Welcome to second edition of the UPChronicle. November was a busy month for the Unified Patent Court, with 45 decisions overall and a particularly influential run of 15 decisions and orders from the Court of Appeal in Luxembourg. A clearer doctrinal framework is emerging across core patent law issues—added matter, sufficiency, claim construction, novelty, and obviousness—anchored by two headline rulings, Amgen v Sanofi and Edwards v Meril. Together, these decisions sharpen the inventive step analysis, confirm a purposive approach to medical use claims that requires therapeutic suitability, and reiterate that injunctions remain the default consequence of proven infringement absent special reasons to the contrary.
Court of Appeal: Amgen v. Sanofi
The appellate court reversed the Munich Central Division and reinstated Amgen’s patent for an anti-PCSK9 inhibitor for use in treating/preventing hypercholesterolemia or reducing the risk of cardiovascular events.
Regarding obviousness, the Court held that a claimed solution is obvious when the skilled person, “starting from a realistic starting point in the state of the art (i.e. the prior art)…wishing to solve the objective problem, would…have arrived at the claimed solution.” The Court contrasted this to a situation where although the skilled person could have arrived at the solution they would not. Applying the law to the facts, the Court held:
The scientific research in the field…had at the priority date not reached the stage where the skilled person could have reasonably predicted that [the claimed] antibody… would be therapeutically effective in treating or preventing the diseases referred to in claim 1 or of reducing the risk associated with such diseases. As such, the skilled person, on the basis of a scientific appraisal of the state of the art at the priority date, did not have a reasonable expectation of success that an antibody approach would have the desired therapeutic effect in vivo…
The Court also clarified the approach to claim construction of medical use-format claims: it is an inherent claim feature that the claimed product must be objectively suitable (i.e. therapeutically effective) for the claimed use. In practice, this means that the claims implicitly require a meaningful therapeutic effect rather than any lowering of cholesterol levels. On added matter, the Court held the original disclosure is adequate if the skilled person can derive the subject matter of the claim from the application “as a whole.” And, finally, on sufficiency the Court held that an invention is “sufficiently disclosed if the patent specification shows the skilled person at least one way…of performing the claimed invention.”
Court of Appeal: Edwards v. Meril
The Court released its decision in Edwards v Meril on the same day as Amgen v Sanofi (above) rejecting Meril’s appeal and maintaining Edwards’ patent (as amended) covering a prosthetic heart valve and a delivery catheter. The importance of the inventive step decision in Amgen v Sanofi was confirmed by Edwards v Meril which repeats the same legal principles. In addition, the Court upheld the infringement ruling from the Munich Local Division confirming that an injunction usually follows a successful infringement claim unless there are special reasons to deny one.
Court of Appeal corrects claim construction
In Seoul Viosys v expert klein, the Court of Appeal confirmed the correct approach to claim interpretation:
The principles governing the interpretation of claims were set out in…NanoString v 10x Genomics. The claim is not only the starting point but the relevant basis for determining the scope of protection of a European patent under Art. 69 EPC in conjunction with the Protocol on the Interpretation of Article 69 EPC. For the interpretation of a patent claim, it is not only its exact wording in the linguistic sense that is decisive, but rather the description and the drawings are always to be consulted as explanatory aids for the interpretation of the patent claim and not only to remedy any ambiguities in the patent claim.
Applying these principles, the Court held that that Dusseldorf Local Division misinterpreted the wording “a Mesa” in the claims. The wording does not necessarily mean that the claim is restricted to one Mesa, rather that at least one Mesa must be present. However, the error was not sufficient to win on appeal and the appeal was dismissed with costs payable by Viosys.
