Dan Whalen is a JD candidate at Osgoode Hall Law School.
On August 17, 2011, Health Canada released proposed revisions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations for stakeholder consultation. In a welcome effort to bring greater efficiency to the drug approval process, the proposed revisions exempt administrative drug submissions from compliance with the burdensome section 5 of the Regulations.
At present, any drug manufacturer seeking a Notice of Compliance (NOC) by filing a submission or supplement thereof referring to another, originating drug must comply with section 5. This provision requires such an application to address on specified grounds each patent registered in association with the originating drug before the applied-for drug can receive a NOC. Although the language of section 5 seems limited to abbreviated new drug submissions (ANDSs), it has been interpreted as including administrative drug submissions as well.
By its nature, an administrative drug submission is approved by comparison or reference to a new drug submission (NDS) or ANDS, which itself must have been approved on the basis of reference to an originating drug. As noted by Jill Daley, Jason Markwell and Kavita Ramamoorthy of Norton Rose, administrative drug submissions are typically filed in the context of corporate restructuring and licensing arrangements. Thus a common practical effect of section 5 is that licensees seeking approval to sell an identical drug in Canada as that of the licensor under a different name must re-address patents already discussed by the licensor in its preceding submission.
This consequence of section 5 has created no small measure of redundancy. Not only must those filing administrative drug submissions repeat the very same work of their forebears, but the overseeing Office of Patent Medicines and Liaison must also re-analyze the same lists of patents with every new administrative submission. Owing to “growing concerns and challenges raised” on these grounds, Health Canada has now formally acknowledged this redundancy and tentatively labelled it unnecessary.
By the proposed revisions, only an originating NDS or ANDS would prompt the application of section 5. In the common example of the licensor-licensee, it is only the licensor that would have to address any patents listed on the Patent Register in association of the originating drug. Subsequently-filed administrative drug submissions by licensees that cross-reference the licensor’s drug submission would not reinitiate section 5. Accordingly, a licensee would be eligible to receive an NOC in respect of its administrative drug submission once the licensor’s drug submission receives its NOC.
Health Canada welcomes comments from interested parties for 60 days following the release of its proposals.