Clifford Chance

Almost one year on, the Court of Justice of the European Union's (CJEU) Phoenix Contact/Harting judgment on patent validity in preliminary injunction proceedings, which found that the German rigor in granting interim injunctions for not validated patents should be reconsidered, is still causing ripples. As the first post-Phoenix decisions on interim injunctions are reported, it is becoming apparent that regional courts in Düsseldorf and Munich are taking quite distinct approaches – which may lead to issues further down the line.

CJEU’s decision on patent validity for interim injunctions

German courts require interim injunction applicants to argue that the injunction is necessary, and to claim probability of infringement. Further, the validity of the patent in question must be sufficiently established. German courts have partly outsourced this question of patent validity to the technical courts by asking plaintiffs for a confirmation on validity by the Federal Patent Court or EPO opposition boards. Such confirmation thereby means, at the very least, a first-instance decision given in opposition or invalidity proceedings.

In Phoenix Contact/Harting, the Regional Court of Munich asked the CJEU whether Article 9(1) of the EU Enforcement Directive(2004/48) must be interpreted as precluding national case law under which an interim injunction for a patent can, in principle, only be granted where the patent’s validity has been confirmed. As expected, the CJEU affirmed the question.

However, the regional court painted a rather specific picture of German injunctive jurisprudence with this question, which judges and practitioners have since disputed. The issue was presented as a black-and-white choice, in which the courts do not weigh different factors regarding a patent’s validity but instead use the technical boards’ assessment as the only criterion.

Preliminary injunctions, however, call for a balancing of interests between effective legal protection and the averting of irreparable damages. The notion that the courts do not act on infringements unless for a confirmed patent is inaccurate. There have previously been criteria that allowed for a direct injunction without the need for confirmation – inter alia a lack of objections, the mere absence of validity proceedings or the fact that the patent is acknowledged and licensed by other market participants.

Reactions to the CJEU's judgment

It was widely anticipated that German courts might change their jurisprudence in reaction to the CJEU judgment. The Düsseldorf and Munich regional courts are taking noticeably different approaches now that the first decisions have been published.

Munich: validity presumed and defendants burdened

In two of the first judgments since the CJEU's judgment (LG München I, 29 November 2022 – 7 O 4716/22, Fingolimod; 27October 2022 – 7 O 10295/22, Bortezomib), the Regional Court of Munich has taken a much more applicant-friendly approach, deciding that: the validity of European patents is presumed to be the new default; it is up to defendants to disprove such a presumption of validity (eg, with a (preliminary) negative assessment of the validity in domestic or foreign proceedings regarding the patent’s validity); and if such negative assessments of the validity exist, the onus is on the applicant to diagnose the negative assessment and forecast how the patent's fault will be overcome in the dispute’s upcoming stages.

However, the patent in this particular case was a pharmaceutical patent infringed by a generic drug manufacturer. Because of this, the undisputed presumption of the higher regional courts towards the validity of patents in generic drug cases (due to high imminent damages for patent holders) stand and the new rule could not take effect.

An appeal to the Fingolimod case is pending at the Higher Regional Court of Munich (6 U 6200/22).

Düsseldorf: presumption is not binding

In its December 2022 decision, the Regional Court of Düsseldorf doubted whether the CJEU's judgment must be interpreted in away that every patent granted by the EPO has a presumption of validity (4c O 62/22, MS-Therapie III).

As expected, Düsseldorf is not keen to alter its previous approach to the general requirement of confirmation for a preliminary injunction. The court ruled that while third-party objections were considered during the examination process, an opposition decision on the parent patent provides a strong presumption against the patent-in-suit’s validity, and therefore it denied the application.
Remarkably, the first published decisions that take recourse to the CJEU's decision would have also had the same outcomes under the previous rules. All three cases made use of the generics exception, which, in itself, proves the situation demonstrated in the referral question to be inaccurate.

The road ahead

The first decisions by the regional courts of Düsseldorf and Munich are unsurprising. It was predictable that the Düsseldorf jurisprudence would adhere to the previous rule: a preliminary injunction requires some kind of confirmation of validity if no exceptions apply. It remains to be seen if – and how – the diverging jurisprudence of the Düsseldorf and Munich courts (not to mention Hamburg and Mannheim, as no decisions have been reported so far) will be settled.

With the new approach in place, actors on both sides should be prepared to present their arguments on the patent’s validity in a timely and substantive manner. If sued in Munich in particular, defendants should be quick on their feet to argue the invalidity of the patent in suit.

^{The article has first been published on iam-media.com}