Pulse 01.2025 – an update from Taylor Wessing

Tech Predictions 2025: what’s in store for the tech industry in the new year 

• Economic downturn, political uncertainty, geopolitical risks: The economic and political conditions in 2025 will be tricky but there is no reason to be pessimistic in the tech world
• Why this is the case and which legal innovations companies should keep in mind
• We analyse five areas: Artificial Intelligence, Data Centre, M&A, Data Economy and Energy 

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Data protection authorities focus on data transfers to China 

• With increasing digitalisation, global data transfers and their legal framework are becoming more and more important
• A current example is the filing of complaints by the data protection organisation “noyb” (None of Your Business), founded by Max Schrems, against companies that transfer data to China
• The article sheds light on the legal background and possible consequences for companies 

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Bindl v Commission – The EGC on international data transfers and non-material damages 

• The case deals with the processing of personal data by EU institutions and raises important questions about the transfer of such data to third countries
• The decision reaffirms the fundamental principles of data protection and data security within the EU 

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The „authorised representative“ under the EU AI Act 

• The obligation requires non-EU companies operating in the EU to set up an easily accessible contact point for European stakeholders
• Following this established pattern, the new European Artificial Intelligence Act (AI Act) also stipulates that certain operators based outside the EU must appoint an "authorised representative" 

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AI liability – who is accountable when artificial intelligence malfunctions? 

• It seems inevitable that we will see AI-related disputes in the coming years and that the courts will have to grapple with the application of traditional legal concepts to new technologies
• We take a brief look at the unique characteristics of AI that raise new liability issues, as well as the current and evolving regimes that may be available to compensate users for harm caused by the failure of AI systems 

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Data protection and AI: consequences of EDPB Opinion 28/2024 for companies 

• On 18 December 2024, the European Data Protection Board (EDPB) published its Opinion 28/2024, which addresses some of the key data protection issues relating to the development and use of AI models
• The opinion provides guidelines on how companies can implement data protection-compliant processes without violating the rights of data subjects
• It reflects the view of the data protection authorities organised in the EDPB on the main topics of anonymity of AI models, legitimate interest as a legal basis and consequences of unlawful data processing 

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Digital legislation in a page 

• EU Artificial Intelligence Act

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• EU Digital Services Act 

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• EU Data Act 

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• EU Data Governance Act 

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• EU Cyber Resilience Act 

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• EU NIS2 Directive 

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• EU Machinery Regulation

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• EU Gigabit Infrastructure Act

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• EU European Health Data Space proposal

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Podcast

AI and data protection – where are we now? 

• What happened in this area in 2024? Which authorities and organisations have commented on what? And what will companies be facing in 2025? 
• Small spoiler: AI training for employees to ensure “AI literacy” will be mandatory from February 

To the Podcast [German only]

Webinar

Digital Devices Discussions | Session #3: Data protection and data exploitation for smart machines and gadgets under the new EU Digital Regulations 
27 March 2025 

• As part of the EU’s so-called digital strategy, a wave of new digital regulations is sweeping across companies in the EU
• Whether you manufacture, distribute or provide aftermarket services for smart machines and devices, you need to be prepared for the upcoming paradigm shift while complying with existing regulations such as the GDPR
• In this third edition, we give you an overview of the most important digital regulations that can affect not only your products but also your business activities, and provide you with practical tips on how to best manage the flood of regulations and the work that lies ahead 

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Events

Business in Germany - legal briefing 2025 | Düsseldorf 

• As part of the Asa no Kai, we will deal intensively with the upcoming implementation of the AI regulation with further digital regulations as well as innovations in employment law for European and Japanese companies
• One of the key questions for the new year will be how we can make the most of digital opportunities and successfully navigate through the challenges of the crisis 
  
  

4. Februar 2025 | Düsseldorf 

To registration [German only]

5. Februar 2025 | München 

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Blogs

Artificial intelligence 

• Artificial intelligence (AI) has long been promised as a ground-breaking innovation and it is now here
• Recent advances have highlighted the potential of this exciting technology and made its adoption a business priority 

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Data Centre Expertise

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Global Data Hub 

• Insights and advice on data protection issues 

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Interface

• We shape the law of the digital future - in our tech magazine Interface, international colleagues write on digitalisation topics at the interface of business and law  
  

