Last month, we published our overview of the UPC's first year. With the Court having passed the significant landmark of its first anniversary, it has now reached the milestone of issuing its first substantive decisions on both patent infringement and validity. Coming around 12 months after the Court opened its doors for business, the decisions bring to fruition the promise of efficient and timely decision making at the UPC (albeit timelines should be kept under review as the Court becomes more popular).
These cases provide some useful guidance on the UPC's approach to key legal issues, though it is likely that they will be the subject of appeal as the Court's practices and procedures continue to bed in.
First substantive decisions
The first decision on the merits was issued by the Düsseldorf Local Division in Kaldewai v Bette (ACT_459767/2023) on 3 July 2024 – the Court found Kaldewai's patent as granted invalid but upheld the validity of an auxiliary request, and found the patent infringed by Bette's products. The Court therefore granted Kaldewai a permanent injunction as well as provisional damages and other remedies. We discuss the Kaldewai case in more detail here.
A few days later, the Paris Local Division issued its decision in Dexcom v Abbott (ORD_37297/2024), finding Dexcom's patent (both in granted form and in the form of two auxiliary requests) invalid. It therefore did not make a finding in relation to alleged infringement by Abbott. We discuss this case in more detail here.
Later in July, the first substantive decisions of the Central Division were issued:
Sanofi & Regeneron v Amgen, Inc, UPC_1/2023 & UPC_14/2023
In the UPC's first decision resulting from a revocation action, the Munich Central Division held that Amgen's patent was invalid and ordered it be revoked in its entirety (highlighting the potential risk for those classic European patents that are not opted out of the UPC during its transitional period). The action is one of a number between Amgen and Sanofi/Regeneron.
Sanofi had filed its revocation action against Amgen's EP 3 666 797 patent at the Munich Central Division on day one of the UPC, 1 June 2023. In response to an infringement action filed by Amgen at the Munich Local Division and based on the same patent, Regeneron filed a counterclaim at the Munich Local Division for revocation. With the parties' agreement, this counterclaim was transferred to the Central Division, which ordered that the revocation action and the counterclaim be dealt with jointly.
The hearing was held jointly on 4 June 2024, with two separate decisions published (UPC_1/2023 & UPC_14/2023), which are identical in content.
Sanofi/Regeneron argued that the Patent added subject matter, was not sufficiently disclosed, was not new, and did not involve an inventive step. The novelty attack depended upon a challenge to the priority date for the Patent. In considering this, the Court applied the teaching set out in G2/98 (EPO's Enlarged Board of Appeal 31 May 2021) i.e., can the skilled person directly and unambiguously derive the subject matter of the claim using common general knowledge from the previous application as a whole? It went on to reject the novelty challenge.
When considering inventive step, after determining a realistic starting point (having a similar underlying problem as the claimed solution), the Court considered whether it would be obvious for the skilled person to arrive at the claimed solution. The Court noted that "a person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used with the aid of the description and the drawings". A claimed solution would be obvious "if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art". However, it could be relevant whether the skilled person would have expected any particular difficulties in taking any next steps. The Court also indicated that a technical effect achieved by the claimed solution compared to the prior art may be an indication of an inventive step, and emphasised that hindsight analysis must be avoided.
The Court ultimately held that the skilled person would arrive at the claimed invention in an obvious way without inventive skill when starting from a certain piece of prior art. This also applied to each of Amgen's 17 auxiliary requests. The Patent was therefore revoked in its entirety, and Amgen ordered to pay Sanofi/Regeneron's costs to an amount of EUR1,375,000.
Meril v Edwards Lifesciences corporation, UPC_CFI_255/2023 & UPC_CFI_15/2023
Meanwhile, the Paris Central Division has found Edwards' heart valve patent valid on the basis of an auxiliary request in a case which saw a revocation action and two counterclaims for revocation, heard jointly.
Meril Italy had filed a revocation action at the Paris Central Division against Edwards' EP 3 646 825 patent, alleging that the Patent added subject matter, was not sufficiently disclosed, lacked novelty and lacked an inventive step. Separately, two other Meril entities had filed counterclaims for revocation in an infringement action commenced by Edwards before the Munich Local Division, on similar grounds.
The Munich Local Division had referred the counterclaims to the Paris Central Division to hear the cases jointly with the standalone revocation action. A single hearing of both the revocation action and the revocation counterclaims was held on 7 June 2024. The infringement action will be heard by the Munich Local Division in September 2024.
Edwards had filed three applications to amend; the first at the time of filing its statement of defence and two subsequently. The Court considered that the first application to amend was admissible, noting that "while a complete lack of explanation in an amendment request can render it inadmissible, an insufficient explanation does not necessarily have the same effect". Although the number of amendments was extremely high (9 conditional amendments and 84 auxiliary requests), this was not an "unreasonable number". The third application was also admissible (comprising one unconditional amendment and six auxiliary requests).
However, the Court considered that the Patent and first auxiliary request (Auxiliary Request I) contained an unallowable intermediate generalisation and therefore added subject matter.
The other admissible auxiliary request (Auxiliary Request II) did not have the same added matter issue and the Court considered that the claims were novel and inventive. When considering inventive step, the Court first considered the technical effect achieved by the claim, and then considered whether the person skilled in the art would have arrived at the technical solution claimed using their technical knowledge and carrying out simple operations. The Court did not use the problem-solution approach, noting that even though the EPO and some national jurisdictions assess inventive step in this way, it is not explicitly provided for in the EPC and is therefore not mandatory. However, applying the problem-solution approach to the present case would not, in the Court's view, have resulted in a different outcome. Accordingly, the Patent was maintained as amended by Auxiliary Request II.
Interestingly in terms of costs, these were split as to be borne 60% by the Meril parties and 40% by Edwards (despite Edwards having maintained the Patent, albeit in amended form).
