The Court of Appeal has allowed Biogen’s appeal against the refusal of an injunction to stop two pharmaceutical companies launching a generic multiple sclerosis drug, while rejecting its separate appeal over an earlier injunction made in the respondents’ absence.
The dispute concerns European Patent No. 2 653 873, a divisional patent covering Tecfidera, whose active ingredient is dimethyl fumarate. The patent was granted by the European Patent Office in June 2022 and published the following month. The court said it has been in force in Ireland since 20 July 2022 and, unless revoked, will expire in February 2028.
Biogen MA Inc. owns the patent and Biogen International GmbH is its exclusive licensee in Ireland. Laboratorios Lesvi S.L. and Neuraxpharm Ireland Limited planned to launch a generic product. They contended that the patent was invalid, relying in part on the revocation of its parent patent. Biogen sought an injunction before the planned launch in August 2022.
The High Court discharged an injunction made on 2 August 2022 because the respondents had not had a genuine opportunity to oppose it. After hearing both sides, it refused to grant a new interlocutory injunction, finding that damages could compensate either side and that the respondents had a strong case that the patent was invalid.
The Court of Appeal agreed that the 2 August order should be discharged and the application heard again between the parties. It said the respondents became aware of the application only after that hearing had concluded, and justice required that they be heard.
However, the appeal court found that the High Court had erred in refusing a fresh injunction. The divisional patent is a separate right and carries a presumption of validity unless and until it is separately found invalid. The court said the respondents had not produced independent expert evidence sufficient to establish a strong case of invalidity at this interim stage, and that decisions on injunction applications in other countries did not amount to consistent rulings on the patent’s validity.
The court also held that Biogen’s past earnings under the parent patent were not relevant to whether the separate divisional patent should be protected. It said the High Court had wrongly treated the earlier monopoly as unlawful and wrongly relied on the public interest in cheaper medicines to outweigh patent rights before invalidity had been determined.
The Court of Appeal said an injunction should have been granted. It allowed the appeal on that issue but refused the appeal concerning discharge of the 2 August order. The case is to return for a short hearing on the form of the order and costs. The court did not determine the patent’s validity at trial.