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Metaverse

• Exciting insights and the latest developments in the context of metaverse, NFTs, web3, cryptocurrencies and blockchain technology 

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Systems Outage: Analysis & Response 

• The global IT outage on 19 July hit companies in various sectors hard and had a significant and lasting financial impact.
• If your company has been affected and you would like to explore the possibility of filing a compensation claim without any upfront financial costs, we will be happy to help you 

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Online content safety

• The UK’s Online Safety Act, the EU’s Digital Services Act and related topics 

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Transformation fund: Federal Ministry of Health specifies requirements for funding as part of the hospital reform 

• The Federal Ministry of Health’s draft bill for a Hospital Transformation Fund Ordinance (“KHTFV”) indicates which specific changes will be financially supported as part of the hospital reform
• Which projects are (not) eligible for funding? What procedure is envisaged?

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Why 2024 was pivotal for SEPs in Europe and what to expect from 2025 

• In 2024, patent holders asserted patents that are essential for the much-discussed mobile communications standards (4G, 5G, WiFi, HEVC, etc.) and also actively developed new application areas for licensing, including, for example, the IoT and smart meter industries
• Patent proprietors have continued to turn to national courts in Europe for the enforcement of patents and are now increasingly including the Unified Patent Court in their considerations
• We summarise the most important developments and court decisions 

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The EU pharmaceutical package: a reform project between progress and open questions  

• The new pharmaceutical strategy for Europe, which was first presented by the European Commission in 2020, aims to make the European pharmaceutical industry fit for the future and competitive
• The aim is to strengthen security of supply, promote research and innovation and improve access to affordable medicines
• The European Commission published its reform proposals on 26 April 2023 in the so-called “EU Medicines Package” - the reform proposals also respond to weaknesses that have become apparent as a result of the COVID-19 pandemic 

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Effects of the new German Medical Research Act on Clinical Trials 

• Studies show a worrying trend: Europe as a pharmaceutical location, and Germany in particular, is becoming increasingly unattractive for conducting clinical trials
• The main reasons for this shift include more favourable regulatory and financial conditions as well as faster patient recruitment in Asia and America 
• With the new Medical Research Act, Germany now wants to take targeted countermeasures to strengthen its competitiveness and make the development and authorisation of medicinal products and medical devices in Germany more attractive 

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Impact of the Data Act on medical and healthcare products  

• The Data Act came into force on 11 January 2024 and is generally applicable from 12 September 2025 - this also applies to the medical device sector 
• As the basis for a data sharing economy in the EU, the Data Act regulates access to and fair use of data 
• However, the new regulations also harbour risks for the affected companies in their role as data owners - in addition to the previously applicable regulation, the Data Act now also applies, which in some cases can lead to overlaps and areas of conflict with existing legislation 

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What will 2025 bring for pharma & biotech patents? 

• Does the Orphan Medicines Regulation grant a subjective civil law right to market exclusivity? What are the criteria for obtaining an SPC for a combination product?
• Process patents in an international context - when is a process patent infringed in Germany/the UPC?
• Competition law: The game of demergers - is it over? 

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The small print has a big impact: The distinction between cosmetics and pharmaceuticals – Administrative Court of Cologne 

• Whether a product is classified as a cosmetic or a medicinal product subject to authorisation is of great importance to the manufacturer
• The Administrative Court of Cologne recently dealt with the question of whether a cream for the care of dry skin and neurodermatitis should be classified as a cosmetic or a medicinal product (judgement of 13/08/2024 - Ref. 7 K 2494/22) 
• The case illustrates which aspects manufacturers must consider when marketing and designing their products to avoid being categorised as medicinal products 

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Game over for the divisional game?  

