Data Protection: Sanofi Gains Standing In Hospira’s Objection to Application of Data Protection

On February 26, 2014, the Federal Court of Canada granted standing to Sanofi-Aventis Canada Inc. (Sanofi) in a case involving a Sanofi product on the Register of Innovative Drugs (the Data Protection Register). The product is currently on the Data Protection Register and subject to data protection under the Food and Drug Regulations (the F&D Regulations).¹

Data Protection Under the F&D Regulations

Under the F&D Regulations, a drug manufacturer filing a New Drug Submission (NDS) for a Notice of Compliance (NOC) may apply for data protection to prevent other manufacturers from using the information supporting the NDS in their own regulatory filings. The data protection regime is triggered when, on a manufacturer’s request, the Minister of Health (the Minister) adds a drug (and by extension the active ingredient) to the Data Protection Register. When a drug is added to the Data Protection Register, a period of six years must pass before the Minister may accept a regulatory submission for a NOC that is based on or refers to the drug on the Data Protection Register. Further, the Minister may not grant a NOC for such regulatory submission for an additional two years. In effect, the F&D Regulations grant the manufacturer of an innovative drug a form of market exclusivity based on the data supporting the NDS for a total of eight years.

Hospira’s Challenge to Sanofi’s Data Protection

Sanofi’s product, Eloxatin, had been placed on the Data Protection Register on June 15, 2007. Before that, on October 27, 2006, Hospira Healthcare Corporation (Hospira) filed an NDS for a drug containing "Chemical Entity A", which Sanofi alleges is identical to the active ingredient in Eloxatin.² Hospira’s NDS was initially rejected, at which point Hospira successfully applied for judicial review.

By the time the Minister resumed his review of the Hospira NDS, Eloxatin had been added to the Data Protection Register. During the course of the review, the Minister submitted questions to Hospira, one of which was responded to by Hospira that referred to the product monograph for Eloxatin. On this basis, the Minister determined that Hospira’s NDS made a comparison to Eloxatin, and therefore informed Hospira that no NOC would be issued until the end of the eight-year data protection period. In the current case, Hospira had applied for judicial review of the Minister’s invoking of the data protection scheme.

Sanofi’s Standing Before the Court

Sanofi sought standing as a party to Hospira’s application for judicial review, arguing that it was directly affected by the case Hospira, in turn, argued that only Sanofi’s economic or competitive interests would be affected, and that was insufficient for Sanofi to gain standing.

All parties agreed that there were two persuasive lines of reasoning related to standing of innovative drug manufacturers (innovators) on judicial review applications of other parties before the Federal Court. One stated that an innovator does not have standing in a judicial review of the issuance of a NOC to another manufacturer under the F&D Regulations. The second stated that an innovator does have standing in a judicial review of whether its rights are engaged under the Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). Hospira argued that the cases showed a bright-line test: that innovators may have standing in judicial reviews under the PM(NOC) Regulations, but not in any judicial review under the F&D Regulations.

Prothonotary Tabib interpreted the cases differently, stating the true test was "whether the order sought affects the legal rights of the innovator, imposes legal obligations on it, or prejudicially affects it in some direct way" regardless of the particular regulatory scheme involved. In this case, the Minister had determined that the data protection scheme had been triggered against Hospira and in favour of Sanofi’s product. Since Hospira’s application would remove that protection, Sanofi’s interests vis-à-vis market exclusivity and data protection would be directly affected. Therefore, Prothonotary Tabib granted Sanofi’s application for standing as a respondent to this application.

Conclusion

This ruling is significant given that an innovator was able to gain standing in a data protection dispute between a generic manufacturer and Health Canada. It may allow innovators to gain standing and submit arguments regarding the scope and application of data protection for their products in the future, rather than exclusively relying on Health Canada to police the data protection regulations. Because NDS submissions are confidential, innovators would need to rely on market surveillance or monitor court filings that may relate to their products. It should also be noted that Hospira’s appeal of this order to the Federal Court was denied, and a further appeal to the Federal Court of Appeal is currently pending.

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* With assistance from Albert Chan, Articling Student.

¹ Hospira Healthcare Corporation v. Canada (Health), 2014 FC 179.

² Hospira has neither admitted nor denied Sanofi’s allegation.