The High Court has dismissed Arthropharm (Europe) Ltd’s challenge to the marketing authorisation for Osteopen, a veterinary medicine for dogs, after finding that the company brought its judicial review proceedings too late and did not justify an extension of time.
In a judgment delivered by Mr Justice Garrett Simons on 14 January 2020, the court held that the three-month period began when the Health Products Regulatory Authority (HPRA) posted the authorisation decision and related documents on its website on 23 July 2018. Arthropharm applied for leave to bring judicial review on 20 December 2018, more than three months later. The decision had been published in Iris Oifigiúil on 8 January 2019, but the court found the website posting was effective public notification for calculating the time limit.
Arthropharm, which has marketed Cartrophen Vet since 1991, challenged the HPRA’s 20 July 2018 authorisation of Osteopen, made by Chanelle Pharmaceuticals Manufacturing Ltd. Arthropharm alleged that the products differed in composition and manufacturing process, and that Osteopen should not have been authorised through the streamlined generic-product procedure. The court did not decide those substantive allegations.
Arthropharm argued that it needed to correspond with the HPRA and obtain and analyse a sample of Osteopen before bringing proceedings. The judge found that the information already published was sufficient to formulate meaningful grounds for challenge. Arthropharm’s detailed objection to the HPRA on 12 October 2018 had raised key complaints before it obtained the product sample. The court said the appropriate course was to begin proceedings within the time limit and seek to amend the grounds later if analysis revealed further issues.
The court also rejected the argument that HPRA solicitors’ letters of 6 March 2019 amounted to fresh decisions restarting the clock. It found that the letters restated and explained the original authorisation decision, rather than recording a formal decision to refuse to withdraw or revoke it.
The proceedings were dismissed in their entirety. The court ordered Arthropharm to pay the HPRA’s and Chanelle’s costs, including reserved costs, with the amount to be determined by the Office of the Legal Costs Adjudicator if the parties could not agree. The judgment noted Arthropharm’s right of appeal to the Court of Appeal.