AbbVie Corporation v. Canada (Health), 2022 FC 1209 (Adalimumab*)
Justice Fothergill - 2022-08-17
Read full decision. Automatically generated summary:
AbbVie seek judicial review of two related decisions of the Minister of Health made pursuant to the PM(NOC) Regulations under the Patent Act. The first application concerns the Minister’s determination that JAMP is not a “second person” for the purposes of s 5(1) of the PM(NOC) Regulations in respect of its new drug submission [NDS] 244990. The second application concerns the Minister’s decision to issue a Notice of Compliance [NOC] to JAMP permitting it to market three drugs in Canada under the brand name SIMLANDI. JAMP’s SIMLANDI is a “biosimilar” of AbbVie’s HUMIRA (adalimumab). ... The Minister’s interpretation of s 5(1) of the PM(NOC) Regulations as applying only to a version of a drug that has a specific drug identification number [DIN] and that is marketed in Canada was reasonable, particularly considering the statutory objective of providing a patent enforcement mechanism only in relation to products that are in fact available to Canadians. The applications for judicial review are therefore dismissed.
Decision relates to:
- T-10-22 - AbbVie Corporation et Al. v. Minister of Health et Al.
- A-203-22 - which is an appeal from this decision
- T-130-22 - ABBVIE CORPORATION et Al. v. THE MINISTER OF HEALTH et Al.