Teva UK Ltd v Chiesi Farmaceutici SpA

In a quia timet patent infringement claim, the relevant question is whether the pleaded material gives a real prospect of establishing at trial that the defendant threatens and intends to infringe. The court asks whether, viewed in all relevant circumstances, there is a sufficiently strong probability that an injunction will be required to prevent the threatened harm. A marketing authorisation need not already exist or be pleaded when the action begins. Revocation proceedings may support an inference of intended launch, although that inference is rebuttable. Properly conducted patent litigation, including court-ordered disclosure between potential competitors, does not ordinarily constitute collusion contrary to article 101 TFEU. Nor does an offer of advance notice of launch ordinarily justify staying infringement issues which should be resolved with validity at trial.

Teva sought revocation of three Chiesi patents concerning inhaled medicinal products. Chiesi counterclaimed for quia timet infringement, alleging that Teva threatened and intended to launch an infringing product before patent expiry. Teva applied to strike out the infringement counterclaim, alternatively to stay it, and argued that disclosure concerning its proposed product and launch plans could infringe competition law.

The court had to decide whether the pleaded facts gave the infringement counterclaim a real prospect of success, whether the counterclaim was an abuse of process, whether disclosure and continuation of the claim were contrary to article 101 TFEU, and whether the claim should be stayed.

1. Strike out. The infringement counterclaim was not struck out. On a strike-out application the issue was not whether the pleaded material proved a threat or intention to infringe, but whether it gave a real prospect of establishing those matters at trial. The governing principle, derived from MSD v Teva [2013] EWHC 1958 (Pat), was whether, in all relevant circumstances, there was a sufficiently strong probability that an injunction would be required to prevent the threatened harm.
2. The court declined to add requirements of grave irreparable harm, imminence, or a pleaded marketing authorisation. Those formulations arose in different contexts or did not qualify the patent-law test. A marketing authorisation was not required when the action commenced. The question concerned an intended launch at some time within the patent term, and the absence of a current authorisation did not prevent the claim having a real prospect of success.
3. Bringing revocation proceedings ordinarily supported a sensible, rebuttable inference that the rival intended to launch a product within the patent term. Teva’s failure to say that it would launch only after successful revocation, together with its limited notice undertaking, supported an inference that it reserved the option of launching at risk. The pleaded case therefore had a real prospect of success.
4. Abuse of process. The counterclaim was not abusive. An ulterior motive is insufficient by itself. Proceedings are abusive only where the court’s process is misused to obtain something not properly available in properly conducted litigation. Chiesi had the legitimate purpose of seeking infringement remedies, and the claim was a counterclaim to Teva’s revocation action.
5. Competition law and stay. Teva and Chiesi could be potential competitors, but article 101 TFEU required collusion or practical cooperation knowingly substituted for the risks of competition. Information exchange can itself constitute a concerted practice, but disclosure required by properly constituted patent litigation and case-management orders did not meet that threshold. Patent litigation resolving validity and infringement was inherently pro-competitive, and disclosure was objectively necessary to that process. Article 101 therefore did not justify a stay. The offer of 14 days’ notice was no substitute for deciding infringement and validity together at trial.
6. The infringement claim would continue, disclosure would be required, and the application for a stay was refused.