On January 29, 2021, the Alberta Court of Appeal dismissed Allergan's appeal of a judicial review decision relating to the interchangeability of its glaucoma drug, LUMIGAN RC ( 0.01% bimatoprost), with a higher concentration bimatoprost product, VISTITAN (0.03% bimatoprost): Allergan Inc v Alberta (Justice and Solicitor General), 2021 ABCA 32.

Alberta Health concluded that VISTITAN was interchangeable with LUMIGAN RC on the basis that LUMIGAN RC had previously been listed as interchangeable with another Allergan bimatoprost product with the same concentration as VISTITAN: LUMIGAN  (0.03% bimatoprost).

On judicial review (reported  here), the reviewing Court agreed that Alberta Health's decision was unreasonable, but the judicial review was nonetheless dismissed as not pertaining to the most final or recent decision on interchangeability. The Court concluded that Allergan ought to have sought judicial review of Alberta Health's later decision on Allergan's resubmission for LUMIGAN RC, which the Court concluded was directed in substance to the interchangeability of LUMIGAN RC and VISTITAN.

On appeal, Allergan argued that the reviewing Court erred in characterizing its resubmission as a request to revisit interchangeability, rather than as a fresh request to consider LUMIGAN RC as a new chemical entity. While the Court of Appeal acknowledged that the resubmission contained statements supportive of Allergan's position, other statements suggested the contrary, such that the reviewing Court's conclusion was reasonable and therefore dismissed the appeal.

Should you have any questions, please do not hesitate to contact a member of the  Life Sciences Regulatory & Compliance Group.

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