Munich court grants Germany's first pan-EU cross-border patent injunction post-BSH v Electrolux

The Munich Regional Court I has issued its written reasons following its decision on 25 September 2025 to grant an interim injunction prohibiting Formycon from selling its biosimilar of Eylea® (aflibercept) in 22 EU countries. This is the first time a national court has granted a cross-border patent injunction following the Court of Justice of the EU's seminal BSH v Electrolux decision. It comes in the wake of a series of decisions from the Unified Patent Court (UPC) granting "long-arm" relief reaching beyond the UPC's contracting states.

The Munich court concluded that each national designation of Regeneron's formulation patent would be found infringed under the doctrine of equivalents, having already held there to be infringement of the German designation on this basis in parallel proceedings. Each designation's validity was also "sufficiently secure", as the German designation had been upheld in amended form by the German Federal Patent Court (FPC).

Given the FPC's "well-recognised expertise", its decision on validity also had a "Europe-wide signal effect" that restarted the urgency period for an injunction in all countries. The court concluded that there was an imminent risk of infringement in at least Germany, Belgium, France and Italy, and also a risk of first-time infringement in the other countries. It found the balance of interests favoured Regeneron, and granted an injunction.

This decision marks the start of national European courts applying the CJEU's reasoning in BSH to revive cross-border patent litigation in Europe. The UPC has already enthusiastically applied BSH and flex its so-called long-arm jurisdiction, but this is the first time a national European court has done the same. Will this cause a rise in cross-border patent litigation in the German (and potentially other national) courts and prompt a move away from the UPC? Or might both national courts and the UPC see a boom in popularity for those seeking cross-border relief?

Regeneron's application

Eylea® (aflibercept) is a blockbuster biologic drug that is used to treat retinal diseases, such as wet age-related macular degeneration. Regeneron's supplementary protection certificate (SPC) protecting aflibercept expires in November 2025, and marketing authorisations have been granted for a number of biosimilars, including Formycon's product. 

Regeneron and its European licensee, Bayer, sued Formycon for a preliminary injunction (PI) covering multiple European countries in the Munich court based on threatened infringement of Regeneron's patent.

The patent claims an aflibercept formulation, and the German designation had recently been upheld (in amended form) by the German Federal Patent Court. In a parallel case, the Munich court had found the German designation infringed by Formycon's product under the doctrine of equivalents.

The applicants originally sought a PI covering 30 countries, including non-EU countries such as Switzerland, Iceland and Turkey. This was later reduced to 22 countries, all within the EU.

The court's jurisdiction 

Both Formycon respondents were domiciled in Germany, and therefore subject to general jurisdiction of the German courts under EU jurisdictional rules. That gave the court basis to rule on all of their alleged infringements.

Both respondents were under the local jurisdiction of the Munich Regional Court under Germany’s own internal jurisdictional rules. The court nonetheless commented obiter on the position of respondents that might be domiciled elsewhere in Germany.

In purely foreign cases (such as this, as infringement in Germany was separate), a German defendant would normally be sued in its local regional court. There are 12 such courts competent to hear patent infringement actions. Despite the lack of a jurisdictional gap, the Munich court considered that the normal rule was "problematic" and it was necessary to deviate from it. It stated that, in cross-border patent cases, it should be possible to sue a German defendant in any competent regional court irrespective of where in Germany it is based. This would allow patentees to take advantage of those courts with a specialist patent chamber.

It considered that opening up jurisdiction in this way was in line with rationale underpinning the EU's IP Enforcement Directive.

The opinion expressed by the court would put the choice of court in the hands of patentees, and would put those German courts with specialist patent chambers (or seen as more patentee friendly), such as Munich, in a good position to attract cross-border infringement actions against German respondents. It remains to be seen whether German's other regional courts will agree with this approach.

The court considered that the existence of a reason for a PI was a procedural matter, and therefore governed by the law of the court seised (that is, German law). This requires applicants to show urgency and that the balance of interest favours a PI.

In German practice, a decision affirming validity of a patent can create a new period of urgency. The court considered that the FPC's decision upholding the German designation created urgency for all designations as the FPC's decisions have "a Europe wide signal effect ('beacon character') due to its recognised expertise". The urgency test was therefore met.

Validity 'sufficiently secure'

According to the guidance in BSH, an infringement court may stay a cross-border infringement action affecting other EU states if there is "a reasonable and non-negligible chance” that the patent would be found invalid in those countries. 

The court considered that all 22 national designations of Regeneron's patent were “sufficiently secure” for it to proceed because the German designation had been upheld in amended form. 

Any national requirement to register the amended version of a patent before it can be enforced was determined to be merely a "procedural rule" that did not prevent the Munich court from granting cross-border injunctive relief based on an amended version. 

Cross-border infringement by equivalents

The court went on to consider whether the national designations of the patent were infringed. Formycon's formulation used a histidine buffer, rather than the phosphate buffer recited in the claim. Infringement could therefore only be under the doctrine of equivalents. 

The court had already ruled that the German designation was infringed by equivalents, and it considered that this earlier decision had a “strong indicative effect” that the same conclusion would be reached in other European Patent Convention (EPC) states. 