• The latest decision by the EU Commission has put the spotlight on a patent application strategy that is well known to lawyers in the generics sector, namely the so-called “divisional game”
• So far, the use of this procedure by patent proprietors has mostly been accepted as a sometimes annoying but permissible strategic use of the existing patent system if it concerned a party that was confronted with numerous divisional patents 
• The situation is new in that a competition authority - and not just any competition authority - is now interested in this practice 

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Podcast

The impact of the Unified Patent Court (UPC) on national patent litigation

• Our experts discuss why the German divisions of the UPC are so popular, what steps Ireland needs to take to join the court and how this has impacted patent practice in the UK 

To the Podcast

Webinars

Coffee Break Life Sciences: UPC – First learnings: Which standard applies the UPC for patents in pharma and biotech preliminary injunction cases? 
19. February 2025 

• Our experts look at the lessons learnt from the first 18 months of the Unified Patent Court (UPC)
• They provide an overview of how the UPC organises patent disputes in the pharmaceutical and biotechnology industries, especially in connection with preliminary injunctions 
• They explain the key considerations for patent owners seeking to enforce their rights and for potential defendants trying to navigate the complexities of the new system 

To registration

Digital Devices Discussions | Session #2: How device connectivity brings challenges of Standard-Essential Patents 
27. February 2025 

• When devices use communication standards (such as Wi-Fi and 5G), these standards are based on technologies that are often patented
• Large patent holders have discovered this source of income and demand licence payments, threatening to enforce their patents. 
• We examine the consequences for digital devices and strategies in the tug-of-war over standard-essential patents (SEPs) and FRAND licences 

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Digital Devices Discussions | Session #5: Implementing the EU Data Act: Digital Medical Devices and Health Apps in Focus 
22. May 2025  

• The EU Data Act creates a comprehensive framework for cross-industry data access and sharing, which has significant implications for digital medical devices and health apps
• These technologies increasingly rely on large amounts of sensitive health data
• In this issue, we highlight the key provisions of the EU Data Act that are relevant to the digital health landscape 

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Digital Devices Discussions | Session #6: IP strategies and tools to protect hardware, software, data and know-how of machines & gadgets 
26. June 2025  

• As today’s digital devices become more innovative and intelligent, protecting the underlying intellectual property becomes increasingly difficult
• This issue explores the legal possibilities of patents, copyrights, designs, trade secrets and beyond, and develops strategies to best protect the innovations of machines and devices 

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Coffee Break Life Sciences Start-ups 

• Session #1: Your safe path through the contract jungle: CDAs, MTAs & Co.

To recording

• Session #2: Don’t forget: Early stage IP strategy

To recording

• Session #3: Tips and tricks for your financing round 

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• Session #4: R&D Collaborations 

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• Session #5: Employment Law in a Nutshell

To recording

• Session #6: Consulting Agreements: Dos and Don’ts 

To recording

• Session #7: Clinical trials in the pharmaceutical area: tips and tricks for CTA negotiations 

To recording

• Session #8: Clinical trials in the medical devices area: tips and tricks for CTA negotiations 

To recording

• Session #9: Data Protection for Life Sciences start-ups, particularly in connection with clinical trials 

To recording

• 16. Oktober 2024: Session #10 Think Big – mögliche Exitstrategien

To recording

• 20 November 2024: Session #11 Website, Social Media, Advertising & Co. 

To recording

• 18. Dezember 2024: Session #12 Regulatory Peculiarities: Combination Products and Companion Diagnostics

To recording

Blogs

The Unified Patent Court

• Insights, videos, FAQs and more on all important aspects of UPC 

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Electricity agreement agreed between the EU and Switzerland 

• The electricity agreement has been negotiated by both sides with breaks for around 20 years
• It is now intended to give Switzerland access to the European internal electricity market - to this end, Switzerland is integrating central EU regulations on the internal electricity market into national law 
• What are the key elements of the agreement? What are the advantages of the electricity agreement? What procedural steps are still outstanding? 

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Webinar

The insolvency of the tenant 

• We will point out the signs that are important for the landlord to identify an impending insolvency of the tenant and present suitable landlord measures before and during ongoing insolvency proceedings 

To presentation [German only]

The EU Packaging Regulation is coming 

• On 16 December 2024, the European Council formally approved the draft regulation on packaging and packaging waste (Packaging Regulation), publication in the Official Journal is expected in January 2025 - the regulation will therefore enter into force shortly
• The new Packaging Regulation also does not provide for a centralised register that would make it easier for manufacturers to comply with their reporting obligations - instead, the national registers of each Member State remain in place 
• The Regulation only provides relief for manufacturers who place less than 10 tonnes of packaging on the market in an EU Member State for the first time each year - but it remains to be seen whether this will be implemented by the individual Member States 

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New risks for manufacturers and distributors: the new EU Product Liability Directive 

• The new Product Liability Directive aims to modernise the European product liability regime in order to adapt it to advancing technologies and the globalisation of supply chains
• In addition, obstacles for consumers in asserting claims for damages due to defective products are to be removed 
• We provide an overview of what companies should know about the new Product Liability Directive and how they can prepare themselves to minimise the increasing liability risks 

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Accessibility Improvement Act: what you need to know now! 

• On 28 June 2025, the Barrier-Free Accessibility Improvement Act comes into force, which obliges private economic actors in numerous sectors to design certain products and services to be barrier-free
• From this date, services offered by the companies concerned must also be accessible to people with disabilities without additional difficulties - the aim is to ensure that people with disabilities have the opportunity to participate fully in social life
• An in-depth analysis 

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Webinars

Digital Devices Discussions | Session #1: Your legal ticket to the Union Market 

• The new European General Product Safety Regulation (GPSR) and the German Radio Equipment Act are just a few of many examples that show that European legislators are defining more and more requirements for product conformity
• Without conformity, however, there is no market - manufacturers, importers and distributors must fulfil the continuously adapted conformity requirements 
• The first edition summarises what is and will be new and explains how to mitigate risks related to product compliance, especially in the area of smart devices and gadgets 

To recording

LkSG webinar on the BAFA handout “Standards, audits and certifications” 
13 February 2025  

• Many companies rely on certifications or seals, e.g. to better categorise their suppliers regarding their human rights and environmental compliance 
• Risk-based audits are also part of the standard repertoire of many companies, either as part of the risk analysis or as part of the preventive measures they take 
• We discuss the questions that companies subject to the LkSG should ask themselves when taking these measures and selecting the appropriate providers
• The webinar is also particularly interesting for providers of certifications, seals, automated risk analyses, audits, etc., as the BAFA handout gives them the opportunity to review their methodology against the background of the LkSG 

To registration [German only]

Sustainability policies in purchasing, sales and distribution 
18 February 2025 

• In the second part of the three-part series, following the topic of “Clauses”, we will now look at the policies required by the CSRD, CSDDD, LkSG, EUDR, BattVO and others
• Analyses of the above legal acts and their practical implementation show that stakeholders and shareholders, auditors, contractual partners, certifiers, rating agencies, authorities and auditors, among others, are asking for guidelines and regulations within the company
• Our expert will show you which sources and content are suitable for sustainability policies in purchasing, sales and distribution 

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Digital Devices Discussions | Session #4: Sold! Successful distribution of Gadgets and Smart Machines in Europe - Tricks and Pitfalls 
24 April 2025 

• In this issue, you will learn how to avoid typical pitfalls: From unintentional infringements of competition law - just think of the new Block Exemption Regulation for vertical agreements - to inadvertently manufacturing a product you do not even recognise
• Data protection and data exploitation for smart machines and devices under the new EU digital regulation
• From labelling and modification in the context of product conformity, to solutions for “it was nobody’s fault” situations - effective allocation of responsibilities in the supply and distribution chain 

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Blog

Supply Chain Act  

• Are you affected by the Supply Chain Act?
• What measures do you need to take now? What sanctions can be imposed for violations? 

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Corporate

Webinar

Forum Annual General Meeting 2025 
30  January 2025 

• We invite you to join us and the experts from Computershare in examining the current issues relating to stock corporation and capital market law in connection with the annual general meetings of listed companies 

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What will change in employment law in 2025? 

• There are some legal changes at the turn of the year that employers should be aware of
• We have briefly summarised what we consider to be the most important changes 

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BAG: Holiday pay compensation after seamless consecutive employment bans 

• The Federal Employment Court (BAG) has already dealt with the forfeiture of leave entitlements for long-term sick employees and in the case of consecutive maternity protection periods and parental leave in various decisions
• However, holiday entitlements can also be accrued in the case of seamless consecutive employment bans in the event of pregnancy - if the employment relationship is terminated shortly after the employment bans, the question of the fate of the holiday days also arises here
• In its ruling of 20 August 2024, the BAG dealt with the question of whether holiday entitlement also arises for periods of employment prohibition under maternity protection law 

