Arthropharm (Europe) Ltd v The Health Products Regulatory Authority

CourtCourt of Appeal (Ireland)
JudgeMr. Justice Murray
Judgment Date10 May 2022
Neutral Citation[2022] IECA 109
Docket NumberCourt of Appeal Record No. 2020/52
Arthropharm (Europe) Limited
The Health Products Regulatory Authority


Chanelle Pharmaceuticals Manufacturing Limited
Notice Party

[2022] IECA 109

Murray J.

Costello J.

Haughton J.

Court of Appeal Record No. 2020/52

High Court Record No. 2018/1080 JR




JUDGMENT of Mr. Justice Murray delivered on the 10 th day of May 2022

The basic facts

. Cartrophen Vet 100 mg/ml solution for injection (‘Cartrophen’) is a veterinary medicinal product. It is used in the treatment of osteoarthritis in dogs. As a medicinal product, it can only be placed on the market in an EU Member State if it is the subject of a marketing authorisation. The respondent (‘HPRA’) is the competent authority responsible for the grant in the State of such authorisations. In October 1991 HPRA 1 granted the applicant (‘Arthropharm’) a relevant authorisation in respect of Cartrophen.


. The legal regime governing such authorisation is now found in the provisions of the European Communities (Animal Remedies) (No. 2) Regulations 2007 ( SI No. 786 of 2007) (‘the 2007 Regulations’) as amended. The 2007 Regulations transposed into domestic law Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (‘the 2001 Directive’). 2


. On 20 July 2018 HPRA granted a marketing authorisation 3 to Chanelle in respect of Osteopen 100 mg/ml solution for injection (‘Osteopen’). This product is also used in the treatment of musculoskeletal disorders in dogs. That authorisation was granted on the basis that Osteopen was a generic of Cartrophen. The 2007 Regulations and 2001 Directive provide that a ‘generic’ medicinal product is one that has the same qualitative and quantitative composition and active substances in the same pharmaceutical form as a reference product that has been previously authorised.


. Because HPRA was satisfied that Osteopen was a generic of Cartrophen, and because Cartrophen had at the time of the application made by Chanelle been authorised for not less than eight years in a Member State of the European Union, the relevant regulatory regime provided that to obtain the authorisation Chanelle did not — as it would otherwise have been required to do — have to provide the results of safety and residue tests or of pre-clinical and clinical trials in respect of the product. 4 Instead, Chanelle was able to ‘piggyback’ on the earlier authorisation granted in respect of Cartrophen.


. Arthropharm was not aware that Chanelle was seeking an authorisation of this kind, and neither the 2001 Directive nor the 2007 Regulations made provision for Arthropharm to be advised that a process to obtain authorisation as a generic by reference to one of its products was in train. Nor is there provision for the holder of an authorisation in respect of a reference product to be advised of the fact of the grant of a generic marketing authorisation.


. Three days after it was made (23 July 2018), the decision to grant the marketing authorisation in respect of Osteopen was published by the HPRA on its website. At the same time a number of documents related to the decision were published in the same way. These included a product authorisation assessment. One month after this publication (23 August 2018) Arthropharm learnt of the grant of that authorisation to Chanelle. It was so informed by its United Kingdom distributor.


. On 20 December 2018 an ex parte application was brought by Arthropharm for leave to apply for judicial review of the decision of the HPRA to grant the marketing authorisation to Chanelle. That application was acceded to and leave was granted on that date.


. While there are a large number of complaints made in the proceedings, central to the action is the claim made by Arthropharm that Osteopen is not properly viewed as a generic of Cartrophen. It makes three essential points. First, Arthropharm says that the quantitative and qualitative composition of the two products are not the same. Second, it contends that HPRA erred in accepting, in the course of the process, the omission of bioequivalence data in circumstances where the active substance in the manufacturing processes for the two products are not the same. Third, it complains that the active ingredient is a biological substance and that Osteopen ought to have been assessed in accordance with Article 13(4) of the Directive. This requires HPRA to take account of differences relating to raw materials or in the manufacturing processes of the two products. It says that variations in the manufacturing processes of the active substance used in Osteopen and Cartrophen result in significant differences between the two products.


. At the time leave was sought and granted HPRA had not complied with the statutory obligation imposed upon it by Regulation 46 of the 2007 Regulations to publish notice of the grant of a veterinary product authorisation in Iris Oifigiúil. HPRA did not do this until 8 January 2019.

