Welcome to our Life sciences and healthcare insights report, where our global team share their insights on the most important commercial, legal, and regulatory issues facing life sciences and healthcare companies around the...more
4/15/2026
/ Artificial Intelligence ,
Biotechnology ,
China ,
Clinical Trials ,
Compliance ,
Cross-Border ,
Data Protection ,
Due Diligence ,
Environmental Social & Governance (ESG) ,
European Commission ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Agencies ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Unified Patent Court
Over the past decade, the European Union has enacted a host of new legislation to protect the environment, promote sustainability, and tackle climate change, including the European Green Deal to new reporting and due...more
4/14/2026
/ Corporate Sustainability Reporting Directive (CSRD) ,
Due Diligence ,
Environmental Policies ,
EU ,
EU Directive ,
European Commission ,
Life Sciences ,
New Legislation ,
Pharmaceutical Industry ,
Popular ,
Regulatory Reform ,
Sustainability ,
Wastewater
The UPC has been reshaping European patent litigation since its launch in June 2023. More than 480 patents have now been litigated in the court, and the number of actions is steadily increasing. Initially, major...more
4/14/2026
/ Appeals ,
Claim Construction ,
EU ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prior Art ,
Unified Patent Court
On February 12, 2026, the Düsseldorf Local Division (LD Düsseldorf) of the Unified Patent Court (UPC) granted a preliminary injunction against a number of group companies, including entities based in the Cayman Islands and...more
4/1/2026
/ Corporate Counsel ,
Enforcement Actions ,
Holding Companies ,
Intellectual Property Protection ,
Jurisdiction ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preliminary Injunctions ,
Unified Patent Court
Emboline v. AorticLab—UPC_CFI_628/2024, judgment of January 13, 2026 -
The UPC Munich Local Division (the LD Munich) has dismissed an infringement action relating to a medical device. It confirmed that a device can still...more
3/24/2026
/ Counterclaims ,
Healthcare ,
Injunctions ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Strategies ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Revocation ,
Unified Patent Court
The European Commission (Commission) published a proposal for a new Digital Networks Act (DNA), and a revised Cybersecurity Act, aiming to reshape the EU regulatory framework for digital connectivity, telecoms, and...more
2/6/2026
/ Competition ,
Cybersecurity ,
EU ,
European Commission ,
Information and Communication Technology (ICT) ,
Infrastructure ,
New Legislation ,
Proposed Legislation ,
Regulatory Reform ,
Satellites ,
Spectrum ,
State Aid ,
Supply Chain ,
Telecommunications
On January 20 2026, the European Commission announced its new cybersecurity package which aims to strengthen the EU’s cybersecurity resilience in response to an evolving threat landscape....more
2/5/2026
/ Certification Requirements ,
Compliance ,
Cybersecurity ,
EU ,
European Commission ,
Information and Communication Technology (ICT) ,
New Legislation ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Reporting Requirements ,
Risk Management ,
Supply Chain ,
Technology Sector
On November 19 2025, the European Commission presented the Digital Omnibus Package (the Package).
