Eli Lilly and Company v Janssen Sciences Ireland UC (Formerly Janssen Alzheimer Immunotherapy)

When deciding whether to stay national patent proceedings pending opposition or appeal proceedings before the European Patent Office, the Patents Court must exercise its wide discretion to achieve the balance of justice in all the circumstances. Although a stay is the default where there are concurrent validity proceedings, that default may be displaced by the need for earlier commercial certainty, the existence of substantial infringement issues within the exclusive jurisdiction of the national court, uncertainty about supplementary protection certificates and the inadequacy of proposed undertakings. Timing, duplication, wasted costs, settlement prospects and the public interest are relevant, but must be assessed together with the prejudice caused by delay. The application should not become a mini-trial.

Eli Lilly sought revocation of specified claims of Janssen’s divisional European patent, together with a declaration of non-infringement concerning solanezumab, an Alzheimer’s treatment. Janssen applied to stay the English proceedings pending opposition proceedings concerning the divisional patent and related EPO proceedings concerning the parent patent. The EPO proceedings were advanced, but the English claim raised substantial infringement issues and commercial questions concerning a possible supplementary protection certificate and royalty exposure. The central issue was whether, applying the guidance in IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWCA Civ 1496, the balance of justice favoured a stay.

1. Application dismissed. Janssen’s application for a stay was refused and the English proceedings were allowed to continue.
2. The discretion to stay is very wide and must be exercised to achieve the balance of justice having regard to all relevant circumstances. Under IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWCA Civ 1496, concurrent EPO proceedings ordinarily make a stay the default, but the default is not decisive. National courts retain exclusive jurisdiction over infringement.
3. The advanced state of the EPO proceedings and the likelihood of expedition favoured a stay. The possibility of postponement or remission did not outweigh the likelihood that the EPO would reach a validity decision before the English proceedings.
4. The infringement issues were substantial and important. A declaration of non-infringement could provide Eli Lilly with commercial certainty which the EPO proceedings could not provide. This was an important factor against a stay, although not conclusive.
5. The proposed undertakings, including no injunction and recovery only of a reasonable royalty, did not adequately resolve the uncertainty concerning the amount and duration of royalty payments or the possible use of Eli Lilly’s marketing authorisation to obtain a supplementary protection certificate. Those matters materially affected decisions about regulatory submission and commercial launch.
6. Wasted costs, the possibility of settlement, the public interest in resolving uncertainty and the availability of an exportable English judgment were considered. They did not outweigh the commercial and infringement-related reasons for refusing a stay. Splitting infringement from validity was not pursued.