The High Court has refused Biogen an interlocutory injunction to stop Neuraxpharm selling a generic version of the multiple sclerosis drug Tecfidera in Ireland. It ordered that the existing interim injunction be lifted, leaving the patent dispute for trial.
Mr Justice Twomey gave judgment on 26 October 2022 in a commercial case brought by Biogen MA Inc. and Biogen International GmbH against Laboratorios Lesvi S.L. and Neuraxpharm Ireland Limited. The application concerned European patent EP (IE) 2 653 873, known as the 873 Patent. The court did not determine its validity or whether the generic infringed it; it found there was a fair issue to be tried.
The judge first considered Neuraxpharm’s request to discharge an interlocutory injunction granted on 2 August, after the defendants did not attend that hearing. Neuraxpharm provided sworn evidence that its lawyers learned of the hearing only after it had taken place: notices had been sent shortly before a bank holiday weekend to customer-facing email addresses that were not consistently monitored. The judge found that account plausible and discharged the injunction in the interests of justice, giving Neuraxpharm an opportunity to be heard.
Having heard both sides, the court then refused Biogen’s request to continue the restraint until trial. It accepted that Biogen could obtain a permanent injunction if it proved its case, and that the dispute raised a fair issue. But the judge found damages could be reasonably estimated for either side if the interim decision later proved wrong, and that the balance of justice favoured refusing the injunction.
A central consideration was the status of the related 537 Parent Patent. The European Patent Office’s Opposition Division revoked it in 2016; its Technical Board of Appeal affirmed revocation in 2022 on added-matter grounds. The judgment noted that the Opposition Division had also found a lack of inventive step, but the appeal decision did not need to decide that ground. The judge made no finding that the later 873 Patent was invalid. He considered Neuraxpharm’s invalidity case strong on a tentative basis, including its argument that the divisional patent was derived from the revoked parent and differed in wording.
The judge also considered the public purse. Neuraxpharm submitted that the generic would save the HSE about €5.5 million annually and around €8 million over the anticipated 12-to-18-month period to trial. These were estimates, not a final finding of savings. The court treated the taxpayer interest as relevant but not decisive; it identified Biogen’s prior benefit from a monopoly based on the invalidated parent patent as the decisive factor in the balance.
The court directed the parties to discuss outstanding matters and provide any agreed draft order to the Registrar. Final orders could be mentioned a week after judgment if needed.