Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 21 June 2024 - is below:

UPC

UPC hands down contrasting preliminary injunction decisions in parallel cases, one of which covers Ireland.

On 19 June 2024, the Local Division of the Hague handed down two preliminary injunction decisions in parallel cases concerning the same parties. Abbott Diabetes Care Inc. (Abbott) filed both applications for preliminary injunctions on 20 March 2024 against Sibio Technology Limited (Sibio), in relation to infringement of two of its patents: (i) EP 2 713 879 (EP 879), and (ii) EP 3 831 283 (EP 283). In relation to EP 879 (the EP 879 application), the Court granted a preliminary injunction, whereas in relation to EP 283 (the EP 283 application), the Court denied Abbott’s application. Abbott withdrew the opt-outs of both patents from the UPC on 14 March 2024. EP 879 and EP 283 protect a series of Abbott’s continuous glucose monitoring (CGM) devices. At the end of 2023, Sibio entered the European market with its own CGM device, GS1. A protective letter providing non-infringement arguments in relation to EP 879 and the GS1 device had been filed by a Chinese company in the same group as Sibio in September 2023.

In its submissions in the EP 879 application, Abbott stated that EP 879 was valid and in force in the Contracting Member States (CMS) of Germany, France, the Netherlands and also Ireland. Abbott further noted that EP 879 is also in force in the UK. The Court appears to have understood Abbott to have been requesting relief in Ireland, a CMS (albeit not ratified), but not the UK (not a CMS). Notably, Sibio did not challenge the competence of the Court with respect to Ireland (in contrast to the parallel case). The Court therefore concluded, according to Art. 31 UPCA and Art. 26, 35 and 71, 71a and 71b of Brussels Regulation Recast, that it was competent to hear the case. In the EP 283 application, Abbott contended that EP 283 is in force in the CMS states of Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands and Sweden. Conversely in this case, Sibio argued that the Court is not competent for Ireland. Abbott then indicated it did not mean to include Ireland, and the Court therefore did not need to decide on its competence with regard to Ireland in the EP 283 application.

In its Objection to the EP 879 application, Sibio did not rely on the non-infringement defence set out in the protective letter or challenge the validity of EP 879. Instead, Sibio provided a unilateral cease-and-desist declaration, which included undertakings concerning the withdrawal of the GS1 device from the market in Germany, France and the Netherlands. Further, Sibio did not dispute the urgency of the application or contest Abbot’s position that it had acted promptly (despite the Court considering that Abbott’s application was inexcusably late). Abbott did not accept the cease-and-desist declaration and demonstrated that in fact, the GS1 device was still available to purchase in the relevant Contracting Member States. Taking these factors into account, the Court concluded that Abbott’s interests outweighed the interests of Sibio and all conditions set out in r. 211 RoP were met regarding a preliminary injunction. The order sought by Abbott was partly allowed, and as the losing party, Sibio was ordered bear the costs of the application. The absence of a warning letter was not sufficient grounds for the Court to rule otherwise, particularly given the proceedings were allegedly anticipated by Sibio in view of the protective letter filed.

In its Objection to the EP 283 application, Sibio took a significantly different approach. Sibio disputed that EP 283 was infringed and asserted that EP 283 was invalid, citing added matter, lack of novelty and inventive step arguments. Further, Sibio contended that the EP 283 application was brought with unreasonable delay and that Abbott lacked sufficient interest in the application. The Court noted that the sufficient degree of certainty that the applicant is entitled to initiate proceedings and that the patent is infringed will be lacking if the Court considers it on the balance of probabilities to be more likely than not that the patent is invalid. The Court conducted a detailed analysis of validity in relation to added matter, finding that, on the balance of probabilities, it is more likely than not that claim 1 (and further dependent claims) of EP 283 will be held to contain added matter relative to the original application as filed. Notably, the Court applied the long-standing case law of the EPO and therefore the “gold-standard” disclosure test, commenting that both parties had relied on this case law and did not indicate whether – and if so how – the Court should apply a different standard. Having come to this conclusion on added matter, the Court did not consider the other issues raised by Sibio. The application for preliminary measures was denied and Abbott was ordered to bear Sibio's reasonable and proportionate costs.

EPO

TBA considers UPC Court of Appeal case law when dealing with claim interpretation.

On 19 March 2024, the TBA of the EPO made its decision in case number T 0177/22. The patent related to a system for controlling the temperature of hot water. The Opposition (OD) had upheld the patent in amended form according to the patentee’s second auxiliary request (AR 2). The decision of the OD was appealed by both the patentee and the opponent.

