Pharma in brief - Data protected: “Innovative Drug” status prevents generic NOC

Case: (1) Hospira Healthcare Corp v Canada (Health) and Sanofi-Aventis, 2015 FC 1205
Case: (2) Hospira Healthcare Corp v Canada (Health) and Sanofi-Aventis, 2015 FC 1206

Drug: ELOXATIN® (oxaliplatin)

Nature of case: (1) Judicial review of Minister’s decision to not issue an NOC based on “innovative drug” data protection
Nature of case: (2) Judicial review of Minister’s decision to not issue an NOC based on an incomplete SNDS

Successful party: Health Canada and Sanofi-Aventis

Date of decision: November 6, 2015

Summary

Sanofi-Aventis (Sanofi) markets and sells oxaliplatin, used for the treatment of life-threatening colorectal cancer, in Canada under the brand name ELOXATIN® for use in the treatment of colorectal cancer. Hospira Healthcare Corp (Hospira) brought two applications for judicial review of two ministerial decisions regarding the approval of two of its generic oxaliplatin products for the same treatment indication.

In 2015 FC 1205 (the First Application), the Federal Court held that where a second-entry manufacturer amends its drug submission post-filing to make a comparison to the brand-name product, the Minister cannot issue a Notice of Compliance (NOC) until data protection for the brand-name product had expired.

In 2015 FC 1206 (the Second Application), the Federal Court held that it did not need to decide if the PM(NOC) Regulations were engaged since the patent that had been listed on the patent register in respect of ELOXATIN® had expired by the date of the hearing.

Sanofi’s ELOXATIN® benefitted from data protection

On November 20, 2006, Sanofi filed an NDS for approval to market and sell ELOXATIN®, used for the treatment of life-threatening colorectal cancer, in Canada and was granted priority review status. The Minister issued an NOC for ELOXATIN® (in both a dried powder form and a solution form for injection) on June 15, 2007 and granted data protection until December 15, 2015.

Hospira’s NDS and post-filing amendment

Hospira filed an NDS for oxaliplatin (dried powder injection product) on October 27, 2006 supported by literature references and post-market experiences.  The Hospira NDS was rejected initially at the screening stage  on the basis that no clinical or pre-clinical data had been supplied, but was ultimately refiled with the Minister for redetermination pursuant to a decision of the Federal Court of Appeal in which the Court also stressed that the Minister had discretion to determine the nature and form of the information necessary to meet the requirements of safety and efficacy.

Hospira’s NDS was accepted for examination on June 3, 2011 and on March 28, 2012, the Minister issued a Notice of Non-Compliance (NON) for Hospira’s proposed product.

On July 24, 2012, Hospira made a post-filing amendment to its NDS to reference the Summary Basis of Decision and Product Monograph for ELOXATIN®.  On October 31, 2013, the Minister refused to issue Hospira an NOC until the data protection on ELOXATIN® had expired.

Data protection applies to post-filing amendments

Hospira argued that, since the reference to ELOXATIN® was made in post-filing amendments to an NDS, it is not subject to a data protection prohibition. The relevant provision of the Food and Drug Regulations is C.08.004.1(3). Justice Gagné rejected this argument and held, when read as a whole, it is “clear that post-filing amendments are subject to the data protection prohibition imposed on the Minister”. Justice Gagné dismissed the First Application and upheld the Minister’s determination that an NOC for Hospira’s oxaliplatin could not be issued until the data protection on ELOXATIN® had expired (December 15, 2015).

No lack of procedural fairness

Hospira argued that it should have been informed earlier that data protection would prevent issuance of its NOC and, since it was not, that it had been denied procedural fairness. Justice Gagné rejected this argument and held that there was no lack of procedural fairness for two reasons: (i) the Minister must first determine that a drug is safe and effective before deciding issues related to data protection; and (ii) Hospira could have, but did not, avail itself of the reconsideration process in response to the Minister’s decision of October 31, 2013.

Second application is moot

The Minister rejected Hospira’s SNDS (solution injection product) on the basis that it did not include a Form V in respect of the patent listed in respect of ELOXATIN® (solution form for injection), which Hospira argued was in error.

Justice Gagné held that the issue was moot for two reasons.  First, the patent listed in respect of ELOXATIN® had expired and a prohibition order could no longer be granted pursuant to the PM(NOC) Regulations.  Second, Sanofi’s ELOXATIN® (both the dried powder and the solution injection products) benefitted from data protection until December 15, 2015.  Even if the Court had found in the First Application that ELOXATIN®’s data protection did not prevent the issuance of an NOC for Hospira’s dried powder injectable product, Hospira’s SNDS was filed after Sanofi had received its NOC and data protection would apply.

Link to decisions:

Hospira Healthcare Corporation v. Canada (Health), 2015 FC 1205

Hospira Healthcare Corporation v. Canada (Health), 2015 FC 1206