Arthropharm (Europe) Ltd v The health Products Regulatory Authority

• Jurisdiction: Ireland
• Judge: Mr Justice Garrett Simons
• Judgment Date: 14 January 2020
• Neutral Citation: [2020] IEHC 16
• Docket Number: 2018 No. 1080 J.R.
• Court: High Court
• Date: 14 January 2020

BETWEEN

ARTHROPHARM (EUROPE) LIMITED

APPLICANT

AND

THE HEALTH PRODUCTS REGULATORY AUTHORITY

RESPONDENT

CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED

NOTICE PARTY

[2020] IEHC 16

Garrett Simons J.

2018 No. 1080 J.R.

THE HIGH COURT

JUDICIAL REVIEW

Judicial review – Time-limit – Marketing authorisation – Applicant seeking to challenge a decision to grant a marketing authorisation – Whether the proceedings were issued within the three month time-limit prescribed under Order 84, rule 21 of the Rules of the Superior Courts

Facts: The applicant, Arthropharm (Europe) Ltd, applied to the High Court seeking to challenge a decision to grant a marketing authorisation in respect of a veterinary medicinal product. The judicial review proceedings had the potential to be a complex piece of litigation, and it was estimated that the substantive hearing of same would take some ten to twelve days before the High Court. The proceedings had been subject to case management, and a number of procedural issues had been identified in respect of which the parties sought rulings in advance of the substantive hearing. The first procedural issue concerned the question of whether the proceedings were issued within the three month time-limit prescribed under Order 84, rule 21 of the Rules of the Superior Courts (as amended in 2011), and, if not, whether an extension of time should be granted. The determination of this issue turned largely on whether the applicant was justified in deferring the institution of proceedings until such time as it secured a sample of the product on the open market and arranged to have same analysed. It was also necessary for the High Court to consider whether a subsequent communication on behalf of the respondent, the Health Products Regulatory Authority, on 6 March 2019, which was to the effect that nothing raised by the applicant in correspondence provided a basis for the regulatory authority to “withdraw” the marketing authorisation, represented a fresh decision which reset the clock for the purposes of the three month time-limit.

Held by Simons J that the relevant date for the calculation of the three month 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 the Authority’s website (23 July 2018); the proceedings were not instituted within three months of that date. Simons J held that the applicant had failed to demonstrate “good and sufficient” reasons for the grant of an extension of time for the bringing of the proceedings. Simons J was satisfied that, on the particular facts of this case, the applicant would have been in a position to formulate a meaningful statement of grounds within the three month time-limit; it was not necessary for it to await receipt of an analysis of a sample of the generic product before launching its legal challenge. Simons J held that 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; 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. Simons J held that the two letters of 6 March 2019 did not represent fresh decisions for the purposes of the calculation of the time-limit under Order 84, rule 21; moreover, there was nothing in the amended part (e) of the statement of grounds which asserted that there had been a breach of article 83 as a result of the letters of 6 March 2019.

Simons J held that the judicial review proceedings would, therefore, be dismissed in their entirety, subject to the caveat that he would hear further submissions from counsel before finalising an order in respect of the amendments made pursuant to the order of 1 May 2019).

Proceedings dismissed.

JUDGMENT of Mr Justice Garrett Simons delivered on 14 January 2020

INTRODUCTION

1 The within judicial review proceedings seek to challenge a decision to grant a marketing authorisation in respect of a veterinary medicinal product. The proceedings have the potential to be a complex piece of litigation, and it is now estimated that the substantive hearing of same will take some ten to twelve days before the High Court. The proceedings have been subject to case management, and a number of procedural issues have been identified in respect of which the parties have sought rulings in advance of the substantive hearing.

2 The first procedural issue concerns the question of whether the proceedings were issued within the three month time-limit prescribed under Order 84, rule 21 of the Rules of the Superior Courts (as amended in 2011), and, if not, whether an extension of time should be granted.