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Frontiers – immigration update   

• Ein Überblick über die neuesten Entwicklungen im Einwanderungsrecht   

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Work/Life: international employment news update    

• Issue 111   

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Webinars

Protection against bogus self-employment - authorities tighten up checks 

• The raid on a well-known estate agent has shown how important it is to take the issue of bogus self-employment seriously 
• As the Deutsche Rentenversicherung (German statutory pension insurance) has already announced that it will be focussing more on this issue from 2025 using AI, there is now a need for action - there is a risk of high back payments and even criminal prosecution 
• How the authorities proceed, how a corresponding compliance process is set up and how digital tools can support such a process 

To recording [German only]

Special Edition: 10 Pitfalls in German employment law #6 – Changes in German employment law in 2025  

• 2025 will bring some ground-breaking changes to German employment law
• The 4th Bureaucracy Reduction Act brings major changes and various simplifications in the digitalisation of personnel documents such as the digital signature of employment contracts
• Our webinar will give you an overview of the most important legislative changes and current developments 

To recording [German only]

HR Coffee Break 2025: What's new in employment law 2025 

• What should you know for the new year?
• In the first HR Coffee Break 2025, our team will provide an overview of changes to labour law and bring you up to date on the latest developments 

To recording [German only]

10 Pitfalls in German employment law #7 - immigration to Germany 
11 February 2025

• Recruiting and posting foreign nationals to Germany is becoming increasingly important for companies in a globalised economy - the good news is that Germany offers clear guidelines that can be followed
• However, compliance with these guidelines can be complex and requires careful attention to detail 
• From visa-free travel to Germany to residence permits - even small mistakes can lead to fines, delays or failed recruitment procedures 

To registration

Unlocking remote work in Spain: seizing opportunities and overcoming challenges in the EU 
20 February 2025 

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10 Pitfalls in German employment law #8 - Employer of Record 
11 March 2025 

• Many international personnel service companies offer “Employer of Record (EoR)” services
• The EoR hires a person for the client and takes care of training and managing the employment relationship - the person hired actually works under the supervision of the client and is (virtually) integrated into the client’s business
• However, due to the highly regulated legal environment in Germany, there are many legal hurdles for a company to implement the EoR model in a compliant manner 

To registration

HR Coffee Break 2024    

• All sessions from 2024 at a glance  

To overview [German only]

digiANF: How our AI looks behind the words and then facilitates the processing of avoidance and liability claims in insolvency proceedings 

• In the world of insolvency administration and digital avoidance, every clue can be crucial - whether it is a hidden message in an email or subtle changes in tone – it is often the nuances that make the difference
• With the advanced technology of our digiANF software, we overcome the limitations of traditional keyword searches and delve deeper into the world of digital processing of avoidance and liability claims with AI 

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Welcome to the future of processing avoidance and liability claims 

• The processing of avoidance and liability claims is revolutionised by digital avoidance
• With our innovative software based on artificial intelligence, avoidance and liability claims in insolvency proceedings can be uncovered more quickly, precisely and efficiently
• What exactly is behind it? 

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German Court of Appeal: attorneys risk breach of trust claims when representing multiple creditors in insolvency proceedings 

• If a lawyer represents several creditors in insolvency proceedings and favours one creditor over another in the event of a conflict of interest, this may constitute a criminal offence of breach of trust (party betrayal) without being able to invoke a justifiable conflict of duties  

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DORA countdown: The new EU digital operational resilience framework becomes operational 

• After more than four years since it was first announced as part of the European Commission’s Digital Finance Package in September 2020, the EU Digital Operational Resilience Regulation (DORA) is officially applied across the EU single market
• What is DORA, who does it apply to and what are some of the key considerations that affected businesses should be aware of from now on? 

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 Webinar

DORA Regulation for Insurance Companies | 11. Februar 2025

• The Digital Operational Resilience Act (DORA) provides for stricter measures in terms of cyber security, emergency planning and risk management - the new regulations focus on securing IT infrastructures and monitoring IT service providers
• The regulations are aimed at financial institutions such as insurance companies and aim to improve their digital resilience 
• Our country experts will report on the current status of challenges in the implementation of DORA by insurance companies in France, Germany, Portugal, Austria and the UK 

To registration