Burden of proof on security for costs
The UPC can require a party to put up money (or a bank guarantee) as security to cover the other side’s recoverable legal costs if there is a real risk those costs might not be paid at the end of the case. This is governed by Article 69(4) UPCA and Rule 158 of the Rules of Procedure. In analysing the evidence, current Court of Appeal guidance requires the Court to assess, on the facts and submissions: (i) recoverability risk: whether the claimant's financial position gives rise to a legitimate and real concern that a potential costs order will not be recoverable; and/or (ii) enforcement risk/burden: how likely it is that a potential costs order may not be enforceable, or that enforcement would be unduly burdensome (for example, because enforcement would have to occur in a jurisdiction where recognition/enforcement is difficult or costly). The party seeking security bears the burden of substantiation and proof and if reliance is placed on foreign enforcement difficulties, the applicant must adduce evidence not only of the relevant foreign law but also of how that law is applied in practice.
In Align Technology v Angelalign, the Dusseldorf Local Division refused to order security for costs because the defendants failed to discharge their evidential burden: they provided insufficient substantiation for why security is appropriate in these circumstances and failed to produce evidence of the applicable foreign law.
The Court of Appeal later confirmed, in Oerlikon v Bhagat, that an application for security for costs may be filed at any time during proceedings and may be filed in both first instance and appeal proceedings. In this proceeding, Bhagat had failed to pay security ordered in the Court of First Instance and Oerlikon sought to increase the security for costs prior to the appeal hearing. The Court increased the security for costs award to reflect only the appeal costs and warned Bhagat that if it failed to comply the Court may grant a decision by default.
Seeking suspension on appeal is burdensome
Suspensive effect is exceptional. Under Article 74(1) of the UPCA, an appeal does not suspend the effect or enforcement of the decision under challenge by default. The starting point is clear: orders and decisions of the Court of First Instance remain effective and enforceable unless, on a reasoned application by a party, the Court of Appeal grants suspensive effect. This framework is designed to ensure the UPC’s decisions have real-time efficacy, particularly in contexts like provisional measures, information and inspection orders, and injunctions, where delay can undermine the remedy.
Two recurring guideposts emerge from the case law: (i) a manifest error; or (ii) the appeal would otherwise be rendered pointless without suspension, for example because compliance would irreversibly disclose confidential information or otherwise irreparably change the status quo. Even then, the Court balances the appellant’s interest in maintaining the status quo pending appeal against the respondent’s interest in the continued effectiveness of the first-instance order.
In Lepu Medical v Occlutech, the Court of Appeal denied Lepu’s request for suspensive effect of Occlutech’s provisional injunction pending the appeal hearing. In dismissing Lepu’s application under Rule 223 of the Rules of Procedure, the judge-rapporteur noted that Lepu failed to demonstrate that the Hamburg Local Division’s findings and considerations constitute manifest errors, i.e. factual findings or legal considerations that are clearly untenable even on the basis of a summary assessment.
In Black Sheep v HL Display, the Court of Appeal denied Black Sheep’s application for suspensive effect of a decision requiring disclosure of information to HL Display for calculating damages and to take further action to prevent infringement. The Court reasoned that because such information is necessary to ensure a high level of protection for the successful party, it is only under exceptional circumstances that the enforcement may be suspended under Rule 223 of the Rules of Procedure. The Court also warned that if the party forsees a risk of disclosure of confidential information this should be raised during the proceeding so that any “appropriate measures” can be provided for. In the result, the Court of Appeal dismissed Black Sheep’s application.
Two technical preliminary objections dismissed
Preliminary objections are the UPC’s fast-track mechanism for defendants to challenge threshold issues before the case gathers momentum. Grounded in Rules 19–21 of the Rules of Procedure, they allow a focused, early decision on forum, division, and language—issues that shape the entire litigation. Used properly, a preliminary objection can re-route the case to the correct forum, change the language of the proceedings, or, in rarer circumstances, trim or end the action. While a preliminary objection can be a useful tool, the Sun Patent decisions below clearly demonstrate they should not be used in weak or frivolous situations.
In Sun Patent v VIVO, the Paris Local Division recently rejected two preliminary objections filed by VIVO to dismiss infringement proceedings brought against it by Sun Patent. The first objection was that Sun Patent sought a declaration that its licence terms were FRAND and this was outside the scope of the UPCA. The second was that none of the defendants were based in France, so the Paris Local Division cannot have jurisdiction.
