Merck Sharp & Dohme LLC v Mylan Ire Healthcare Ltd and Mylan Ireland Ltd and McDermott Laboratories T/A as Gerard Laboratories T/A as Mylan Dublin

• Jurisdiction: Ireland
• Judge: Mr Justice Mark Sanfey
• Judgment Date: 20 January 2023
• Neutral Citation: [2023] IEHC 24
• Court: High Court
• Docket Number: [Record No. 2022/4794P]

Between:

Merck Sharp & Dohme LLC

Plaintiff

and

Mylan Ire Healthcare Limited and Mylan Ireland Limited and McDermott Laboratories T/A as Gerard Laboratories T/A as Mylan Dublin

Defendants

[2023] IEHC 24

[Record No. 2022/4794P]

THE HIGH COURT

COMMERCIAL

Interlocutory injunction – Balance of convenience – Balance of justice – Plaintiff seeking an interlocutory injunction – Whether the balance of justice favoured the granting of injunctive relief

Facts: The plaintiff, Merck Sharp & Dohme LLC (MSD), applied to the High Court seeking an interlocutory injunction restraining the defendants, Mylan IRE Healthcare Ltd, Mylan Ireland Ltd and McDermott Laboratories (Mylan), from offering, putting on the market or using products containing sitagliptin and metformin prior to the expiry on 7 April 2023 of supplementary protection certificate number 2008/024 (the 024 SPC). The 024 SPC protected sitagliptin used in combination with metformin, the products of which combination were sold and marketed by the plaintiff under the brand name “Janumet” in Ireland. The plaintiff contended that: (1) the principles set out by the Supreme Court in Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2020] 2 IR 1 should be applied by the High Court, and the same result should ensue; (2) damages were an adequate remedy for the defendants if the injunction was found to be wrongly granted and there were no concerns as to the substance of the plaintiff’s undertaking in that regard; (3) there were no strong grounds for the contended invalidity of the SPC; (4) neither had there been “successive determinations” in the defendants’ favour of similar challenges in other jurisdictions; (5) the High Court was not bound by the Court of Appeal decision on the merits in Merck v Clonmel; (6) the Supreme Court had decided in its judgment of 21 February 2022 that the position in law regarding the principles governing challenges to the validity of SPCs was not acte clair, and required to be resolved by a reference to the Court of Justice of the European Union (CJEU); (7) the finding by the Supreme Court that the law was unclear and required clarification from the CJEU was binding on the High Court; (8) as the Supreme Court recognised, the SPC was, as a matter of law, valid and effective until declared invalid by a court of competent jurisdiction; (9) no steps had been taken by the defendants of a practical or regulatory nature to clarify matters as to the SPC’s validity.

Held by the High Court (Sanfey J) that it was not bound by the Court of Appeal’s preference in Merck v Clonmel for an “invention-based” approach rather than an “identificatory” approach, so that the strengths of the respective cases of the parties must be judged by that standard, in circumstances where the Supreme Court was of the view that a ruling of the CJEU was necessary for the court to reach its decision on the appeal in that case. Sanfey J noted that Mylan had not produced evidence of “successive determinations”. He held that it was for the party resisting the injunction to show that the circumstances of its case were such that the presumption should be rebutted. His view was that damages were not an adequate remedy for either party, and neither did the balance of potential irreparable harm favour either party decisively. It seemed to him that, particularly given the uncertainty in relation to the legal principles to be applied, it could not be said, on a preliminary basis, that the strength of the defendant’s case in relation to the invalidity of the 024 SPC was such that the presumption of validity must be set aside. In the absence of strong grounds for doing so, he accepted that the plaintiff was entitled to develop its business and marketing strategies on the basis of certainty as to the period for which its products were protected as a statutory monopoly. In his view, the failure of Mylan to take steps to “clear the way” was a factor in support of the court preserving the status quo ante by granting injunctive relief.

Sanfey J held that the balance of convenience and the balance of justice favoured the granting of injunctive relief.

Application granted.

JUDGMENT of Mr Justice Mark Sanfey delivered on the 20th day of January 2023.

Introduction

1 In this application, the plaintiff seeks an interlocutory injunction restraining the defendants from offering, putting on the market or using products containing sitagliptin and metformin prior to the expiry on 7 April 2023 of supplementary protection certificate number 2008/024 (‘the 024 SPC’). The 024 SPC in essence protects sitagliptin used in combination with metformin, the products of which combination are sold and marketed by the plaintiff (‘MSD’) under the brand name “Janumet” in Ireland. Janumet is a medicine commonly used in treating type 2 diabetes.