Number (and locations) of cases
On 31 July 2024, the UPC issued its most recent caseload update. As at that date, there had been 447 cases brought before the UPC, including 170 infringement actions and 41 standalone revocation actions (as well as 192 counterclaims for revocation).
The Munich Local Division continues to lead the way with 67 infringement actions, with the Paris Central Division still receiving the bulk of revocation actions (36). The Milan Central Division officially opened its doors on 27 June 2024, and has received its first revocation action.
We have reported previously on predictions that English would soon be the main choice for UPC proceedings. The latest update confirms this: 51% of cases have adopted English as the language of proceedings, with 43% adopting German (and 2% each for French, Italian and Dutch).
In the context of language of proceedings, it is worth noting the Düsseldorf Local Division's decision in Ona Patents v Apple (UPC_CFI_99/2024) where Ona Patents had issued proceedings in German, and Apple had applied to change this to English. The Court refused Apple's application. English was the language commonly used in the technology, the corporate language of Apple and the language of the Patent but, balancing the respective interests of the parties, Ona would suffer a significant drawback as a result of the change of language, whilst Apple would experience a slight advantage. Ona had relevant reasons to file the action in German: the language skills of the person running the proceedings, the location of the registered offices of two of the defendants, and the existence of parallel proceedings handled in German.
The Unitary patent dashboard indicates that, as at 28 July 2024, some 13,736 Unitary Patents had been registered. Johnson & Johnson (followed by Siemens, Samsung, Qualcomm and LM Ericsson) continue to lead the way as applicants.
Meanwhile, in what will be welcome news to beleaguered users of the UPC's case management system (CMS), the UPC has entered into a cooperation agreement with the European Patent Office regarding IT related matters, with the first project being to develop a new CMS.
Preliminary injunctions and scope of order
Abbott Diabetes Care Inc v Sibio Technology Ltd, UPC_CFI_130/2024 & UPC_CFI_131/2024
In two parallel cases, Abbott Diabetes Care Inc brought proceedings against Sibio Technologies Ltd before the Hague Local Division, based on two of its European patents.
In the first case (UPC_CFI_130/2024), the Court granted Abbott a preliminary injunction, delivery up of Sibio's device and a EUR10,000 penalty for each violation of the order. The claim was based on Abbott's European Patent EP 2 713 879, which is in force in Germany, France, The Netherlands, Ireland and the UK.
Sibio did not rely on arguments it had set out in the protective letter it had filed, nor did it contest validity or infringment. Instead, it argued that the application for provisional measures was unnecessary as it had offered a cease-and-desist declaration including an undertaking to remove the allegedly infringing device from Germany, France and The Netherlands. Sibio also requested that Abbott pay its fees as Abbott had not sent a warning letter ahead of taking action.
However, despite Sibio's undertaking, Abbott was still able to purchase Sibio's device and have it delivered in both Germany and The Netherlands. The Court therefore did not place much value on Sibio's undertaking, and also noted that, had it indeed left the relevant markets, it would have had no legitimate need to oppose a preliminary injunction. Sibio also argued Abbott had known about its product since October 2023 and should have made its request for provisional measures sooner. The Court did not find this persuasive but this should be compared to the Hamburg Local Division's decision in Ballinno v Uefa (UPC_CFI_151/2024) where a period of almost three months after knowledge of the alleged infringement, without significant efforts to clarify the possible infringement, was found not to amount to the necessary urgency.
Interestingly, the Court's order extended to Ireland, even though Ireland has not yet ratified the UPC Agreement (news on Ireland's ratification is awaited). Sibio did not challenge Ireland's inclusion, but this raises a number of interesting questions around the impact of the ratification process. The Court did not comment on its competence to extend orders to the UK but noted that it considered Abbott's application for provisional measures to not relate to the UK since the UK is no longer a contracting UPC member state.
In the second case (UPC_CFI_131/2024), the Hague Local Division refused Abbott's application for provisional measures based on EP 3831283 (a European divisional filing). Sibio argued that the Patent was not infringed and that it was likely invalid owing to added matter, lack of novelty and lack of inventive step.
When considering the added matter attack, the Court applied the EPO's "gold standard" test for added matter – i.e., is the subject matter directly and unambiguously derivable from the application as originally filed? The Court noted that, although it is permissible to base new claims for a divisional application partly or entirely on the original description or drawings and that literal support is not required, the original application cannot be treated as a 'reservoir of features'. As a result, the Court held that claim 1 of the Patent appeared to be the result of an unallowable intermediate generalisation and that, on the balance of probabilities, the Patent would more likely than not be held to be invalid. The Court declined to consider the novelty and inventive step arguments.
In this case, the Court indicated that there was no need to decide on its competence to grant an order extending to Ireland, as here Abbott indicated that it did not mean to include Ireland in its request.
Security for costs and suspensive effect
ICPillar LLC v ARM Ltd and others, UPC_COA_301/2024
In April 2024, ARM filed an application requesting the Paris Local Division to order ICPillar provide adequate security for legal costs and other expenses incurred by ARM. The Paris Local Division allowed the application but ICPillar appealed and requested that the order be set aside. ICPillar also requested that the order to provide security for costs be given suspensive effect, or its appeal be expedited.
The Court of Appeal rejected ICPillar's application. First, appealed orders should only be given suspensive effect under exceptional circumstances and there were no such exceptional circumstances in this case. ICPillar's interest in maintaining the status quo until the appeal decision did not sufficiently outweigh ARM's interest in enforcing the order without delay.
On expedition, the Court noted that it must balance the interests of both parties, and due account must be given to principles of due process. The circumstances were not such to be of an urgent nature that ICPillar's outweighed Arm's interests and the principles of due process.