Through a preliminary injunction (PI) in patent litigation matters, an applicant can obtain a fast ruling in exceptional cases to secure its overriding interest in stopping acts of patent infringement in Germany. PI proceedings are summary proceedings, which means that the court conducts a summary examination (Regional Court Düsseldorf, Decision of 4 March 2021, 4c O 25/20).
Applying for a preliminary injunction
German courts will only grant a PI if there is a basis for an injunction (Verfügungsanspruch) and a requirement for a PI (Verfügungsgrund).
A warning letter to the alleged infringer prior to requesting the PI is not a prerequisite, however, the absence of a letter of this kind will affect the possibility of obtaining an ex parte PI (see below). While the applicant does not have to provide security initially, the enforcement of an adjudicated PI can be ordered to be dependent on the provision of security.
For the basis of the injunction, the applicant must show that its patent is being infringed. Prima facie evidence showing patent infringement is enough in principle. In practice, however, it is only in clear-cut infringement cases that obtaining a PI is likely.
Additionally, the applicant must demonstrate that there is a requirement for a preliminary injunction. In particular, it should be shown that swift action has been taken to address the matter (demonstrating urgency), there is a sufficient likelihood that the enforced patent is valid, and it would be unreasonable to wait for the outcome of proceedings on the merits.
In terms of urgency, the applicant must not have hesitated to request the PI. There is no legally regulated or fixed deadline for this (Higher Regional Court Düsseldorf, Decision of 5 May 2017, 2 W 6/17). It is within the court's discretion to assess whether the urgency requirement is met, and thus German courts have established various benchmarks. Generally, German courts require that a PI request be filed within one to two months after the applicant has become aware of the infringing acts. In some situations, urgency may also re-arise eg if a patent is upheld in validity proceedings.
In addition, the applicant must show that the validity of the patent is sufficiently secured. Given that the court has limited time to assess the case, it is difficult to scrutinise the validity. When there is doubt on the validity of the patent upon a pending opposition before the German Patent and Trade Mark Office (GPTO) or the European Patent Office (EPO), or a nullity action before the Federal Patent Court against the patent, the request for a PI will be dismissed. Usually, German courts require a practical 'certificate of validity' going beyond the mere fact that the patent was granted by the GPTO or EPO. Secured validity may be evidenced if the patent has survived opposition or nullity proceedings, or if reputable companies hold licences and rely on its validity (Higher Regional Court Düsseldorf, 29 April 2010, 2 U 126/09 – Harnkatheterset).
Finally, the applicant must show that a PI is required and that proceedings on the merits cannot be awaited. This requirement is met when the applicant demonstrates that considerable damage would be suffered without the PI. The court will then balance the interests of the applicant and the alleged infringer to assess whether a PI can be issued.
In principle, ex parte injunctions are possible in Germany. However, the German Federal Constitutional Court recently ruled in a number of media law and unfair competition cases (Federal Constitutional Court, Decision of 30 September 2018, 1 BvR 2421/17 – Steuersparmodell eines Fernsehmoderators; Federal Constitutional Court, Decision of 27 July 2020, 1 BvR 1379/20 - Zahnabdruckset) that the opposition’s procedural right to be heard is violated if no opportunity to respond to the applicant’s accusation has been granted before requesting a PI, eg by a warning letter. This also applies to patent litigation matters.
Evidence required
Contrary to proceedings on the merits, where the Plaintiff must fully prove patent infringement, a smaller degree of judicial conviction is enough in PI proceedings to establish the probability of the alleged facts prima facie. Under Section 294 German Code of Civil Procedure, this requires the applicant to demonstrate an overriding probability that its allegations are correct. Therefore, there must be more evidence that supports the asserted claim than against it.
Given that PI proceedings are of a summary nature, the applicant cannot offer, eg testimonies. Rather, affidavits are required.
Factors that the courts take into consideration
The courts do not consider the merits of the case. Instead, they hand down a fast decision through a summary assessment of the case. The courts consider the balance of convenience between the applicant and the respondent to see if a PI can be issued. The courts consider commercial factors, such as irreparable damage to a party, the market position of the applicant and the danger of a significant price undercutting by the respondent.
Obtaining preliminary injunctions
Usually, injunctions are awarded either within just a few days or hours (ex parte) or a few weeks (inter partes, usually with an oral hearing). If an oral hearing takes place, the PI is issued as a judgment; otherwise, it is issued as an order.
PI proceedings in Germany are not limited to the pharmaceutical sector. In general, the applicant can obtain a PI for any type of patent.
Enforcement
Once a PI has been issued, it becomes directly effective upon service to the respondent.
With the PI, the court will define a penalty for the respondent in case the PI is not complied with. This penalty is usually an administrative fine or administrative detention. If the Respondent is in breach of obligations pursuant to the PI, the Applicant may request imposition of a penalty.
The applicant must ensure that the PI is enforced within one month after the issuance. If the applicant fails to do so, the PI loses its effect by law and must be revoked immediately upon the respondents' request. The applicant is not obliged to initiate proceedings on the merits. However, the Respondent may apply to the competent court for an order requiring the party who obtained the PI to bring an action within a specified period.
Appeal
If a preliminary injunction is granted without an oral hearing (by order), the respondent can challenge it by filing an objection. The court that issued the preliminary injunction (the Regional Court) will then hold an oral hearing. Filing an objection does not have suspensive effect, however, the respondent may request suspension of enforcement.
If the preliminary injunction is granted by the court following a hearing, the respondent may appeal this decision; in such a case, the matter will be referred to the court of second instance, the Higher Regional Court. In both cases, the court would set a date for an oral hearing in the short term and render a decision quickly after that.
Liability
Even if a PI has become final, it can be lifted in accordance with Section 927 of the German Code of Civil Procedure in the event of changed circumstances. In patent matters, this can be the case if a decision on legal validity destroys the assumption of secured legal validity. If the PI proves to be unjustified from the beginning or if it is revoked, eg on the basis of Section 926 (2) of the German Code of Civil Procedure (expiration of the deadline following the order to bring the action on the merits, see above), the applicant is obliged to compensate the respondent for damages caused by the enforcement.
