In its new drug submission for SIMLANDI, a biosimilar containing adalimumab, JAMP Pharma Corporation (“JAMP”) sought approval for three specific presentations: (i) 40 mg/0.4 mL pre-filled syringe; (ii) 40 mg/0.4 mL auto-injector pen; and (iii) 80 mg/0.8 mL pre-filled syringe.
Given that AbbVie did not market the equivalent presentations of HUMIRA (adalimumab) in Canada, in a comprehensive and detailed decision, the Minister of Health (the “Minister”) determined that JAMP was not a “second person” for purposes of subsection 5(1) of the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”) and was thus not required to address patents listed on the patent register by AbbVie before being issued a Notice of Compliance (“NOC”).
Subsequently, the Minister issued an NOC to JAMP for its three presentations of SIMLANDI.
In AbbVie Corporation et al. v. The Minister of Health and JAMP Pharma Corporation, 2022 FC 1209, Justice Fothergill of the Federal Court dismissed AbbVie’s applications to judicially review the Minister’s decisions, on the basis that the Minister’s decisions were reasonable.
Justice Fothergill observed that the “PM(NOC) Regulations are closely connected with the Minister’s functions, and the Minister has great expertise in their application and interpretation”.
In summary, Justice Fothergill determined that 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”.
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