Because of this "strong presumption", it was not necessary for the court to obtain expert opinions on applicable foreign law. The court considered that this would make the effective enforcement of IP rights, as required by the Enforcement Directive, unreasonably difficult for patentees.

Instead, it was up to a respondent to provide “concrete evidence” (in the form of declarations from legal experts) if it wished to rebut the presumption, emphasising that “it is incumbent upon you to explain why other states would come to a different assessment.” 

The only relevant criterion here was whether national statutes or established case law modified the requirements of the EPC in a way that would lead to a different result. Differences in legal practice or procedure, or whether there was a fundamental scepticism towards the doctrine of equivalents in a country, were irrelevant. Boldly, the court noted that judges who do not regularly deal with patent infringement are "typically reluctant" to apply the doctrine.

Formycon had submitted declarations on national law for a number of the 22 countries. However, these did not persuade the court to change its mind. It remained of the view that infringement by equivalence would be found in all of them.

The court also briefly considered the judgment of the English Patents Court in parallel proceedings between the parties. In that case, Mr Justice Meade had considered equivalents and held that the Formycon product did not infringe the UK designation. The Munich court stated that a more specific, dependent claim had been in issue in the UK and that the parties had presented different arguments there. Accordingly the English judgment did not undermine its conclusion on equivalence.

Imminence of infringement 

The Munich court considered that the requirement for a PI applicant to show a risk of first infringement "must not be excessive". It would be enough for an applicant to present facts that made it "appear sufficiently probable that an immediate patent infringement could be imminent" in all countries. It would be sufficient to argue that an application for approval had been filed and that a distribution structure existed that would enable the product to be distributed. 

The court noted that the considerable investments required in the pharmaceutical sector could only be recouped by making products widely available. This applied particularly to biosimilars, which are costly to develop. Were such an argument to be made, it would be for the respondent to show either that distribution was not planned or that the legal requirements would not justify a PI in a particular country. 

On the evidence, the court concluded that the respondents were "planning a global marketing strategy with a particular focus on rapid introduction in Europe". It also pointed to Formycon having sought declarations of non-infringement in the French, Belgian and German courts, and the publication of the summary of product information and package insert on the Belgian medicines agency's website. 

Formycon had "a uniform European marketing authorisation", so there were no major regulatory hurdles to marketing the product in any EU country.

The court held that there was an established, imminent risk of launch at least in Germany, Belgium, France and Italy. Formycon had argued that staggered market entry is common in Europe, with launch occurring in larger markets first. The court took this as an admission that biosimilars are launched either simultaneously or with a delay. Against that background, it held that there was also a risk of first-time infringement for the other markets. 

Balance of interests

The court concluded that the balance of interests favoured a PI. Having held that the patent was valid and infringed, the default position was to grant the injunction. It found no compelling reasons to deviate from this.

Although a PI would affect Formycon's "significant economic interests", they had to accept this damage as the infringer. As the parties were direct competitors, Regeneron and Bayer also had a "particular economic interest" and therefore "an increased need for protection". The PI has subsequently reportedly been confirmed by the Munich court granting a permanent injunction. 

Osborne Clarke comment 

This important, patentee-friendly decision is the first judgment by the German (or indeed any) national courts relying on BSH to grant a cross-border PI. 

The Munich court repeatedly emphasised the principle of effective protection of IP rights underlying the Enforcement Directive. It appeared keen to minimise both procedural and evidential burdens on patentees seeking to bring proceedings. For example, national requirements (such as recording a patent licence or a patent amendment) should not stand in the way of cross-border enforcement, patentees should be free to bring cross-border actions in their choice of German regional court, and the burden should be on the respondent to prove that foreign law would produce a different result.

The court was also clear that the requirement for PI applicants to demonstrate a risk of infringement "must not be excessive". The indication that it would be sufficient to show that "an application for approval has at least been filed and that a distribution structure exists that would enable the product to be distributed" – after which the burden shifts to the respondent to prove it could not or would not launch – appears to be a low threshold. 

It can be contrasted with the test set by the UPC Court of Appeal for imminent infringement in Boehringer Ingelheim v Zentiva. There, the UPC stated that the application for a marketing authorisation does not amount to imminent infringement, nor does the grant of one create imminence. Moreover, the UPC's position was that while completion of national pricing and reimbursement processes can create imminence, this needed to be assessed in light of the national regulatory context. In the Formycon case, however, the Munich court appeared to put more weight on the commercial pressure to launch pharmaceutical products widely, particularly drawing attention to the high cost of biosimilar development.

The decision would seem to position the Munich Regional Court as a patentee-friendly rival to the UPC for cross-border relief against possible infringers domiciled anywhere in Germany. The decision was ultimately limited to EU Member States, but BSH made it clear that EU law does not prevent wider reach.

The UPC has already granted injunctions affecting non-EU designations of European patents, but its jurisdiction is limited by the UPC Agreement to patents granted under the EPC. Although the Munich court's decision relied on the EPC for its finding of infringement, it may soon be seen if a German court would go further still and rule on non-European patents: it has been reported that an action alleging infringement of two US patents has recently been filed in Munich.