Court Dismisses Judicial Review of Marketing Authorisation Grant for Falling Outside Time Limits - A Cautionary Note to Pharmaceutical Manufacturers
In an appeal challenging the marketing authorisation of a generic drug, the Court of Appeal applied the time limits within which to bring judicial review applications with strict rigour.

 

On 10 May 2022, the Court of Appeal (COA) dismissed an appeal brought by the veterinary pharmaceutical manufacturer, Arthropharm, over the High Court's (HC) rejection of its judicial review (JR) challenge against the Health Products Regulatory Authority (HPRA). The HC and COA held that Arthropharm's JR challenge was taken outside the three-month time limit permitted under Order 84, rule 21(1) of the Rules of the Superior Courts. (Arthropharm (Europe) Limited -v- The Health Products Regulatory Authority & anor [2022] IECA 109)

Background:

Arthropharm had been authorised to market Cartrophen, a veterinary medicinal product which is used to treat osteoarthritis in dogs, since 1991. On 20 July 2018, HPRA granted Chanelle Pharmaceuticals Manufacturing Ltd a marketing authorisation (MA) in respect of its product, Osteopen, on the basis that it was a generic of Cartrophen. 

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

High Court Proceedings

Arthropharm became aware of the grant of the Osteopen MA on 23 August 2018. On 20 December 2018, Arthropharm successfully made an ex parte application for leave to judicially review the  HPRA's decision. Central to Arthropharm's claim was its argument that Osteopen should not be viewed as a generic of Cartrophen. 

Shortly before the full action was due to be heard,  Mr Justice Garrett Simons determined that the applicable three-month period ran from 23 July 2018, and Arthropharm was therefore prevented from progressing 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 issue JR proceedings until it could obtain a sample of Osteopen, which launched on 8 November 2018, and could arrange for comparative testing to be carried out.

The COA further rejected Arthropharm's argument that the time for an appeal did not start to run until the HPRA published its decision in Iris Oifigiúil on 8 January 2019.  In its judgment, the COA commented that:

"Arthropharm could easily have positioned itself to find out about this decision if not by the very simple expedient of subscribing to the free RSS feed, then by either ascertaining from HPRA how precisely it complied with Article 25 of the 2001 Directive or by consulting the (fully searchable) HPRA website (hardly an unexpected location in which to find a record of a regulator's activities)."

Key Takeaways:

This judgment is a salient reminder of parties responsibilities to ensure they adhere strictly to the time limits to initiate judicial review proceedings.

Key Terms:

Marketing authorisation is the process of approving products to be marketed as a medicine. Products, which have medicinal claims, need marketing authorisation from the HPRA.

 

Contributed by Imogen Boles Gray and Aisling Casey

Key Contacts

Laura Scott Partner

Colette Brady Partner

Related Practice Areas