2,409,059 / exemestane / AROMASIN
2,261,630 / infliximab / REMICADE / INFLECTRA
Section 3.4.1 of the most recent (2012) Guidance Document: Patented Medicines (Notice of Compliance) Regulations, states that when a generic manufacturer of a drug that already holds an NOC licenses a second generic to sell “the identical drug,” the second / licensee generic need only file an administrative drug submission which does not trigger s 5 of the NOC Regulations. This reversed the prior policy, under which the second generic’s submission was considered to trigger s 5. The change in policy resulted from the Minister of Health’s interpretation of the term “submission” in s 5(1) of the NOC Regulations, and not from any change in the regulations themselves. In this decision, the FCA held that the Minister’s interpretation of the Regulations was owed deference, and that the new interpretation was reasonable, reversing Gleason J on both points. This means that a patentee cannot decide whether to respond to an NOA in light of the threat it perceives from the particular generic; instead, a patentee must respond to every NOA it receives, or take the risk that the generic in question will subsequently license. With that said, according to the Guidance Document, the submission by the second generic will only be considered administrative if the drug is “identical.” In the cases under appeal, the second generic certified that its product would be manufactured in the same location with identical specifications and procedures. That is, as I understand it, the first generic, which had received the NOC, was manufacturing the drug for sale by the second generic. The FCA decision suggested that when a drug is manufactured by the second generic in circumstances that give rise to a “to a new or different basis for asserting that a particular product is infringing” , the submission should not be considered administrative. I would imagine that manufacturing by the second generic in a different facility might by considered sufficiently different, even if under licence by the first generic, but the Guidance Document is not explicit on this issue. And regardless of this suggestion by the FCA, the Minister’s interpretation on this point would be reviewed on a deferential standard.
As described in my post on Gleason J’s decision, GMP filed an ANDS with respect to exemestane using Pfizer’s exemestane product, AROMASIN, as the reference product. GMP served Pfizer with an NOA with respect to the ‘059 Patent, and Pfizer chose not to respond, apparently because GMP does not sell products in Canada . An NOC was then issued to GMP. On the same day, Health Canada also issued an NOC to Teva with respect to exemestane. This NOC was granted on the basis of an “administrative” ANDS filed by Teva, based on a licensing agreement with GMP. The NOC issued to Teva also shows AROMASIN as the Canadian Reference product. Teva never served an NOA on Pfizer. An important point which was not apparent from Gleason J’s decision is that Teva also certified that its drug product “would be manufactured in the same location as GMP’s drug product, with identical specifications and procedures” , . Pfizer sought judicial review to set aside the NOC granted to Teva, and was successful at first instance before Gleason J. On appeal, the FCA reversed, holding that in the circumstances, the NOC was properly granted to Teva, and that Teva was not required to serve an NOA on Pfizer.
The same issue was raised in a slightly different factual context in a second appeal which was consolidated with Teva v Pfizer. It related to Celltrion’s subsequent entry biologic INFLECTRA which contained the medicinal ingredient infliximab. Celltrion’s NDS referenced Janssen’s REMICADE. At the filing date of Celltrion’s NDS, no patent was listed on the Patent Register in respect of REMICADE, and the Minister issued a NOC to Celltrion . Shortly thereafter, the 630 patent issued and was listed on the Patent Register against REMICADE. Subsequently, Hospira filed an NDS cross-referencing Celltrion’s NDS seeking approval to market INFLECTRA. In its NDS Hospira certified that it had entered into a licensing agreement with Celltrion with respect to INFLECTRA, and that all aspects of Hospira’s drug product were identical to the cross-referenced Celltrion drug product and that the product would be manufactured in the same location with identical specifications and procedures. Again, the Minister issued an NOC Hospira -, and again the FCA declined to interfere with the Minister’s decision.
There were two main issues, both at first instance and on appeal. First, what is the standard of review of the Minister decision? Second, should the Mininster’s decision be upheld, in light of the appropriate standard of review? At first instance, Gleason J had held that the standard of review is correctness, and that the Minister’s decision granting an NOC to Teva should be set aside as the Minister’s interpretation of the NOC Regulations was incorrect. The FCA reversed, holding that the standard of review is reasonableness , and that the Minister decision to grant the NOC was reasonable in both cases , .
In my post on the standard of review aspect of Gleason J’s decision, I agreed with her conclusion that the standard of review is correctness, in part because I felt that the issue had already been addressed by the SCC in Biolyse 2005 SCC 26. But as I said in that post, “I am not an administrative law expert,” and the FCA held that Biolyse has been overtaken by subsequent SCC cases. I’m told by my colleague Prof Kislowicz, who, unlike me, is an administrative law expert, that the FCA’s holding is not very surprising, and is consistent with the jurisprudence which has characterized Dunsmuir 2008 SCC 9 and subsequent cases as effecting a sea change in Canadian administrative law. To avoid risking further error, I won’t attempt any in depth analysis of the FCA decision, except to say that I understand it as saying that the Minister of Health’s interpretation of the PMNOC Regulations will generally be owed deference, as being closely related to the Minister’s function , and in particular, the Minister’s interpretation of whether a drug submission triggers s 5 is owed deference, and should be reviewed on a standard of reasonableness .
The holding on the standard of review effectively determined the outcome, as Gleason J at first instance had accepted that the Minister’s interpretation was reasonable , and that view was shared by the FCA . (See here for my post on the substantive aspects of Gleason J’s decision.)
The FCA did provide additional guidance which is more generally applicable, saying:
 [W]hen characterizing a drug submission the focus should be upon the drug product itself. The question should be whether the changes reflected in the drug submission give rise to a new or different basis for asserting that a particular product is infringing.
On the facts, Teva had certified that its product “was identical to GMP’s drug except for the name of the manufacturer and the product. It also certified that its drug product would be manufactured in the same location as GMP’ s drug product, with identical specifications and procedures” . Hospira similarly certified that “except for the name of the manufacturer, all aspects of its drug product were identical to Celltrion’s product and its product would be manufactured in the same location with identical specifications and procedures to that of Celltrion’s drug” . Consequently, the Minister’s decision to issue an NOC was reasonable , . In supporting this conclusion, the FCA also noted that “any interpretation of the Regulations not limited to preventing infringement occurring as a result of the early working exception will exceed the scope of regulation-making authority conferred by subsection 55.2(4) of the Act” .
This guidance from the FCA suggests that when the second generic manufactures under licence from the first, but in a difference facility, the submission should perhaps not be considered administrative. However, the Guidance Document is not explicit on this issue. And regardless of this suggestion by the FCA, the Minister’s interpretation of what is considered “identical” would be reviewed on a deferential standard.