Federal Court holds that post-filing amendments are subject to data protection provisions

5 minute read
01 November 2015

In Hospira Healthcare Corporation v Canada (Minister of Health) (2015 FC 1205), Justice Gagné of the Federal Court dismissed Hospira’s application for judicial review of the Minister’s refusal to issue a Notice of Compliance (NOC) to Hospira for its oxaliplatin product until the expiry of the data exclusivity period for Sanofi-Aventis’ oxaliplatin product (ELOXATIN®).

Broadly speaking, the issue in this case was whether an amendment to a drug submission could trigger the data protection provisions if the initial filing of the submission had not done so. Justice Gagné agreed with the Minister that it could and, in this case, did.

The circumstances of this case were somewhat unique in that Hospira filed its drug submission before Sanofi-Aventis’ submission for ELOXATIN® was filed. Typically, approval of a generic version of a drug is obtained by way of an Abbreviated New Drug Submission (ANDS), in which the generic relies on information in the innovator’s submission concerning safety and effectiveness. This allows the generic company to avoid having to complete time-consuming and expensive clinical trials. Since Hospira wished to obtain a NOC for its oxaliplatin product before Sanofi-Aventis had received its NOC for ELOXATIN®, Hospira had to file a New Drug Submission (NDS). Hospira did so on Oct. 27, 2006. 

Shortly thereafter, Sanofi-Aventis filed its NDS for ELOXATIN® and received a NOC on June 15, 2007. ELOXATIN® was subject to data protection under the Food and Drug Regulations.

Meanwhile, Hospira faced obstacles in respect of its submission, as it did not have clinical trial data for its product.  Ultimately, Hospira received a Notice of Noncompliance (NON) on March 28, 2012, due in part to Hospira’s failure to establish clinical safety and efficacy.

On July 24, 2012, Hospira responded to the NON by relying on ELOXATIN®’s approval. On Oct. 31, 2013, the Minister advised Hospira that it would not receive its NOC until after expiry of the data exclusivity period for ELOXATIN®.

Before the Court, Hospira argued that the Minister had misinterpreted section C.08.004.1(3) of the data protection provisions.  This provision provides that, if a manufacturer directly or indirectly compares its drug with an innovative drug covered by data protection:

(a) the generic manufacturer cannot file its submission until 6 years after the issuance of the innovator’s NOC; and

(b) the Minister cannot approve the generic’s submission until 8 years after the issuance of the innovator’s NOC 

Hospira argued that, in order for the data protection provisions to be triggered, it had to run afoul of both (a) and (b). Since the 2006 filing of Hospira’s NDS had not triggered the application of the data protection provision under (a), Hospira argued that the Minister could not apply paragraph (b) to prevent Hospira from receiving its NOC.

The Court disagreed with Hospira’s interpretation of C.08.004.1(3). In deciding that the Minister’s interpretation was correct, the Court relied in part on the data protection provisions’ purpose of protecting innovators from unfair commercial use of undisclosed data. Further, the Court held that Hospira’s interpretation would be contrary to Canada’s obligations under NAFTA and TRIPS.

In a related case, Hospira Healthcare Corporation v Canada (Minister of Health) (2015 FC 1206), Hospira had challenged the Minister’s decision that it must address a patent on the Patented Medicines (Notice of Compliance) Regulations Patent Register in respect of ELOXATIN®. Hospira’s NDS was filed prior to the listing of the patent on the Patent Register, but Hospira had filed a SNDS after the patent had been listed.  Justice Gagné dismissed the application as moot, since the patent had expired and, in any event, the Minister could not issue Hospira its NOC due to the data protection provisions.

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