likely take a few days, and that the NOC would likely be issued by the end of that week (i.e., by November 26, 2004).

[8]                On November 29, 2004, Novopharm was issued an NOC by Health Canada in relation to NOVO-LEVOFLOXACIN.

[9]                On November 29, 2004, the appellants filed a Notice of Appeal from the Order of Mr. Justice Mosley.

[10]            On November 29, 2004, the appellants filed a notice of motion seeking, inter alia, an order staying the Judgment and Order of Mr. Justice Mosley pending final disposition of the appeal.

[11]            On December 6, 2004, the appellants filed a supplementary notice of motion seeking to quash the Minister's Notice of Compliance and seeking a declaration of invalidity of subsection 7(4) of the Regulations.

[12]            Both of these motions were dealt with under Rule 369 and the relief requested by the appellants was denied by an order made on January 4, 2005.

[13]            Novopharm alleges that the issuance of the NOC to Novopharm on November 29, 2004 has rendered the appeal moot.

[14]            In the recent decision in AstraZeneca AB v. Apotex Inc., 2004 FCA 224, [2004] F.C.J. No. 1006 (F.C.A.) (QL) at para. 1 , this Court, in dismissing an appeal for mootness reaffirmed the jurisprudence of this Court in this matter:

[1] Having heard the representations and read the submissions of both parties, we are not persuaded that there is any basis for distinguishing this case from Merck Frosst Canada Inc. et al. v. Apotex et al. (1999), 240 N.R. 195 (F.C.A.), Pfizer Canada Inc. v. Nu-Pharm Inc.; Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4^th) 245 (F.C.A.), Novartis Pharmaceuticals Canada Inc. v. Rhoxalpharma Inc. (2001), 16 C.P.R. (4^th) 188 (F.C.A.) and Novartis AG v. Apotex Inc. (2002), 22 C.P.R. (4^th) 450 (F.C.A.). We are persuaded that this appeal is moot, and that there is no sound basis for hearing the appeal despite its mootness.

[15]            The circumstances of this case are not distinguishable from those in the above cases.

[16]            The appellants submit that this Court should exercise its discretion to hear the moot appeal for three reasons:

(a)        an adversarial relationship between the parties exists because of the outstanding infringement action between the parties and that the "[t]rial court would benefit strongly from this Court's hearing of the case..";

(b)         other generic manufacturers will bring PMNOC Regulations challenges for levofloxacin;

(c)        the legal issues are of importance to the patent bar.

[17]            With respect to the existence of an adversarial relationship between the parties because of the outstanding infringement action between the parties, this Court has held that a decision holding that an appeal is moot is not adjudicative of issues in an action for infringement.

[18]            In Pfizer Canada Inc. v. Nu-Pharm Inc., [2001] F.C.J. No. 17 (C.A.) (QL) at para. 25, this Court stated:

[25] It should be noticed that a decision by this Court that the appeals are moot does not mean that the appellants are without remedies. They may commence actions for infringement if so advised and the facts warrant. This Court has been very clear on the fact that s. 6 proceedings are not adjudicative of the rights of the patentee. In Merck Frosst Canada, supra, at 319, Hugessen J.A. rejected the notion that prohibition proceedings could be assimilated to an action of any kind:

The proceedings are not an action and their object is solely to prohibit the issuance of a notice of compliance under the Food and Drug Regulations. Manifestly, they do not constitute "an action for infringement of a patent" ...

In these circumstances, it is idle to suggest that any decision that this Court makes in these appeals could be used to attack collaterally a judgment in an infringement action.

[19]            Similarly, in Novartis v. Apotex, 2002 FCA 440, [2002] F.C.J. No. 1551 (C.A.) (QL), this Court stated:

[9] I believe that the fundamental principles applicable are those stated in the reasons of Isaac J.A. in the Pfizer case, as approved and followed by another panel of this Court in the Rhoxalpharma case less than one year ago. The basic principle is that the extraordinary procedures provided by the Regulations are for the public law purpose of enabling the Trial Division to prevent a public officer from issuing a Notice of Compliance, designed for the protection of the public's health, if the patentee can show that the patents, as referred to by a generic company in its notice of allegation seeking a Notice of Compliance, are owned by the applicant "first person" and that the relevant claims are not invalid and would be infringed. This is a finding of the Court for the limited purpose of deciding whether or not the Minister can issue a Notice of Compliance: no one could suppose that this is a scheme designed for res judicata determinations of the scope or validity of patents.

[20]            With respect to the argument that there will be other challenges for levofloxacin, the Supreme Court of Canada, in Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342 at para. 34, rejected the relevance of such considerations as follows:

[34] The mere fact, however, that a case raising the same point is likely to recur even frequently should not by itself be a reason for hearing an appeal which is moot. It is preferable to wait and determine the point in a genuine adversarial context unless the circumstances suggest that the dispute will have always disappeared before it is ultimately resolved.

[21]            Finally, the submission that the legal issues are of importance to the patent bar does not meet the relevant test in Borowski as follows:

[37] There also exists as rather ill-defined basis for justifying the deployment of judicial resources in cases which raise [an] issue of public importance of which resolution is in the public interest. The economics of judicial involvement are weighed against the social cost of continued uncertainty in the law...

There must, therefore, be the additional ingredient of social cost in leaving the matter undecided.

[22]            There is no evidence that there is a social cost in leaving the matter of "selection" patents undecided.

[23]            For these reasons, the motion will be granted and the appeal will be dismissed on the ground of mootness with costs to Novopharm Limited.

                                                                                                                                          "J. Richard"                

                                                                                                                                         Chief Justice               

"I agree

Marshall Rothstein J.A."

"I agree

J.D.Denis Pelletier J.A."

                                                  FEDERAL COURT OF APPEAL

                            NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                           A-630-04

STYLE OF CAUSE:

JANSSEN-ORTHO INC. and DAIICHI PHARMACEUTICAL CO., LTD. v. NOVOPHARM LIMITED and THE MINISTER OF HEALTH

MOTION DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES

REASONS FOR ORDER BY:          RICHARD C.J.

CONCURRED IN BY:                      ROTHSTEIN J.A.

PELLETIER J.A.

DATED:                                              January 6, 2005

WRITTEN REPRESENTATIONS BY:

SOLICITORS OF RECORD: