Legal News

When is a medical device including AI subject to the EU AI Act? Any medical device that is, or incorporates, an AI system as defined by the EU AI Act, and is intended for the EU market, must comply with the Act’s rules. The term ‘ AI system’ is interpreted broadly and can encompass solutions that leverage big data to generate, for example, reasonably accurate predictions of an indication, even if they are not strictly what many would regard as artificial intelligence. As a consequence, many medical devices already available are captured within the Act’s scope... Medical devices and high- or limited-risk AI systems under the EU AI Act Medical devices may fall into high-risk or otherwise limited-risk categories. High-risk devices are subject to a more demanding regulatory framework that, in addition to medical device regulation obligations, requires Notified Body...

Questions & unsatisfactory answers—the European Commission publishes guidance on the importer requirements of the EU Methane Regulation On 19 November 2024, the Commission released ‘ Questions and answers on importer requirements of EU Methane Regulation ( EU) 2024/1787’ (the Methane Q& A). In essence, the Methane Q& A seeks—albeit inadequately—to resolve key issues that have preoccupied the energy sector since Regulation ( EU) 2024/1787 of the European Parliament and of the Council of 13 June 2024 on the reduction of methane emissions in the energy sector and amending Regulation ( EU) 2019/942 (the EU Methane Regulation) took effect on 4 August 2024. The EU Methane Regulation imposes extensive obligations on: operators with gas, oil or coal activities within the EU, and importers placing on the EU market natural gas, oil or coal extracted outside the EU The Methane Q& A...

In September 2024, the UPC delivered its inaugural main action decision on a standard-essential patent ( SEP) in Philips v Belkin ( UPC_ CFI_390/2023). The court confirmed the patent’s validity, found infringement by Belkin, and granted a permanent injunction covering eight countries. Strikingly for an SEP matter, no FRAND defence was run, so the first UPC main action decision tackling FRAND questions is still awaited. Of broader interest in this decision is that the court held......

Kwantum Nederland BV v Kwantum België BVVitra Collections AG, Case C-227/23 What are the practical implications of this case? This judgment carries tangible consequences, as it meaningfully reinforces protection for original works of applied art coming from non‑ EU member states within the framework of harmonised EU copyright law. By preventing Member States from invoking, in their national laws, the material reciprocity test (as set out in the Berne Convention), the Court of Justice further curtails national discretion to secure deeper harmonisation of EU copyright. Accordingly, the Court effectively unlocks for numerous creators based outside the Union the ability to advance claims under EU copyright, even where their works are only traded inside the EU yet stem from countries affording lesser protection, or none. The ruling stands as a precedent for applying international copyright norms within the EU. It may yield more uniform...

In this issue: EU fundamentals Commercial Competition and state aid Data protection and cybersecurity Dispute resolution Free movement, immigration and employment Financial services Energy Environment Insurance and reinsurance IP Life sciences TMT Daily and weekly news alerts New and updated content Trackers EU fundamentals European Parliament and Council agree on 2025 EU annual budget The European Parliament and the Council of the EU have struck a deal on the 2025 EU budget, amounting to €199.4bn in commitments. It is designed to advance political priorities, respond to crises, and keep backing flagship programmes such as Horizon Europe. Funding is distributed across innovation, cohesion, the environment, migration, and security. Formal sign-off is anticipated by November 2024. See: LNB News 18/11/2024 for details and reference here European Commission releases November 2024...

Dish and Sling v AYLO , Case No. UPC- Co A-188/2024 The Co A, in its ruling, upheld the order issued by the Court of First Instance, Local Division Mannheim. In the substantive proceedings, Dish and Sling commenced infringement proceedings against AYLO. The patent at issue concerned a method for presenting rate‑adaptive streams using a media player. AYLO was said to have indirectly infringed the patent in numerous UPC Member States, including Germany, by offering and supplying both the video files made available for streaming and the media players through which those videos are streamed. Invoking Rule 19.1(a) of the UPC Rules of Procedure, AYLO filed a preliminary objection asking that the infringement action be dismissed for lack of UPC jurisdiction. After that objection was rejected, AYLO brought an appeal against the order of the Local Division Mannheim. It argued that the UPC lacked...

In a significant step for AI oversight, the European AI Office has unveiled the inaugural draft of its General- Purpose AI Code of Practice (the Draft Code). Serving as a linchpin of the EU’s approach to building a sturdy regulatory architecture for AI, it steers providers towards compliance, accountability, and wider societal value. The Draft Code will be scrutinised by close to 1,000 stakeholders and refined through multiple consultation rounds, with the definitive text slated for publication in May 2025. Codes of practice and the EU AI Act The EU AI Act’s codes of practice, set out in Article 56, are not legally binding. Nevertheless, following these codes affords a ‘presumption of conformity’ with the Act’s duties for providers of general-purpose AI models until formal standards are in place. Thus, although participation is voluntary, alignment with the codes can function as proof of meeting...

The adaptability of general-purpose AI makes stringent AUPs essential to curb misuse. Without these rules, providers and users may unwittingly breach legal and ethical norms—particularly the EU AI Act—exposing themselves to substantial liabilities, regulatory duties and penalties. Defining AUPs Acceptable use policies are contractual terms that set out allowed and forbidden uses of technology. In the realm of foundation models, they delineate what users may and may not do with AI systems, aiming to prevent harmful or unlawful applications. By baking these limits into terms of service or model licences, developers impose binding obligations on users, thereby extending their control over how their technologies are used. The necessity of AUPs for AI systems The value of AUPs is highlighted by findings from Stanford University’s Centre for Research on Foundation Models. Research by Kevin Klyman observes that foundation model developers are increasingly proactive in adopting AUPs to prevent...

The European Commission stated that Facebook’s owner exploited its power in social media to push Marketplace adverts on users, unlawfully linking the two products in breach of EU competition rules. The Commission said Facebook’s parent company had abused its dominance by doing so. The regulator further alleged the tech giant set unfair terms for other classified advertising firms wishing to market their services on Facebook, granting the company access to data from those rivals’ adverts to strengthen its own Marketplace proposition. Margrethe Vestager, Executive Vice- President of the Commission, said the practice breaches EU antitrust law and that Meta must now cease this behaviour. According to the Commission, Meta coupled its online classified adverts service, Facebook Marketplace, with its personal social network, Facebook, while imposing inequitable trading conditions on competing online classified ads providers......

General Court backs Glenmark over COPD inhaler trade mark The General Court has backed the UK based Glenmark Pharmaceuticals Europe Ltd in its successful opposition to the trade mark owned by Boehringer Ingelheim Pharma Gmb H & Co. KG concerning an inhaler for chronic obstructive pulmonary disease, a disorder that leads to breathing difficulties. According to the judgment, the German company’s sign is composed solely of elements required to achieve a technical outcome. As a result, it cannot function as a valid trade mark under the EU’s intellectual property framework, the court noted. An earlier European Union Intellectual Property Office......

Nuctech’s five pleas Nuctech advanced five pleas in its application to set aside the Commission’s decision. The General Court found three inadmissible because they were not sufficiently substantiated: that the Commission violated Nuctech’s right to the inviolability of business premises and its right to privacy; that the decision was arbitrary owing to inadequate evidence; and that Nuctech’s rights of defence were breached. The remaining two were examined on their merits: first, that the Commission breached public international law by requiring Nuctech to supply documents stored on servers in China; and, secondly, that compliance with the decision would inadvertently cause Nuctech to infringe Chinese law... Commission has power to request information located outside the EU In addressing the first plea—alleging a breach of public international law arising from a request for documents held in China—the Court noted it is commonplace for the Commission to issue an...

The General Court determined that appellate officials at the European Union Intellectual Property Office ( EUIPO) properly rejected the State Border Guard Service of Ukraine’s bid to register the slogan, concluding it is merely a political statement expressing solidarity with Ukraine during the Russian invasion. The judgment explains that the phrase has been used heavily in a non-commercial setting tied to Russian aggression and, for the relevant public, will be closely and inevitably linked to that context. In view of the breadth of media coverage, the court said, the wording will be associated with a recent historical moment, one well known to the average EU consumer. Consequently, buyers will not see the sign as indicating commercial origin or as pointing to any particular brand, company, or organisation; they will perceive it only as a political message. The State Border Guard Service of...

In this issue: Commercial Competition and state aid Data protection and cybersecurity Financial services Environment Insurance and reinsurance IP Life sciences Regulatory Restructuring and insolvency TMT International Trade Daily and weekly news alerts New and updated content Commercial Temu’s practices found to breach EU consumer laws The European Commission has informed Temu that a number of its practices breach EU consumer law and has instructed the platform to bring them into line. A co-ordinated investigation by the Consumer Protection Cooperation ( CPC) Network, the Commission and national authorities concluded that Temu misled shoppers with bogus discounts, pushed customers into purchases by falsely claiming limited stock and looming deadlines, and provided incomplete or inaccurate details about consumers’ rights on returns and refunds. Investigators also reported that users were forced to play a ‘spin the...

TR v Land Hessen ECLI- EU- C-2024-785 What are the practical implications of this case? This judgment spotlights that enforcement by data protection regulators under the EU’s General Data Protection Regulation, Regulation ( EU) 2016/679 (the EU GDPR), is inherently discretionary, stressing that remedial measures, including administrative fines, do not follow a breach as a matter of course. Rather, regulators must determine if steps are suitable, necessary and proportionate in light of the particular context. For practitioners, it offers vital steer when counselling clients who may face EU GDPR probes or enforcement by supervisory bodies. It also illustrates why organisations should mount strong breach responses, with prompt remediation and open engagement with regulators. Evidencing accountability and taking initiative can materially shape a regulator’s choice not to levy sanctions. The ruling likewise highlights the importance of internal processes and training to reduce the risk of...

After a series of high-profile probes, several US technology firms have halted the training of generative AI systems across the 27 EU Member States in 2024 throughout the bloc. Supervisory authorities fear such training may breach the EU GDPR, as generative AI can ingest immense volumes of personal data without users’ consent or an appropriate legal basis. Building these models depends on sweeping up data from the public internet, spanning personal, non-personal and mixed datasets, much of it scraped from publicly accessible sources, including social media platforms, often at scale. This approach has triggered knotty debates about how data protection rules should be interpreted and enforced. How can AI providers develop generative models while fully honouring GDPR principles such as lawfulness, transparency and fairness, purpose limitation, data minimisation, storage limitation, accuracy, security and accountability? Authors and creators also face the pressing concern of whether these...

On 7 October 2024, following a public consultation, the EDPB adopted the final version of ‘ Guidelines 2/2023 on the technical scope of Article 5(3) of the e Privacy Directive’—often referred to as the ‘cookie rule’ (the Guidelines). The authors previously reviewed the first draft in December 2023 (see News Analysis: EU— New EDPB guidelines on the scope of the ‘cookie rule’). Only limited differences separate that draft from the endorsed text. The EDPB still pursues an extremely expansive interpretation of the cookie rule, with most amendments simply providing clarification. This piece outlines the substance of the Guidelines and offers brief observations on their practical implications. Background It has long been accepted that conventional internet cookies engage the cookie rule. With newer tracking approaches—such as pixels, URL tracking and Java Script code—emerging, the EDPB sought to dispel potential ambiguities. The Guidelines...

The European Union’s executive body intends to reduce the administrative burden by drafting a single, wide‑ranging law that ‘draws from numerous dossiers to curb bureaucracy, to lighten reporting obligations’, the Commission President told assembled journalists during a press conference. Von der Leyen’s statement followed a meeting of EU heads of state and government held on 8 November 2024 in Budapest, where they......

The European Commission, the EU’s executive arm, announced that the bloc will cooperate with global partners at the COP29 conference in Azerbaijan from 11–22 November 2024 to push forward actions keeping the temperature increase as near as possible to 1.5 degrees Celsius. It stressed that its chief priority at the meeting is agreeing a new collective quantified target for climate finance. The Paris Agreement, a worldwide pact concluded in 2015, commits countries to hold warming well below 2 degrees Celsius above pre-industrial levels, and to strive for 1.5 degrees Celsius. The Commission added that parties to the Paris Agreement are expected to bring international financial flows into line with climate objectives, unlocking investment by settling on a new collective quantified goal under Paris Agreement to unlock investments......

In this issue: Competition and state aid Data protection and cybersecurity Financial services Energy Environment Insurance and reinsurance IP Life sciences Regulatory TMT Lex Talk®EU Law: a Lexis®Nexis community Daily and weekly news alerts New and updated content Competition and state aid The long journey of parity clauses and their antitrust implications ( Booking.com and Booking.com ( Deutschland)) In its judgment, the Court of Justice carefully considered two issues sent by the District Court of Amsterdam concerning how Article 101 TFEU should be construed for guidance. First, it asked whether broad and limited parity provisions amount to an ancillary restraint for the purposes of Article 101(1) TFEU in practice; secondly, it queried how to delineate the relevant market precisely where dealings are facilitated by an Online Travel Agency ( OTA). The Court of...

Booking.com and Booking.com ( Deutschland) Case C-264/23 What are the practical implications of this case? The Court of Justice judgment carries particular substantive weight for online platforms. It provides unambiguous direction that, in the Court’s assessment, neither wide nor narrow parity clauses fulfil the criteria of an ancillary restraint, as they are not objectively required for carrying out the principal operation. Consequently, such provisions cannot be treated as collateral to the core service. In this matter, the principal operation is the supply of online hotel reservation services by platforms such as Booking.com. Although, in specific instances and depending on the precise business model, advancing an ancillary-restraint justification may not be entirely out of the question, the obstacles to doing so are exceptionally high, and the evidential burden is significant. For Booking.com itself, the ruling has limited...