Monday, May 10, 2021

Thirty Day Listing Period under NOC Regs Is Not Discretionary

Merck Canada Inc v Canada (Health) 2021 FC 345 Fothergill J

             2,830,806 / pembrolizumab / KEYTRUDA

Subsection 4(6) of the PM(NOC) Regulations provides that in order to be listed on the Patent Register, the patent list must be submitted within 30 days after issuance. The 806 patent was issued on May 12, 2020 [7]. It would otherwise have been eligible for listing against KEYTRUDA, but due to an apparent oversight, the 806 patent was not submitted until after the close of business on June 12, 2020, and was consequently deemed to have been filed on the next business day, Monday, June 15, 2020 [8], which was just outside 30 days. (The 30th day after issuance was the June 11, if I’m counting correctly.) Tthe Minister consequently refused to list the 806 patent on the Register on the basis that the list had not been submitted within 30 days of the issuance.

Merck appealed on the basis that the Minister’s determination that the Covid-19 Time Limits Act did not have the effect of suspending the 30 day time period specified in s 4(6) was unreasonable, and that the Minister’s determination that she had no discretion to extend the 30 day time period was also unreasonable [14]. Fothergill J found that the Minister’s determination on both these points was reasonable. I won’t go into the details except to say that, for what it’s worth, Fothergill J’s reasoning strikes me as sound.

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