Monday, November 16, 2020

Split Consent Effective under the NOC Regs

 Fresenius Kabi Canada Ltd v Canada (Health) 2020 FC 1013 Manson J

IDACIO / HUMIRA / adalimumab

AbbVie is the owner of several patents relating to adalimumab / HUMIRA. AbbVie and Fresenius Kabi entered into a confidential licensing agreement evidently allowing Fresenius Kabi to market its biosimiliar IDACIO. Fresenius Kabi then sought an NOC relying on s 7(2) of the PM(NOC) Regulations which permits the Minister to grant an NOC if the owner of the patent consents to "the making, constructing, using or selling of the drug." AbbVie wrote to the Minister consenting to "the making, constructing, and, on and after February 15, 2021, to the using and selling" in Canada by Fresenius Kabi of IDACIO [4]. Evidently the temporal split in the consent was to allow Fresenius Kabi to stockpile the drug for launch on February 15. The Minister refused to accept this as effective consent for the purposes of s 7(2), on the basis that the "or" should be read as "and" to avoid an absurd result [12]. Manson J reversed on reasonableness review [9], holding that "or" should be read as "or" [22]-[25] and that this did not result in any absurdity [31]-[33]. Manson J also noted that the Minister's interpretation failed to recognize that one purpose of the Regulations is to allow the timely market entry of generics [29]-[30]; if the temporal split in consent were not permitted, this would result in delayed launch [35].

Manson J’s analysis strikes me as being entirely compelling. The direct practical implication is that the NOC Regulations will not prevent parties from entering into an agreement that ensures launch on a specific date, but not before.

A broader point is that different judges of the Federal Court have consistently interpreted reasonableness review under Vavilov 2019 SCC 65 as endorsing a fairly robust review of Health Canada’s statutory interpretation decisions: in addition to this decision of Manson J, see also Natco 2020 FC 788 McHaffie J (here); ViiV Healthcare 2020 FC 756 Fuhrer J (here); Glaxosmithkline 2020 FC 397 Barnes J (here), all reversing Health Canada on statutory interpretation issues. (I’m not an admin law expert, so I don’t really know how different the results would have been prior to Vavilov.) Substantively, I’m pleased to see this, as Health Canada’s interpretation struck me as unreasonable in all these cases and the FC intervention has helped ensure that the law develops in the manner that would have been intended by the legislature. Of course, Health Canada isn’t always wrong in its stat interp decisions — see Janssen 2020 FC 904 (here) (though even there Health Canada was simply following an FCA decision)—but statutory interpretation just doesn’t seem to be one of Health Canada’s strengths. That is fair enough, given that their mandate is focused on “helping Canadians maintain and improve their health.”

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