CaseJanssen Inc v Canada (AG), the Minister of Health and Hospira Healthcare Corporation, T-1516-14, appeal filed by Minister of Health in A-143-15 and by Hospira in A-172-15

Drug: REMICADE® / INFLECTRA® (infliximab)

Nature of case: Judicial review of Minister of Health’s decision to issue NOC to Hospira

Successful Party: Janssen

Date of decision: March 9, 2015

Summary

Janssen Inc [Janssen] sells infliximab under the brand name REMICADE®. On June 4, 2014, the Minister of Health [Minister] issued a Notice of Compliance [NOC] to Hospira Healthcare Corporation [Hospira] for its subsequent entry biologic [SEB] infliximab product, INFLECTRA®, which was compared to REMICADE®. The Minister did not require Hospira to address Canadian Patent No. 2,261,630 [the ‘630 Patent] listed against REMICADE® on the Patent Register on the basis that Hospira’s administrative drug submission for infliximab was based on Celltrion’s prior infliximab approval issued before the ‘630 Patent was added to the Register. Janssen brought an Application to have the NOC granted to Hospira quashed [Application] on the basis that the patent should have been addressed. Prior to any decision on the merits of this Application, the Federal Court issued two decisions in unrelated proceedings quashing NOCs issued for an administrative drug submission in similar circumstances on the basis that Health Canada acted without jurisdiction.1 The parties consented to Judgment in the Application setting aside the NOC issued to Hospira while maintaining the parties’ rights to appeal [Judgment]. The Minister and Hospira have now appealed the Judgment to the Federal Court of Appeal.

Background

Janssen has sold infliximab in Canada since 2001 under the brand name REMICADE®. REMICADE® is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α) used to treat autoimmune diseases. The ‘630 Patent pertains to a 100mg/vial infliximab powder for solution product.  In and around December of 2012, the ‘630 Patent became the only patent listed on the Patent Register for REMICADE®.

Prior to the ‘630 Patent being added to the Patent Register for REMICADE®, Celltrion Healthcare Co Ltd [Celltrion] filed an SEB submission for an infliximab product compared to REMICADE®. Since there were no patents listed on the Patent Register at the time of Celltrion’s submission, the Patented Medicines (Notice of Compliance) Regulations [Regulations] were not engaged. The Minister of Health therefore issued an NOC to Celltrion for its infliximab product, INFLECTRA®, on January 15, 2014.

On April 7, 2014, Hospira filed an administrative new drug submission [NDS] which cross-referenced Celltrion’s drug submission for INFLECTRA® and sought approval to become the manufacturer for same. As a result, the Minister determined that Hospira’s administrative NDS did not trigger section 5 of theRegulations despite the intervening listing of the ‘630 Patent. On June 4, 2014, the Minister issued an NOC to Hospira for infliximab.

Janssen commenced an Application on or about July 2, 2014 against Hospira, the Attorney General of Canada, and the Minister requesting, inter alia, that the Federal Court quash the NOC issued to Hospira for failing to require Hospira to address the ‘630 Patent under the Regulations.

Intervening decisions re setting aside NOCs based on cross-referenced administrative NDS

After Janssen commenced the present Application, Justice Gleason of the Federal Court released two decisions wherein NOCs were set aside: Pfizer Canada Inc v Canada (AG), 2014 FC 1243 [Pfizer] andActelion Pharmaceuticals Canada v Canada (AG), 2014 FC 1249 [Actelion]. These two decisions granted the innovators’ applications to set aside the Minister’s decision to issue NOCs to second persons based on administrative drug submissions without complying with the Regulations. The three generic drug submissions at issue in Pfizer and Actelion had each cross-referenced the submission of another generic company that had previously complied with the requirements under the Regulations. The Minister had not required these three companies to comply with the Regulations as previously reported in our Pharma in brief dated January 2015.  Both decisions are under appeal.

Judgment on consent and subsequent appeal

By Judgment dated March 9, 2015, the parties consented to an Order setting aside the NOC issued to Hospira for its infliximab product without prejudice to any right of appeal. The Judgment indicates that the parties may seek to have their appeal consolidated or heard together with the pending appeals in Pfizer and Actelion (A-27-15 and A-28-15).

The Minister filed a Notice of Appeal on March 16, 2015 in A-143-15, asking the FCA to overturn Justice Gleason’s underlying Judgment and declare the Minister’s decision to issue the NOC to Hospira, without complying with the Regulations, to be valid. Hospira also filed a Notice of Appeal on March 27, 2015 in A-172-15.

Link to decision:

Pharma in brief re Federal Court decisions setting aside NOCs may be found here.