High Court: Pharmaceutical company was out of time to challenge generic’s marketing authorisation

High Court
High Court

A pharmaceutical company seeking to challenge the decision to grant marketing authorisation to a generic product nearly thirty years after its originator product entered the market, has had its judicial review proceedings dismissed in their entirety.

Concluding that the relevant date for calculation of the time-limit under Order 84, rule 21 of the Rules of the Superior Courts was when the Health Products Regulatory Authority posted its decision on its website, Mr Justice Garrett Simons said there was no good reason why the company had waited for five months to institute proceedings and refused to grant an extension of time.

Marketing authorisation for generic product

In 1991, Arthropharm (Europe) Ltd was granted authorisation to market Cartrophen, which is a product used for the treatment of osteoarthritis and related musculoskeletal disorders in dogs.

The notice party, Chanelle Pharmaceuticals Manufacturing Ltd, applied for and obtained a marketing authorisation for Osteopen, which is a “generic” of Cartrophen. In July 2018, the Health Products Regulatory Authority (HPRA) granted the authorisation sought.

Under EU law, there is a streamlined procedure for the grant of marketing authorisation for generic medicinal products that have the same composition and active substances in the same pharmaceutical form as a “originator” product which is already authorised. The authorisation for generic medicinal products is issued without any clinical trials, allowing the generic company to “piggyback” on the authorisation of the originator product. Such authorisation can only be granted ten years after the initial authorisation of the originator product.

Judicial review proceedings

In the present judicial review proceedings, Arthropharm sought to challenge HPRA’s decision to grant marketing authorisation for Osteopen.

Arthropharm alleged that the manufacturing processes for the two products are not the same, and that Osteopen does not have the same qualitative and quantitative composition as Cartrophen.

HPRA has submitted that Arthropharm does not even have a “sufficient interest” or locus standi to maintain an application for judicial review.

Mr Justice Simons said the proceedings had “the potential to be a complex piece of litigation”, and explained that the present judgment dealt with the procedural issue of whether the proceedings were issued within the three month time-limit under Order 84, rule 21 of the Rules of the Superior Courts (as amended in 2011).

Proceedings issued out of time

Mr Justice Simons explained that the proceedings were instituted in December 2018, some five months after marketing authorisation was granted for Osteopen. On the face of it, the proceedings would appear to have been instituted well outside the three month time limit, however, Arthropharm argued that the legal position was more nuanced and placed reliance on the fact that it engaged in correspondence with HPRA after the authorisation was granted.

The main issue for determination was whether Arthropharm was justified in deferring the institution of proceedings until it secured a sample of the product on the open market and arranged to have it analysed.

Another issue was whether letters from the HPRA in March 2019, stating that there was no basis for it to withdraw the marketing authorisation, could represent a “fresh” decision and reset the clock for the purposes of the three month time limit.

After considering the chronology of events, Mr Justice Simons concluded that the relevant date for the calculation of the time-limit under Order 84, rule 21 of the Rules of the Superior Courts was the date of the posting of the decision to grant the marketing authorisation on HPRA’s website – that is, on 23 July 2018.

Mr Justice Simons was also satisfied that Arthropharm failed to demonstrate “good and sufficient” reasons for the grant of an extension of time for the bringing of the proceedings.

Satisfied that Arthropharm “would have been in a position to formulate a meaningful statement of grounds within the three month time-limit”, Mr Justice Simons said it “was not necessary for it to await receipt of an analysis of a sample of the generic product before launching its legal challenge. The correct approach would have been to institute proceedings within time, and to apply thereafter to amend the statement of grounds in the event that the analysis disclosed additional grounds of challenge subsequently”.

Mr Justice Simons said that this approach “would have ensured that one of the principal objectives underlying the time-limit, namely ensuring that affected parties are put on notice of a legal challenge in early course, would have been observed”.

In the circumstances, Mr Justice Simons dismissed the judicial review proceedings in their entirety.

© Irish Legal News Ltd 2020

Other judgments by Mr Justice Garrett Simons