The Package contains the following three proposals for regulations on: (i) the simplification of the digital acquis...more
12/23/2025
/ AI Act ,
Artificial Intelligence ,
Cloud Computing ,
Digital Platforms ,
Digital Wallets ,
EU ,
European Commission ,
New Legislation ,
New Regulations ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform
The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device manufacturer and its Dutch subsidiary over the infringement of a patent for...more
12/8/2025
/ Enforcement Actions ,
EU ,
Healthcare ,
Infringement ,
Intellectual Property Protection ,
International Litigation ,
Jurisdiction ,
Medical Devices ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preliminary Injunctions ,
Regulatory Requirements ,
Unified Patent Court
Over the past decade, the European Union has enacted a host of new legislation to protect the environment, promote sustainability and tackle climate change, ranging from the European Green Deal to new reporting and due...more
11/20/2025
/ Corporate Sustainability Reporting Directive (CSRD) ,
Due Diligence ,
Environmental Policies ,
EU ,
European Commission ,
Extended Producer Responsibility (EPR) ,
New Legislation ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Reporting Requirements ,
Risk Assessment ,
Sustainability ,
Wastewater
On October 20 2025, the European Data Protection Board (EDPB) announced that it had adopted two opinions on the European Commission’s draft implementing decisions which propose to extend the validity of the UK adequacy...more
11/7/2025
/ Data Privacy ,
Data Protection ,
European Commission ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Law Enforcement ,
New Legislation ,
Personal Data ,
Privacy Laws ,
UK ,
UK GDPR
The UPC Court of Appeal (the CoA) has issued a significant judgment in Koninklijke Philips v. Belkin clarifying the scope of directors’ liability. The court also confirmed the availability of corrective measures such as...more
On 10 September 2025, the Belgian Competition Authority (the BCA) published a communication clarifying the conditions under which pharmaceutical companies may exchange information specifically in the context of reimbursement...more
Welcome to our inaugural Life sciences and healthcare insights report, where our global team share their insights on the most important commercial, legal, and regulatory issues facing life sciences and healthcare companies...more
9/18/2025
/ Artificial Intelligence ,
Biologics ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
In a landmark ruling the UPC Court of Appeal has for the first time in the pharmaceutical sector granted a provisional injunction for imminent patent infringement, clarifying that completing administrative procedures for...more
On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy).
...more
7/17/2025
/ Biotechnology ,
Clinical Trials ,
EU ,
Healthcare ,
Innovation ,
Investment ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Research and Development
On April 9 2025, the European Commission published the AI Continent Action Plan (the Action Plan), which outlines the EU’s strategy to enhance innovation, competitiveness and regulatory compliance in artificial intelligence...more
On March 24 2025, the European Commission (EC) adopted the final draft Delegated Regulation setting out Regulatory Technical Standards (RTS) for subcontracting ICT services supporting critical or important functions under the...more
4/16/2025
/ Cybersecurity ,
Data Protection ,
Digital Operational Resilience Act (DORA) ,
EU ,
European Commission ,
Financial Institutions ,
Information Technology ,
Regulatory Requirements ,
Risk Management ,
Subcontractors ,
Third-Party Service Provider
On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more
On February 11 2025, the European Commission (the EU Commission) released its 2025 work programme in which it published its AI and privacy initiatives for 2025 (the Work Programme) in order to boost competitiveness, enhance...more
2/27/2025
/ AI Act ,
Artificial Intelligence ,
Data Privacy ,
Data Protection ,
EU ,
European Commission ,
General Data Protection Regulation (GDPR) ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector
Companies deploying high-risk artificial intelligence (AI) systems must prepare to conduct Fundamental Rights Impact Assessment (FRIA) by 2 August 2026. In this edition of our “Zooming in on AI” series we explain what this...more
When the AI Act was first proposed by the European Commission in 2021, the concept of “general purpose AI” was nowhere to be found. These rules were introduced during the legislative process to align the AI Act to the...more
Highlight of the week - On 21 May 2024, the Council of the European Union (the Council) issued a press release announcing it had approved the Proposal for a Regulation of the European Parliament and of the Council Laying Down...more
The UPC decides that the defendant’s financial situation and location matter.
On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more
12/20/2023
/ Enforcement Actions ,
EU ,
Ex Parte ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Fees & Costs ,
Patent Litigation ,
Patents ,
Revocation ,
UK ,
Unified Patent Court
The European Parliament (the Parliament) and the Council of the European Union (the Council) reached a compromise on the Artificial Intelligence Act (the AI Act) on 8 December 2023. Although the final text is not yet...more
12/18/2023
/ Artificial Intelligence ,
Enforcement Actions ,
EU ,
European Commission ,
European Parliament ,
Intellectual Property Protection ,
Legislative Agendas ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management ,
Technology Sector