Court dismisses Allergan’s judicial review application of Alberta Minister of Health’s bimatoprost interchangeability designation

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Smart & BiggarOn August 8, 2019, the Court of Queen’s Bench of Alberta dismissed Allergan’s application for judicial review of a decision by the Alberta Minister of Health (the Minister) to designate Allergan’s glaucoma treatment product LUMIGAN RC 0.01% and Sandoz’s generic bimatoprost ophthalmic solution VISTITAN 0.03% as interchangeable: Allergan v Alberta (Justice and Solicitor General), 2019 ABQB 610. Justice Romaine held that judicial review of the impugned decision was not appropriate because it was not the final or most recent decision of the Minister on the issue. However, Justice Romaine indicated that if judicial review were appropriate, she would have found the decision unreasonable. 

Allergan had marketed two different bimatoprost products: LUMIGAN 0.03% and LUMIGAN RC 0.01%. At Allergan’s request, LUMIGAN 0.03% and LUMIGAN RC 0.01% were listed as interchangeable in 2010. Interchangeability requires a finding that the drugs “are expected to be safe when interchanged with other Drug Products in the interchangeable grouping, and to have the same therapeutic effectiveness when administered to patients under the conditions specific in the labelling”. At Allergan’s request, LUMIGAN 0.03% was delisted in 2011. 

In 2015, Sandoz applied for VISTITAN 0.03% to be listed as interchangeable with LUMIGAN RC 0.01%. In October 2016, the Minister advised Allergan of the Expert Committee’s opinion that since LUMIGAN 0.03% and LUMIGAN RC 0.01% had been listed as interchangeable, any generic bimatoprost 0.03% demonstrated to be pharmaceutically equivalent to LUMIGAN 0.03% may be designated interchangeable with LUMIGAN RC 0.01%. This was communicated to Allergan (the 2016 Decision), and VISTITAN 0.03% and LUMIGAN RC 0.01% were subsequently designated interchangeable. Allergan then filed a resubmission, requesting that LUMIGAN RC 0.01% be reviewed as a new chemical entity rather than as a therapeutic alternative to any other product containing bimatoprost. The Minister advised Allergan (the 2017 Decision) that no change would be made to the interchangeable listing status of LUMIGAN RC 0.01%. The 2016 Decision was the subject of the judicial review.

Justice Romaine found that the purpose of Allergan’s resubmission was to remove the interchangeability designation made in 2016. While the criteria for interchangeability decisions and resubmissions may differ, the questions as framed by Allergan were “opposite sides of the same coin.” Because Allergan did not apply for judicial review of the 2017 Decision, judicial review of the earlier, superseded decision was not appropriate.

However, Justice Romaine indicated that if judicial review were appropriate, she would have found the 2016 Decision unreasonable because it failed to make the comparison between VISTITAN 0.03% and LUMIGAN RC 0.01% as required by the interchangeability test.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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