The FRAND preliminary objection was based on a narrow reading of the UPCA: that Sun Patent issued a claim seeking a determination of the terms of a FRAND licence between the parties and this was not permitted under the UPCA. However, the Paris Local Division viewed Sun Patent’s pleading as primarily an infringement claim with an ancillary request for FRAND determination; and as such it was within the jurisdiction of the UPC.
As set out above, VIVO also objected to the jurisdiction of the Paris Local Division to hear the dispute given that none of the VIVO group companies were based in France. However, Sun Patent had purchased an allegedly infringing product from a French-dedicated VIVO website and the Local Division found jurisdiction on the basis of Article 33(1)(a) of the UPCA which permits patent infringement claims to be brought before “the local division hosted by the Contracting Member State where the actual or threatened infringement has occurred or may occur, or the regional division in which that Contracting Member State participates…”. The Court therefore deemed the purchase sufficient to satisfy Article 33(1)(a) and rejected the preliminary objection.
VIVO immediately filed a request to the Court of Appeal to stay the underlying proceedings given the “uncertainty that the unprecedented jurisdictional challenge of an active FRAND determination request creates for VIVO’s proper defence strategy.” Notably, this was not an application for a stay pending appeal but a stay of the underlying proceedings. The Court of Appeal was not prepared to stay proceedings before the Court of First Instance absent “exceptional circumstances” because the Court of First Instance is better informed of all the circumstances and has a margin of discretion in managing the case.
Serving UPC documents on parties in China
Serving court documents on Chinese defendants in UPC proceedings has proven both slow and unpredictable.
The governing route is the Hague Service Convention (HSC), using China’s Central Authority online service portal. Because China requires translations and does not permit direct service via email, parties should plan to submit full Chinese translations of originating documents to the Central Authority, and to expect extended delays. The practical difficulties are significant – despite portal acceptance and forwarding to the Supreme People’s Court, months often pass without a certificate of service. These patterns have led to standstills that are incompatible with the UPC’s case management needs, particularly in urgent matters.
The UPC has therefore developed pragmatic responses.
First, it will consider alternative service under Rule 275.1 of the Rules of Procedure after parties make a genuine attempt to serve under the HSC and can show good reason. Divisions have authorised service within the EU in practical settings, such as in person delivery to the defendant’s personnel at a trade fair.
Second, for urgent cases, divisions have issued “good service” orders pursuant to Rule 275.2 of the Rules of Procedure deeming steps already taken to be effective, particularly where the applicant shows the address in China is correct, has made sustained inquiries and follow ups (including attempts at voluntary acceptance), and where awaiting formal service would defeat the urgency of the relief sought. To enhance awareness, some orders have been publicised on the UPC website.
Third, if a defendant has an EU representative of record connected to the patent, service on that representative can proceed under Rule 271, sidestepping the HSC route entirely.
In Hewlett-Packard v Zhuhai ouguan Electronic Technology, HP sought a preliminary injunction against a China based defendant. HP submitted all the necessary documents to the official online portal of the Chinese Central Authority on June 4, 2025. Months later, HP asked the Dusseldorf Local Division to make enquiries of the Chinese authorities; which it did, and was informed that “no such company exists at the address provided.” In order to effect service of its urgent PI application, HP sought an order from the Dusseldorf Local Division that the steps already taken be considered good service. After noting the delays and receiving credible evidence that the defendant Zhuhai was based at the address given to the Chinese authorities, the Local Division made the order. The Local Division said the state of the affairs, including the urgency of the PI, justified confirming the steps already taken as good service under Rule 275.2 of the Rules of Procedure. The Local Division ordered that service was effective as of the date of its order and directed that the order be published on the Court’s website.
The Dusseldorf Local Division made similar orders in another case of Hewlett-Packard v Shenzhen Moan. The main difference from Zhuhai (above) was that in this decision the Local Division did not receive any response from Chinese authorities before it issued the Order.