Summary:
La législation actuelle sur l’intelligence artificielle (IA) dans le domaine des sciences de la vie se concentre sur la nécessité d’une contribution humaine substantielle pour que les inventions assistées par IA soient éligibles à la protection par brevet aux États-Unis. Cette exigence redéfinie soulève des questions sur la propriété intellectuelle et l’inventivité dans un contexte d’innovation rapide, nécessitant des démarches proactives pour évaluer le statut d’inventeur des créations issues de l’IA.
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**Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025**
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional “human inventorship” requirement for U.S. patents. Recent guidance from the USPTO clarifies that a substantial human contribution is required for AI-assisted inventions to be eligible for patent protection. This article explores the implications, highlighting the need for proactive inventorship inquiries to navigate the complexities of AI-driven innovation.
**Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals**
Multiple pharmaceutical manufacturers have challenged the Inflation Reduction Act’s so-called Drug Price Negotiation Program, alleging constitutional and Administrative Procedure Act violations. As appellate courts prepare to rule, these cases could reshape Medicare’s pricing power and the government’s ability to impose conditions on federal spending programs, with potential Supreme Court involvement looming.
**State Attorneys General Increasing Oversight and Focus on Private Equity in Health Care Industry**
State attorneys general are ramping up oversight of private equity investments in health care, with new legislation across several states creating a greater role for AGs to review, and in some cases approve, such investments. Several other states have proposed legislation to further strengthen existing “corporate practice of medicine” prohibitions limiting control and direction of various activities, including non-clinical functions, by entities not owned or controlled by licensed health providers (forestalling traditional PE-backed structures).
**EU Markets Become More Accessible to Small and Medium-Sized Enterprises Thanks to Changes to the EU Prospectus Regulation: A Welcome Development for Companies Active in the Medical Sector**
The EU Listing Act introduces significant changes to the EU Prospectus Regulation, easing market access for small and medium-sized enterprises, including biotech and med-tech. Key updates include higher dilution thresholds, new exemptions, simplified prospectus requirements, and improved IPO conditions, enhancing funding opportunities and reducing administrative burdens.
**Earnouts in M&A Transactions: Recent Decisions From Delaware**
In 2024, Delaware courts issued multiple instructive decisions on earnout provisions in life sciences M&A transactions. These decisions highlight the importance of drafting clear and precise earnout provisions in M&A transactions, assessing whether a party can consider its own self-interest in satisfying any commercially reasonable efforts or similar obligation, maintaining clear and thorough records supporting actions taken with respect to programs subject to earnouts, and proactively considering how dispute resolution procedures and fee-shifting provisions in transaction documents may impact post-closing disputes.
**EXECUTIVE ORDERS AND POLICY UPDATES**
Since President Trump’s inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era initiatives on health care access and equity, withdrawing from the World Health Organization, reducing indirect costs for NIH grants, and suspending foreign aid.
**RELEVANT RESOURCES**
– Copyrightability of AI Outputs: U.S. Copyright Office Analyzes Human Authorship Requirement
– FDA’s Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
– FDA’s Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications
– President Trump Pauses DOJ FCPA Enforcement and Orders Preparation of New Enforcement Guideline
– EU Geopolitical Risk Update – Key Policy & Regulatory Developments No. 119
– DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations
– China Unveils New Anti-Monopoly Guidelines for the Pharmaceutical Sector
– CMS’s New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
– China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry
– CMS Finalizes the Increasing Organ Transplant Access Model
– Immigration Enforcement Directives Create New Hurdles for Hospitals Advancing Standard Patient Care
– The Year in Bankruptcy: 2024
– EU Geopolitical Risk Update – Key Policy & Regulatory Developments No. 118
– FDA’s Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
– FDA’s Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications
– Vital Signs: Digital Health Law Update | Fall-Winter 2024
– Business Restructuring Review Vol. 23 No. 6 | November–December 2024
– New Year, New Illinois Employment Laws
**DISCLAIMER:** Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.