Background:

• Bayer and Regeneron Pharmaceuticals appealed a Federal Court decision that dismissed their application for judicial review regarding a health regulatory decision benefiting Biosimilar Collaborations Ireland Limited under the Patented Medicines (Notice of Compliance) Regulations.

Legal Issues:

• Whether the Minister of Health's decision granting regulatory benefits to Biosimilar Collaborations Ireland Limited was reasonable.
• Appropriate standard of review for the Minister's decision.

Court’s Analysis and Decision:

• The Federal Court of Appeal found the reasonableness standard was correctly applied, as there was no concurrent jurisdiction issue between the Federal Court and the Minister regarding section 5 of the Regulations.
• The court agreed with the lower court that the Minister's decision was justifiable and justified, aligning with the purpose and scheme of the Regulations.
• The appellants’ arguments did not demonstrate any errors in the Minister's reasoning that would necessitate court intervention.

Outcome:

• The appeal was dismissed with costs awarded to the respondents, affirming the Minister's decision's reasonableness and the lower court's application of judicial standards.
• No amount for costs specified.