ISSUES AND UPDATES
Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions
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.
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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.
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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).
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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.
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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.
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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.
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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
NEWSWORTHY
- Jones Day Lawyers and Practices Earn Top Rankings inChambers France2025
- Jones Day Lawyers and Practices Earn Top Rankings inChambers Greater China
- Sage Revell to Join Jones Day in London as Partner in Corporate Practice
- Jones Day Announces Leadership Appointments for Antitrust, Litigation, Latin America, Brussels, Houston, and San Diego
- Michiel Huizinga and Pierre-Olivier Mahieu Join Jones Day as Partners in Corporate Practice
- Former IRS Trial Attorney Michael Coravos Joins Jones Day in Boston
- Jones Day to Host Reception During 43rd Annual J.P. Morgan Healthcare Conference
- Jones Day Partner Eric Tung Named toLos Angeles Business Journal's list of "Leaders of Influence: Thriving in Their Forties"Leading Jones Day Lawyers and Practices Ranked inChambers Asia-Pacific
- Jones Day Names 37 New Partners
LAWYER SPOTLIGHT
Ted Powers
Ted Powers, partner in Jones Day's New York Office, represents private equity and other sponsors, acquirers, targets, and financial advisors in multibillion dollar global mergers and acquisitions, divestitures, equity and debt investments, and joint ventures. He also advises management and boards of directors on strategic and governance matters. Ted's practice spans multiple industries, including technology, life sciences, energy, financial services, and industrials. Click here to watch as Ted explains more about his practice.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
