Court dismisses judicial review of granting marketing authorization for failure to meet deadlines – A warning to pharmaceutical manufacturers

On May 10, 2022, the Court of Appeal (certificate of authenticity) dismissed an appeal by veterinary pharmaceutical manufacturer, Arthropharm, against the High Court’s decision (CS) rejection of its judicial review (J.R.) challenge against the Health Products Regulatory Authority (HPRA). The HC and COA found that Arthropharm JR’s challenge was taken outside the three-month time limit allowed under Order 84, Rule 21(1) of the Superior Court Rules. (Arthropharm (Europe) Limited -v- The Health Products Regulatory Authority and anor [2022] IEC 109)

Background:

Arthropharm had been authorized to market Cartrophen, a veterinary medicinal product used in the treatment of osteoarthritis in dogs, since 1991. On July 20, 2018, the HPRA granted Chanelle Pharmaceuticals Manufacturing Ltd a marketing authorization (MY) regarding its product, Osteopen, on the grounds that it was a generic of Cartrophen.

The HPRA’s decision to grant the MA to Osteopen was published on its website on July 23, 2018, along with a number of documents related to this decision.

High Court Proceedings

Arthropharm became aware of the granting of the Osteopen Marketing Authorization on August 23, 2018. On December 20, 2018, Arthropharm successfully submitted an ex parte request for authorization for judicial review of the HPRA’s decision. At the heart of Arthropharm’s claim was its argument that Osteopen should not be considered a generic of Cartrophen.

Shortly before the hearing of the full action, Judge Garrett Simons determined that the applicable three-month period ran from July 23, 2018, and Arthropharm was therefore barred from pursuing its JR challenge. Arthropharm appealed to the COA.

Court of Appeal Proceedings

Upholding the HC’s decision, the COA rejected Arthropharm’s argument that it was entitled to wait to initiate JR proceedings until it could obtain a sample of Osteopen, which was launched on November 8, 2018, and that he can organize the performance of comparative tests.

The COA further rejected Arthropharm’s argument that the appeal period only began to run when the HPRA published its decision in Iris Oifigiúil on January 8, 2019. In its judgment, the COA stated that :

“Arthropharm could easily have positioned itself to be aware of this decision if not by the simple expedient of subscribing to the free RSS feed, then either by ensuring with the HPRA of its precise compliance with article 25 of the directive of 2001, or by consulting the (fully searchable) HPRA website (not an unexpected place to find a record of a regulator’s activities).”

Key points to remember:

This judgment is an important reminder of the responsibility of the parties to ensure that they strictly respect the deadlines for initiating judicial review proceedings.

Key words:

Marketing authorization is the process of approving products to be marketed as a medicine. Products that have medicinal claims must obtain marketing authorization from the HPRA.