The Court of Appeal has dismissed an appeal brought by a veterinary pharmaceutical manufacturer in its challenge to a marketing authorisation for a generic drug used to treat osteoarthritis in dogs.
In a judgment on Tuesday on behalf of the three-judge court, Mr Justice Brian Murray said Arthropharm (Europe) Limited’s judicial review against the Health Products Regulatory Authority (HPRA) was brought outside the applicable time limits.
The challenge was over a marketing authorisation granted by the HPRA on July 20th, 2018, to Chanelle Pharmaceuticals Manufacturing Ltd for a generic product known as Osteopen 100mg/ml solution for injection for dogs.
Arthropharm, which has been authorised since 1991 to market Cartrophen Vet 100mg/ml solution for injection, used to treat osteoarthritis and related musculoskeletal disorders in dogs, challenged the Osteopen authorisation on several grounds.
Notice party
However, the HPRA and Chanelle, as a notice party, asserted Arthropharm was out of time to seek the relief it claimed.
The Court of Appeal agreed with the High Court’s Mr Justice Garrett Simons in concluding the proceedings, initiated on December 20th, 2018, were out of time.
The three-month period in which they were entitled to launch an action “strictly speaking” began to run on July 20th, 2018, when the grant of authorisation was made, said Mr Justice Murray.
Had Arthropharm taken reasonable steps to acquaint itself with the HPRA publication methods, it would have learnt of the decision through the HPRA website on July 23rd, 2018, he said.
Even if the court was to consider the clock began ticking on August 23rd, when Arthropharm learned of the authorisation, the latest time for initiating its challenge would have been in November, said the judge.
The court rejected the argument that Arthropharm was entitled to wait until it obtained a sample of Osteopen on the open market.
Ms Justice Caroline Costello and Mr Justice Robert Haughton agreed with the judgment.
