Sunday, October 27, 2019

Loss in Old s 6 NOC Application Does Not Preclude Action under New s 6

Pfizer Canada Inc v Amgen Inc 2019 FCA 249 Nadon JA: Pelletier, de Montigny JJA aff’g 2018 FC 1078 Milczynski J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

I’ll have another post on Canmar 2019 FC 1233 later this week, but I don’t want to delay any more in posting on the decision of the FCA in Pfizer v Apotex, which raises a transitional issue arising out of the recent amendments to the PM(NOC) Regulations that converted an NOC proceeding from an application to prohibit the Minister from issuing a NOC into an action for patent infringement [8]. In this case Pfizer wanted to launch a biosimilar to Amgen’s Neupogen. Amgen had listed its 537 patent against Neupogen, and Pfizer accordingly served an NOA. Amgen responded by commencing an action under s 6 of the new Regulations, asserting the 537 patent.

The twist is that Amgen had previously asserted the 537 patent against Apotex in proceedings under the old Regulations, and lost before Hughes J: Amgen v Apotex 2015 FC 1261 [the Hughes Decision] aff’d as moot 2016 FCA 196. Under the former Regulations, a patentee that had lost an NOC proceeding against one generic would be prevented from bringing another NOC proceeding against a different generic in respect of the same drug, on the basis of abuse of process: Sanofi 2007 FCA 163. The question in this case was whether it was also an abuse of process for a patentee that had lost an NOC proceeding under the former Regulations to bring another NOC proceeding against a different generic under the new Regulations.

In this decision, the FCA held that this does not constitute an abuse, essentially because an action under the new s 6 (like a s 55 action), results in a determination of validity and infringement, while proceedings under the old s 6 only determined whether the Minister should be prohibited from issuing a NOC to the generic [63], [65]. In Pfizer Ireland 2011 FCA 77 the FCA clearly held that a s 55 action cannot be prevented by reason of a decision made under s 6 of the former Regulations; in this decision, the FCA pointed out that the same reasoning applies to an action under s 6 of the new Regulations, which is substantively identical to a s 55 action [83].

While “Pfizer cannot succeed on the motion now before this Court, it remains open to it to raise issue estoppel and abuse of process once Amgen’s action goes to trial. Whether or not Pfizer can succeed on those grounds in respect of factual findings and legal determinations made by the Hughes Decision, shall. . . depend on the trial judge’s assessment of these issues in light of the evidence” [84]. Note that this was also true under the old Regulations: Pfizer Ireland 2011 FCA 77 [19].

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