Pharma company out of time to bring judicial review proceedings against decision to grant market authorisation

By: Lawrence Morris BL

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Court of Appeal, in judicial review proceedings relating to a challenge by the applicant pharmaceutical company to the Health Products Regulatory Authority's decision to grant market authorisation to the notice party in respect of a veterinary medicinal product, dismisses the applicant's appeal against the decision of the High Court to dismiss the proceedings where the applicant was out of time for the purposes of leave to apply for judicial review, on the grounds, inter alia, that: (1) proceedings were brought outside of time, both in terms of the date of the publication of the market authorisation on the HPRA's website and in terms of when the applicant knew or ought to have known of the decision; and (2) where it was not appropriate to extend time for the bringing of the proceedings.

Whether applicant out of time for leave to apply for judicial review - market authorisation - veterinary medicinal product - treatment of osteoarthritis in dogs - respondent Health Products Regulatory Authority EU organisations which can grant market authorisation - generic medicinal product - HPRA granted market authorisation to notice party for one of their products - notice party's product was deemed a generic of applicant's product - notice party was able to piggy back on applicant's earlier authorisation - applicant not aware notice party was seeking authorisation - Order 84 Rule 21(1) RSC - application for leave for JR shall be made within 3 months - court empowered to extend time - application leave moved 5 months after decision to grant market authorisation made - 4 months after applicant became aware of it - leave granted - High Court then considered issue of time - High Court found that time should not be extended - appeal of this decision - analysis of English case law - publication of decision - Court of Appeal notes what the applicant knew and when it knew is critical - application of provisions governing extension of time - Court of Appeal ultimately concludes that applicant has brought - 3 months began from when it knew or ought to have known - it should have take reasonable steps to acquaint itself with publications by HPRA - it would have known earlier - but even from date it found out it was out of time - that it is not appropriate to extend time - from combined effect of a number of factors - permitting a challenge out of time would cause prejudice to notice party - appeal dismissed.

Note: This is intended to be a fair and accurate report of a decision made public by a court of law. Any errors should be notified to the editor and will be dealt with accordingly.

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