2 The proceedings issued on 19 September 2022. The present motion was filed on 27 September 2022. The parties exchanged affidavits until early December 2022, and the matter was heard by this Court on 14–15 December 2022. Extensive written submissions were exchanged in advance of the hearing, and these were ably supplemented by helpful oral submissions from counsel at the hearing itself.

The parties

3 The plaintiff is a wholly owned subsidiary of Merck & Co Inc, the ultimate parent of the Merck group of companies which carry out research, development, production and sale of pharmaceutical treatments. The plaintiff – MSD – is the proprietor of the 024 following a merger of the plaintiff with Merck Sharpe & Dohme Corp, which was the registered owner of the SPC.

4 The defendant companies (collectively ‘Mylan’) were not differentiated as to function for the purpose of the present application. The lead affidavit on behalf of the defendants was sworn by Melissa Fisher, who describes herself as “General Manager of Viatris”, and avers that she is “responsible for the commercial entity that is Mylan Ire Healthcare including sales, monitoring competitor activity, new product launches and for the Defendant's portfolio in Ireland…” [para. 2]. Ms Fisher goes on to aver at para. 4 of her affidavit that the defendants

“…are part of the global Viatris group of companies which is one of the world's leading global pharmaceutical companies…Viatris is not a solely generics focused pharmaceutical company…we have one of the industry's broadest and most diverse portfolios and offer more than 1400 molecules across more than ten major therapeutic areas. We employ over 1500 people in Ireland, and our global revenue in 2020 was US$11.496 billion…”.

The nature of MSD's complaints

5 The plaintiff's grounding affidavit is sworn by Mairead McCaul, who avers that she is managing director of Merck Sharp and Dohme Ireland (Human Health) Limited (‘MSD Ireland’), but has authority to swear the affidavit on behalf of the plaintiff.

6 Essentially, the plaintiff seeks injunctive relief to preserve the exclusivity conferred by the 024 SPC. The plaintiff is proprietor of European Patent 1 412 357 (‘the 357 patent’) “…which is for beta-amino tetrahydroimidazo (1,2-A) Pyrazines and tetrahydotriazolo (4,3-A) Pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes, with a priority date of 6 July 2001” [written submissions, para. 2]. It appears to be accepted by the parties that the 357 patent discloses sitagliptin as an inventive treatment for diseases including diabetes. The plaintiff makes the point that the 357 patent discloses the sitagliptin/metformin combination, also for the treatment of diabetes although, as we shall see, there is an issue as regards the 024 SPC as to whether the mere disclosure of the combination suffices to satisfy the requirements for the grant of a supplementary protection certificate.

7 The 357 patent, which had a priority date of 6 July 2001, was filed on 5 July 2002. On 13 August 2007, the plaintiff filed for a supplementary protection certificate 2007/029 (‘the 029 SPC’) for a medicinal product identified as “sitagliptin, optionally in the form of a pharmaceutically acceptable salt”. The 029 SPC was granted on 1 August 2012, and it expired on 22 September 2022.

8 On 14 August 2008, the plaintiff applied for a supplementary protection certificate 2008/024 for a medicinal product identified as “sitagliptin optionally in the form of a pharmaceutically acceptable salt, in particular the monophosphate, plus metformin optionally in the form of a pharmaceutically acceptable salt, in particular the hydrochloride”. This SPC referred to the sitagliptin/metformin combination product, and was granted on 14 October 2009. It will expire on 7 April 2023. It was of some significance during the submissions that, while application was made first for the 029 SPC in respect of the sitagliptin product, the 024 SPC which related to the sitagliptin/metformin combination product was granted before the grant of the 029 SPC.

9 The plaintiff points to the rationale for SPCs articulated by O'Donnell J in Merck Sharp & Dohme Corp v Clonmel Healthcare Limited [2020] 2 IR 1 at para. 7 as follows:—

“It is well known that the underlying objective justifying the grant of a patent is to provide a monopoly for a limited period in order to encourage invention and the dissemination of knowledge, which is beneficial to the wider community. However, the grant of a valid patent does not in itself lead inevitably to a commercially viable product. Because of the necessity to seek a patent at the earliest viable stage, claims are made at a point where it may not be clear how the invention may ultimately be marketed, if at all. Particularly in the medicinal and pharmaceutical field, the process of obtaining authorisation for the marketing of a product is lengthy and demanding. Accordingly, it may be some time before a commercial product can be launched to exploit the monopoly granted by the patent. Even then, there is no...