Novartis’s divisional patent application, EP 2 959 894 (“EP894”), claimed a once daily dosage of 0.5mg of fingolimod. Fingolimod is used as a disease modifying treatment for relapse remitting multiple sclerosis and is supplied by Novartis in the UK under the “Gilenya” brand.

EP894 was published on 30 December 2015, but claimed priority from 27 July 2006.

In November 2020, the European Patent Office (EPO) Examining Division refused to grant the patent on the basis of lack of novelty. Novartis appealed to the Technical Board of Appeal of the EPO (TBA) and, at a hearing in February 2022, the TBA confirmed that the patent should be granted. As a result of the EPO’s procedural requirements, formal grant of the patent was not expected to be until mid-June 2022, however, it was common ground between the parties that EP894 would ultimately be granted.

Novartis issued proceedings before the High Court in March 2022 against manufacturers/ suppliers of generic pharmaceuticals, Teva and others, and applied for interim injunctive relief on an urgent basis to prevent them from launching their generic versions of fingolimod.

Defendants Dr Reddy’s and Zentiva contended that the Court did not have jurisdiction to issue injunctive relief prior to the grant of EP894; the remaining defendants adopted a neutral position on the question of jurisdiction.

In its decision, the High Court confirmed that it had jurisdiction prior to the grant of EP894 to issue an injunction in order to restrain the defendants from acts which would have infringed the patent had it been granted. The Court considered that the Patents Act 1977 did not set out an exhaustive code of circumstances in which relief might be available where a patent has not been granted. Section 69 of the Patents Act 1977 provides an applicant with the right to subsequently obtain damages for infringement in respect of acts taking place after publication but prior to the grant of a patent, but does not explicitly refer to injunctive relief.

Further, the High Court commented that, as Novartis would be entitled (after EP894 granted) to claim for damages for loss suffered between the generic market entry and the date of grant, it could not be regarded as an abuse of process for Novartis to seek interim relief to restrain the acts which would otherwise give rise to that loss.

The High Court emphasised that its ability to exercise jurisdiction to issue injunctive relief prior to the grant of a patent was justified by the exceptional circumstances of this case, in which it was common ground that EP894 would be granted and the scope of the claims to be granted had already been determined. Without certainty as to the scope of the prospective monopoly, it was suggested that the Patents Court would be “wary” of other such attempts to seek interim relief prior to the grant of a patent. The Court therefore rejected the suggestion that this decision would open the floodgates for such applications.

However, although the High Court found it had jurisdiction to grant Novartis injunctive relief, it declined to do so in the circumstances.

Novartis argued that it would suffer direct financial damage and damage to reputation if the injunction was refused. However, the Court found that the risk of a downward price spiral was “unlikely” on the facts and considered that, if Novartis ultimately sustained its patent protection, future sales of Novartis’s product were unlikely to be materially affected by the temporary introduction of generics to the market. In refusing to grant injunctive relief sought, the Court distinguished the facts of the present case (involving a drug whose price is not determined by the NHS drug tariff) from “the kind of significant price spiral often referred to in pharmaceutical interim injunction cases”. Noting the previous decision of the Court of Appeal in Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd [2020] EWCA Civ 793, the appropriate question to consider was whether damages were an adequate remedy, not a perfect one.

The Court held that damages would be an adequate remedy to Novartis and no interim relief should be granted. Going on to consider the position of Teva and the other defendants, the Court observed that their damages would have been difficult to adequately quantify had injunctive relief been granted. The Court noted that it would have reached the same conclusion to deny interim injunctive relief had it considered the overall question of whether the least risk of irremediable prejudice resulted from the grant or refusal of interim relief.  

Authored by Jemma Trainor 

Case: Novartis AG and others v Teva UK Ltd and others[2022] EWHC 959 (Ch)