DOES AN INNOVATOR HAVE STANDING AND A RIGHT TO BE MADE A PARTY TO A JUDICIAL REVIEW OF THE MINISTER OF HEALTH’S DECISION RELATING TO THE APPLICATION OF THE DATA PROTECTION REGIME?

This question was recently considered in the Reasons for Order and Order released today in relation to HOSPIRA HEALTHCARE CORPORATION v THE MINISTER OF HEALTH AND ATTORNEY GENERAL OF CANADA (a copy of the Order can be found at http://decisions.fct-cf.gc.ca/fc-cf/decisions/en/70967/1/document.do)

Canada’s Data Protection Regime “aims to protect the data submitted in support of an application for approval to market innovative drugs containing a new chemical entity, by preventing others from using the innovator’s data in support of their own applications for drug approval. When a drug is placed on the Register of Innovative Drugs, the Minister is precluded from receiving from another manufacturer an application for a Notice of Compliance entitling it to market that drug in Canada for a period of six years, where that application is based on or refers to the data provided by the innovator. The Minister may not, either, issue an NOC for such an application for a further period of two years.” (see paragraph [3]).

Sanofi-Aventis Canada Inc.’s drug Eloxatin (which contains the active ingredient oxaliplatin) was found to be an innovative drug in accordance with Canada’s Data Protection Regime and was listed on the Register of Innovative Drugs (the “Register”) on June 15, 2007.

Prior to oxaliplatin’s listing on the Register, Hospira filed a New Drug Submission (NDS) for a drug containing “Chemical Entity A” that was reasonably assumed to be oxaliplatin. During examination of the NDS, Hospira responding to a request for additional information by the Minister of Health “made reference to the product monograph for Eloxatin. The Minister considered that Hospira had thereby made “direct or indirect comparison” between its drug and Eloxatin, and advised Hospira that, pursuant to section C.08.004.1, it would not issue Hospira’s NOC for the drug until the expiration of the data protection period, even though Hospira’s ANDS was otherwise approvable.” (see paragraph [5] of order].

Hospira sought a judicial review of this decision stating that (1) “the data protection provisions do not apply to its NDS because it was filed before Eloxatin was entered on the Register” and (2) “it did not directly or indirectly compare its product to Eloxatin, that if it did, the reference did not appear in its initial NDS and that post-filing amendments are excluded from the scope of the relevant section, and that the reference was mandated by the Minister without due notice that it would be deemed to trigger the application of data protection” (see paragraph [6]).

Sanofi was not named or served the notice of application for judicial review by Hospira. Sanofi argued “that it is a person directly affected by the order sought by Hospira in this judicial review application, and that as such, Hospira ought to have, and should be ordered to, name it as a party respondent”. Madam Prothonotary Tabib agreed with Sanofi and found that “it is clear that an order reversing the Minister’s determination that the data protection regime was engaged and ordering the issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct way, and not merely because it would suffer economic or competitive prejudice” and order Hospira to amend its Notice of Application to add Sanofi.

Claire Palmer, Ph.D.