On August 17, 2022, the Federal Court of Canada (the Court) issued its decision in AbbVie Corporation v Canada (Health), 2022 FC 1209, dismissing AbbVie Corporation’s and AbbVie Biotechnology Ltd.’s (collectively, AbbVie) applications for judicial review concerning: (i) the Minister of Health’s (the Minister) determination that JAMP Pharma Corporation (JAMP) did not constitute a “second person” for the purposes of Section 5(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) in respect of its new drug submission (NDS); and (ii) the Minister’s decision to issue a Notice of Compliance to JAMP permitting it to market three drugs in Canada under the brand name SIMLANDI.
In December 2020 or January 2021, JAMP sought regulatory approval in Canada for SIMLANDI, a biosimilar of AbbVie’s HUMIRA (adalimumab). JAMP relied on three HUMIRA formulations with the same dosage forms, strengths, and routes of administration as the drugs to be marketed as SIMLANDI.
In December 2021, the Minister determined that JAMP was not a "second person" for the purposes of Section 5(1) of the Regulations, as none of the HUMIRA formulations were marketed in Canada by AbbVie at the time JAMP submitted its NDS. The Minister maintained that certain obligations under the Regulations did not arise unless the NDS directly or indirectly compared the drug with, or referenced “another drug”. The Minister clarified that “another drug” must be interpreted to refer to a DIN-specific “another drug”, and cannot be broadened to encompass any strength or dosage form of the medicinal ingredient in the reference biologic drug or Canadian Reference Product (as the case may be).
The Court first held that the appropriate standard of review in this case was reasonableness, and rejecting AbbVie’s reading of the Regulations as conferring concurrent jurisdiction on the executive and judicial branches with respect to the application of Section 5(1).
The Court then found that the Minister’s determination that JAMP was not a “second person” for the purposes of Section 5(1) of the Regulations was reasonable, and upheld the Minister’s interpretation of the provision as applying only to a DIN-specific version of a drug that is marketed in Canada. The Court noted the statutory objective of the patent enforcement mechanism in the Regulations and maintained that such mechanism is only available to an innovator that actually markets its innovative drug in Canada.
Lastly, the Court found that the Minister’s decision to issue a Notice of Compliance to JAMP for its SIMLANDI drugs was reasonable, as AbbVie had challenged the decision on the sole basis that the Minister unreasonably found JAMP not to be a “second person”.
The Court therefore dismissed AbbVie’s applications for judicial review.
Summary By: Steffi Tran
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