About this case:

• Citation:
  [2023] IEHC 24
• Judgment:
  External link
• Court:
  High Court
• Judge:
  Mr Justice Mark Sanfey

The competitor, Mylan Ireland Limited, had claimed that the SPC was invalid and that it was entitled to enter the Irish market immediately.

Delivering judgment in the case, Mr Justice Mark Sanfey considered the principles outlined in the similar case of Merck Sharp & Dohme Corp v. Clonmel Healthcare Limited [2020] 2 IR 1 and held that the balance of convenience favoured the grant of the injunction.

In so ruling, the court held Mylan did not establish a strong case that the protection would be invalidated following a full hearing. Further, Mylan had failed to “clear the way” by taking proactive steps to invalidate the patent, the court said.

Background

The plaintiff had obtained a supplementary protection certificate (SPC) for a product which combined sitagliptin and metformin. The protection was known as the 024 SPC and was marketed in Ireland as Janumet. Janumet was commonly used to treat type 2 diabetes.

The 024 SPC granted exclusivity to the plaintiff to sell the sitagliptin/metformin combination. The 024 SPC was granted on the basis that the plaintiff held a European patent (the 357 patent) which determined that sitagliptin was an inventive treatment for diseases.

The 024 SPC was due to expire in April 2023. The 357 patent expired in July 2022. The defendant indicated that it would enter the Irish market after September 2022 to sell a generic version of the drug at a much cheaper price than the plaintiff. The defendant adopted the view that the 024 SPC was invalid because it did not involve a necessary inventive element and, accordingly, claimed that there was no bar to Mylan entering the market before April 2023.

The plaintiff issued proceedings against Mylan seeking to restrain it from selling the generic drug prior to April 2023. The plaintiff also sought an interlocutory injunction restraining the sale of the drug until the trial of the action. In this regard, both parties relied heavily on the various court decisions in Merck Sharp & Dohme Corp v. Clonmel Healthcare Limited, which dealt with both the test for an interlocutory injunction and the substantive decision on the validity of an SPC.

The plaintiff’s case was relatively straightforward. It outlined that it owned the 024 SPC which was still valid until April 2023. No attempt had been made by Mylan to “clear the way” for the generic drug by taking invalidity proceedings in Ireland. It was said that damages would not be an adequate remedy and there were no strong grounds to say that that the 024 SPC was invalid.

It was also pointed out that the Supreme Court in Merck Sharp & Dohme Limited v. Clonmel Healthcare Limited [2022] IESC 11 (dealing with the invalidity of an SPC) had sought a reference to the ECJ as to the appropriate interpretation of the SPC Regulation. Accordingly, it was said that the principles for invalidity were not acte clair.

The defendant argued that the injunction should not be granted. It was argued that the Supreme Court in the Merck v. Clonmel injunction proceedings established that a court was entitled to consider whether a party had a strong case as to the validity that an SPC was invalid. In this regard, the defendant relied on the High Court and Court of Appeal decisions in Merck v. Clonmel which held that an SPC which did not involve an inventive step was invalid.

The defendant argued that the 024 SPC merely involved the combination of chemicals which was not an inventive step and, as such, there was a strong case that the 024 SPC was invalid. Further, the defendant relied on a German judgment which determined that the 024 SOC was invalid.

Finally, Mylan outlined the importance of being the first mover in the generic drug market and the potential damage it would suffer if it was restrained from entering the market until April 2023. As such, it was said that damages were not an adequate remedy.

High Court

Mr Justice Sanfey began by outlining the decisions in the Merck v. Clonmel case on both the test for an interlocutory injunction and the substantive issue of the validity of the SPC. The court emphasised that it was only required to determine an interlocutory application and had not conducted a full trial of the issues.

In applying the principles for an interlocutory injunction as set out in Merck v. Clonmel, the court held that the plaintiff might obtain a permanent injunction at trial and that there were fair issues to be tried in the case. In considering the balance of convenience, the court followed the reasoning of the Supreme Court that damages would not be an adequate remedy for either party in the case.

The court then considered the strength of the rival cases, as the Supreme Court had indicated that this could be appropriate in finely balanced cases. The court also noted that the presumption of validity applied to the 024 SPC which had to be dislodged by the defendant.

The court held that, in order to assess the strengths of the parties’ cases, it was necessary for there to be clarity on the principles which would govern the determination of the issues at trial. However, in Merck v. Clonmel, the Supreme Court had seen fit to refer questions to the ECJ because the principles were not clear, despite the decisions of the Court of Appeal and High Court in the same case.

As such, the court held that it was not bound by the Court of Appeal’s “invention-based” approach to the validity of SPCs. Further, the court noted that there had not been “successive determinations” in Mylan’s favour in other jurisdictions. There were “varied” results in Europe and many decisions were under appeal. As such, there was no definitive trend that the SPC was invalid, the court held.

In light of these findings, the court held that Mylan did not have such a strong case that the presumption of invalidity of the 024 SPC had to be set aside. Mr Justice Sanfey also held that Mylan had failed to clear the way for the generic drug as no proactive steps had been taken to invalidate the SPC in Ireland.

Conclusion

The court held that damages were not an adequate remedy for either party and the potential for irreparable harm did not favour either party. On this basis, the court held that the uncertainty of the legal principles to be applied at trial (due to the ECJ reference by the Supreme Court) meant that it could not be said that Mylan had a strong case as to invalidity.

Further, a refusal to grant the injunction could have a negative effect on the patent system, which was designed to give a statutory monopoly to the owners of SPCs. Finally, the defendant had failed to clear the way, which tipped the finely balanced case in favour of Merck.

Merck Sharp & Dohme LLC v. Mylan Ire Healthcare Limited and Ors. [2023] IEHC 24