One of the arguments raised by the opponent related to sufficiency of disclosure under Art.100(b) EPC. In particular, the opponent alleged that the term “upstream” in the claims of AR 2 did not make it clear as to where in the system a temperature sensor should be installed, since it was possible that the direction of water flow could be reversed.

The TBA rejected this argument, noting that the skilled person would interpret “upstream” to refer to the direction which would be upstream during normal operation of the system. Further, the TBA noted further restrictions elsewhere in the claims which would make it possible for the skilled person to work out where to put the temperature sensor so as to carry out the invention. In support of this finding, the TBA cited case law on the well-known point that a claim feature is to be interpreted not only in the context of the other features in that claim, but also in the context of the description as granted.

Although the point of law is unremarkable, it is noteworthy that among the recent cited case law was UPC_CoA_335/2023, in which the UPC Court of Appeal lifted the preliminary injunction obtained by 10x Genomics against Nanostring (as covered previously in WU 9/2024). The TBA in particular noted the UPC Court of Appeal’s statement that the principles for the interpretation of a patent claim apply equally to the infringement and validity of a European patent, and its reference to the patent claim as the decisive basis for determining the subject-matter and scope of protection for that claim.

This decision marks the first time that the TBA has referred to UPC case law when dealing with claim interpretation.

UPC

Hamburg Local Division orders disclosure of documents relating to transfer of patent.

On 4 June 2024, the Hamburg Local Division gave its decision (UPC_CFI_54/2023) in relation to a disclosure application in the ongoing UPC action between Avago and Tesla.

Tesla applied for an order for Avago to provide certain documents relating to the transfer of the patent-in-suit into Avago’s ownership. Tesla argued that there were doubts as to whether the authorisations for the transfer of the patent were valid, and therefore whether Avago had standing to bring their claim. On the other hand, Avago argued that Tesla were concerned with the internal decision-making of Avago’s management, rather than the admissibility of the transaction.

Judge-Rapporteur Stefan Schilling noted that since Avago was registered as the proprietor in the European Patent Register, there was a rebuttable presumption that Avago was indeed the proprietor of the patent. However, Avago had explicitly referred to the requested documents in the annexes of one of their previous briefs. Further, Avago had admitted that certain of the requested documents were relevant to the question of whether there was appropriate authorisation for the transaction. On balance, the Judge held that this was sufficient grounds to order that the referenced documents should be disclosed.

The Judge therefore ordered Avago to submit of three of the four requested documents for inspection within one week of the order.

DE

Draft Medical Research Act debated at first reading.

In January 2024, the German Federal Ministry of Health published the draft bill for its Medical Research Act. The main focus is on the reform of the law relating to clinical trials for medicinal products, medical devices and in vitro diagnostic devices. The bill also includes some changes to the regulations on drug prices.

Among the proposed changes to clinical trials are:

• Reorganisation of ethics committee procedures, including the establishment of a “Federal Ethics Committee” to oversee particularly urgent or demanding clinical trials.
• Facilitation of decentralised clinical trials by modifying pharmaceutical distribution rules.
• Making it easier for patients to give consent electronically.
• Reform of labelling rules to allow certain investigational products to be labelled exclusively in English.
• Introduction of Standard Contractual Clauses for clinical trial agreements – however, it is not expected that a legal obligation to use these clauses will be introduced.

On 12 June 2024, the bill was debated by the Health Committee of the Bundestag. The resulting changes to the bill have yet to be published but the current draft timeline allows certain provisions to take effect on 1 January 2025.

EPO/UPC

EPO publishes Travaux préparatoires to UP and UPC.

On 7 June 2024, the EPO published an online collection of travaux préparatoires to the UP Regulations and the UPC Agreement. The collection comprises over 250 documents relating to the history of the UPC, in particular the negotiations that shaped the UPC system. The collection contains documents from three distinct periods: (i) the core negotiation phase, from 2007 to 2013 (the focus of the collection); (ii) preparations for launch of the UP and start of operations of the UPC, from 2013 to 2023; and (iii) other texts of relevance that did not enter into force but constitute important sources regarding the origin of many provisions, from 1975 to 2006.

Publication of the travaux préparatoires assists users of the system by informing the legal interpretation of legislative provisions, enhances transparency and provides valuable insights into legislators’ discussions over the years. The EPO also noted that the collection is a tribute to the work of Margot Fröhlinger, who revived the dream of the old Community Patent in 2007 and “with unwavering commitment accompanied the project throughout”.