CaseJanssen Inc and Millennium Pharmaceuticals Inc v Teva Canada Limited and Minister of Health, 2015 FCA 36

DrugVELCADE® (bortezomib)  

Nature of caseMotion by Teva to dismiss Applicants’ appeal of decision refusing to issue a section 6 prohibition order pursuant to the PM(NOC) Regulations

Successful partyTeva Canada Limited  

Date of decisionFebruary 4, 2015

Summary

Janssen Inc. et al. (Janssen) appealed from the decision of Justice Barnes of the Federal Court refusing to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Teva Canada Limited (Teva) for bortezomib.

Teva received its NOC and moved for an order dismissing the appeal due to mootness.  Janssen argued that Article 9 bis of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union gives it “equivalent and effective rights of appeal”. The Federal Court of Appeal (FCA) rejected this submission because: (i) CETA is not yet part of Canadian law; and (ii) a decision-maker cannot exercise discretion in accordance with a law that has not come into force.

Accordingly, Janssen’s appeal was dismissed on the basis of mootness.

Background

Teva served Janssen with a notice of allegation (NOA) challenging the validity of Canadian Patent No. 2,203,936 on several grounds. In response, Janssen sought an order under the PM(NOC) Regulationsprohibiting the Minister of Health from issuing an NOC to Teva. On December 10, 2014, Justice Barnes of the Federal Court dismissed Janssen’s application for a prohibition order (2014 FC 1192, T-2194-12, public reasons for judgment not yet released as at February 9, 2015). Eight days later on December 18, 2014, the Minister of Health issued Teva its NOC.  On December 22, 2014, Janssen filed a notice of appeal asking for Justice Barnes’ decision to be quashed and to prohibit the Minister of Health from issuing an NOC until patent expiry.

Issue

The main issue concerned whether Janssen established circumstances justifying the hearing of a moot appeal.

Disposition

An appeal from an order dismissing an application for a prohibition order under the PM(NOC) Regulationsbecomes moot once the NOC issues.1 The FCA may nevertheless exercise its discretion to hear the appeal.2Janssen argued that the present situation is unusual because Article 9 bis of CETA guarantees it “equivalent and effective rights of appeal”, which militates in favour of the FCA exercising its discretion to hear the appeal.

The FCA disagreed with Janssen’s CETA argument and refused to hear the appeal: (i) it does not answer the Court’s objection based on judicial economy in the sense that the Janssen retains the right to pursue an infringement action; and (ii) CETA is not yet part of Canadian law and until it receives Royal Assent, a decision-maker cannot exercise discretion to follow it.3

Janssen also argued that since Teva has filed a new Abbreviated New Drug Submission and served an NOA on the same drug but for a new route of administration, there is an ongoing adversarial context necessitating the FCA to hear the present appeal. Again, the FCA disagreed with Janssen’s submissions and held that if and when Janssen begins a prohibition proceeding for that NOA, a new adversarial context will arise but only for that new proceeding.

Accordingly, Janssen’s appeal was determined to be moot and dismissed.