UPC grants medtech company injunction over UK

The ruling is the first time a UPC division has applied guidance concerning how the UPC should manage infringement of non-UPC country designations of European patents set out by the UPC Court of Appeal earlier this year.

The UPC system enables holders of unitary patents or European patents not opted out of the system to more easily enforce their patent rights on a cross-jurisdictional basis. Conversely, patents in-scope of the UPC’s jurisdiction are at risk of being revoked in multiple countries via a single ruling. Only EU member states can participate in the UPC system, though just 18 of the 27 countries eligible to participate have become UPC contracting member states to-date.

However, as the UPC Court of Appeal confirmed in a ruling in a case involving Fujifilm and Kodak, in certain circumstances, the UPC may exert its ‘long-arm jurisdiction’ to award relief arising from the infringement of a European patent in certain jurisdictions outside its territory – including non-UPC EU countries such as Spain, and non-EU ‘third countries’ such as the UK.

In the case before the Düsseldorf LD, German surgical instrument manufacturer Aesculap AG brought an infringement action against three entities of the Chinese Bojin group concerning a European patent in force in Germany, France and the UK. The proceedings related to two surgical cutting tools marketed under the Bojin brand. 

Aesculap AG reached a settlement with two of the companies – the Chinese manufacturer and its distribution arm – but not with Hamburg-based Shanghai International Holding Corporation GmbH (Europe) (SIH Europe), which had responsibility for regulatory compliance functions for the other Bojin entities as the EU authorised representative under the EU’s Medical Device Regulation.

The Düsseldorf LD held that both of the products in question infringed Aesculap’s patent. However, SIH Europe was not held liable as a direct infringer, joint tortfeasor, instigator, or accessory. Instead, the court considered it was liable solely as an intermediary under Article 63(1) of the UPC Agreement (UPCA) which grants UPC judges the powers to grant injunctions against both a patent infringer and an intermediary whose services are being used by a third party to infringe a patent.

The Düsseldorf LD considered that an EU authorised representative performs an “indispensable role” in the lawful marketing of medical devices, since such products cannot be distributed within the EU without that appointment. The court considered that, by accepting that role, SIH Europe enabled the accused products to be placed on the market and that it was in a position to influence, and ultimately stop, the infringement by terminating its services. As a result, the company was deemed to qualify as an intermediary for the purposes of Article 63(1) of the UPCA. 

The remedies imposed by the court were different in respect of Germany and France, on the one hand, and in relation to the UK on the other.

SIH Europe was ordered to cease providing its services as EU authorised representative in Germany and France in respect of the infringing products. The company is also subject to an information order which requires it to disclose details relating to the infringement in those jurisdictions.

In respect of the UK, the Düsseldorf LD cited the guidance set out in the Fujifilm v Kodak case, confirming that its powers to issue orders extending to non-EU countries are subject to a suspensive condition that the patent is not declared invalid by the competent national authority in that third country. It further determined that infringement of the UK designation fell to be assessed under UK substantive law.

Aesculap established that UK law permits injunctions against an intermediary and that SIH Europe, as EU authorised representative, had created a necessary precondition for the infringing products to reach the UK market. The Düsseldorf LD therefore granted it an injunction extending to the UK, subject to the condition that the patent is not subsequently found invalid by the UK courts.  

However, Aesculap failed to demonstrate that acting solely as an EU authorised representative under Article 11 of the EU’s Medical Device Regulation was enough to classify SIH Europe as a patent infringer under section 60 of the UK’s Patents Act 1977. Since SIH Europe was liable only as an intermediary, no information order could be made in respect of the UK, as the right to information under s61 of the Patents Act 1977 accrues only against a patent infringer.  

The Düsseldorf LD made these findings despite the ongoing referral before the EU’s highest court, the Court of Justice of the European Union (CJEU), in the dispute between electronics maker Dyson and Hong Kong-based manufacturer Dreame International concerning hair stylers.

The CJEU has been asked to clarify the UPC’s scope to issue relief for patent infringement in EU countries that are not UPC contracting states and in relation to the liability of EU-based authorised representatives. The CJEU’s judgment is not expected until 2028 at the earliest. According to the Düsseldorf LD, the issues to be ruled on by the CJEU could be sufficiently distinguished from the issues it was asked to rule on in the Aesculap case. As a result, it declined to delay ruling on the case until the CJEU hands down its judgment.