The issues

. On its face, the timing of all of this gave rise to an issue. Order 84 Rule 21(1) of the Rules of the Superior Courts (‘RSC’) provides that an application for leave to apply for judicial review shall be made ‘ within three months from the date when grounds for the application first arose’. The court is empowered under certain conditions to extend this time. The application for leave was moved five months after the decision to grant the marketing authorisation was made and published to the world at large, and four months after Arthropharm became aware of it. In their opposition papers HPRA and Chanelle asserted that Arthropharm was out of time to seek the relief it claimed.


. When granting leave to apply for judicial review the High Court directed that any questions as to whether it was necessary to extend time for seeking such relief and, if so, whether such an extension should be granted, should be left to the trial judge. Shortly before the full action was due to come on for trial, the High Court judge managing the judicial review list directed the trial of an issue as to whether the proceedings had been brought within the period specified in Order 84 Rule 21(1) and, if not, whether time should be extended (as enabled by Order 84 Rule 21(3)). The trial of that issue came before Simons J. For reasons explained in a detailed and careful reserved judgment, ( [2020] IEHC 16) he answered both of these questions in the negative. In this appeal from that decision, the following issues arise:

  • (i) Whether the trial judge erred in finding that the date from which the three month period ran is 23 July 2018 (as HPRA contended) or whether (as Arthropharm argued) it ran either (a) from the point at which HPRA complied with its statutory obligation to publish notice of the grant of the licence in Iris Oifigiúil, or (b) from 30 October 2018, this being the point at which HPRA responded to an ‘objection’ to the registration made by Arthropharm on 12 October 2018 5 which, inter alia requested HPRA to suspend the authorisation.

  • (ii) If the answer to (i) is in the negative, whether the trial judge erred in refusing to extend the time for bringing the application for leave having regard to (a) the fact that Arthropharm did not learn of the decision until 23 August 2018, (b) the claim made by Arthropharm that even then the information available about Osteopen was (it claims) limited, (c) the contention that it was only after the launch of Osteopen on the market on 8 November 2018 that Arthropharm was in a position to obtain a sample of the product for comparative analysis, (d) that correspondence from HPRA responding to complaints from Arthropharm did not come to the latter's attention until 14 December 2018, (e) the fact that there were ongoing exchanges between the parties as of the date of the application for leave to seek judicial review and (f) the fact that the decision had not been published in Iris Oifigiúil as of the date of that application.

  • (iii) Irrespective of the answer to the first two of these questions, whether a fresh decision was made by HPRA when, by letter dated 6 March 2019, it refused to accede to Arthropharm's request that it withdraw or suspend the product licence.

The point from which time began to run under Order 84 Rule 21(1)
(a) The provisions governing publication of the decision.

. In the High Court, much of the argument around when time began to run for the bringing of a challenge became meshed with the issue of when and how the decision of HPRA was and ought to have been published; indeed Arthropharm argued that when leave was sought time had not started to run at all by reason of the failure of HPRA to publish the decision in Iris Oifigiúil until 8 January 2019.


. At least some of the difficulty arose from the fact – to which I have referred earlier — that the regulatory scheme governing the grant of authorisations of this kind does not envisage the holder of the authorisation for the reference product being either advised of or involved in the process leading to the grant of a generic marketing authorisation, as well as from the fact that no provision is made for informing them of an authorisation once granted. Instead, the assumption appears to be that the holder of the authorisation for the reference product will learn of the grant of the generic marketing authorisation through public notification of such a decision once made. This was, Simons J. believed, a ‘ surprising feature of the legislative regime’ (at para. 9).


. The Directive addresses public notification in two provisions, Article 25 and Article 94. Article 25(3) provides (emphasis added):

The competent authority shall make the marketing authorisation publicly available without...

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    ...with the eight-week time-limit in the planning context or other time limits in similar commercial contexts (see per Murray J. in ( [2022] IECA 109 Arthropharm (Europe) Ltd v. The Health Products Regulatory Authority Unreported, Court of Appeal, 10th May, 2022)). Even exceeding the limitatio......
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    ...It cites a recent decision of the Court of Appeal in Arthropharm (Europe) Limited v. The Health Products Regulatory Authority [2022] IECA 109 regarding the importance of time limits and the need for certainty, especially in the commercial sphere. While it is correct that compliance decision......

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