3 The determination of this issue turns largely on whether the applicant for judicial review was justified in deferring the institution of proceedings until such time as it secured a sample of the product on the open market and arranged to have same analysed. It will also be necessary to consider whether a subsequent communication on behalf of the regulatory authority on 6 March 2019, which is to the effect that nothing raised by the applicant in correspondence provided a basis for the regulatory authority to “withdraw” the marketing authorisation, represents a fresh decision which reset the clock for the purposes of the three month time-limit.

OVERVIEW OF FACTUAL BACKGROUND

4 The applicant for judicial review, Arthropharm (Europe) Ltd., has been authorised to market a particular veterinary medicinal product in Ireland since 1991. The product is known as “Cartrophen Vet 100 mg/ml Solution for Injection” ( “Cartrophen”), and is used for the treatment of osteoarthritis and related musculoskeletal disorders in dogs.

5 The notice party to these proceedings, Chanelle Pharmaceuticals Manufacturing Ltd., applied for and obtained a marketing authorisation in respect of what it says is a “generic” of Cartrophen. As explained in more detail under the next heading below, EU law prescribes a streamlined procedure for the grant of marketing authorisation for the sale of generic medicinal products. The concept of a “generic” medicinal product in the present context refers to a veterinary medicinal product which has the same qualitative and quantitative composition and active substances in the same pharmaceutical form as a “reference” product which is already authorised. A marketing authorisation can be issued for a generic medicinal product without any requirement for the applicant to provide the results of safety and residue tests or of pre-clinical and clinical trials. Put otherwise, an applicant for marketing authorisation can “piggyback” on the earlier authorisation of the reference product to obtain its own marketing authorisation. The proprietary rights of the producer of the reference product are protected to the extent that an authorisation for a generic product may only be granted once ten years have elapsed from the initial authorisation of the reference product. The grant of a marketing authorisation is stated to be without prejudice to the Patents Act 1992 (as amended).

6 The marketing authorisation impugned in these proceedings was granted to Chanelle Pharmaceuticals Manufacturing Ltd. by the Health Products Regulatory Authority on 20 July 2018. The authorised generic product is known as “Osteopen 100 mg/ml Solution for injection for dogs” ( “Osteopen”).

7 Arthropharm (Europe) Ltd. has sought to challenge the grant of the marketing authorisation on a number of grounds. It will be necessary to consider these in more detail presently in order to address the question of whether the delay in instituting the proceedings was justified. For introductory purposes, however, the grounds might be summarised as entailing an allegation 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.

8 Where convenient, the following shorthand will be employed in this judgment to describe the parties: (i) Arthropharm (Europe) Ltd. will be referred to as “the Objector”; (ii) Chanelle Pharmaceuticals Manufacturing Ltd. as “the Authorisation Holder”; and (iii) the Health Products Regulatory Authority as “the Authority”.

9 The legislative regime governing the grant of marketing authorisations is discussed in detail under the next heading below. It might be helpful, however, to flag one surprising feature of the legislative regime from the outset. The holder of the marketing authorisation in respect of the reference product, i.e. the original producer of the product, is not afforded any special status in respect of an application for the authorisation of a generic product. There is no requirement to put the original producer on notice of either the making of the application or of the grant of the marketing authorisation. Instead, the original producer has to rely on the public notification of the decision.

10 The Authority has gone so far as to plead that the original producer in these proceedings, Arthropharm (Europe) Ltd., does not even have a “sufficient interest” or locus standi to maintain an application for judicial review. It is not necessary to determine this issue for the purposes of the preliminary ruling on the time-limit point.

11 These proceedings were instituted by way of an ex parte application for leave to apply for judicial review on 20 December 2018. The decision to grant the marketing authorisation had been made on 20 July 2018, and thus the application was made some five months after that decision. At first blush, the proceedings would appear to have been instituted well outside the three month time-limit prescribed under Order...