On 8 August 2019 the Court of Queen's Bench of Alberta dismissed Allergan's application for judicial review of the Alberta minister of health's decision to designate Allergan's glaucoma treatment product Lumigan RC 0.01% and Sandoz's generic bimatoprost ophthalmic solution Vistitan 0.03% as interchangeable.(1)
Justice Romaine held that judicial review of the impugned decision was inappropriate because it was not the minister's final or most recent decision on the issue. However, 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 as 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.
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". As Allergan did not apply for judicial review of the 2017 decision, judicial review of the earlier, superseded decision was inappropriate.
However, 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.
Endnotes
(1) Allergan v Alberta (Justice and Solicitor General), 2019 ABQB 610.
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