Novartis AG & Anor. v Teva UK Limited & Ors.

The High Court has jurisdiction to grant interim injunctive relief before a patent is formally granted. The statutory scheme governing damages for acts occurring before grant does not create an exhaustive bar on interim relief under the Senior Courts Act 1981.

The jurisdiction remains exceptional and must be exercised consistently with the legislative policy of the Patents Act 1977. Applying the American Cyanamid approach, damages were adequate for the prospective patentee because the period of generic entry was short and the likely loss could be calculated. Damages for the generics would have been difficult to quantify, but that did not require an injunction. The application was refused.

Novartis sought an urgent interim injunction preventing several generic manufacturers from supplying fingolimod, pending formal grant of a European divisional patent concerning a once-daily 0.5 mg dosage.

The patent application had been refused by the EPO Examining Division but the Technical Board of Appeal had ordered that the patent be granted. Formal grant was expected several months later. The defendants argued that the court lacked jurisdiction before grant. The central issues were whether pre-grant interim relief was legally available and, if so, whether the interim injunction test was satisfied.

1. Jurisdiction. The court had jurisdiction under section 37 of the Senior Courts Act 1981 to grant an interim injunction although the patent had not yet been formally granted. The jurisdiction is broad and flexible, subject to statutory restriction and established equitable principles. A claimant seeking an injunction under section 37 need not have an accrued cause of action.
2. Section 69 of the Patents Act 1977 gives the applicant a post-grant right to recover damages for qualifying pre-grant acts. It does not expressly address interim injunctions. The provision was not to be interpreted as a statutory bar on interim relief. The reasoning in Sevcon Ltd v Lucas CAV Ltd supported treating the restriction as procedural and applying an abuse-of-process, merits-based analysis.
3. The circumstances were exceptional. Grant of the patent and its scope were effectively certain, and any later claim for damages would cover the loss caused by interim generic entry. Seeking interim relief was therefore not an abuse of process.
4. The American Cyanamid test applied. There was a serious issue to be tried. However, damages were adequate for Novartis: the pre-tender period was short, tender prices and volumes would be known, and any loss was capable of estimation. Alleged reputational harm and loss of future branded sales were speculative and unconvincing. Damages need not be a perfect remedy.
5. Damages under the cross-undertaking would not have been adequate for the generic defendants because their counterfactual sales volumes, prices and tender success would have been highly uncertain. The court therefore did not reach the balance of convenience, although it observed that Novartis’s divisional and amendment strategy, which prevented the generics from clearing the way, was a factor against interim relief.
6. The application for interim relief was refused. The court would have reached the same result under the overall least-risk-of-irremediable-prejudice approach.