Innovative Insights: Legal Updates in the Life Sciences
ISSUES AND UPDATES
Trade Secret Litigation Trends in Life Sciences
Trade secret litigation has risen sharply in recent years, driven by increased employee mobility, complex collaboration agreements, and heightened competition in the health care and life sciences industries. A deep understanding of trade secret law can help sophisticated companies manage risk and safeguard valuable assets. Further, trade secret litigation presents health care and life sciences companies with opportunities in the form of significant remedies available to aggrieved parties, including substantial monetary damages and patent reassignment. Jones Day has significant experience handling complex trade secret matters, in particular in the health care and life sciences space, and can offer practical guidance for clients seeking to protect their valuable proprietary information.
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Rising Scrutiny of Employer Health Plan Administration: ERISA Fiduciary Litigation, Federal Transparency Initiatives, State Enforcement, and Compliance Considerations
As federal and state governments continue to prioritize drug pricing reform, employers across the nation face a rapidly evolving landscape of legal and regulatory scrutiny regarding the management of their health plans. A convergence of class action ERISA litigation, inquiries from a coalition of fourteen states, and increased federal emphasis on health care price transparency has created new compliance challenges and potential areas of risk for plan fiduciaries. Ongoing developments shed light on the implications for employers and compliance considerations for their health plans as related to health care and prescription drug management.
The Proposed European Biotech Act, 100 Days On
On December 16, 2025, the European Commission published a proposal for a European Biotech Act, a central pillar of the Commission's broader strategy to boost EU biotechnology competitiveness. Nearly 100 days later, the EU's data protection authorities adopted a joint opinion on the mentioned proposal and the FAST-EU pilot program for accelerated clinical trial authorizations was also launched, bringing the proposal's practical implications into sharper focus. The proposed Biotech Act aims to create an enabling environment for health biotechnology by reducing clinical trial approval timelines, harmonizing data protection rules for multinational trials, introducing regulatory sandboxes for innovative trial approaches, and establishing a strategic projects framework to strengthen the EU's biomanufacturing capacity. The proposed Biotech Act continues to progress through the EU legislative process and is anticipated to significantly impact clinical trial sponsors and the life sciences sector at large.
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EXECUTIVE ORDERS AND POLICY UPDATES
In the end of 2025 and the first quarter of 2026, the Trump administration and federal agencies have released a number of executive orders and other regulatory actions with potential impact for the life sciences industry. Some notable policy activities cover drug pricing and artificial intelligence strategy, while other actions remain the subject of ongoing litigation.
RELEVANT RESOURCES
Shareholder Proposal Litigation Increases Following the SEC's Revised Rule 14a-8 Process
Unintended Consequences: GAO Report Questions Impact of Exercising March-In Rights for Drug Pricing
JONES DAY TALKS®: The CNPV Pilot Program – FDA’s High-Speed Lane for Drug Approval
2025 Securities Litigation Year in Review
Federal Court Rules that a Defendant's Communications With Generative AI are Not Privileged
EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 125
HHS Signals Policy Direction to Accelerate Adoption of AI in Clinical Care
Vital Signs: Digital Health Law Update | Winter 2026
EMA and FDA Align on Good AI Practice in Drug Development
False Claims Act Recoveries Reach Record $6.8 Billion in Fiscal Year 2025
A Relaxing 2026? FDA Updates General Wellness and Clinical Decision Support Software Guidance
EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 124
CMS Proposes MFN Drug Pricing Strategy for Mandatory GLOBE and GUARD Models
NEWSWORTHY
Sanofi sells generic business Medley to EMS
LymphaTech acquired by Tactile Systems Technology
Riverside acquires Western Botanicals
Tiger BioSciences acquires advanced wound care technology from Bahai Medical
Bristol Myers Squibb acquires Orbital Therapeutics
Anteris Technologies completes $230 million public offering of Common Stock
Axion Biosystems acquires CytoTronics, Inc.
PRP Diagnostic Imaging (PRP) acquires GXU Radiology Specialists